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详情 详情 版本年份 2020 日期 发布: 2020年9月28日 文本类型 实施规则/实施细则 主题 商标, 植物品种保护, 工业品外观设计, 专利(发明), 版权与相关权利(邻接权) The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 entered into force immediately before IP completion day; except Parts 7 and 8 which entered into force on IP completion day (see its regulation 1(2) under Chapter 1).

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主要文本 主要文本 英语 The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050)        
 The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

This Statutory Instrument has been printed to correct errors in S.I. 2019/269, S.I. 2019/605, S.I. 2019/638 and S.I. 2019/801 and is being issued free of charge to all known recipients of those Statutory Instruments.

STATUTORY INSTRUMENTS

2020 No. 1050

EXITING THE EUROPEAN UNION INTELLECTUAL PROPERTY

The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020

Made - - - - 28th September 2020

Coming into force in accordance with regulation 1(2)

The Secretary of State makes these Regulations in exercise of the powers conferred by sections 8(1), 8B(1)(a) and 8B(2)(a)(1) of, and paragraph 1 of Schedule 4 and paragraph 21(b) of Schedule 7 to, the European Union (Withdrawal) Act 2018(2) and by section 36 of the Registered Designs Act 1949(3) and by section 78 of the Trade Marks Act 1994(4) and with the consent of the Treasury. In accordance with paragraphs 1(1) and 12(1) of Schedule 7 to the European Union (Withdrawal) Act 2018, a draft of this instrument has been laid before Parliament and approved by resolution of each House of Parliament.

PART 1 Introduction

Citation, commencement and interpretation

1.—(1) These Regulations may be cited as the Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020.

(2) These Regulations come into force immediately before IP completion day except Parts 7 and 8 which come into force on IP completion day.

(1) Section 8B was inserted by section 18 of the European Union (Withdrawal Agreement) Act 2020 c. 1. (2) 2018 c. 16. Section 8 is amended by section 27 of the European Union (Withdrawal Agreement) Act 2020 c. 1. (3) 1949 c. 88. (4) 1994 c. 26.

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(3) In these Regulations— “1949 Act” means the Registered Designs Act 1949; “1994 Act” means the Trade Marks Act 1994; “2005 Regulations” means the Community Design Regulations 2005(5); “Design Regulation” means Council Regulation (EC) No 6/2002 of 12th December 2001 on Community Designs(6) as amended by Council Regulation (EC) No 1891/2006 of 18th December 2006 to give effect to the accession of the European Community to the Geneva Act of the Hague Agreement concerning the international registration of industrial designs and by the Decision of the European Union of 5th December 2011 on the admission of the Republic of Croatia to the European Union(7); and “Registered Designs Rules” means the Registered Designs Rules 2006(8).

PART 2 Amendments to the Intellectual Property (Copyright and

Related Rights) (Amendment) (EU Exit) Regulations 2019 2. The Intellectual Property (Copyright and Related Rights) (Amendment) (EU Exit) Regulations

2019(9) are amended in accordance with this Part.

3. For regulation 31(a) substitute— “(a) in paragraph (3)—

(i) in sub-paragraph (a) omit “and the relevant database maintained by the Office for Harmonization in the Internal Market; and”;

(ii) omit sub-paragraph (b);”.

4. In regulation 38, for “exit day” substitute “IP completion day”.

PART 3 Amendments to the Intellectual Property

(Exhaustion of Rights) (EU Exit) Regulations 2019 5. The Intellectual Property (Exhaustion of Rights) (EU Exit) Regulations 2019(10) are amended

in accordance with this Part.

6. In regulation 2(1) for “exit day”, in each place it occurs, substitute “IP completion day”.

(5) S.I. 2005/2339, amended by S.I. 2006/1028, 2007/3378, 2011/1043 and 2014/2400 and the Intellectual Property (Unjustified Threats) Act 2017, c. 14.

(6) OJ L3, 5.1.2002, p.1. (7) OJ L386, 29.12.2006, p.14. (8) S.I. 2006/1975, as amended by S.I. 2008/2683, 2009/546, 2013/444 and 2014/2405. (9) S.I. 2019/605. (10) S.I. 2019/265.

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PART 4 Amendments to the Trade Marks (Amendment etc.) (EU Exit) Regulations 2019

7. The Trade Marks (Amendment etc.) (EU Exit) Regulations 2019(11) are amended in accordance with this Part.

8. In regulation 2, for “exit day”, in both places it occurs, substitute “IP completion day”.

9. Schedule 1 (Amendments to the 1994 Act to make provision for certain trade marks registered as European Union trade marks to be treated as registered trade marks and about certain applications for such marks) is amended as follows—

(a) in section 52A of the 1994 Act(12) (to be inserted by paragraph 2), for “exit day”, in both places it occurs, substitute “IP completion day”;

(b) in Schedule 2A to the 1994 Act (to be inserted by paragraph 3)— (i) for “exit day”, in each place it occurs, substitute “IP completion day”;

(ii) after paragraph 21, insert—

Existing EUTM: effect of invalidity or revocation

21A.—(1) This paragraph applies where, on IP completion day, an existing EUTM is the subject of proceedings under Article 58 (Grounds for revocation), 59 (Absolute grounds for invalidity) or 60 (Relative grounds for invalidity) which have been instituted but not finally determined before IP completion day (“cancellation proceedings”).

(2) Subject to sub-paragraph (4), where— (a) the existing EUTM is revoked or declared invalid (whether wholly

or partially) pursuant to a decision in the cancellation proceedings which is finally determined, and

(b) the registrar has— (i) received notice of the situation referred to in paragraph (a) (“a

cancellation notice”), or (ii) otherwise become aware of the situation referred to in

paragraph (a), the registration of the comparable trade mark (EU) which derives from the existing EUTM must be revoked or declared invalid to the same extent as the existing EUTM.

(3) Where (by virtue of sub-paragraph (2)) the registration of a comparable trade mark (EU) is revoked or declared invalid to any extent, the registrar must—

(a) remove the comparable trade mark (EU) from the register (where the revocation or declaration of invalidity relates to all the goods or services for which the existing EUTM was registered); or

(b) amend the entry in the register listing the goods or services for which the comparable trade mark (EU) is registered (where the revocation or declaration of invalidity relates to only some of the goods or services for which the existing EUTM was registered).

(11) S.I. 2019/269. (12) 1994 c. 26.

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(4) The registration of a comparable trade mark (EU) must not be revoked or declared invalid under sub-paragraph (2) where the grounds on which the existing EUTM was revoked or declared invalid (whether wholly or partially) would not apply or would not have been satisfied in relation to the comparable trade mark (EU)—

(a) if the comparable trade mark (EU) had existed as at the date the cancellation proceedings were instituted, and

(b) an application for the revocation or a declaration of invalidity of the comparable trade mark (EU) based on those grounds had been made on that date under section 46 or 47 (as the case may be).

(5) Where a comparable trade mark (EU) is revoked or declared invalid to any extent pursuant to this paragraph—

(a) the rights of the proprietor are deemed to have ceased to that extent as from the date on which the rights of the proprietor of the existing EUTM are deemed to have ceased under the EUTM Regulation;

(b) subject to any claim for compensation for damage caused by negligence or lack of good faith on the part of the proprietor or a claim for restitution based upon the unjust enrichment of the proprietor, the revocation or invalidity of the comparable trade mark (EU) does not affect—

(i) a decision arising from infringement proceedings which has been finally determined and which has been enforced prior to the date on which the entry in the register of the comparable trade mark (EU) has been removed or amended pursuant to sub-paragraph (3) (“the decision date”);

(ii) any contract entered into prior to the decision date to the extent that it has been performed prior to the decision date, subject to the right of a party to the contract to claim the repayment of any consideration paid under the contract where, having regard to the circumstances, it is fair and equitable for such repayment to be made.

(6) A cancellation notice may be submitted to the registrar by any person. (7) For the purposes of this paragraph—

(a) proceedings are instituted if an application or counterclaim for revocation or for a declaration of invalidity—

(i) has been filed (and not subsequently withdrawn) with the European Union Intellectual Property Office or a court designated for the purposes of Article 123, and

(ii) meets the requirements for being accorded a filing date under the European Union Trade Mark Regulation and Commission Delegated Regulation (EU) 2018/625 of 5th March 2018;

(b) a decision is finally determined when— (i) it has been determined, and

(ii) there is no further possibility of the determination being varied or set aside (disregarding any power to grant permission to appeal out of time).”.

10. Schedule 3 (Other amendments to the 1994 Act) is amended as follows—

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(a) for paragraph 2(4) substitute— “(4) In subsection (4B)—

(a) in paragraph (a) for “provision of EU law” substitute “enactment or rule of law”;

(b) in paragraph (b) for “EU” substitute “United Kingdom”.”; (b) in paragraph 4(5)(a), for “exit day” substitute “IP completion day”; (c) in paragraph 10, for “exit day” substitute “IP completion day”.

11. Schedule 4 (Amendments to the Rules) is amended as follows— (a) for paragraph 6 substitute—

6.—(1) Rule 11 is amended as follows. (2) At the end of paragraph (1)(d), omit “.” and substitute “;”. (3) After paragraph (1)(d) insert—

“(e) a proprietor of a comparable trade mark (EU) who sends a derogation notice to the registrar under rule 43A.”.

(4) In paragraph (4), for “another EEA state” substitute “an EEA state”.”. (b) after paragraph 6 insert—

6A.—(1) Rule 12 is amended as follows. (2) At the end of paragraph (4)(d), omit “.” and substitute “;”. (3) After paragraph (4)(d), insert—

“(e) in the case of the proprietor who sends a derogation notice to the registrar, the registrar must proceed as if the proprietor had not sent a derogation notice.”.”.

(c) after paragraph 10 insert—

10A.—(1) Rule 43 is amended as follows. (2) At the end of paragraph (1)(b), omit “, or” and substitute “;”. (3) At the end of paragraph (1)(c), omit “,” and substitute “; or”. (4) After paragraph (1)(c), insert—

“(d) the registration of a comparable trade mark (EU) is revoked or declared invalid to any extent under rule 43A(6),”.

(5) In paragraph (2), after “application and shall” insert “, in the cases referred to in paragraph (1)(a) to (c),”.

(6) In paragraph (3)— (a) after “TM8” insert “or the derogation notice”; (b) after “TM26(O)” omit “or” and substitute “,”; (c) after “TM 26(I)” insert “or notification from the registrar under rule 43(4)(b)

that the comparable trade mark (EU) will be revoked or declared invalid to the same extent as the corresponding EUTM”.

10B. After rule 43 insert—

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Invalidation or revocation of Existing EUTM: Cancellation notice and procedure on application for derogation; Schedule 2A paragraph 21A

43A.—(1) A cancellation notice under paragraph 21A of Schedule 2A must—

(a) identify the existing EUTM by the number under which the existing EUTM was registered in the EUTM Register immediately before IP completion day, together with a representation of the mark,

(b) include the following details with regard to the decision pursuant to which the existing EUTM was revoked or declared invalid (whether wholly or partially)—

(i) the date of the decision (including any decision determined on appeal),

(ii) whether the revocation or declaration of invalidity related to all or part of the goods or services for which the existing EUTM was registered,

(iii) where the existing EUTM was revoked (whether wholly or partially) the date on which the revocation took effect,

(c) be accompanied by a copy of the decision (including any decision determined on appeal) pursuant to which the existing EUTM was revoked or declared to be invalid, and

(d) include a statement confirming that the decision pursuant to which the existing EUTM was revoked or declared invalid (whether wholly or partially) has been finally determined.

(2) Where a cancellation notice is submitted to the registrar by the proprietor of the comparable trade mark (EU) which derives from the existing EUTM, the cancellation notice must be accompanied by—

(a) a notice (a “derogation notice”) in writing to the registrar that, based upon the provisions in paragraph 21A(4) of Schedule 2A, the comparable trade mark (EU) should not be revoked or declared invalid (whether wholly or partially), and

(b) a statement of the reasons why paragraph 21A(4) of Schedule 2A applies (a “statement”) together with relevant supporting evidence (“supporting evidence”).

(3) Where the proprietor of a comparable trade mark (EU) submits a cancellation notice to the registrar but fails to send a derogation notice, a statement or supporting evidence, the registration of the comparable trade mark (EU) which derives from the existing EUTM identified in the cancellation notice must be revoked or declared invalid to the same extent as the existing EUTM, unless the registrar directs otherwise.

(4) Where the registrar receives a cancellation notice submitted by a person other than the proprietor of the comparable trade mark (EU) which derives from the existing EUTM, the registrar must as soon as reasonably practicable after receipt of the cancellation notice—

(a) send a copy of the cancellation notice to the proprietor of the comparable trade mark (EU) which derives from the existing EUTM identified in the cancellation notice, and

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(b) notify the proprietor of the comparable trade mark (EU) which derives from the existing EUTM that based upon the revocation or declaration of invalidity of the existing EUTM, the comparable trade mark (EU) will be revoked or declared invalid to the same extent as the corresponding EUTM.

(5) Where the registrar has become aware of the situation referred to in paragraph 21A(2)(a) of Schedule 2A otherwise than by a cancellation notice, the registrar must as soon as reasonably practicable after becoming aware of that situation, notify the proprietor of the comparable trade mark (EU) which derives from the existing EUTM in the terms provided in paragraph (4)(b).

(6) The proprietor of a comparable trade mark (EU) referred to in paragraph (4) and (5) must, within such period of not less than one month as may be specified in the notice referred to in paragraph (4)(b) and (5), send to the registrar a derogation notice accompanied by a statement and supporting evidence as referred to in paragraph (2), failing which the registration of the comparable trade mark (EU) must be revoked or declared invalid to the same extent as the corresponding EUTM, unless the registrar directs otherwise.

(7) The registrar must, in reaching a decision as to whether paragraph 21A(4) of Schedule 2A applies to a comparable trade mark (EU), have regard to the statement and supporting evidence filed by the proprietor of the comparable trade mark (EU) and must send written notice of the decision to the proprietor, stating the reasons for that decision.

(8) For the purposes of any appeal against a decision referred to in sub- paragraph (7), the date on which the notice is sent must be taken to be the date of the decision.

(d) in rule 47(n) (to be inserted by paragraph 11(6)), after “corresponding EUTM” insert “, and where the corresponding EUTM is subject to cancellation proceedings, that cancellation is pending”.

12. In Schedule 5 (Consequential amendments, repeals, revocations, transitional and saving provisions), in paragraph 6, in column 2 of the first entry in the Table, for “Schedule 12” substitute “Schedule 21”.

PART 5 Amendments to the Designs and International Trade

Marks (Amendment etc.) (EU Exit) Regulations 2019 13. The Designs and International Trade Marks (Amendment etc.) (EU Exit) Regulations

2019(13) are amended in accordance with this Part.

14. In the heading to regulation 4 and in regulation 4(1), for “exit day”, in each place it occurs, substitute “IP completion day”.

15. In regulation 5, for “exit day”, in each place it occurs, substitute “IP completion day”.

16. In regulation 6, for “exit day”, in both places it occurs, substitute “IP completion day”.

17. Schedule 1, Part 1 (Design Regulation and supplementary unregistered designs) is amended as follows—

(13) S.I. 2019/638. 7

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(a) in Article 1(3) of the Design Regulation (as substituted by paragraph 2), for “exit day” substitute “IP completion day”;

(b) in Article 7 of the Design Regulation (as substituted by paragraph 8), for “exit day”, in both places it occurs, substitute “IP completion day”;

(c) for paragraph 19(b) substitute— “(b) for “Community”, in the third place it appears, substitute “United Kingdom

or the European Economic Area”.”; (d) in paragraph 27(b), for “placee” substitute “place”; (e) in Article 81(2)(d) (as substituted by paragraph 29), omit “a continuing”.

18. In Schedule 1, Part 2 (2005 Regulations and the supplementary unregistered design right), in regulation 4(3) of the 2005 Regulations (as substituted by paragraph 63(b)), for “exit day” substitute “IP completion day”.

19. Schedule 2, Part 1 (Design Regulation and continuing unregistered Community designs) is amended as follows—

(a) in paragraph 5, for “exit day” substitute “IP completion day”; (b) in Article 81(2) of the Design Regulation (as substituted by paragraph 29)—

(i) in sub-paragraphs (a) to (c)— (aa) for “supplementary”, in each place it occurs, substitute “continuing”; (bb) after “unregistered”, insert “Community”;

(ii) in sub-paragraph (d)— (aa) omit “a supplementary”; (bb) after “unregistered”, insert “Community”;

(c) in Articles 82 and 83 of the Design Regulation (as substituted by paragraph 30), for “exit day”, in each place it occurs, substitute “IP completion day”.

20. In Schedule 2, Part 2 (2005 Regulations and continuing unregistered Community designs), in regulation 4(3)(a) of the 2005 Regulations (as substituted by paragraph 58(b)), for “exit day” substitute “IP completion day”.

21. Schedule 3 (Amendments to the 1949 Act to make provision for certain registered Community designs and International designs to be treated as registered under the 1949 Act from exit day and about certain applications for registered Community designs made before exit day) is amended as follows—

(a) in the heading, for “exit day”, in both places it occurs, substitute “IP completion day”; (b) in sections 12A and 12B of the 1949 Act (as prospectively inserted by paragraph 2), for

“exit day”, in each place it occurs, substitute “IP completion day”; (c) in Schedule 1A to the 1949 Act (as prospectively inserted by paragraph 3)—

(i) for “exit day”, in each place it occurs, substitute “IP completion day”; (ii) after paragraph 9 insert—

Existing registered Community design: effect of invalidity

9A.—(1) This paragraph applies where, on IP completion day, an existing registered Community design is the subject of proceedings under Article 25 (Grounds for invalidity) which have been instituted but not finally determined before IP completion day (“invalidation proceedings”).

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(2) Subject to sub-paragraph (4) where— (a) the existing registered Community design is declared invalid

(whether wholly or partly) pursuant to a decision which is finally determined, and

(b) the registrar has either— (i) received notice of the situation referred to in paragraph (a) (“an

invalidation notice”), or (ii) otherwise become aware of the situation referred to in

paragraph (a), the registration of the re-registered design which derives from the existing registered Community design must be declared invalid to the same extent as the existing registered Community design.

(3) Where (by virtue of sub-paragraph (2)) the registration of a re-registered design is declared invalid, the registrar must—

(a) where there is a partial declaration of invalidity, amend the entry in the register of designs;

(b) otherwise, remove the re-registered design from the register. (4) The registration of a re-registered design must not be declared invalid

under sub-paragraph (2) where the grounds on which the existing registered Community design was declared invalid (whether wholly or partly) would not apply or would not have been satisfied in relation to the re-registered Community design if—

(a) the re-registered design had been the subject of an entry on the register as at the date the invalidation proceedings were instituted, and

(b) an application for a declaration of invalidity of the re-registered design based on those grounds had been made on that date under section 11ZA.

(5) Where the registration of a re-registered design is declared invalid to any extent pursuant to this paragraph—

(a) it shall to that extent be treated as having been invalid from the date on which the rights of the proprietor of the existing registered Community design from which it derives are deemed to have ceased under the Community Design Regulation;

(b) subject to any claim for compensation for damage caused by negligence or lack of good faith on the part of the proprietor or a claim for restitution based upon the unjust enrichment of the proprietor, the invalidity of the registration of the re-registered design does not affect—

(i) a decision arising from infringement proceedings which has been finally determined and which has been enforced prior to the date of the declaration of invalidity made pursuant to sub- paragraph (2) (“the invalidity declaration date”);

(ii) any contract entered into prior to the invalidity declaration date to the extent that it has been performed prior to that date, subject to the right of a party to the contract to claim the repayment of any consideration paid under the contract where,

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having regard to the circumstances, it is fair and equitable for such repayment to be made.

(6) Where a declaration is made under sub-paragraph (2), section 11ZE(2) does not apply.

(7) An invalidation notice may be sent by any person. (8) For the purposes of this paragraph—

(a) proceedings are instituted if an application or counterclaim for a declaration of invalidity—

(i) has been filed (and not subsequently withdrawn) with the European Union Intellectual Property Office or a court designated for the purposes of Article 80, and

(ii) meets the requirements for being accorded a filing date under the Community Design Regulation and Commision Regulation (EC) No 2245/2002 of 21 October 2002;

(b) a decision is finally determined when— (i) it has been determined; and

(ii) there is no further possibility of the determination being varied or set aside (disregarding any power to grant permission to appeal out of time).

(9) An appeal lies from a declaration of invalidity under sub- paragraph (2).”;

(d) in Schedule 1B to the 1949 Act (as prospectively inserted by paragraph 3)— (i) for “exit day”, in each place it occurs, substitute “IP completion day”;

(ii) in the heading to paragraph 7, omit “registered” the first time it occurs.

22. Schedule 4 (Amendments to the 1994 Act to make provision for certain international trade marks protected in the European Union to be treated as registered trade marks and about certain applications for such marks and transformation applications) is amended as follows—

(a) in section 54A of the 1994 Act (as prospectively inserted by paragraph 2), for “exit day”, in each place it occurs, substitute “IP completion day”;

(b) in Schedule 2B to the 1994 Act (as prospectively inserted by paragraph 3), for “exit day”, in each place it occurs, substitute “IP completion day”.

23. Schedule 5, Part 1 (Fees payable in respect of a re-registered design or a re-registered international design) is amended as follows—

(a) in paragraph 1(2)— (i) omit “of six months”;

(ii) for “exit day” substitute “IP completion day”; (b) in paragraph 1(3)—

(i) for “ending” substitute “beginning”; (ii) for “exit day” substitute “IP completion day”.

24. Schedule 6 (Amendments to the Registered Designs Rules) is amended as follows— (a) in paragraph 3(a), for “exit day”, in both places it occurs, substitute “IP completion day”; (b) after paragraph 3 insert—

3A. After rule 15 insert—

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Invalidation of existing registered Community design: invalidation notice and procedure on application for derogation; Schedule 1A paragraph 9A

15A.—(1) An invalidation notice under paragraph 9A of Schedule 1A must—

(a) identify the existing registered Community design by the number under which it was registered in the RCD register immediately before IP completion day, together with a representation of the design,

(b) be accompanied by a copy of the decision (including any decision determined on appeal) pursuant to which the existing registered Community design was declared to be invalid, and

(c) include a statement confirming that the decision pursuant to which the registered Community design was declared invalid (whether wholly or partly) has been finally determined.

(2) Where an invalidation notice is sent to the registrar by the proprietor of the re-registered design which derives from the existing registered Community design, the invalidation notice must be accompanied by—

(a) a notice (a “derogation notice”) in writing to the registrar that, based upon the provisions in paragraph 9A(4) of Schedule 1A, the re- registered design should not be declared invalid (whether wholly or partly), and

(b) a statement of the reasons why paragraph 9A of Schedule 1A applies (a “statement”) together with relevant supporting evidence (“supporting evidence”).

(3) Where the proprietor of a re-registered design submits an invalidation notice to the registrar but fails to send a derogation notice, a statement, or supporting evidence, the registration of the re-registered design which derives from the existing registered Community design identified in the invalidation notice must be declared invalid to the same extent as the existing registered Community design, unless the registrar directs otherwise.

(4) Where the registrar has received an invalidation notice from a person other than the proprietor of the re-registered design which derives from the existing registered Community design, the registrar must as soon as reasonably practicable after receipt of the invalidation notice—

(a) send a copy of the invalidation notice to the proprietor of the re-registered design which derives from the existing registered Community design identified in the invalidation notice, and

(b) notify the proprietor of the re-registered design which derives from the existing registered Community design that based upon the declaration of invalidity of the existing registered Community design, the re-registered design will be declared invalid to the same extent as the existing registered Community design from which it derives.

(5) Where the registrar has become aware of the situation referred to in paragraph 9A of Schedule 1A otherwise than by an invalidation notice, the registrar must as soon as reasonably practicable after becoming aware of

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that situation notify the proprietor of the re-registered design which derives from the existing registered Community design in the terms provided in paragraph (4)(b).

(6) The proprietor of the re-registered design referred to in paragraphs (4) and (5) must, within such period of not less than one month as may be specified in the notice referred to in paragraphs (4)(b) and 5, send to the registrar a derogation notice accompanied by a statement and supporting evidence as referred to in paragraph (2), failing which the registration of the re-registered design must be declared invalid to the same extent as the registered Community design from which the re-registered design derives, unless the registrar directs otherwise.

(7) The registrar must, in reaching a decision as to whether paragraph 9A of Schedule 1A applies to a re-registered design, have regard to the statement and supporting evidence filed by the proprietor of the re-registered design and must send written notice of the decision to the proprietor, stating the reasons for that decision.

(8) For the purposes of any appeal against a decision referred to in sub- paragraph (7), the date on which the notice is sent must be taken to be the date of the decision.

(c) in rule 27(e) of the Registered Designs Rules (as prospectively inserted by paragraph 6(b)), for “exit day” substitute “IP completion day”;

(d) for paragraph 8 substitute—

8.—(1) Rule 42 (address for service) is amended as follows. (2) At the end of sub-paragraph (c) omit “, or” and substitute “;”. (3) After sub-paragraph (1)(c) insert—

“(d) a proprietor of a re-registered design who sends a derogation notice to the registrar under rule 15A.”.

(4) In paragraph (4), for “another EEA state” substitute “an EEA state”. ”; (e) after paragraph 8 insert—

9.—(1) Rule 43 (failure to furnish an address for service) is amended as follows. (2) At the end of sub-paragraph 4(c) omit “, or” and substitute “;”. (3) After sub-paragraph (4)(c) insert—

“(d) in the case of a proprietor who sends a derogation notice to the registrar, the registrar must proceed as if the proprietor had not sent a derogation notice.

25. In Schedule 8, Part 1 (Further amendments to the 1949 Act), omit paragraph 7.

PART 6 Amendments to the Patents (Amendment) (EU Exit) Regulations 2019

26. The Patents (Amendment) (EU Exit) Regulations 2019(14) are amended in accordance with this Part.

(14) S.I. 2019/801. 12

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27. For regulation 3(a) and (b), substitute— “(a) in the heading for “EU compulsory”, substitute “Compulsory pharmaceutical”; (b) in subsection (1), for “an “EU compulsory”, substitute “a “compulsory

pharmaceutical”;”.

28. Omit regulation 4.

29. For the definition of “plant breeders’ right” substituted by regulation 7(2)(c), substitute— ““plant breeders’ right” means— (a) any right granted under, or having effect as if granted under, section 3 of the 1997 Act

(including existing rights as defined by section 40(4) of that Act); and (b) any right which by virtue of regulation 3 of the Plant Breeders’ Rights (Amendment

etc.) (EU Exit) Regulations 2019(15) is treated as if it were a plant breeders’ right granted in accordance with the 1997 Act and as if the variety were registered in accordance with regulations under section 18(1)(c) of the 1997 Act;”.

30. Omit regulation 17.

31. In the insertion after paragraph 10 of Regulation (EC) No 1610/96 made by regulation 20(3), for paragraph 12 substitute—

12. ‘court’ means— (a) as respects England and Wales, the High Court; (b) as respects Scotland, the Court of Session; (c) as respects Northern Ireland, the High Court in Northern Ireland.”.

32. Omit regulation 21.

33. In regulation 24(3), in the insertion of paragraph 8(1)(b), for “Part A section 1, points 1 to 7 or Part B, Section 1 points 1 to 5”, substitute “Part A section 1, points 1.1 to 1.7 or Part B, Section 1 points 1.1 to 1.4.3”.

34. In Regulation 52(3) in the insertion after Article 1(e) of Regulation (EC) No 469/2009— (a) for paragraph (g), substitute—

“(g) ‘court’ means— (i) as respects England and Wales, the High Court;

(ii) as respects Scotland, the Court of Session; (iii) as respects Northern Ireland, the High Court in Northern Ireland;” and

(b) in paragraph (j), after “granted” insert “or having effect as if granted”.

35. Omit regulation 53.

36. In regulation 62, omit “before”.

37. In regulation 69, for “exit day” in each place it occurs, substitute “IP completion day”.

(15) S.I. 2019/204. 13

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PART 7 Amendments to the Patents Act 1977

38. The Patents Act 1977(16) is amended as follows.

39. In Schedule A1— (a) in paragraph 1, omit the definition of “Council Regulation”; (b) in paragraph 3(3), for “Article 14(3) fourth indent of the Council Regulation”, substitute

“regulation 20A of the Plant Breeders’ Rights Regulations 1998(17)”; (c) in paragraph 4, for “Article 14(3) third indent of the Council Regulation”, substitute

“section 9(10) of the Plant Varieties Act 1997(18)”.

PART 8 Amendments to Regulation (EC) No 469/2009 and related amendments

Amendments to Regulation (EC) No 469/2009

40. Regulation (EC) No 469/2009(19) of the European Parliament and of the Council of 6th May 2009 concerning the supplementary protection certificate for medicinal products is amended as set out in the Schedule.

Amendment to Regulation (EU) No 2019/933

41.—(1) Regulation (EU) 2019/933 of the European Parliament and of the Council of 20th May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products is amended as follows.

(2) After Article 2 (entry into force), omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”.

Amendment to the Patents Rules 2007

42. In the Patents Rules 2007(20), after rule 116, insert—

Notifications relating to supplementary protection certificates

116A. Notifications under Article 5(2)(b) and (c) of the Medicinal Products Regulation must be made on Patents Form SP5.”.

Transitional provisions

43.—(1) Paragraph (2) applies where, before IP completion day, a product or a medicinal product containing that product, as defined in Article 1 of Regulation EC (No) 469/2009, is marked in accordance with that Regulation with the logo set out in Annex -I of that Regulation.

(2) That product or medicinal product containing that product so marked is not required, after these Regulations come into force, to have the words “UK export” affixed to it.

(16) 1977 c. 37. (17) S.I. 1998/1027. Regulation 20A is prospectively inserted into the1998 Regulations by S.I. 2019/204, reg 17(5). (18) 1997 c. 66. Section 9(10) is prospectively inserted into the 1997 Act by S.I. 2019/204, reg 15(2)(c). (19) OJ L152, 16.6.2009, p.1 amended by Regulation (EU) 2019/933, OJ L153, 11.6.2019, p.1. (20) S.I. 2007/3291, as amended by 2011/2052; there are other amending instruments but none are relevant.

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(3) Paragraph (4) applies where, before IP completion day, a notification is made to the Comptroller-General of Patents, Designs and Trade Marks in the form set out in Annex -Ia of Regulation (EC) No 469/2009.

(4) That notification is to be treated, on and after IP completion day, as a notification made— (a) on Patents Form SP5; and (b) on the same date as the notification made on the form set out in that Annex -Ia.

22nd September 2020

Amanda Solloway Parliamentary Under Secretary

Department for Business, Energy and Industrial Strategy

We consent to the making of these Regulations

28th September 2020

Maggie Throup Rebecca Harris

Two of the Lords Commissioners of Her Majesty’s Treasury

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SCHEDULE Regulation 40

Amendments to Regulation (EC) No 469/2009

Interpretation of Schedule

1. In this Schedule, a reference to an Article, paragraph, point or Annex is to that of Regulation (EC) No 469/2009.

Article 1: definitions

2. In Article 1, in relation to the definition of “maker”— (a) for “Union”, substitute “United Kingdom”; (b) omit “third”; (c) after “countries”, insert “outside the United Kingdom, the Isle of Man and the Member

States of the European Union”; and (d) renumber that definition as paragraph (k) and insert after the definition of “UK

authorisation(21)”.

Article 5: effects of the certificate

3. In Article 5— (a) in paragraph 2(a)—

(i) in point (i)— (aa) omit “third”; and (bb) after “countries”, insert “outside the United Kingdom, the Isle of Man and

the Member States of the European Union”; (ii) in point (ii), for “Union”, substitute “United Kingdom”;

(iii) in point (iii)— (aa) for “Member State of making”, substitute “United Kingdom”; (bb) for “Member States”, substitute “the United Kingdom, the Isle of Man or

one or more Member States of the European Union”; (iv) in point (iv), for “Union”, substitute “United Kingdom”;

(b) in paragraph 2(b)— (i) for “authority” to “take place”, substitute “comptroller”;

(ii) for “that Member State”, substitute “the United Kingdom”; (iii) for “a”, where it appears before the last occurrence of “certificate”, substitute “that”;

(c) in paragraph 2(c), for “authority referred to in Article 9(1)”, substitute “comptroller”; (d) in paragraph 2(d)—

(i) omit “third”; (ii) after “countries”, insert “outside the United Kingdom, the Isle of Man and the

Member States of the European Union”; (iii) for “a logo, in the form set out in Annex -I, is affixed”, substitute “the words ‘UK

export’ are affixed so as to be sufficiently clear and visible to the naked eye”;

(21) The definition of “UK authorisation” is inserted by S.I. 2019/801. 16

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(e) in paragraph 2(e), omit from “and” to the end of the sentence; (f) in paragraph 3, for “Union”, substitute “United Kingdom”; (g) in paragraph 5—

(i) omit point (c); (ii) in point (d), omit from “granted” the first time it appears to “making” the second

time it appears; (iii) in point (e)—

(aa) omit “third”, both times it appears; (bb) after “countries”, insert “outside the United Kingdom, the Isle of Man and

the Member States of the European Union”; (h) in paragraph 6—

(i) for “authority”, substitute “comptroller”; (ii) for “contained in Annex -Ia”, substitute “prescribed by rules made under section 123

of the Patents Act 1977”; (i) in paragraph 7—

(i) omit “third”; (ii) after “country”, the first time it appears, insert “outside the United Kingdom, the Isle

of Man and the Member States of the European Union”; (j) omit paragraph 8, including its footnote; (k) after paragraph 10, insert—

11. The Secretary of State may by regulations make further provision as to the manner and form (including design and colour) of affixing the words “UK export” to the outer packaging of the product, or the medicinal product containing that product, referred to in paragraph 2(a)(i) of this Article, and, where feasible, to its immediate packaging.

12. Those regulations are to be made by statutory instrument which is subject to annulment pursuant to a resolution of either House of Parliament.”.

Article 11: publication

4. In Article 11(4)— (a) for “authority referred to in Article 9(1)”, substitute “comptroller”; (b) for “It”, substitute “The comptroller”.

Article 21a: evaluation

5. Omit Article 21a.

Annex -I and Annex -I: logo and standard form

6. Omit Annex -I and Annex -Ia.

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EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the following statutory instruments (the “existing regulations”) which were made as a consequence of the United Kingdom exiting the European Union:

The Intellectual Property (Exhaustion of Rights) (EU Exit) Regulations 2019 (S.I. 2019/265); The Trade Marks (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/269) (“the Trade Marks Regulations”); The Intellectual Property (Copyright and Related Rights) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/605) (“the Copyright Regulations”); The Designs and International Trade Marks (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/638) (“the Designs Regulations”); and The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801) (“the Patents Regulations”).

These Regulations substitute “IP completion day” for the various references to “exit day” in the existing regulations (“IP completion day” is defined in the European Union (Withdrawal Agreement) Act 2020 (c.1) (“the 2020 Act”) as 11pm on 31st December 2020). This will ensure that the provisions in the existing regulations will take effect by reference to IP completion day rather than exit day. The existing regulations will come into force on IP completion day by operation of paragraph 1 of Schedule 5 to the 2020 Act. These Regulations also amend certain errors contained in the existing regulations. For example, Part 2 corrects an error where a reference to Schedule ZA1 to the Copyright, Designs & Patents Act 1988 had been inadvertently retained in regulation 31(a) of the Copyright Regulations despite its deletion from that Act by another provision of the Copyright Regulations. Part 4 amends the Trade Marks Regulations to make further changes to the Trade Marks Act 1994 (“the 1994 Act”) and the Trade Marks Rules 2008 to implement Article 54(3) of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community signed on 24th January 2020 (“the Withdrawal Agreement”), insofar as it relates to European Union trade marks. The Trade Marks Regulations provide that a European Union trade mark (“an existing EUTM”) which is registered immediately before exit day (now amended to “IP completion day”) is to be treated on and after that day as if it were a trade mark registered under the 1994 Act (“a comparable trade mark (EU)”). New paragraph 21A of Schedule 2A to the 1994 Act applies where on IP completion day an existing EUTM is the subject of revocation or invalidity proceedings, which after IP completion day results in the revocation of or a declaration of invalidity in respect of the existing EUTM. Where the registrar (as defined in the 1994 Act) receives notice or otherwise becomes aware of such revocation or declaration of invalidity, the comparable trade mark (EU) which derives from the existing EUTM must be revoked or declared invalid to the same extent as the existing EUTM and with effect from the same date except where the grounds on which the existing EUTM was revoked or declared invalid would not have applied had the proceedings been brought against the comparable trade mark (EU) under the 1994 Act. New rule 43A of the Trade Marks Rules 2008 (S.I. 2008/1797) sets out the procedural matters which apply where the registrar receives notice or otherwise becomes aware of the revocation of or declaration of invalidity in respect of an existing EUTM.

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Part 5 amends the Designs Regulations to make further changes to the Registered Designs Act 1949 (“the 1949 Act”) and the Registered Designs Rules 2006 to implement Article 54(3) of the Withdrawal Agreement insofar as it relates to registered Community designs. The Designs Regulations provide that a registered Community design (“an existing registered Community design”) which is registered immediately before exit day (now amended to “IP completion day”) is to be treated on and after that day as if it were a design registered under the 1949 Act (“a re- registered design”). New paragraph 9A of Schedule 1A to the 1949 Act applies where on IP completion day an existing registered Community design is the subject of invalidity proceedings, which after IP completion day results in a declaration of invalidity. Where the registrar (as defined in the 1949 Act) receives notice or otherwise becomes aware of such declaration of invalidity, the re-registered design which derives from the existing registered Community design must be declared invalid to the same extent as the existing registered Community design and with effect from the same date, except where the grounds on which the existing registered Community design was declared invalid would not have applied had the proceedings been brought against the re-registered design under the 1949 Act. New rule 15A of the Registered Designs Rules 2006 (S.I. 2006/1975) sets out the procedural matters which apply where the registrar receives notice or otherwise becomes aware of the declaration of invalidity in respect of an existing registered Community design. Part 6 amends the Patents Regulations to correct minor errors, to acknowledge the treatment of Community plant variety rights as plant breeders’ rights by virtue of the Plant Breeders’ Rights (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/204) (“the Plant Breeders’ Regulations”), and to update transitional provisions to refer to IP completion day. Part 7 amends the Patents Act 1977 to replace references to EU law with equivalent domestic legislation, aligning with amendments made by the Plant Breeders’ Regulations. Part 8 and the Schedule relate to supplementary protection certificates for medicinal products and arise out of changes made by Regulation (EU) 2019/933 of the European Parliament and of the Council of 20th May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products. Part 8 amends Regulation 2019/933 and the Patents Rules 2007 (S.I. 2007/3291) and contains transitional provisions. The Schedule amends Regulation (EC) No 469/2009 to address inoperabilities occurring as a result of the aforementioned changes. An impact assessment has not been produced for this instrument as no, or no significant, impact on the private, public and voluntary sectors is foreseen. An explanatory memorandum is available alongside this instrument on the Legislation UK website at www.legislation.gov.uk.

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 The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020

DExEU/EM/7-2018.2 1

EXPLANATORY MEMORANDUM TO

THE INTELLECTUAL PROPERTY (AMENDMENT ETC.) (EU EXIT)

REGULATIONS 2020

2020 No. 1050

1. Introduction

1.1 This explanatory memorandum has been prepared by the Intellectual Property Office

(IPO), an executive agency of the Department for Business, Energy & Industrial

Strategy, and is laid before Parliament by Act.

1.2 This memorandum contains information for the Joint Committee on Statutory

Instruments.

2. Purpose of the instrument

2.1 This instrument amends a number of pieces of intellectual property (IP) legislation

which were made in 2019 in preparation for a potential “no deal” exit from the EU

and the expected retention of EU law as domestic law at that point. This legislation is

listed in paragraph 6.3 and is referred to collectively as “the 2019 Regulations” in this

memorandum.

2.2 As the UK has left the EU under the terms of the Withdrawal Agreement, the retention

of EU law will now take place at the end of the transition period1. The provisions in

this instrument reflect commitments made in the Withdrawal Agreement and ensure

that the retained EU law will continue to function effectively, taking account of the

transition period. They also deal with inoperabilities arising from new EU law which

entered into force during the extended Article 50 period and correct some minor

errors in the 2019 Regulations.

Explanations

What did any relevant EU law do before exit day?

2.3 In brief, and as explained further in paragraphs 7.7, 7.11, 7.15-7.16, and 7.25, the

relevant EU law:

• provided a framework for the EU trade mark;

• established a system of EU-wide registered and unregistered designs;

• provided for a supplementary protection certificate (SPC) system for patented

pharmaceuticals and agrochemicals;

• developed the principle of a regional regime for the exhaustion of IP rights;

and

• established an IP right for databases.

2.4 As set out in more detail in paragraphs 7.8, 7.12, 7.17 and 7.26, these pieces of EU

law were the subject of amendments by the 2019 Regulations, which, amongst other

things:

1 This point in time is defined in s.1A of the European Union (Withdrawal) Act 2018 as “IP completion day”.

DExEU/EM/7-2018.2 2

• created comparable UK intellectual property rights in place of EU trade marks,

registered designs and unregistered designs which would have ceased to have

protection on exit day, including rights which have been protected at an

international level;

• enabled the filing of new UK applications for trade marks and designs where

EU or international applications would have still been pending on exit day

whilst retaining the relevant filing date;

• provided for the continued functioning of the SPC system;

• ensured that goods whose IP rights should be treated as exhausted remain so;

and

• limited eligibility for new database rights to UK nationals while providing for

continued protection of database rights held by EEA individuals and

businesses that were in force on exit day.

2.5 After the 2019 Regulations were made, Regulation (EU) 2019/933 amending

Regulation (EC) No 469/2009 concerning the supplementary protection certificate for

medicinal products2 introduced what is known as the “manufacturing waiver” to the

SPC system. As explained further in paragraph 7.27, this enables third parties to

manufacture SPC-protected products without requiring the consent of the SPC holder,

but only for export outside the EU or for storing in the EU for sale on the EU market

after the SPC has expired. Doing so will not infringe the SPC right.

Why is it being changed?

2.6 The 2019 Regulations do not reflect that there is now a transition period in which EU

law continues to apply in the UK - if they came into force, they would retroactively

make changes as from exit day; 31 January 2020. They also do not address the

commitments made in the Withdrawal Agreement or provide fixes to any

inoperabilities in new EU law which will be retained at the end of the transition

period.

2.7 This last point applies to the manufacturing waiver specifically. The retained EU law

would not be clear on how the waiver would apply in the UK after the transition

period; there would be uncertainty about what actions third parties could take without

infringing the SPC, and without prompting legal action from the rightsholder.

What will it now do?

2.8 For the most part, the changes ensure that the provisions of the 2019 Regulations will

apply with effect from the end of the transition period as opposed to exit day. This

will ensure that, in particular, any EU IP rights arising during that period will be

properly protected in the UK going forward.

2.9 In relation to trade marks and designs, the changes also implement commitments

contained in the Withdrawal Agreement so that, as set out in paragraphs 7.22-7.23,

certain decisions taken by EU bodies or courts on the validity of such rights are

recognised in the UK.

2.10 In relation to the manufacturing waiver, as set out in paragraph 7.29, the retained law

will allow third parties to manufacture SPC-protected products in the UK, without the

2 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2019.153.01.0001.01.ENG

DExEU/EM/7-2018.2 3

rightsholder’s consent, either for export outside of the UK or EU or for stockpiling in

the UK for sale in the UK or EU once the SPC has expired.

3. Matters of special interest to Parliament

Matters of special interest to the Joint Committee on Statutory Instruments

3.1 This instrument corrects several drafting errors identified in the 2019 Regulations. In

particular:

• regulation 3 fixes an error where a reference was retained to a schedule which

was repealed in the same instrument;

• regulation 19(b) corrects a provision where the wrong type of unregistered

design was named;

• regulation 23 fixes an error where the period in which no additional fees are

due for renewing a converted EU registered design was set to expire, rather

than begin, on a specific date; and

• regulation 25 fixes an error where a conflicting amendment was made to the

underlying Act by two different sets of amending regulations.

Other provisions fix typographical errors.

3.2 The Department and the IPO have therefore followed the requirement in paragraph

4.7.6 of Statutory Instrument Practice to consult the SI Registrar, and the free issue

procedure has been applied because of the length and mix of the new and correcting

provisions.

Matters relevant to Standing Orders Nos. 83P and 83T of the Standing Orders of the House

of Commons relating to Public Business (English Votes for English Laws)

3.3 The territorial application of this instrument includes Scotland and Northern Ireland.

3.4 The powers under which this instrument is made cover the entire United Kingdom

(see section 24(1) of the European Union (Withdrawal) Act 2018) and the territorial

application of this instrument is not limited either by the Act or by the instrument.

4. Extent and Territorial Application

4.1 The territorial extent of this instrument is all of the United Kingdom.

4.2 The territorial application of this instrument is to all of the United Kingdom.

5. European Convention on Human Rights

5.1 The Parliamentary Under Secretary of State (Minister for Science, Research and

Innovation), Amanda Solloway MP, has made the following statement regarding

Human Rights:

“In my view the provisions of the Intellectual Property (Amendment etc.) (EU Exit)

Regulations 2020 are compatible with the Convention rights.”

6. Legislative Context

6.1 These regulations are made primarily under section 8 of the European Union

(Withdrawal) Act 2018 (EUWA). This allows a Minister to make regulations to

resolve any deficiencies in law that arise as a result of the UK’s departure from the

European Union, including in EU law which continues to form part of domestic law at

DExEU/EM/7-2018.2 4

the end of the transition period under section 2 and 3 of the EUWA (namely the

saving of EU-derived domestic legislation and the incorporation of direct EU

legislation) and under section 4 (which relates to certain enforceable EU rights).

6.2 The European Union (Withdrawal Agreement) Act 2020 (WAA) amended the powers

in section 8 EUWA to include the ability to deal with any deficiencies in law which

arise as a result of the transition period. It also added section 8B, which allows a

Minister to make regulations to implement the provisions set out in Part 3 of the

Withdrawal Agreement. These Regulations are also made under section 8B.

6.3 As part of the Government’s legislative programme to prepare for a “no deal”

outcome, five statutory instruments relating to intellectual property were laid before

Parliament in 2019 and approved (the 2019 Regulations)3. These instruments, which

relied upon the power in section 8 EUWA, are:

• The Intellectual Property (Exhaustion of Rights) (EU Exit) Regulations 2019

(SI 2019/265; “the Exhaustion Regulations”),

• The Trade Marks (Amendment etc.) (EU Exit) Regulations 2019 (SI

2019/269; “the Trade Mark Regulations”),

• The Intellectual Property (Copyright and Related Rights) (Amendment) (EU

Exit) Regulations 2019 (SI 2019/605; “the Copyright Regulations”),

• The Designs and International Trade Marks (Amendment etc.) (EU Exit)

Regulations 2019 (SI 2019/638; “the Designs Regulations”), and

• The Patents (Amendment) (EU Exit) Regulations 2019 (SI 2019/801; “the

Patents Regulations”).

6.4 Parts 1 to 6 of these Regulations amend each of these instruments, whilst Parts 7 and 8

make new changes to the Patents Act 1977 and Regulation 469/2009.

7. Policy background

What is being done and why?

7.1 The UK has left the EU under the terms of the Withdrawal Agreement, and there is

now a transition period until the end of 2020 while the UK and EU negotiate

additional arrangements. The current rules on trade, travel, and business for the UK

and EU continue to apply during the transition period.

7.2 The 2019 Regulations were drafted and designed to function in the event that the UK

left the EU without an agreement being reached by exit day. They do not reflect the

legal situation that now exists following the UK’s entry into the Withdrawal

Agreement. This instrument is needed to ensure that the law properly reflects the

obligations in the Withdrawal Agreement, and to ensure that it otherwise works

effectively at the end of the transition period.

7.3 Because the 2019 Regulations take a similar approach to the arrangements set out in

the Withdrawal Agreement, the legislative gap between the two is minimal. This

instrument will ensure that the arrangements set out in the Withdrawal Agreement are

fully implemented.

3 An additional instrument, the Design Right (Semiconductor Topographies) (Amendment) (EU Exit)

Regulations 2018 (SI 2018/1052), was made in 2018, but is not amended by this draft instrument.

DExEU/EM/7-2018.2 5

7.4 As the 2019 Regulations were intended to take effect on exit day, they do not take

account of the transition period, or that EU law now continues to apply until the end

of that period. The WAA has deferred the coming into force of instruments made

under the EUWA, including the 2019 Regulations, by glossing their commencement

provisions so that they refer to IP completion day instead of exit day4. However, this

change does not extend to other references to exit day in the 2019 Regulations (such

as in transitional provisions). If those references are not updated when the 2019

Regulations come into force, the law will be changed retroactively and rights which

currently exist may not be properly recognised.

7.5 In addition, the 2019 Regulations could only operate on the UK and EU law as it

stood at the time they were made. Any new legislation, or any amendment to existing

legislation, since that time needs to be accounted for and, if necessary, any

inoperabilities addressed. As far as possible, the approach remains to ensure that the

law which currently applies in the UK will continue to do so at the end of the

transition period, to ensure continuity and certainty for businesses and rightsholders.

7.6 This instrument covers a number of different IP rights. The specific policy

background to each is explored in more detail in the following sections.

Copyright and database rights

7.7 Database rights are a form of IP protection unique to EU law. They give database

creators the right to prevent others copying or sharing the contents of their databases

where a substantial investment has been made in obtaining, verifying or presenting

the data. The right is automatic and unregistered; however, only databases made by

EEA nationals, residents and businesses are eligible for the right.

7.8 Among other things, the Copyright Regulations amended the retained EU law on

database rights so that only databases created by UK nationals, residents and

businesses will be eligible for the right in the UK after exit day. However, it included

a transitional provision (regulation 38) which ensured that any database rights existing

before exit day would continue to be recognised for the remainder of their duration,

including those made by EEA nationals, residents or businesses.

7.9 Article 58 of the Withdrawal Agreement requires the UK to continue to recognise any

database rights which arose before the end of the transition period. As the Copyright

Regulations only do so for database rights from EEA makers that existed before exit

day, an amendment is needed to ensure any rights arising during the transition period

are properly protected. Regulation 4 does this by changing the provision to cover any

database right existing before IP completion day.

7.10 In addition, regulation 3 corrects an error in the Copyright Regulations in relation to

orphan works (orphan works are copyright works where one or more rightsholders are

unknown or cannot be found). A reference to Schedule ZA1 to the Copyright, Designs

& Patents Act 1988 had been inadvertently retained in regulation 31(a), despite its

deletion from that Act by an earlier provision of the Copyright Regulations.

Exhaustion of rights

7.11 IP rights are said to be “exhausted” if the IP-protected product has been first sold with

the approval of the rightsholder. As a result, the rightsholder cannot use their IP rights

to prevent the product being resold. In the EU, exhaustion occurs if the product is

4 As provided in paragraph 1(1) of schedule 5 to the WAA.

DExEU/EM/7-2018.2 6

lawfully sold anywhere in the EEA; the product can be resold freely within the EEA

and the rightsholder cannot stop it moving between Member States even if they have

IP rights in a particular country. This forms part of the principle of free movement of

goods set out in the EU treaties.

7.12 The Exhaustion Regulations preserved the effect of the EEA exhaustion regime in the

UK by reference to the retention of EU law and enforceable rights in the EUWA on

exit day. This meant that the IP rights of any product lawfully sold in the EEA, either

before or after exit day, would continue to be treated as having been exhausted in the

UK.

7.13 Article 61 of the Withdrawal Agreement commits the UK and the EU to recognise that

any IP rights which are exhausted before the end of the transition period will continue

to be treated as such.

7.14 Regulation 6 replaces references to “exit day” in the Exhaustion Regulations with “IP

completion day”. This ensures that, although any products sold during the transition

period would be correctly treated as exhausted under the existing provision, the rights

which are enforceable are those which are available at the end of the transition period.

This also provides legal certainty.

Trade marks, registered designs and unregistered designs

7.15 Trade marks and designs are intellectual property rights that distinguish the goods or

services from one trader to another, or protect the appearance of a product,

respectively. EU law provides for EU-wide trade marks, registered and unregistered

designs, the first two of which are granted by the EU Intellectual Property Office

(EUIPO). These rights will cease to apply in the UK when it is no longer treated as an

EU Member State, although they continue to have effect during the transition period.

7.16 EU-wide protection of trade marks and registered designs can also be obtained by

applying through the World Intellectual Property Organisation and designating the

territories in which protection is sought. International trade marks and designs

designating the EU will also cease to apply in the UK when it is no longer treated as

an EU Member State.

7.17 The Trade Mark Regulations and the Designs Regulations provided for comparable

rights to be granted under UK law for any EU trade marks or designs, or international

rights designating the EU, that were in force on exit day. They also enabled new UK

applications to be filed where an application for an EU right was pending on exit day,

retaining the original filing date of the EU application.

7.18 Articles 54-57 and 59 of the Withdrawal Agreement require the UK to take these

measures for EU rights in force, and applications pending, at the end of the transition

period. This instrument therefore amends the Trade Mark Regulations and the

Designs Regulations so that the grant of comparable rights and the right to file

replacement applications both operate with effect from IP completion day, rather than

exit day.

7.19 Failing to do so would mean that any EU rights which were granted during the

transition period would not be converted and could potentially be lost - this could be

as many as 200,000 rights.

7.20 The amendments in Parts 4 and 5 make the necessary substitutions.

DExEU/EM/7-2018.2 7

7.21 In addition, some minor errors found in the two sets of regulations have been

corrected. Regulation 19(b) provides a fix so that UK “design courts” correctly have

exclusive jurisdiction over converted EU unregistered designs. Regulation 23 corrects

an error in the Designs Regulations so that the period where no additional fees would

be due on top of the applicable fee to renew a converted EU registered design is

correctly set at six months, instead of one day as originally, inadvertently, drafted.

Regulation 25 corrects a conflict of amendments between the Design Regulations and

the Exhaustion Regulations.

7.22 Third parties can challenge the registration of an EU trade mark or registered design at

the EUIPO, or as a counterclaim in infringement actions heard before courts

designated as EU courts in Member States; the right may be cancelled or reduced in

scope if the challenge is successful. Article 54(3) of the Withdrawal Agreement

requires the UK to honour decisions made by the EUIPO, the CJEU on appeal from

the EUIPO, or Member State courts on cancellation actions which were in progress at

the end of the transition period, and to apply the decision to the comparable UK right.

This means that successful parties will not need to launch a separate cancellation

action in the UK. There is an exception where the grounds for revocation/invalidity

would not apply if considered under UK law.

7.23 Regulations 9(b)(ii) and 11 (for trade marks) and 21(c)(ii) and 24 (for registered

designs) provide for the IPO to take account of cancellation decisions on the EU

rights, to determine if the exception applies based on evidence from the rightsholder,

and to take action on the comparable right. A right of appeal is provided against the

decision of the IPO on whether the exception applies.

Patents and supplementary protection certificates

7.24 A patent protects an invention and lets the owner of that patent take legal action

against anyone who makes, uses, sells or imports that invention without the owner’s

permission – this is known as infringement of the patent. A patent can provide such

protection for up to twenty years.

7.25 Supplementary protection certificates (SPCs) provide a period of additional protection

for patented medicines and agrochemicals, to compensate for the need for lengthy

regulatory approval procedures during the patent lifetime before the product can be

sold and research investment recouped. The SPC gives the approved product the same

rights and protection as the patent, subject to the same limitations, for up to five years

after the patent expires. SPCs are provided by EU Regulations but operate as

individual national rights.

7.26 The Patents Regulations, amongst other things, ensured that the retained EU SPC

Regulations would continue to function as domestic law, replacing references to EU

regulatory legislation with their UK equivalents and ensuring that the method for

calculation of an SPC’s duration would remain the same. The provisions of the

Patents Regulations do not, in general, refer to “exit day”, and so do not need

changing to be able to work correctly when brought into force at the end of the

transition period.

7.27 In July 2019 - during the extended Article 50 period - the EU introduced a new

exception to the rights provided by an SPC. This “manufacturing waiver” allows third

parties to manufacture SPC-protected medicinal products, without needing the

permission of the SPC holder. The product can only be manufactured for export to

countries outside the EU where protection does not exist or has expired, or (in the

DExEU/EM/7-2018.2 8

final 6 months of the SPC term) for storing the product in the Member State of

making (“stockpiling”), ready for sale in the EU when the corresponding SPC expires.

Acts which are necessary for the manufacture of the product, its export or storage, are

also permitted as these too would otherwise infringe the protection provided by the

SPC. The product must be specifically labelled with an “EU export” logo so it can be

identified as having been made under the waiver; this is intended to prevent illicit

diversion of the product back onto the EU market.

7.28 Article 60 of the Withdrawal Agreement requires that any applications for an SPC

which are pending at the end of the transition period should be considered in

accordance with the EU law in force at that time, and any SPC granted based on those

applications should provide for the same level of protection provided for in EU law.

This will now need to include the manufacturing waiver.

7.29 Regulations 40-43 and the accompanying Schedule make additional amendments to

Regulation 469/2009 to fix inoperabilities in the manufacturing waiver legislation and

make consequential amendments to other legislation. These maintain the scope of the

waiver so that third parties can manufacture SPC-protected products in the UK,

without the rightsholder’s consent, either for export outside of the UK or EU or (in the

final 6 months of the SPC term) for stockpiling in the UK for sale in the UK or EU

once the SPC has expired. This means that the scope of the waiver within the UK will

remain essentially unchanged at the end of the transition period.

7.30 Paragraph 3(d) of the Schedule changes the labelling requirement so that the product

must be identified with “UK export” wording; this allows it to be distinguished from

one made in the EU under its waiver. Paragraph 3(k) provides a power to further

regulate the form and manner of that wording by negative statutory instrument, whilst

a transitional provision in regulation 43 ensures that any product which has already

been manufactured under the waiver does not require relabelling. The provision also

preserves the effect of any notification of intention to use the waiver filed before the

end of the transition period; as regulation 42 amends the Patents Rules 2007 to

designate a specific form for such notifications after 1 January 2021.

7.31 Beyond the manufacturing waiver, Article 60 of the Withdrawal Agreement also

applies to applications to extend the duration of an SPC for a medicine which has

been tested for paediatric use; regulation 37 updates transitional provisions in the

Patents Regulations so that they apply to applications pending at the end of the

transition period, as well as extensions already granted.

7.32 In addition, some small changes have been made to other provisions of the Patents

Regulations, to correct minor typographical errors and update cross-references to

other domestic law. Regulation 29 ensures that plant breeders’ rights which have been

converted from Community plant variety rights are able to be cross-licensed.

Regulations 28 and 39 replace a provision which preserved pre-exit day EU

legislation with a cross-reference to equivalent domestic definitions.

8. European Union (Withdrawal) Act/Withdrawal of the United Kingdom from the

European Union

8.1 This instrument is being made using the power in section 8 of the European Union

(Withdrawal) Act 2018 in order to address failures of retained EU law to operate

effectively or other deficiencies arising from the withdrawal of the United Kingdom

from the European Union. The instrument is also made under the powers in section

8B of that Act in order to implement provisions in Part 3 of the Withdrawal

DExEU/EM/7-2018.2 9

Agreement. In accordance with the requirements of that Act the Minister has made the

relevant statements as detailed in Part 2 of the Annex to this Explanatory

Memorandum.

9. Consolidation

9.1 No consolidation of the relevant legislation is planned at present. Informal

consolidated texts of domestic intellectual property legislation are publicly available

for free on the gov.uk website5. The Intellectual Property Office is considering

whether informal consolidation of the retained EU law as amended by this instrument

will be necessary.

10. Consultation outcome

10.1 In relation to the manufacturing waiver, a public call for views was issued, seeking

feedback on draft legislation to fix the inoperabilities in the EU law in the event of a

“no deal” outcome6. The call for views was open from 5 July 2019 to 9 August 2019.

In addition, meetings were held with major representative bodies from the innovative

pharmaceutical industry, the manufacturers of generic pharmaceuticals, and the patent

attorney profession during the period to discuss the proposed draft.

10.2 Six responses were received before the call for views closed, from representative

organizations of rightsholders, pharmaceutical innovators, legal representatives, and

the generics industry. All of the respondents were in favour of ensuring the proper

functioning of the waiver and avoiding legal uncertainty. Most of the respondents

highlighted the importance of preserving the status quo regarding the territory to

which export could take place; the consultation draft would have allowed manufacture

for export to any country outside the UK. Other issues raised included the requirement

for a logo or other indication on the packaging for medicines intended for export and

the need for transitional arrangements.

10.3 In response to the feedback received, the Government made changes to the drafting of

the provisions to maintain the current markets for export and stockpiling, to provide

powers to allow for additional labelling requirements if necessary, and to include

additional transitional arrangements covering use of forms and the use of the pre-

existing labelling requirements on any products manufactured before the end of the

transition period. The drafting was then incorporated into this instrument.

10.4 The Government response to the call for views was published on 13 July 20206;

publication was initially delayed because the ratification of the Withdrawal

Agreement made it necessary to reassess the drafting of both the response and the

legislation itself. The Government’s focus on prioritising communications relating to

coronavirus necessitated a further delay.

10.5 As the other changes were largely technical and minor in nature, in line with Cabinet

Office principles on consultation, a formal public consultation was not considered to

be useful in determining the Government’s approach on drafting. Informal views on

the drafting of those changes were sought from relevant stakeholders; in particular,

the provisions on cancelling trade marks and designs were provided to representative

organisations and key users of the trade mark and design systems for comment and to

5 https://www.gov.uk/topic/intellectual-property/law-practice 6 https://www.gov.uk/government/consultations/supplementary-protection-certificate-waiver-no-deal-legislation

DExEU/EM/7-2018.2 10

familiarise them with the proposed approach. Responses generally approved of the

drafting of the legislation.

11. Guidance

11.1 Guidance was published in January 2020 on the effect of the transition period on

intellectual property rights, how the law will change at the end of that period, and

what preparations businesses may need to make7. The Intellectual Property Office

expects to update that guidance to reflect the contents of this instrument once it has

been approved by Parliament.

12. Impact

12.1 There is no, or no significant, impact on business, charities or voluntary bodies.

12.2 There is no, or no significant, impact on the public sector.

12.3 An Impact Assessment has not been prepared for this instrument because the changes

being made are largely technical in nature. The Government’s assessment is that the

combined policy impacts of this instrument fall below the threshold for a formal

impact assessment; a de minimis assessment has been carried out. The instrument will

update existing EU Exit regulations that were designed for a ‘no deal’ outcome to

account for the transition period and the obligations of the Withdrawal Agreement,

and address inoperabilities in the retained EU SPC Waiver Regulation arising as a

result of EU Exit. In both cases, the changes will ensure that existing legislation

continues to operate in the same way as before. As the status quo is being maintained,

it imposes no new obligations or burdens on private, public or third sector bodies and

does not require re-familiarisation; the changes are therefore not expected to result in

costs for businesses.

12.4 Where this instrument departs from the status quo is in implementing Article 54(3) of

the Withdrawal Agreement, under which the UK is obliged to recognise the outcome

of cancellation proceedings against EU-level registered rights that are underway as of

the end of the transition period. The impact of this is expected to be a small saving for

businesses, as separate cancellation proceedings will not need to be prosecuted in both

territories. This provision is expected to impact only around 1200 registered rights.

13. Regulating small business

13.1 The legislation applies to activities that are undertaken by small businesses.

13.2 No specific action is proposed to minimise regulatory burdens on small businesses.

13.3 The basis for the final decision on what action to take to assist small businesses is that,

as the principal purpose of the instrument is to maintain the status quo, it introduces

no new burdens to small businesses that need to be mitigated.

14. Monitoring & review

14.1 The approach to monitoring of this legislation is to assess the effect of the changes

being made as part of the course of normal departmental business.

14.2 As this instrument is made under the EU Withdrawal Act 2018, no review clause is

required.

7 https://www.gov.uk/government/news/intellectual-property-and-the-transition-period

DExEU/EM/7-2018.2 11

15. Contact

15.1 Michael Warren at the Intellectual Property Office, Telephone: 01633 813988 or

email: Michael.Warren@ipo.gov.uk can be contacted with any queries regarding the

instrument.

15.2 James Porter, Deputy Director at the Intellectual Property Office can confirm that this

Explanatory Memorandum meets the required standard.

15.3 Amanda Solloway MP, Parliamentary Under Secretary of State at the Department for

Business, Energy & Industrial Strategy can confirm that this Explanatory

Memorandum meets the required standard.

DExEU/EM/7-2018.2 12

Annex Statements under the European Union (Withdrawal) Act

2018

Part 1

Table of Statements under the 2018 Act

This table sets out the statements that may be required under the 2018 Act.

Statement Where the requirement sits To whom it applies What it requires

Sifting Paragraphs 3(3), 3(7) and

17(3) and 17(7) of Schedule

7

Ministers of the Crown

exercising sections 8(1), 9 and

23(1) to make a Negative SI

Explain why the instrument should be

subject to the negative procedure and, if

applicable, why they disagree with the

recommendation(s) of the SLSC/Sifting

Committees

Appropriate-

ness

Sub-paragraph (2) of

paragraph 28, Schedule 7

Ministers of the Crown

exercising sections 8(1), 9 and

23(1) or jointly exercising

powers in Schedule 2

A statement that the SI does no more than

is appropriate.

Good Reasons Sub-paragraph (3) of

paragraph 28, Schedule 7

Ministers of the Crown

exercising sections 8(1), 9 and

23(1) or jointly exercising

powers in Schedule 2

Explain the good reasons for making the

instrument and that what is being done is a

reasonable course of action.

Equalities Sub-paragraphs (4) and (5)

of paragraph 28, Schedule 7

Ministers of the Crown

exercising sections 8(1), 9 and

23(1) or jointly exercising

powers in Schedule 2

Explain what, if any, amendment, repeals

or revocations are being made to the

Equalities Acts 2006 and 2010 and

legislation made under them.

State that the Minister has had due regard

to the need to eliminate discrimination and

other conduct prohibited under the

Equality Act 2010.

Explanations Sub-paragraph (6) of

paragraph 28, Schedule 7

Ministers of the Crown

exercising sections 8(1), 9 and

23(1) or jointly exercising

powers in Schedule 2

In addition to the statutory

obligation the Government has

made a political commitment

to include these statements

alongside all EUWA SIs

Explain the instrument, identify the

relevant law before exit day, explain the

instrument’s effect on retained EU law and

give information about the purpose of the

instrument, e.g., whether minor or

technical changes only are intended to the

EU retained law.

DExEU/EM/7-2018.2 13

Criminal

offences

Sub-paragraphs (3) and (7)

of paragraph 28, Schedule 7

Ministers of the Crown

exercising sections 8(1), 9, and

23(1) or jointly exercising

powers in Schedule 2 to create

a criminal offence

Set out the ‘good reasons’ for creating a

criminal offence, and the penalty attached.

Sub-

delegation

Paragraph 30, Schedule 7 Ministers of the Crown

exercising sections 10(1), 12

and part 1 of Schedule 4 to

create a legislative power

exercisable not by a Minister

of the Crown or a Devolved

Authority by Statutory

Instrument.

State why it is appropriate to create such a

sub-delegated power.

Urgency Paragraph 34, Schedule 7 Ministers of the Crown using

the urgent procedure in

paragraphs 4 or 14, Schedule

7.

Statement of the reasons for the Minister’s

opinion that the SI is urgent.

Explanations

where

amending

regulations

under 2(2)

ECA 1972

Paragraph 14, Schedule 8 Anybody making an SI after

exit day under powers outside

the European Union

(Withdrawal) Act 2018 which

modifies subordinate

legislation made under s. 2(2)

ECA

Statement explaining the good reasons for

modifying the instrument made under s.

2(2) ECA, identifying the relevant law

before exit day, and explaining the

instrument’s effect on retained EU law.

Scrutiny

statement

where

amending

regulations

under 2(2)

ECA 1972

Paragraph 15, Schedule 8 Anybody making an SI after

exit day under powers outside

the European Union

(Withdrawal) Act 2018 which

modifies subordinate

legislation made under s. 2(2)

ECA

Statement setting out:

a) the steps which the relevant authority

has taken to make the draft instrument

published in accordance with paragraph

16(2), Schedule 8 available to each House

of Parliament,

b) containing information about the

relevant authority’s response to—

(i) any recommendations made by a

committee of either House of Parliament

about the published draft instrument, and

(ii) any other representations made to the

relevant authority about the published draft

instrument, and,

c) containing any other information that

the relevant authority considers appropriate

in relation to the scrutiny of the instrument

or draft instrument which is to be laid.

DExEU/EM/7-2018.2 14

Part 2

Statements required when using enabling powers

under the European Union (Withdrawal) 2018 Act

1. Appropriateness statement

1.1 The Parliamentary Under Secretary of State (Minister for Science, Research and

Innovation), Amanda Solloway MP, has made the following statement regarding use

of legislative powers in the European Union (Withdrawal) Act 2018:

“In my view the Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020

do no more than is appropriate”.

1.2 This is the case because the changes ensure compliance with the specific provisions of

the Withdrawal Agreement, and only correct deficiencies to the extent necessary to

maintain the continued functioning of the intellectual property system at the end of

the transition period.

2. Good reasons

2.1 The Parliamentary Under Secretary of State (Minister for Science, Research and

Innovation), Amanda Solloway MP, has made the following statement regarding use

of legislative powers in the European Union (Withdrawal) Act 2018:

“In my view there are good reasons for the provisions in this instrument, and I have

concluded they are a reasonable course of action”.

2.2 These are: that it is critical to implement the commitments agreed in the Withdrawal

Agreement and to ensure that EU law retained at the end of the transition period

functions effectively as domestic law.

3. Equalities

3.1 The Parliamentary Under Secretary of State (Minister for Science, Research and

Innovation), Amanda Solloway MP, has made the following statement(s):

“The draft instrument does not amend, repeal or revoke a provision or provisions in

the Equality Act 2006 or the Equality Act 2010 or subordinate legislation made under

those Acts.”.

3.2 The Parliamentary Under Secretary of State (Minister for Science, Research and

Innovation), Amanda Solloway MP, has made the following statement regarding use

of legislative powers in the European Union (Withdrawal) Act 2018:

“In relation to the draft instrument, I, Amanda Solloway have had due regard to the

need to eliminate discrimination, harassment, victimisation and any other conduct that

is prohibited by or under the Equality Act 2010.”.

4. Explanations

4.1 The explanations statement has been made in section 2 of the main body of this

explanatory memorandum.

其他文本 世贸组织通知首页 (3 文本) 世贸组织通知首页 (3 文本) 英语 The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050) 法语 Règlement sur la propriété intellectuelle (modification, etc.) (sortie de l'UE) 2020 (S.I. 2020/1050) 西班牙语 Reglamento de Propiedad Intelectual de 2020 (Modificación, etc.) (Retirada de la UE) (S.I. 2020/1050)
 The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

This Statutory Instrument has been printed to correct errors in S.I. 2019/269, S.I. 2019/605, S.I. 2019/638 and S.I. 2019/801 and is being issued free of charge to all known recipients of those Statutory Instruments.

STATUTORY INSTRUMENTS

2020 No. 1050

EXITING THE EUROPEAN UNION INTELLECTUAL PROPERTY

The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020

Made - - - - 28th September 2020

Coming into force in accordance with regulation 1(2)

The Secretary of State makes these Regulations in exercise of the powers conferred by sections 8(1), 8B(1)(a) and 8B(2)(a)(1) of, and paragraph 1 of Schedule 4 and paragraph 21(b) of Schedule 7 to, the European Union (Withdrawal) Act 2018(2) and by section 36 of the Registered Designs Act 1949(3) and by section 78 of the Trade Marks Act 1994(4) and with the consent of the Treasury. In accordance with paragraphs 1(1) and 12(1) of Schedule 7 to the European Union (Withdrawal) Act 2018, a draft of this instrument has been laid before Parliament and approved by resolution of each House of Parliament.

PART 1 Introduction

Citation, commencement and interpretation

1.—(1) These Regulations may be cited as the Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020.

(2) These Regulations come into force immediately before IP completion day except Parts 7 and 8 which come into force on IP completion day.

(1) Section 8B was inserted by section 18 of the European Union (Withdrawal Agreement) Act 2020 c. 1. (2) 2018 c. 16. Section 8 is amended by section 27 of the European Union (Withdrawal Agreement) Act 2020 c. 1. (3) 1949 c. 88. (4) 1994 c. 26.

Document Generated: 2020-10-01 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

(3) In these Regulations— “1949 Act” means the Registered Designs Act 1949; “1994 Act” means the Trade Marks Act 1994; “2005 Regulations” means the Community Design Regulations 2005(5); “Design Regulation” means Council Regulation (EC) No 6/2002 of 12th December 2001 on Community Designs(6) as amended by Council Regulation (EC) No 1891/2006 of 18th December 2006 to give effect to the accession of the European Community to the Geneva Act of the Hague Agreement concerning the international registration of industrial designs and by the Decision of the European Union of 5th December 2011 on the admission of the Republic of Croatia to the European Union(7); and “Registered Designs Rules” means the Registered Designs Rules 2006(8).

PART 2 Amendments to the Intellectual Property (Copyright and

Related Rights) (Amendment) (EU Exit) Regulations 2019 2. The Intellectual Property (Copyright and Related Rights) (Amendment) (EU Exit) Regulations

2019(9) are amended in accordance with this Part.

3. For regulation 31(a) substitute— “(a) in paragraph (3)—

(i) in sub-paragraph (a) omit “and the relevant database maintained by the Office for Harmonization in the Internal Market; and”;

(ii) omit sub-paragraph (b);”.

4. In regulation 38, for “exit day” substitute “IP completion day”.

PART 3 Amendments to the Intellectual Property

(Exhaustion of Rights) (EU Exit) Regulations 2019 5. The Intellectual Property (Exhaustion of Rights) (EU Exit) Regulations 2019(10) are amended

in accordance with this Part.

6. In regulation 2(1) for “exit day”, in each place it occurs, substitute “IP completion day”.

(5) S.I. 2005/2339, amended by S.I. 2006/1028, 2007/3378, 2011/1043 and 2014/2400 and the Intellectual Property (Unjustified Threats) Act 2017, c. 14.

(6) OJ L3, 5.1.2002, p.1. (7) OJ L386, 29.12.2006, p.14. (8) S.I. 2006/1975, as amended by S.I. 2008/2683, 2009/546, 2013/444 and 2014/2405. (9) S.I. 2019/605. (10) S.I. 2019/265.

2

Document Generated: 2020-10-01 Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

PART 4 Amendments to the Trade Marks (Amendment etc.) (EU Exit) Regulations 2019

7. The Trade Marks (Amendment etc.) (EU Exit) Regulations 2019(11) are amended in accordance with this Part.

8. In regulation 2, for “exit day”, in both places it occurs, substitute “IP completion day”.

9. Schedule 1 (Amendments to the 1994 Act to make provision for certain trade marks registered as European Union trade marks to be treated as registered trade marks and about certain applications for such marks) is amended as follows—

(a) in section 52A of the 1994 Act(12) (to be inserted by paragraph 2), for “exit day”, in both places it occurs, substitute “IP completion day”;

(b) in Schedule 2A to the 1994 Act (to be inserted by paragraph 3)— (i) for “exit day”, in each place it occurs, substitute “IP completion day”;

(ii) after paragraph 21, insert—

Existing EUTM: effect of invalidity or revocation

21A.—(1) This paragraph applies where, on IP completion day, an existing EUTM is the subject of proceedings under Article 58 (Grounds for revocation), 59 (Absolute grounds for invalidity) or 60 (Relative grounds for invalidity) which have been instituted but not finally determined before IP completion day (“cancellation proceedings”).

(2) Subject to sub-paragraph (4), where— (a) the existing EUTM is revoked or declared invalid (whether wholly

or partially) pursuant to a decision in the cancellation proceedings which is finally determined, and

(b) the registrar has— (i) received notice of the situation referred to in paragraph (a) (“a

cancellation notice”), or (ii) otherwise become aware of the situation referred to in

paragraph (a), the registration of the comparable trade mark (EU) which derives from the existing EUTM must be revoked or declared invalid to the same extent as the existing EUTM.

(3) Where (by virtue of sub-paragraph (2)) the registration of a comparable trade mark (EU) is revoked or declared invalid to any extent, the registrar must—

(a) remove the comparable trade mark (EU) from the register (where the revocation or declaration of invalidity relates to all the goods or services for which the existing EUTM was registered); or

(b) amend the entry in the register listing the goods or services for which the comparable trade mark (EU) is registered (where the revocation or declaration of invalidity relates to only some of the goods or services for which the existing EUTM was registered).

(11) S.I. 2019/269. (12) 1994 c. 26.

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(4) The registration of a comparable trade mark (EU) must not be revoked or declared invalid under sub-paragraph (2) where the grounds on which the existing EUTM was revoked or declared invalid (whether wholly or partially) would not apply or would not have been satisfied in relation to the comparable trade mark (EU)—

(a) if the comparable trade mark (EU) had existed as at the date the cancellation proceedings were instituted, and

(b) an application for the revocation or a declaration of invalidity of the comparable trade mark (EU) based on those grounds had been made on that date under section 46 or 47 (as the case may be).

(5) Where a comparable trade mark (EU) is revoked or declared invalid to any extent pursuant to this paragraph—

(a) the rights of the proprietor are deemed to have ceased to that extent as from the date on which the rights of the proprietor of the existing EUTM are deemed to have ceased under the EUTM Regulation;

(b) subject to any claim for compensation for damage caused by negligence or lack of good faith on the part of the proprietor or a claim for restitution based upon the unjust enrichment of the proprietor, the revocation or invalidity of the comparable trade mark (EU) does not affect—

(i) a decision arising from infringement proceedings which has been finally determined and which has been enforced prior to the date on which the entry in the register of the comparable trade mark (EU) has been removed or amended pursuant to sub-paragraph (3) (“the decision date”);

(ii) any contract entered into prior to the decision date to the extent that it has been performed prior to the decision date, subject to the right of a party to the contract to claim the repayment of any consideration paid under the contract where, having regard to the circumstances, it is fair and equitable for such repayment to be made.

(6) A cancellation notice may be submitted to the registrar by any person. (7) For the purposes of this paragraph—

(a) proceedings are instituted if an application or counterclaim for revocation or for a declaration of invalidity—

(i) has been filed (and not subsequently withdrawn) with the European Union Intellectual Property Office or a court designated for the purposes of Article 123, and

(ii) meets the requirements for being accorded a filing date under the European Union Trade Mark Regulation and Commission Delegated Regulation (EU) 2018/625 of 5th March 2018;

(b) a decision is finally determined when— (i) it has been determined, and

(ii) there is no further possibility of the determination being varied or set aside (disregarding any power to grant permission to appeal out of time).”.

10. Schedule 3 (Other amendments to the 1994 Act) is amended as follows—

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(a) for paragraph 2(4) substitute— “(4) In subsection (4B)—

(a) in paragraph (a) for “provision of EU law” substitute “enactment or rule of law”;

(b) in paragraph (b) for “EU” substitute “United Kingdom”.”; (b) in paragraph 4(5)(a), for “exit day” substitute “IP completion day”; (c) in paragraph 10, for “exit day” substitute “IP completion day”.

11. Schedule 4 (Amendments to the Rules) is amended as follows— (a) for paragraph 6 substitute—

6.—(1) Rule 11 is amended as follows. (2) At the end of paragraph (1)(d), omit “.” and substitute “;”. (3) After paragraph (1)(d) insert—

“(e) a proprietor of a comparable trade mark (EU) who sends a derogation notice to the registrar under rule 43A.”.

(4) In paragraph (4), for “another EEA state” substitute “an EEA state”.”. (b) after paragraph 6 insert—

6A.—(1) Rule 12 is amended as follows. (2) At the end of paragraph (4)(d), omit “.” and substitute “;”. (3) After paragraph (4)(d), insert—

“(e) in the case of the proprietor who sends a derogation notice to the registrar, the registrar must proceed as if the proprietor had not sent a derogation notice.”.”.

(c) after paragraph 10 insert—

10A.—(1) Rule 43 is amended as follows. (2) At the end of paragraph (1)(b), omit “, or” and substitute “;”. (3) At the end of paragraph (1)(c), omit “,” and substitute “; or”. (4) After paragraph (1)(c), insert—

“(d) the registration of a comparable trade mark (EU) is revoked or declared invalid to any extent under rule 43A(6),”.

(5) In paragraph (2), after “application and shall” insert “, in the cases referred to in paragraph (1)(a) to (c),”.

(6) In paragraph (3)— (a) after “TM8” insert “or the derogation notice”; (b) after “TM26(O)” omit “or” and substitute “,”; (c) after “TM 26(I)” insert “or notification from the registrar under rule 43(4)(b)

that the comparable trade mark (EU) will be revoked or declared invalid to the same extent as the corresponding EUTM”.

10B. After rule 43 insert—

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Invalidation or revocation of Existing EUTM: Cancellation notice and procedure on application for derogation; Schedule 2A paragraph 21A

43A.—(1) A cancellation notice under paragraph 21A of Schedule 2A must—

(a) identify the existing EUTM by the number under which the existing EUTM was registered in the EUTM Register immediately before IP completion day, together with a representation of the mark,

(b) include the following details with regard to the decision pursuant to which the existing EUTM was revoked or declared invalid (whether wholly or partially)—

(i) the date of the decision (including any decision determined on appeal),

(ii) whether the revocation or declaration of invalidity related to all or part of the goods or services for which the existing EUTM was registered,

(iii) where the existing EUTM was revoked (whether wholly or partially) the date on which the revocation took effect,

(c) be accompanied by a copy of the decision (including any decision determined on appeal) pursuant to which the existing EUTM was revoked or declared to be invalid, and

(d) include a statement confirming that the decision pursuant to which the existing EUTM was revoked or declared invalid (whether wholly or partially) has been finally determined.

(2) Where a cancellation notice is submitted to the registrar by the proprietor of the comparable trade mark (EU) which derives from the existing EUTM, the cancellation notice must be accompanied by—

(a) a notice (a “derogation notice”) in writing to the registrar that, based upon the provisions in paragraph 21A(4) of Schedule 2A, the comparable trade mark (EU) should not be revoked or declared invalid (whether wholly or partially), and

(b) a statement of the reasons why paragraph 21A(4) of Schedule 2A applies (a “statement”) together with relevant supporting evidence (“supporting evidence”).

(3) Where the proprietor of a comparable trade mark (EU) submits a cancellation notice to the registrar but fails to send a derogation notice, a statement or supporting evidence, the registration of the comparable trade mark (EU) which derives from the existing EUTM identified in the cancellation notice must be revoked or declared invalid to the same extent as the existing EUTM, unless the registrar directs otherwise.

(4) Where the registrar receives a cancellation notice submitted by a person other than the proprietor of the comparable trade mark (EU) which derives from the existing EUTM, the registrar must as soon as reasonably practicable after receipt of the cancellation notice—

(a) send a copy of the cancellation notice to the proprietor of the comparable trade mark (EU) which derives from the existing EUTM identified in the cancellation notice, and

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(b) notify the proprietor of the comparable trade mark (EU) which derives from the existing EUTM that based upon the revocation or declaration of invalidity of the existing EUTM, the comparable trade mark (EU) will be revoked or declared invalid to the same extent as the corresponding EUTM.

(5) Where the registrar has become aware of the situation referred to in paragraph 21A(2)(a) of Schedule 2A otherwise than by a cancellation notice, the registrar must as soon as reasonably practicable after becoming aware of that situation, notify the proprietor of the comparable trade mark (EU) which derives from the existing EUTM in the terms provided in paragraph (4)(b).

(6) The proprietor of a comparable trade mark (EU) referred to in paragraph (4) and (5) must, within such period of not less than one month as may be specified in the notice referred to in paragraph (4)(b) and (5), send to the registrar a derogation notice accompanied by a statement and supporting evidence as referred to in paragraph (2), failing which the registration of the comparable trade mark (EU) must be revoked or declared invalid to the same extent as the corresponding EUTM, unless the registrar directs otherwise.

(7) The registrar must, in reaching a decision as to whether paragraph 21A(4) of Schedule 2A applies to a comparable trade mark (EU), have regard to the statement and supporting evidence filed by the proprietor of the comparable trade mark (EU) and must send written notice of the decision to the proprietor, stating the reasons for that decision.

(8) For the purposes of any appeal against a decision referred to in sub- paragraph (7), the date on which the notice is sent must be taken to be the date of the decision.

(d) in rule 47(n) (to be inserted by paragraph 11(6)), after “corresponding EUTM” insert “, and where the corresponding EUTM is subject to cancellation proceedings, that cancellation is pending”.

12. In Schedule 5 (Consequential amendments, repeals, revocations, transitional and saving provisions), in paragraph 6, in column 2 of the first entry in the Table, for “Schedule 12” substitute “Schedule 21”.

PART 5 Amendments to the Designs and International Trade

Marks (Amendment etc.) (EU Exit) Regulations 2019 13. The Designs and International Trade Marks (Amendment etc.) (EU Exit) Regulations

2019(13) are amended in accordance with this Part.

14. In the heading to regulation 4 and in regulation 4(1), for “exit day”, in each place it occurs, substitute “IP completion day”.

15. In regulation 5, for “exit day”, in each place it occurs, substitute “IP completion day”.

16. In regulation 6, for “exit day”, in both places it occurs, substitute “IP completion day”.

17. Schedule 1, Part 1 (Design Regulation and supplementary unregistered designs) is amended as follows—

(13) S.I. 2019/638. 7

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(a) in Article 1(3) of the Design Regulation (as substituted by paragraph 2), for “exit day” substitute “IP completion day”;

(b) in Article 7 of the Design Regulation (as substituted by paragraph 8), for “exit day”, in both places it occurs, substitute “IP completion day”;

(c) for paragraph 19(b) substitute— “(b) for “Community”, in the third place it appears, substitute “United Kingdom

or the European Economic Area”.”; (d) in paragraph 27(b), for “placee” substitute “place”; (e) in Article 81(2)(d) (as substituted by paragraph 29), omit “a continuing”.

18. In Schedule 1, Part 2 (2005 Regulations and the supplementary unregistered design right), in regulation 4(3) of the 2005 Regulations (as substituted by paragraph 63(b)), for “exit day” substitute “IP completion day”.

19. Schedule 2, Part 1 (Design Regulation and continuing unregistered Community designs) is amended as follows—

(a) in paragraph 5, for “exit day” substitute “IP completion day”; (b) in Article 81(2) of the Design Regulation (as substituted by paragraph 29)—

(i) in sub-paragraphs (a) to (c)— (aa) for “supplementary”, in each place it occurs, substitute “continuing”; (bb) after “unregistered”, insert “Community”;

(ii) in sub-paragraph (d)— (aa) omit “a supplementary”; (bb) after “unregistered”, insert “Community”;

(c) in Articles 82 and 83 of the Design Regulation (as substituted by paragraph 30), for “exit day”, in each place it occurs, substitute “IP completion day”.

20. In Schedule 2, Part 2 (2005 Regulations and continuing unregistered Community designs), in regulation 4(3)(a) of the 2005 Regulations (as substituted by paragraph 58(b)), for “exit day” substitute “IP completion day”.

21. Schedule 3 (Amendments to the 1949 Act to make provision for certain registered Community designs and International designs to be treated as registered under the 1949 Act from exit day and about certain applications for registered Community designs made before exit day) is amended as follows—

(a) in the heading, for “exit day”, in both places it occurs, substitute “IP completion day”; (b) in sections 12A and 12B of the 1949 Act (as prospectively inserted by paragraph 2), for

“exit day”, in each place it occurs, substitute “IP completion day”; (c) in Schedule 1A to the 1949 Act (as prospectively inserted by paragraph 3)—

(i) for “exit day”, in each place it occurs, substitute “IP completion day”; (ii) after paragraph 9 insert—

Existing registered Community design: effect of invalidity

9A.—(1) This paragraph applies where, on IP completion day, an existing registered Community design is the subject of proceedings under Article 25 (Grounds for invalidity) which have been instituted but not finally determined before IP completion day (“invalidation proceedings”).

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(2) Subject to sub-paragraph (4) where— (a) the existing registered Community design is declared invalid

(whether wholly or partly) pursuant to a decision which is finally determined, and

(b) the registrar has either— (i) received notice of the situation referred to in paragraph (a) (“an

invalidation notice”), or (ii) otherwise become aware of the situation referred to in

paragraph (a), the registration of the re-registered design which derives from the existing registered Community design must be declared invalid to the same extent as the existing registered Community design.

(3) Where (by virtue of sub-paragraph (2)) the registration of a re-registered design is declared invalid, the registrar must—

(a) where there is a partial declaration of invalidity, amend the entry in the register of designs;

(b) otherwise, remove the re-registered design from the register. (4) The registration of a re-registered design must not be declared invalid

under sub-paragraph (2) where the grounds on which the existing registered Community design was declared invalid (whether wholly or partly) would not apply or would not have been satisfied in relation to the re-registered Community design if—

(a) the re-registered design had been the subject of an entry on the register as at the date the invalidation proceedings were instituted, and

(b) an application for a declaration of invalidity of the re-registered design based on those grounds had been made on that date under section 11ZA.

(5) Where the registration of a re-registered design is declared invalid to any extent pursuant to this paragraph—

(a) it shall to that extent be treated as having been invalid from the date on which the rights of the proprietor of the existing registered Community design from which it derives are deemed to have ceased under the Community Design Regulation;

(b) subject to any claim for compensation for damage caused by negligence or lack of good faith on the part of the proprietor or a claim for restitution based upon the unjust enrichment of the proprietor, the invalidity of the registration of the re-registered design does not affect—

(i) a decision arising from infringement proceedings which has been finally determined and which has been enforced prior to the date of the declaration of invalidity made pursuant to sub- paragraph (2) (“the invalidity declaration date”);

(ii) any contract entered into prior to the invalidity declaration date to the extent that it has been performed prior to that date, subject to the right of a party to the contract to claim the repayment of any consideration paid under the contract where,

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having regard to the circumstances, it is fair and equitable for such repayment to be made.

(6) Where a declaration is made under sub-paragraph (2), section 11ZE(2) does not apply.

(7) An invalidation notice may be sent by any person. (8) For the purposes of this paragraph—

(a) proceedings are instituted if an application or counterclaim for a declaration of invalidity—

(i) has been filed (and not subsequently withdrawn) with the European Union Intellectual Property Office or a court designated for the purposes of Article 80, and

(ii) meets the requirements for being accorded a filing date under the Community Design Regulation and Commision Regulation (EC) No 2245/2002 of 21 October 2002;

(b) a decision is finally determined when— (i) it has been determined; and

(ii) there is no further possibility of the determination being varied or set aside (disregarding any power to grant permission to appeal out of time).

(9) An appeal lies from a declaration of invalidity under sub- paragraph (2).”;

(d) in Schedule 1B to the 1949 Act (as prospectively inserted by paragraph 3)— (i) for “exit day”, in each place it occurs, substitute “IP completion day”;

(ii) in the heading to paragraph 7, omit “registered” the first time it occurs.

22. Schedule 4 (Amendments to the 1994 Act to make provision for certain international trade marks protected in the European Union to be treated as registered trade marks and about certain applications for such marks and transformation applications) is amended as follows—

(a) in section 54A of the 1994 Act (as prospectively inserted by paragraph 2), for “exit day”, in each place it occurs, substitute “IP completion day”;

(b) in Schedule 2B to the 1994 Act (as prospectively inserted by paragraph 3), for “exit day”, in each place it occurs, substitute “IP completion day”.

23. Schedule 5, Part 1 (Fees payable in respect of a re-registered design or a re-registered international design) is amended as follows—

(a) in paragraph 1(2)— (i) omit “of six months”;

(ii) for “exit day” substitute “IP completion day”; (b) in paragraph 1(3)—

(i) for “ending” substitute “beginning”; (ii) for “exit day” substitute “IP completion day”.

24. Schedule 6 (Amendments to the Registered Designs Rules) is amended as follows— (a) in paragraph 3(a), for “exit day”, in both places it occurs, substitute “IP completion day”; (b) after paragraph 3 insert—

3A. After rule 15 insert—

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Invalidation of existing registered Community design: invalidation notice and procedure on application for derogation; Schedule 1A paragraph 9A

15A.—(1) An invalidation notice under paragraph 9A of Schedule 1A must—

(a) identify the existing registered Community design by the number under which it was registered in the RCD register immediately before IP completion day, together with a representation of the design,

(b) be accompanied by a copy of the decision (including any decision determined on appeal) pursuant to which the existing registered Community design was declared to be invalid, and

(c) include a statement confirming that the decision pursuant to which the registered Community design was declared invalid (whether wholly or partly) has been finally determined.

(2) Where an invalidation notice is sent to the registrar by the proprietor of the re-registered design which derives from the existing registered Community design, the invalidation notice must be accompanied by—

(a) a notice (a “derogation notice”) in writing to the registrar that, based upon the provisions in paragraph 9A(4) of Schedule 1A, the re- registered design should not be declared invalid (whether wholly or partly), and

(b) a statement of the reasons why paragraph 9A of Schedule 1A applies (a “statement”) together with relevant supporting evidence (“supporting evidence”).

(3) Where the proprietor of a re-registered design submits an invalidation notice to the registrar but fails to send a derogation notice, a statement, or supporting evidence, the registration of the re-registered design which derives from the existing registered Community design identified in the invalidation notice must be declared invalid to the same extent as the existing registered Community design, unless the registrar directs otherwise.

(4) Where the registrar has received an invalidation notice from a person other than the proprietor of the re-registered design which derives from the existing registered Community design, the registrar must as soon as reasonably practicable after receipt of the invalidation notice—

(a) send a copy of the invalidation notice to the proprietor of the re-registered design which derives from the existing registered Community design identified in the invalidation notice, and

(b) notify the proprietor of the re-registered design which derives from the existing registered Community design that based upon the declaration of invalidity of the existing registered Community design, the re-registered design will be declared invalid to the same extent as the existing registered Community design from which it derives.

(5) Where the registrar has become aware of the situation referred to in paragraph 9A of Schedule 1A otherwise than by an invalidation notice, the registrar must as soon as reasonably practicable after becoming aware of

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that situation notify the proprietor of the re-registered design which derives from the existing registered Community design in the terms provided in paragraph (4)(b).

(6) The proprietor of the re-registered design referred to in paragraphs (4) and (5) must, within such period of not less than one month as may be specified in the notice referred to in paragraphs (4)(b) and 5, send to the registrar a derogation notice accompanied by a statement and supporting evidence as referred to in paragraph (2), failing which the registration of the re-registered design must be declared invalid to the same extent as the registered Community design from which the re-registered design derives, unless the registrar directs otherwise.

(7) The registrar must, in reaching a decision as to whether paragraph 9A of Schedule 1A applies to a re-registered design, have regard to the statement and supporting evidence filed by the proprietor of the re-registered design and must send written notice of the decision to the proprietor, stating the reasons for that decision.

(8) For the purposes of any appeal against a decision referred to in sub- paragraph (7), the date on which the notice is sent must be taken to be the date of the decision.

(c) in rule 27(e) of the Registered Designs Rules (as prospectively inserted by paragraph 6(b)), for “exit day” substitute “IP completion day”;

(d) for paragraph 8 substitute—

8.—(1) Rule 42 (address for service) is amended as follows. (2) At the end of sub-paragraph (c) omit “, or” and substitute “;”. (3) After sub-paragraph (1)(c) insert—

“(d) a proprietor of a re-registered design who sends a derogation notice to the registrar under rule 15A.”.

(4) In paragraph (4), for “another EEA state” substitute “an EEA state”. ”; (e) after paragraph 8 insert—

9.—(1) Rule 43 (failure to furnish an address for service) is amended as follows. (2) At the end of sub-paragraph 4(c) omit “, or” and substitute “;”. (3) After sub-paragraph (4)(c) insert—

“(d) in the case of a proprietor who sends a derogation notice to the registrar, the registrar must proceed as if the proprietor had not sent a derogation notice.

25. In Schedule 8, Part 1 (Further amendments to the 1949 Act), omit paragraph 7.

PART 6 Amendments to the Patents (Amendment) (EU Exit) Regulations 2019

26. The Patents (Amendment) (EU Exit) Regulations 2019(14) are amended in accordance with this Part.

(14) S.I. 2019/801. 12

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27. For regulation 3(a) and (b), substitute— “(a) in the heading for “EU compulsory”, substitute “Compulsory pharmaceutical”; (b) in subsection (1), for “an “EU compulsory”, substitute “a “compulsory

pharmaceutical”;”.

28. Omit regulation 4.

29. For the definition of “plant breeders’ right” substituted by regulation 7(2)(c), substitute— ““plant breeders’ right” means— (a) any right granted under, or having effect as if granted under, section 3 of the 1997 Act

(including existing rights as defined by section 40(4) of that Act); and (b) any right which by virtue of regulation 3 of the Plant Breeders’ Rights (Amendment

etc.) (EU Exit) Regulations 2019(15) is treated as if it were a plant breeders’ right granted in accordance with the 1997 Act and as if the variety were registered in accordance with regulations under section 18(1)(c) of the 1997 Act;”.

30. Omit regulation 17.

31. In the insertion after paragraph 10 of Regulation (EC) No 1610/96 made by regulation 20(3), for paragraph 12 substitute—

12. ‘court’ means— (a) as respects England and Wales, the High Court; (b) as respects Scotland, the Court of Session; (c) as respects Northern Ireland, the High Court in Northern Ireland.”.

32. Omit regulation 21.

33. In regulation 24(3), in the insertion of paragraph 8(1)(b), for “Part A section 1, points 1 to 7 or Part B, Section 1 points 1 to 5”, substitute “Part A section 1, points 1.1 to 1.7 or Part B, Section 1 points 1.1 to 1.4.3”.

34. In Regulation 52(3) in the insertion after Article 1(e) of Regulation (EC) No 469/2009— (a) for paragraph (g), substitute—

“(g) ‘court’ means— (i) as respects England and Wales, the High Court;

(ii) as respects Scotland, the Court of Session; (iii) as respects Northern Ireland, the High Court in Northern Ireland;” and

(b) in paragraph (j), after “granted” insert “or having effect as if granted”.

35. Omit regulation 53.

36. In regulation 62, omit “before”.

37. In regulation 69, for “exit day” in each place it occurs, substitute “IP completion day”.

(15) S.I. 2019/204. 13

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PART 7 Amendments to the Patents Act 1977

38. The Patents Act 1977(16) is amended as follows.

39. In Schedule A1— (a) in paragraph 1, omit the definition of “Council Regulation”; (b) in paragraph 3(3), for “Article 14(3) fourth indent of the Council Regulation”, substitute

“regulation 20A of the Plant Breeders’ Rights Regulations 1998(17)”; (c) in paragraph 4, for “Article 14(3) third indent of the Council Regulation”, substitute

“section 9(10) of the Plant Varieties Act 1997(18)”.

PART 8 Amendments to Regulation (EC) No 469/2009 and related amendments

Amendments to Regulation (EC) No 469/2009

40. Regulation (EC) No 469/2009(19) of the European Parliament and of the Council of 6th May 2009 concerning the supplementary protection certificate for medicinal products is amended as set out in the Schedule.

Amendment to Regulation (EU) No 2019/933

41.—(1) Regulation (EU) 2019/933 of the European Parliament and of the Council of 20th May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products is amended as follows.

(2) After Article 2 (entry into force), omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”.

Amendment to the Patents Rules 2007

42. In the Patents Rules 2007(20), after rule 116, insert—

Notifications relating to supplementary protection certificates

116A. Notifications under Article 5(2)(b) and (c) of the Medicinal Products Regulation must be made on Patents Form SP5.”.

Transitional provisions

43.—(1) Paragraph (2) applies where, before IP completion day, a product or a medicinal product containing that product, as defined in Article 1 of Regulation EC (No) 469/2009, is marked in accordance with that Regulation with the logo set out in Annex -I of that Regulation.

(2) That product or medicinal product containing that product so marked is not required, after these Regulations come into force, to have the words “UK export” affixed to it.

(16) 1977 c. 37. (17) S.I. 1998/1027. Regulation 20A is prospectively inserted into the1998 Regulations by S.I. 2019/204, reg 17(5). (18) 1997 c. 66. Section 9(10) is prospectively inserted into the 1997 Act by S.I. 2019/204, reg 15(2)(c). (19) OJ L152, 16.6.2009, p.1 amended by Regulation (EU) 2019/933, OJ L153, 11.6.2019, p.1. (20) S.I. 2007/3291, as amended by 2011/2052; there are other amending instruments but none are relevant.

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(3) Paragraph (4) applies where, before IP completion day, a notification is made to the Comptroller-General of Patents, Designs and Trade Marks in the form set out in Annex -Ia of Regulation (EC) No 469/2009.

(4) That notification is to be treated, on and after IP completion day, as a notification made— (a) on Patents Form SP5; and (b) on the same date as the notification made on the form set out in that Annex -Ia.

22nd September 2020

Amanda Solloway Parliamentary Under Secretary

Department for Business, Energy and Industrial Strategy

We consent to the making of these Regulations

28th September 2020

Maggie Throup Rebecca Harris

Two of the Lords Commissioners of Her Majesty’s Treasury

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SCHEDULE Regulation 40

Amendments to Regulation (EC) No 469/2009

Interpretation of Schedule

1. In this Schedule, a reference to an Article, paragraph, point or Annex is to that of Regulation (EC) No 469/2009.

Article 1: definitions

2. In Article 1, in relation to the definition of “maker”— (a) for “Union”, substitute “United Kingdom”; (b) omit “third”; (c) after “countries”, insert “outside the United Kingdom, the Isle of Man and the Member

States of the European Union”; and (d) renumber that definition as paragraph (k) and insert after the definition of “UK

authorisation(21)”.

Article 5: effects of the certificate

3. In Article 5— (a) in paragraph 2(a)—

(i) in point (i)— (aa) omit “third”; and (bb) after “countries”, insert “outside the United Kingdom, the Isle of Man and

the Member States of the European Union”; (ii) in point (ii), for “Union”, substitute “United Kingdom”;

(iii) in point (iii)— (aa) for “Member State of making”, substitute “United Kingdom”; (bb) for “Member States”, substitute “the United Kingdom, the Isle of Man or

one or more Member States of the European Union”; (iv) in point (iv), for “Union”, substitute “United Kingdom”;

(b) in paragraph 2(b)— (i) for “authority” to “take place”, substitute “comptroller”;

(ii) for “that Member State”, substitute “the United Kingdom”; (iii) for “a”, where it appears before the last occurrence of “certificate”, substitute “that”;

(c) in paragraph 2(c), for “authority referred to in Article 9(1)”, substitute “comptroller”; (d) in paragraph 2(d)—

(i) omit “third”; (ii) after “countries”, insert “outside the United Kingdom, the Isle of Man and the

Member States of the European Union”; (iii) for “a logo, in the form set out in Annex -I, is affixed”, substitute “the words ‘UK

export’ are affixed so as to be sufficiently clear and visible to the naked eye”;

(21) The definition of “UK authorisation” is inserted by S.I. 2019/801. 16

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(e) in paragraph 2(e), omit from “and” to the end of the sentence; (f) in paragraph 3, for “Union”, substitute “United Kingdom”; (g) in paragraph 5—

(i) omit point (c); (ii) in point (d), omit from “granted” the first time it appears to “making” the second

time it appears; (iii) in point (e)—

(aa) omit “third”, both times it appears; (bb) after “countries”, insert “outside the United Kingdom, the Isle of Man and

the Member States of the European Union”; (h) in paragraph 6—

(i) for “authority”, substitute “comptroller”; (ii) for “contained in Annex -Ia”, substitute “prescribed by rules made under section 123

of the Patents Act 1977”; (i) in paragraph 7—

(i) omit “third”; (ii) after “country”, the first time it appears, insert “outside the United Kingdom, the Isle

of Man and the Member States of the European Union”; (j) omit paragraph 8, including its footnote; (k) after paragraph 10, insert—

11. The Secretary of State may by regulations make further provision as to the manner and form (including design and colour) of affixing the words “UK export” to the outer packaging of the product, or the medicinal product containing that product, referred to in paragraph 2(a)(i) of this Article, and, where feasible, to its immediate packaging.

12. Those regulations are to be made by statutory instrument which is subject to annulment pursuant to a resolution of either House of Parliament.”.

Article 11: publication

4. In Article 11(4)— (a) for “authority referred to in Article 9(1)”, substitute “comptroller”; (b) for “It”, substitute “The comptroller”.

Article 21a: evaluation

5. Omit Article 21a.

Annex -I and Annex -I: logo and standard form

6. Omit Annex -I and Annex -Ia.

17

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EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the following statutory instruments (the “existing regulations”) which were made as a consequence of the United Kingdom exiting the European Union:

The Intellectual Property (Exhaustion of Rights) (EU Exit) Regulations 2019 (S.I. 2019/265); The Trade Marks (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/269) (“the Trade Marks Regulations”); The Intellectual Property (Copyright and Related Rights) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/605) (“the Copyright Regulations”); The Designs and International Trade Marks (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/638) (“the Designs Regulations”); and The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801) (“the Patents Regulations”).

These Regulations substitute “IP completion day” for the various references to “exit day” in the existing regulations (“IP completion day” is defined in the European Union (Withdrawal Agreement) Act 2020 (c.1) (“the 2020 Act”) as 11pm on 31st December 2020). This will ensure that the provisions in the existing regulations will take effect by reference to IP completion day rather than exit day. The existing regulations will come into force on IP completion day by operation of paragraph 1 of Schedule 5 to the 2020 Act. These Regulations also amend certain errors contained in the existing regulations. For example, Part 2 corrects an error where a reference to Schedule ZA1 to the Copyright, Designs & Patents Act 1988 had been inadvertently retained in regulation 31(a) of the Copyright Regulations despite its deletion from that Act by another provision of the Copyright Regulations. Part 4 amends the Trade Marks Regulations to make further changes to the Trade Marks Act 1994 (“the 1994 Act”) and the Trade Marks Rules 2008 to implement Article 54(3) of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community signed on 24th January 2020 (“the Withdrawal Agreement”), insofar as it relates to European Union trade marks. The Trade Marks Regulations provide that a European Union trade mark (“an existing EUTM”) which is registered immediately before exit day (now amended to “IP completion day”) is to be treated on and after that day as if it were a trade mark registered under the 1994 Act (“a comparable trade mark (EU)”). New paragraph 21A of Schedule 2A to the 1994 Act applies where on IP completion day an existing EUTM is the subject of revocation or invalidity proceedings, which after IP completion day results in the revocation of or a declaration of invalidity in respect of the existing EUTM. Where the registrar (as defined in the 1994 Act) receives notice or otherwise becomes aware of such revocation or declaration of invalidity, the comparable trade mark (EU) which derives from the existing EUTM must be revoked or declared invalid to the same extent as the existing EUTM and with effect from the same date except where the grounds on which the existing EUTM was revoked or declared invalid would not have applied had the proceedings been brought against the comparable trade mark (EU) under the 1994 Act. New rule 43A of the Trade Marks Rules 2008 (S.I. 2008/1797) sets out the procedural matters which apply where the registrar receives notice or otherwise becomes aware of the revocation of or declaration of invalidity in respect of an existing EUTM.

18

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Part 5 amends the Designs Regulations to make further changes to the Registered Designs Act 1949 (“the 1949 Act”) and the Registered Designs Rules 2006 to implement Article 54(3) of the Withdrawal Agreement insofar as it relates to registered Community designs. The Designs Regulations provide that a registered Community design (“an existing registered Community design”) which is registered immediately before exit day (now amended to “IP completion day”) is to be treated on and after that day as if it were a design registered under the 1949 Act (“a re- registered design”). New paragraph 9A of Schedule 1A to the 1949 Act applies where on IP completion day an existing registered Community design is the subject of invalidity proceedings, which after IP completion day results in a declaration of invalidity. Where the registrar (as defined in the 1949 Act) receives notice or otherwise becomes aware of such declaration of invalidity, the re-registered design which derives from the existing registered Community design must be declared invalid to the same extent as the existing registered Community design and with effect from the same date, except where the grounds on which the existing registered Community design was declared invalid would not have applied had the proceedings been brought against the re-registered design under the 1949 Act. New rule 15A of the Registered Designs Rules 2006 (S.I. 2006/1975) sets out the procedural matters which apply where the registrar receives notice or otherwise becomes aware of the declaration of invalidity in respect of an existing registered Community design. Part 6 amends the Patents Regulations to correct minor errors, to acknowledge the treatment of Community plant variety rights as plant breeders’ rights by virtue of the Plant Breeders’ Rights (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/204) (“the Plant Breeders’ Regulations”), and to update transitional provisions to refer to IP completion day. Part 7 amends the Patents Act 1977 to replace references to EU law with equivalent domestic legislation, aligning with amendments made by the Plant Breeders’ Regulations. Part 8 and the Schedule relate to supplementary protection certificates for medicinal products and arise out of changes made by Regulation (EU) 2019/933 of the European Parliament and of the Council of 20th May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products. Part 8 amends Regulation 2019/933 and the Patents Rules 2007 (S.I. 2007/3291) and contains transitional provisions. The Schedule amends Regulation (EC) No 469/2009 to address inoperabilities occurring as a result of the aforementioned changes. An impact assessment has not been produced for this instrument as no, or no significant, impact on the private, public and voluntary sectors is foreseen. An explanatory memorandum is available alongside this instrument on the Legislation UK website at www.legislation.gov.uk.

19

 The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020

DExEU/EM/7-2018.2 1

EXPLANATORY MEMORANDUM TO

THE INTELLECTUAL PROPERTY (AMENDMENT ETC.) (EU EXIT)

REGULATIONS 2020

2020 No. 1050

1. Introduction

1.1 This explanatory memorandum has been prepared by the Intellectual Property Office

(IPO), an executive agency of the Department for Business, Energy & Industrial

Strategy, and is laid before Parliament by Act.

1.2 This memorandum contains information for the Joint Committee on Statutory

Instruments.

2. Purpose of the instrument

2.1 This instrument amends a number of pieces of intellectual property (IP) legislation

which were made in 2019 in preparation for a potential “no deal” exit from the EU

and the expected retention of EU law as domestic law at that point. This legislation is

listed in paragraph 6.3 and is referred to collectively as “the 2019 Regulations” in this

memorandum.

2.2 As the UK has left the EU under the terms of the Withdrawal Agreement, the retention

of EU law will now take place at the end of the transition period1. The provisions in

this instrument reflect commitments made in the Withdrawal Agreement and ensure

that the retained EU law will continue to function effectively, taking account of the

transition period. They also deal with inoperabilities arising from new EU law which

entered into force during the extended Article 50 period and correct some minor

errors in the 2019 Regulations.

Explanations

What did any relevant EU law do before exit day?

2.3 In brief, and as explained further in paragraphs 7.7, 7.11, 7.15-7.16, and 7.25, the

relevant EU law:

• provided a framework for the EU trade mark;

• established a system of EU-wide registered and unregistered designs;

• provided for a supplementary protection certificate (SPC) system for patented

pharmaceuticals and agrochemicals;

• developed the principle of a regional regime for the exhaustion of IP rights;

and

• established an IP right for databases.

2.4 As set out in more detail in paragraphs 7.8, 7.12, 7.17 and 7.26, these pieces of EU

law were the subject of amendments by the 2019 Regulations, which, amongst other

things:

1 This point in time is defined in s.1A of the European Union (Withdrawal) Act 2018 as “IP completion day”.

DExEU/EM/7-2018.2 2

• created comparable UK intellectual property rights in place of EU trade marks,

registered designs and unregistered designs which would have ceased to have

protection on exit day, including rights which have been protected at an

international level;

• enabled the filing of new UK applications for trade marks and designs where

EU or international applications would have still been pending on exit day

whilst retaining the relevant filing date;

• provided for the continued functioning of the SPC system;

• ensured that goods whose IP rights should be treated as exhausted remain so;

and

• limited eligibility for new database rights to UK nationals while providing for

continued protection of database rights held by EEA individuals and

businesses that were in force on exit day.

2.5 After the 2019 Regulations were made, Regulation (EU) 2019/933 amending

Regulation (EC) No 469/2009 concerning the supplementary protection certificate for

medicinal products2 introduced what is known as the “manufacturing waiver” to the

SPC system. As explained further in paragraph 7.27, this enables third parties to

manufacture SPC-protected products without requiring the consent of the SPC holder,

but only for export outside the EU or for storing in the EU for sale on the EU market

after the SPC has expired. Doing so will not infringe the SPC right.

Why is it being changed?

2.6 The 2019 Regulations do not reflect that there is now a transition period in which EU

law continues to apply in the UK - if they came into force, they would retroactively

make changes as from exit day; 31 January 2020. They also do not address the

commitments made in the Withdrawal Agreement or provide fixes to any

inoperabilities in new EU law which will be retained at the end of the transition

period.

2.7 This last point applies to the manufacturing waiver specifically. The retained EU law

would not be clear on how the waiver would apply in the UK after the transition

period; there would be uncertainty about what actions third parties could take without

infringing the SPC, and without prompting legal action from the rightsholder.

What will it now do?

2.8 For the most part, the changes ensure that the provisions of the 2019 Regulations will

apply with effect from the end of the transition period as opposed to exit day. This

will ensure that, in particular, any EU IP rights arising during that period will be

properly protected in the UK going forward.

2.9 In relation to trade marks and designs, the changes also implement commitments

contained in the Withdrawal Agreement so that, as set out in paragraphs 7.22-7.23,

certain decisions taken by EU bodies or courts on the validity of such rights are

recognised in the UK.

2.10 In relation to the manufacturing waiver, as set out in paragraph 7.29, the retained law

will allow third parties to manufacture SPC-protected products in the UK, without the

2 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2019.153.01.0001.01.ENG

DExEU/EM/7-2018.2 3

rightsholder’s consent, either for export outside of the UK or EU or for stockpiling in

the UK for sale in the UK or EU once the SPC has expired.

3. Matters of special interest to Parliament

Matters of special interest to the Joint Committee on Statutory Instruments

3.1 This instrument corrects several drafting errors identified in the 2019 Regulations. In

particular:

• regulation 3 fixes an error where a reference was retained to a schedule which

was repealed in the same instrument;

• regulation 19(b) corrects a provision where the wrong type of unregistered

design was named;

• regulation 23 fixes an error where the period in which no additional fees are

due for renewing a converted EU registered design was set to expire, rather

than begin, on a specific date; and

• regulation 25 fixes an error where a conflicting amendment was made to the

underlying Act by two different sets of amending regulations.

Other provisions fix typographical errors.

3.2 The Department and the IPO have therefore followed the requirement in paragraph

4.7.6 of Statutory Instrument Practice to consult the SI Registrar, and the free issue

procedure has been applied because of the length and mix of the new and correcting

provisions.

Matters relevant to Standing Orders Nos. 83P and 83T of the Standing Orders of the House

of Commons relating to Public Business (English Votes for English Laws)

3.3 The territorial application of this instrument includes Scotland and Northern Ireland.

3.4 The powers under which this instrument is made cover the entire United Kingdom

(see section 24(1) of the European Union (Withdrawal) Act 2018) and the territorial

application of this instrument is not limited either by the Act or by the instrument.

4. Extent and Territorial Application

4.1 The territorial extent of this instrument is all of the United Kingdom.

4.2 The territorial application of this instrument is to all of the United Kingdom.

5. European Convention on Human Rights

5.1 The Parliamentary Under Secretary of State (Minister for Science, Research and

Innovation), Amanda Solloway MP, has made the following statement regarding

Human Rights:

“In my view the provisions of the Intellectual Property (Amendment etc.) (EU Exit)

Regulations 2020 are compatible with the Convention rights.”

6. Legislative Context

6.1 These regulations are made primarily under section 8 of the European Union

(Withdrawal) Act 2018 (EUWA). This allows a Minister to make regulations to

resolve any deficiencies in law that arise as a result of the UK’s departure from the

European Union, including in EU law which continues to form part of domestic law at

DExEU/EM/7-2018.2 4

the end of the transition period under section 2 and 3 of the EUWA (namely the

saving of EU-derived domestic legislation and the incorporation of direct EU

legislation) and under section 4 (which relates to certain enforceable EU rights).

6.2 The European Union (Withdrawal Agreement) Act 2020 (WAA) amended the powers

in section 8 EUWA to include the ability to deal with any deficiencies in law which

arise as a result of the transition period. It also added section 8B, which allows a

Minister to make regulations to implement the provisions set out in Part 3 of the

Withdrawal Agreement. These Regulations are also made under section 8B.

6.3 As part of the Government’s legislative programme to prepare for a “no deal”

outcome, five statutory instruments relating to intellectual property were laid before

Parliament in 2019 and approved (the 2019 Regulations)3. These instruments, which

relied upon the power in section 8 EUWA, are:

• The Intellectual Property (Exhaustion of Rights) (EU Exit) Regulations 2019

(SI 2019/265; “the Exhaustion Regulations”),

• The Trade Marks (Amendment etc.) (EU Exit) Regulations 2019 (SI

2019/269; “the Trade Mark Regulations”),

• The Intellectual Property (Copyright and Related Rights) (Amendment) (EU

Exit) Regulations 2019 (SI 2019/605; “the Copyright Regulations”),

• The Designs and International Trade Marks (Amendment etc.) (EU Exit)

Regulations 2019 (SI 2019/638; “the Designs Regulations”), and

• The Patents (Amendment) (EU Exit) Regulations 2019 (SI 2019/801; “the

Patents Regulations”).

6.4 Parts 1 to 6 of these Regulations amend each of these instruments, whilst Parts 7 and 8

make new changes to the Patents Act 1977 and Regulation 469/2009.

7. Policy background

What is being done and why?

7.1 The UK has left the EU under the terms of the Withdrawal Agreement, and there is

now a transition period until the end of 2020 while the UK and EU negotiate

additional arrangements. The current rules on trade, travel, and business for the UK

and EU continue to apply during the transition period.

7.2 The 2019 Regulations were drafted and designed to function in the event that the UK

left the EU without an agreement being reached by exit day. They do not reflect the

legal situation that now exists following the UK’s entry into the Withdrawal

Agreement. This instrument is needed to ensure that the law properly reflects the

obligations in the Withdrawal Agreement, and to ensure that it otherwise works

effectively at the end of the transition period.

7.3 Because the 2019 Regulations take a similar approach to the arrangements set out in

the Withdrawal Agreement, the legislative gap between the two is minimal. This

instrument will ensure that the arrangements set out in the Withdrawal Agreement are

fully implemented.

3 An additional instrument, the Design Right (Semiconductor Topographies) (Amendment) (EU Exit)

Regulations 2018 (SI 2018/1052), was made in 2018, but is not amended by this draft instrument.

DExEU/EM/7-2018.2 5

7.4 As the 2019 Regulations were intended to take effect on exit day, they do not take

account of the transition period, or that EU law now continues to apply until the end

of that period. The WAA has deferred the coming into force of instruments made

under the EUWA, including the 2019 Regulations, by glossing their commencement

provisions so that they refer to IP completion day instead of exit day4. However, this

change does not extend to other references to exit day in the 2019 Regulations (such

as in transitional provisions). If those references are not updated when the 2019

Regulations come into force, the law will be changed retroactively and rights which

currently exist may not be properly recognised.

7.5 In addition, the 2019 Regulations could only operate on the UK and EU law as it

stood at the time they were made. Any new legislation, or any amendment to existing

legislation, since that time needs to be accounted for and, if necessary, any

inoperabilities addressed. As far as possible, the approach remains to ensure that the

law which currently applies in the UK will continue to do so at the end of the

transition period, to ensure continuity and certainty for businesses and rightsholders.

7.6 This instrument covers a number of different IP rights. The specific policy

background to each is explored in more detail in the following sections.

Copyright and database rights

7.7 Database rights are a form of IP protection unique to EU law. They give database

creators the right to prevent others copying or sharing the contents of their databases

where a substantial investment has been made in obtaining, verifying or presenting

the data. The right is automatic and unregistered; however, only databases made by

EEA nationals, residents and businesses are eligible for the right.

7.8 Among other things, the Copyright Regulations amended the retained EU law on

database rights so that only databases created by UK nationals, residents and

businesses will be eligible for the right in the UK after exit day. However, it included

a transitional provision (regulation 38) which ensured that any database rights existing

before exit day would continue to be recognised for the remainder of their duration,

including those made by EEA nationals, residents or businesses.

7.9 Article 58 of the Withdrawal Agreement requires the UK to continue to recognise any

database rights which arose before the end of the transition period. As the Copyright

Regulations only do so for database rights from EEA makers that existed before exit

day, an amendment is needed to ensure any rights arising during the transition period

are properly protected. Regulation 4 does this by changing the provision to cover any

database right existing before IP completion day.

7.10 In addition, regulation 3 corrects an error in the Copyright Regulations in relation to

orphan works (orphan works are copyright works where one or more rightsholders are

unknown or cannot be found). A reference to Schedule ZA1 to the Copyright, Designs

& Patents Act 1988 had been inadvertently retained in regulation 31(a), despite its

deletion from that Act by an earlier provision of the Copyright Regulations.

Exhaustion of rights

7.11 IP rights are said to be “exhausted” if the IP-protected product has been first sold with

the approval of the rightsholder. As a result, the rightsholder cannot use their IP rights

to prevent the product being resold. In the EU, exhaustion occurs if the product is

4 As provided in paragraph 1(1) of schedule 5 to the WAA.

DExEU/EM/7-2018.2 6

lawfully sold anywhere in the EEA; the product can be resold freely within the EEA

and the rightsholder cannot stop it moving between Member States even if they have

IP rights in a particular country. This forms part of the principle of free movement of

goods set out in the EU treaties.

7.12 The Exhaustion Regulations preserved the effect of the EEA exhaustion regime in the

UK by reference to the retention of EU law and enforceable rights in the EUWA on

exit day. This meant that the IP rights of any product lawfully sold in the EEA, either

before or after exit day, would continue to be treated as having been exhausted in the

UK.

7.13 Article 61 of the Withdrawal Agreement commits the UK and the EU to recognise that

any IP rights which are exhausted before the end of the transition period will continue

to be treated as such.

7.14 Regulation 6 replaces references to “exit day” in the Exhaustion Regulations with “IP

completion day”. This ensures that, although any products sold during the transition

period would be correctly treated as exhausted under the existing provision, the rights

which are enforceable are those which are available at the end of the transition period.

This also provides legal certainty.

Trade marks, registered designs and unregistered designs

7.15 Trade marks and designs are intellectual property rights that distinguish the goods or

services from one trader to another, or protect the appearance of a product,

respectively. EU law provides for EU-wide trade marks, registered and unregistered

designs, the first two of which are granted by the EU Intellectual Property Office

(EUIPO). These rights will cease to apply in the UK when it is no longer treated as an

EU Member State, although they continue to have effect during the transition period.

7.16 EU-wide protection of trade marks and registered designs can also be obtained by

applying through the World Intellectual Property Organisation and designating the

territories in which protection is sought. International trade marks and designs

designating the EU will also cease to apply in the UK when it is no longer treated as

an EU Member State.

7.17 The Trade Mark Regulations and the Designs Regulations provided for comparable

rights to be granted under UK law for any EU trade marks or designs, or international

rights designating the EU, that were in force on exit day. They also enabled new UK

applications to be filed where an application for an EU right was pending on exit day,

retaining the original filing date of the EU application.

7.18 Articles 54-57 and 59 of the Withdrawal Agreement require the UK to take these

measures for EU rights in force, and applications pending, at the end of the transition

period. This instrument therefore amends the Trade Mark Regulations and the

Designs Regulations so that the grant of comparable rights and the right to file

replacement applications both operate with effect from IP completion day, rather than

exit day.

7.19 Failing to do so would mean that any EU rights which were granted during the

transition period would not be converted and could potentially be lost - this could be

as many as 200,000 rights.

7.20 The amendments in Parts 4 and 5 make the necessary substitutions.

DExEU/EM/7-2018.2 7

7.21 In addition, some minor errors found in the two sets of regulations have been

corrected. Regulation 19(b) provides a fix so that UK “design courts” correctly have

exclusive jurisdiction over converted EU unregistered designs. Regulation 23 corrects

an error in the Designs Regulations so that the period where no additional fees would

be due on top of the applicable fee to renew a converted EU registered design is

correctly set at six months, instead of one day as originally, inadvertently, drafted.

Regulation 25 corrects a conflict of amendments between the Design Regulations and

the Exhaustion Regulations.

7.22 Third parties can challenge the registration of an EU trade mark or registered design at

the EUIPO, or as a counterclaim in infringement actions heard before courts

designated as EU courts in Member States; the right may be cancelled or reduced in

scope if the challenge is successful. Article 54(3) of the Withdrawal Agreement

requires the UK to honour decisions made by the EUIPO, the CJEU on appeal from

the EUIPO, or Member State courts on cancellation actions which were in progress at

the end of the transition period, and to apply the decision to the comparable UK right.

This means that successful parties will not need to launch a separate cancellation

action in the UK. There is an exception where the grounds for revocation/invalidity

would not apply if considered under UK law.

7.23 Regulations 9(b)(ii) and 11 (for trade marks) and 21(c)(ii) and 24 (for registered

designs) provide for the IPO to take account of cancellation decisions on the EU

rights, to determine if the exception applies based on evidence from the rightsholder,

and to take action on the comparable right. A right of appeal is provided against the

decision of the IPO on whether the exception applies.

Patents and supplementary protection certificates

7.24 A patent protects an invention and lets the owner of that patent take legal action

against anyone who makes, uses, sells or imports that invention without the owner’s

permission – this is known as infringement of the patent. A patent can provide such

protection for up to twenty years.

7.25 Supplementary protection certificates (SPCs) provide a period of additional protection

for patented medicines and agrochemicals, to compensate for the need for lengthy

regulatory approval procedures during the patent lifetime before the product can be

sold and research investment recouped. The SPC gives the approved product the same

rights and protection as the patent, subject to the same limitations, for up to five years

after the patent expires. SPCs are provided by EU Regulations but operate as

individual national rights.

7.26 The Patents Regulations, amongst other things, ensured that the retained EU SPC

Regulations would continue to function as domestic law, replacing references to EU

regulatory legislation with their UK equivalents and ensuring that the method for

calculation of an SPC’s duration would remain the same. The provisions of the

Patents Regulations do not, in general, refer to “exit day”, and so do not need

changing to be able to work correctly when brought into force at the end of the

transition period.

7.27 In July 2019 - during the extended Article 50 period - the EU introduced a new

exception to the rights provided by an SPC. This “manufacturing waiver” allows third

parties to manufacture SPC-protected medicinal products, without needing the

permission of the SPC holder. The product can only be manufactured for export to

countries outside the EU where protection does not exist or has expired, or (in the

DExEU/EM/7-2018.2 8

final 6 months of the SPC term) for storing the product in the Member State of

making (“stockpiling”), ready for sale in the EU when the corresponding SPC expires.

Acts which are necessary for the manufacture of the product, its export or storage, are

also permitted as these too would otherwise infringe the protection provided by the

SPC. The product must be specifically labelled with an “EU export” logo so it can be

identified as having been made under the waiver; this is intended to prevent illicit

diversion of the product back onto the EU market.

7.28 Article 60 of the Withdrawal Agreement requires that any applications for an SPC

which are pending at the end of the transition period should be considered in

accordance with the EU law in force at that time, and any SPC granted based on those

applications should provide for the same level of protection provided for in EU law.

This will now need to include the manufacturing waiver.

7.29 Regulations 40-43 and the accompanying Schedule make additional amendments to

Regulation 469/2009 to fix inoperabilities in the manufacturing waiver legislation and

make consequential amendments to other legislation. These maintain the scope of the

waiver so that third parties can manufacture SPC-protected products in the UK,

without the rightsholder’s consent, either for export outside of the UK or EU or (in the

final 6 months of the SPC term) for stockpiling in the UK for sale in the UK or EU

once the SPC has expired. This means that the scope of the waiver within the UK will

remain essentially unchanged at the end of the transition period.

7.30 Paragraph 3(d) of the Schedule changes the labelling requirement so that the product

must be identified with “UK export” wording; this allows it to be distinguished from

one made in the EU under its waiver. Paragraph 3(k) provides a power to further

regulate the form and manner of that wording by negative statutory instrument, whilst

a transitional provision in regulation 43 ensures that any product which has already

been manufactured under the waiver does not require relabelling. The provision also

preserves the effect of any notification of intention to use the waiver filed before the

end of the transition period; as regulation 42 amends the Patents Rules 2007 to

designate a specific form for such notifications after 1 January 2021.

7.31 Beyond the manufacturing waiver, Article 60 of the Withdrawal Agreement also

applies to applications to extend the duration of an SPC for a medicine which has

been tested for paediatric use; regulation 37 updates transitional provisions in the

Patents Regulations so that they apply to applications pending at the end of the

transition period, as well as extensions already granted.

7.32 In addition, some small changes have been made to other provisions of the Patents

Regulations, to correct minor typographical errors and update cross-references to

other domestic law. Regulation 29 ensures that plant breeders’ rights which have been

converted from Community plant variety rights are able to be cross-licensed.

Regulations 28 and 39 replace a provision which preserved pre-exit day EU

legislation with a cross-reference to equivalent domestic definitions.

8. European Union (Withdrawal) Act/Withdrawal of the United Kingdom from the

European Union

8.1 This instrument is being made using the power in section 8 of the European Union

(Withdrawal) Act 2018 in order to address failures of retained EU law to operate

effectively or other deficiencies arising from the withdrawal of the United Kingdom

from the European Union. The instrument is also made under the powers in section

8B of that Act in order to implement provisions in Part 3 of the Withdrawal

DExEU/EM/7-2018.2 9

Agreement. In accordance with the requirements of that Act the Minister has made the

relevant statements as detailed in Part 2 of the Annex to this Explanatory

Memorandum.

9. Consolidation

9.1 No consolidation of the relevant legislation is planned at present. Informal

consolidated texts of domestic intellectual property legislation are publicly available

for free on the gov.uk website5. The Intellectual Property Office is considering

whether informal consolidation of the retained EU law as amended by this instrument

will be necessary.

10. Consultation outcome

10.1 In relation to the manufacturing waiver, a public call for views was issued, seeking

feedback on draft legislation to fix the inoperabilities in the EU law in the event of a

“no deal” outcome6. The call for views was open from 5 July 2019 to 9 August 2019.

In addition, meetings were held with major representative bodies from the innovative

pharmaceutical industry, the manufacturers of generic pharmaceuticals, and the patent

attorney profession during the period to discuss the proposed draft.

10.2 Six responses were received before the call for views closed, from representative

organizations of rightsholders, pharmaceutical innovators, legal representatives, and

the generics industry. All of the respondents were in favour of ensuring the proper

functioning of the waiver and avoiding legal uncertainty. Most of the respondents

highlighted the importance of preserving the status quo regarding the territory to

which export could take place; the consultation draft would have allowed manufacture

for export to any country outside the UK. Other issues raised included the requirement

for a logo or other indication on the packaging for medicines intended for export and

the need for transitional arrangements.

10.3 In response to the feedback received, the Government made changes to the drafting of

the provisions to maintain the current markets for export and stockpiling, to provide

powers to allow for additional labelling requirements if necessary, and to include

additional transitional arrangements covering use of forms and the use of the pre-

existing labelling requirements on any products manufactured before the end of the

transition period. The drafting was then incorporated into this instrument.

10.4 The Government response to the call for views was published on 13 July 20206;

publication was initially delayed because the ratification of the Withdrawal

Agreement made it necessary to reassess the drafting of both the response and the

legislation itself. The Government’s focus on prioritising communications relating to

coronavirus necessitated a further delay.

10.5 As the other changes were largely technical and minor in nature, in line with Cabinet

Office principles on consultation, a formal public consultation was not considered to

be useful in determining the Government’s approach on drafting. Informal views on

the drafting of those changes were sought from relevant stakeholders; in particular,

the provisions on cancelling trade marks and designs were provided to representative

organisations and key users of the trade mark and design systems for comment and to

5 https://www.gov.uk/topic/intellectual-property/law-practice 6 https://www.gov.uk/government/consultations/supplementary-protection-certificate-waiver-no-deal-legislation

DExEU/EM/7-2018.2 10

familiarise them with the proposed approach. Responses generally approved of the

drafting of the legislation.

11. Guidance

11.1 Guidance was published in January 2020 on the effect of the transition period on

intellectual property rights, how the law will change at the end of that period, and

what preparations businesses may need to make7. The Intellectual Property Office

expects to update that guidance to reflect the contents of this instrument once it has

been approved by Parliament.

12. Impact

12.1 There is no, or no significant, impact on business, charities or voluntary bodies.

12.2 There is no, or no significant, impact on the public sector.

12.3 An Impact Assessment has not been prepared for this instrument because the changes

being made are largely technical in nature. The Government’s assessment is that the

combined policy impacts of this instrument fall below the threshold for a formal

impact assessment; a de minimis assessment has been carried out. The instrument will

update existing EU Exit regulations that were designed for a ‘no deal’ outcome to

account for the transition period and the obligations of the Withdrawal Agreement,

and address inoperabilities in the retained EU SPC Waiver Regulation arising as a

result of EU Exit. In both cases, the changes will ensure that existing legislation

continues to operate in the same way as before. As the status quo is being maintained,

it imposes no new obligations or burdens on private, public or third sector bodies and

does not require re-familiarisation; the changes are therefore not expected to result in

costs for businesses.

12.4 Where this instrument departs from the status quo is in implementing Article 54(3) of

the Withdrawal Agreement, under which the UK is obliged to recognise the outcome

of cancellation proceedings against EU-level registered rights that are underway as of

the end of the transition period. The impact of this is expected to be a small saving for

businesses, as separate cancellation proceedings will not need to be prosecuted in both

territories. This provision is expected to impact only around 1200 registered rights.

13. Regulating small business

13.1 The legislation applies to activities that are undertaken by small businesses.

13.2 No specific action is proposed to minimise regulatory burdens on small businesses.

13.3 The basis for the final decision on what action to take to assist small businesses is that,

as the principal purpose of the instrument is to maintain the status quo, it introduces

no new burdens to small businesses that need to be mitigated.

14. Monitoring & review

14.1 The approach to monitoring of this legislation is to assess the effect of the changes

being made as part of the course of normal departmental business.

14.2 As this instrument is made under the EU Withdrawal Act 2018, no review clause is

required.

7 https://www.gov.uk/government/news/intellectual-property-and-the-transition-period

DExEU/EM/7-2018.2 11

15. Contact

15.1 Michael Warren at the Intellectual Property Office, Telephone: 01633 813988 or

email: Michael.Warren@ipo.gov.uk can be contacted with any queries regarding the

instrument.

15.2 James Porter, Deputy Director at the Intellectual Property Office can confirm that this

Explanatory Memorandum meets the required standard.

15.3 Amanda Solloway MP, Parliamentary Under Secretary of State at the Department for

Business, Energy & Industrial Strategy can confirm that this Explanatory

Memorandum meets the required standard.

DExEU/EM/7-2018.2 12

Annex Statements under the European Union (Withdrawal) Act

2018

Part 1

Table of Statements under the 2018 Act

This table sets out the statements that may be required under the 2018 Act.

Statement Where the requirement sits To whom it applies What it requires

Sifting Paragraphs 3(3), 3(7) and

17(3) and 17(7) of Schedule

7

Ministers of the Crown

exercising sections 8(1), 9 and

23(1) to make a Negative SI

Explain why the instrument should be

subject to the negative procedure and, if

applicable, why they disagree with the

recommendation(s) of the SLSC/Sifting

Committees

Appropriate-

ness

Sub-paragraph (2) of

paragraph 28, Schedule 7

Ministers of the Crown

exercising sections 8(1), 9 and

23(1) or jointly exercising

powers in Schedule 2

A statement that the SI does no more than

is appropriate.

Good Reasons Sub-paragraph (3) of

paragraph 28, Schedule 7

Ministers of the Crown

exercising sections 8(1), 9 and

23(1) or jointly exercising

powers in Schedule 2

Explain the good reasons for making the

instrument and that what is being done is a

reasonable course of action.

Equalities Sub-paragraphs (4) and (5)

of paragraph 28, Schedule 7

Ministers of the Crown

exercising sections 8(1), 9 and

23(1) or jointly exercising

powers in Schedule 2

Explain what, if any, amendment, repeals

or revocations are being made to the

Equalities Acts 2006 and 2010 and

legislation made under them.

State that the Minister has had due regard

to the need to eliminate discrimination and

other conduct prohibited under the

Equality Act 2010.

Explanations Sub-paragraph (6) of

paragraph 28, Schedule 7

Ministers of the Crown

exercising sections 8(1), 9 and

23(1) or jointly exercising

powers in Schedule 2

In addition to the statutory

obligation the Government has

made a political commitment

to include these statements

alongside all EUWA SIs

Explain the instrument, identify the

relevant law before exit day, explain the

instrument’s effect on retained EU law and

give information about the purpose of the

instrument, e.g., whether minor or

technical changes only are intended to the

EU retained law.

DExEU/EM/7-2018.2 13

Criminal

offences

Sub-paragraphs (3) and (7)

of paragraph 28, Schedule 7

Ministers of the Crown

exercising sections 8(1), 9, and

23(1) or jointly exercising

powers in Schedule 2 to create

a criminal offence

Set out the ‘good reasons’ for creating a

criminal offence, and the penalty attached.

Sub-

delegation

Paragraph 30, Schedule 7 Ministers of the Crown

exercising sections 10(1), 12

and part 1 of Schedule 4 to

create a legislative power

exercisable not by a Minister

of the Crown or a Devolved

Authority by Statutory

Instrument.

State why it is appropriate to create such a

sub-delegated power.

Urgency Paragraph 34, Schedule 7 Ministers of the Crown using

the urgent procedure in

paragraphs 4 or 14, Schedule

7.

Statement of the reasons for the Minister’s

opinion that the SI is urgent.

Explanations

where

amending

regulations

under 2(2)

ECA 1972

Paragraph 14, Schedule 8 Anybody making an SI after

exit day under powers outside

the European Union

(Withdrawal) Act 2018 which

modifies subordinate

legislation made under s. 2(2)

ECA

Statement explaining the good reasons for

modifying the instrument made under s.

2(2) ECA, identifying the relevant law

before exit day, and explaining the

instrument’s effect on retained EU law.

Scrutiny

statement

where

amending

regulations

under 2(2)

ECA 1972

Paragraph 15, Schedule 8 Anybody making an SI after

exit day under powers outside

the European Union

(Withdrawal) Act 2018 which

modifies subordinate

legislation made under s. 2(2)

ECA

Statement setting out:

a) the steps which the relevant authority

has taken to make the draft instrument

published in accordance with paragraph

16(2), Schedule 8 available to each House

of Parliament,

b) containing information about the

relevant authority’s response to—

(i) any recommendations made by a

committee of either House of Parliament

about the published draft instrument, and

(ii) any other representations made to the

relevant authority about the published draft

instrument, and,

c) containing any other information that

the relevant authority considers appropriate

in relation to the scrutiny of the instrument

or draft instrument which is to be laid.

DExEU/EM/7-2018.2 14

Part 2

Statements required when using enabling powers

under the European Union (Withdrawal) 2018 Act

1. Appropriateness statement

1.1 The Parliamentary Under Secretary of State (Minister for Science, Research and

Innovation), Amanda Solloway MP, has made the following statement regarding use

of legislative powers in the European Union (Withdrawal) Act 2018:

“In my view the Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020

do no more than is appropriate”.

1.2 This is the case because the changes ensure compliance with the specific provisions of

the Withdrawal Agreement, and only correct deficiencies to the extent necessary to

maintain the continued functioning of the intellectual property system at the end of

the transition period.

2. Good reasons

2.1 The Parliamentary Under Secretary of State (Minister for Science, Research and

Innovation), Amanda Solloway MP, has made the following statement regarding use

of legislative powers in the European Union (Withdrawal) Act 2018:

“In my view there are good reasons for the provisions in this instrument, and I have

concluded they are a reasonable course of action”.

2.2 These are: that it is critical to implement the commitments agreed in the Withdrawal

Agreement and to ensure that EU law retained at the end of the transition period

functions effectively as domestic law.

3. Equalities

3.1 The Parliamentary Under Secretary of State (Minister for Science, Research and

Innovation), Amanda Solloway MP, has made the following statement(s):

“The draft instrument does not amend, repeal or revoke a provision or provisions in

the Equality Act 2006 or the Equality Act 2010 or subordinate legislation made under

those Acts.”.

3.2 The Parliamentary Under Secretary of State (Minister for Science, Research and

Innovation), Amanda Solloway MP, has made the following statement regarding use

of legislative powers in the European Union (Withdrawal) Act 2018:

“In relation to the draft instrument, I, Amanda Solloway have had due regard to the

need to eliminate discrimination, harassment, victimisation and any other conduct that

is prohibited by or under the Equality Act 2010.”.

4. Explanations

4.1 The explanations statement has been made in section 2 of the main body of this

explanatory memorandum.

其他文本 备注 (1 文本) 备注 (1 文本) 英语 The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050)
 The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020

Status: This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

This Statutory Instrument has been printed to correct errors in S.I. 2019/269, S.I. 2019/605, S.I. 2019/638 and S.I. 2019/801 and is being issued free of charge to all known recipients of those Statutory Instruments.

STATUTORY INSTRUMENTS

2020 No. 1050

EXITING THE EUROPEAN UNION INTELLECTUAL PROPERTY

The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020

Made - - - - 28th September 2020

Coming into force in accordance with regulation 1(2)

The Secretary of State makes these Regulations in exercise of the powers conferred by sections 8(1), 8B(1)(a) and 8B(2)(a)(1) of, and paragraph 1 of Schedule 4 and paragraph 21(b) of Schedule 7 to, the European Union (Withdrawal) Act 2018(2) and by section 36 of the Registered Designs Act 1949(3) and by section 78 of the Trade Marks Act 1994(4) and with the consent of the Treasury. In accordance with paragraphs 1(1) and 12(1) of Schedule 7 to the European Union (Withdrawal) Act 2018, a draft of this instrument has been laid before Parliament and approved by resolution of each House of Parliament.

PART 1 Introduction

Citation, commencement and interpretation

1.—(1) These Regulations may be cited as the Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020.

(2) These Regulations come into force immediately before IP completion day except Parts 7 and 8 which come into force on IP completion day.

(1) Section 8B was inserted by section 18 of the European Union (Withdrawal Agreement) Act 2020 c. 1. (2) 2018 c. 16. Section 8 is amended by section 27 of the European Union (Withdrawal Agreement) Act 2020 c. 1. (3) 1949 c. 88. (4) 1994 c. 26.

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(3) In these Regulations— “1949 Act” means the Registered Designs Act 1949; “1994 Act” means the Trade Marks Act 1994; “2005 Regulations” means the Community Design Regulations 2005(5); “Design Regulation” means Council Regulation (EC) No 6/2002 of 12th December 2001 on Community Designs(6) as amended by Council Regulation (EC) No 1891/2006 of 18th December 2006 to give effect to the accession of the European Community to the Geneva Act of the Hague Agreement concerning the international registration of industrial designs and by the Decision of the European Union of 5th December 2011 on the admission of the Republic of Croatia to the European Union(7); and “Registered Designs Rules” means the Registered Designs Rules 2006(8).

PART 2 Amendments to the Intellectual Property (Copyright and

Related Rights) (Amendment) (EU Exit) Regulations 2019 2. The Intellectual Property (Copyright and Related Rights) (Amendment) (EU Exit) Regulations

2019(9) are amended in accordance with this Part.

3. For regulation 31(a) substitute— “(a) in paragraph (3)—

(i) in sub-paragraph (a) omit “and the relevant database maintained by the Office for Harmonization in the Internal Market; and”;

(ii) omit sub-paragraph (b);”.

4. In regulation 38, for “exit day” substitute “IP completion day”.

PART 3 Amendments to the Intellectual Property

(Exhaustion of Rights) (EU Exit) Regulations 2019 5. The Intellectual Property (Exhaustion of Rights) (EU Exit) Regulations 2019(10) are amended

in accordance with this Part.

6. In regulation 2(1) for “exit day”, in each place it occurs, substitute “IP completion day”.

(5) S.I. 2005/2339, amended by S.I. 2006/1028, 2007/3378, 2011/1043 and 2014/2400 and the Intellectual Property (Unjustified Threats) Act 2017, c. 14.

(6) OJ L3, 5.1.2002, p.1. (7) OJ L386, 29.12.2006, p.14. (8) S.I. 2006/1975, as amended by S.I. 2008/2683, 2009/546, 2013/444 and 2014/2405. (9) S.I. 2019/605. (10) S.I. 2019/265.

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PART 4 Amendments to the Trade Marks (Amendment etc.) (EU Exit) Regulations 2019

7. The Trade Marks (Amendment etc.) (EU Exit) Regulations 2019(11) are amended in accordance with this Part.

8. In regulation 2, for “exit day”, in both places it occurs, substitute “IP completion day”.

9. Schedule 1 (Amendments to the 1994 Act to make provision for certain trade marks registered as European Union trade marks to be treated as registered trade marks and about certain applications for such marks) is amended as follows—

(a) in section 52A of the 1994 Act(12) (to be inserted by paragraph 2), for “exit day”, in both places it occurs, substitute “IP completion day”;

(b) in Schedule 2A to the 1994 Act (to be inserted by paragraph 3)— (i) for “exit day”, in each place it occurs, substitute “IP completion day”;

(ii) after paragraph 21, insert—

Existing EUTM: effect of invalidity or revocation

21A.—(1) This paragraph applies where, on IP completion day, an existing EUTM is the subject of proceedings under Article 58 (Grounds for revocation), 59 (Absolute grounds for invalidity) or 60 (Relative grounds for invalidity) which have been instituted but not finally determined before IP completion day (“cancellation proceedings”).

(2) Subject to sub-paragraph (4), where— (a) the existing EUTM is revoked or declared invalid (whether wholly

or partially) pursuant to a decision in the cancellation proceedings which is finally determined, and

(b) the registrar has— (i) received notice of the situation referred to in paragraph (a) (“a

cancellation notice”), or (ii) otherwise become aware of the situation referred to in

paragraph (a), the registration of the comparable trade mark (EU) which derives from the existing EUTM must be revoked or declared invalid to the same extent as the existing EUTM.

(3) Where (by virtue of sub-paragraph (2)) the registration of a comparable trade mark (EU) is revoked or declared invalid to any extent, the registrar must—

(a) remove the comparable trade mark (EU) from the register (where the revocation or declaration of invalidity relates to all the goods or services for which the existing EUTM was registered); or

(b) amend the entry in the register listing the goods or services for which the comparable trade mark (EU) is registered (where the revocation or declaration of invalidity relates to only some of the goods or services for which the existing EUTM was registered).

(11) S.I. 2019/269. (12) 1994 c. 26.

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(4) The registration of a comparable trade mark (EU) must not be revoked or declared invalid under sub-paragraph (2) where the grounds on which the existing EUTM was revoked or declared invalid (whether wholly or partially) would not apply or would not have been satisfied in relation to the comparable trade mark (EU)—

(a) if the comparable trade mark (EU) had existed as at the date the cancellation proceedings were instituted, and

(b) an application for the revocation or a declaration of invalidity of the comparable trade mark (EU) based on those grounds had been made on that date under section 46 or 47 (as the case may be).

(5) Where a comparable trade mark (EU) is revoked or declared invalid to any extent pursuant to this paragraph—

(a) the rights of the proprietor are deemed to have ceased to that extent as from the date on which the rights of the proprietor of the existing EUTM are deemed to have ceased under the EUTM Regulation;

(b) subject to any claim for compensation for damage caused by negligence or lack of good faith on the part of the proprietor or a claim for restitution based upon the unjust enrichment of the proprietor, the revocation or invalidity of the comparable trade mark (EU) does not affect—

(i) a decision arising from infringement proceedings which has been finally determined and which has been enforced prior to the date on which the entry in the register of the comparable trade mark (EU) has been removed or amended pursuant to sub-paragraph (3) (“the decision date”);

(ii) any contract entered into prior to the decision date to the extent that it has been performed prior to the decision date, subject to the right of a party to the contract to claim the repayment of any consideration paid under the contract where, having regard to the circumstances, it is fair and equitable for such repayment to be made.

(6) A cancellation notice may be submitted to the registrar by any person. (7) For the purposes of this paragraph—

(a) proceedings are instituted if an application or counterclaim for revocation or for a declaration of invalidity—

(i) has been filed (and not subsequently withdrawn) with the European Union Intellectual Property Office or a court designated for the purposes of Article 123, and

(ii) meets the requirements for being accorded a filing date under the European Union Trade Mark Regulation and Commission Delegated Regulation (EU) 2018/625 of 5th March 2018;

(b) a decision is finally determined when— (i) it has been determined, and

(ii) there is no further possibility of the determination being varied or set aside (disregarding any power to grant permission to appeal out of time).”.

10. Schedule 3 (Other amendments to the 1994 Act) is amended as follows—

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(a) for paragraph 2(4) substitute— “(4) In subsection (4B)—

(a) in paragraph (a) for “provision of EU law” substitute “enactment or rule of law”;

(b) in paragraph (b) for “EU” substitute “United Kingdom”.”; (b) in paragraph 4(5)(a), for “exit day” substitute “IP completion day”; (c) in paragraph 10, for “exit day” substitute “IP completion day”.

11. Schedule 4 (Amendments to the Rules) is amended as follows— (a) for paragraph 6 substitute—

6.—(1) Rule 11 is amended as follows. (2) At the end of paragraph (1)(d), omit “.” and substitute “;”. (3) After paragraph (1)(d) insert—

“(e) a proprietor of a comparable trade mark (EU) who sends a derogation notice to the registrar under rule 43A.”.

(4) In paragraph (4), for “another EEA state” substitute “an EEA state”.”. (b) after paragraph 6 insert—

6A.—(1) Rule 12 is amended as follows. (2) At the end of paragraph (4)(d), omit “.” and substitute “;”. (3) After paragraph (4)(d), insert—

“(e) in the case of the proprietor who sends a derogation notice to the registrar, the registrar must proceed as if the proprietor had not sent a derogation notice.”.”.

(c) after paragraph 10 insert—

10A.—(1) Rule 43 is amended as follows. (2) At the end of paragraph (1)(b), omit “, or” and substitute “;”. (3) At the end of paragraph (1)(c), omit “,” and substitute “; or”. (4) After paragraph (1)(c), insert—

“(d) the registration of a comparable trade mark (EU) is revoked or declared invalid to any extent under rule 43A(6),”.

(5) In paragraph (2), after “application and shall” insert “, in the cases referred to in paragraph (1)(a) to (c),”.

(6) In paragraph (3)— (a) after “TM8” insert “or the derogation notice”; (b) after “TM26(O)” omit “or” and substitute “,”; (c) after “TM 26(I)” insert “or notification from the registrar under rule 43(4)(b)

that the comparable trade mark (EU) will be revoked or declared invalid to the same extent as the corresponding EUTM”.

10B. After rule 43 insert—

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Invalidation or revocation of Existing EUTM: Cancellation notice and procedure on application for derogation; Schedule 2A paragraph 21A

43A.—(1) A cancellation notice under paragraph 21A of Schedule 2A must—

(a) identify the existing EUTM by the number under which the existing EUTM was registered in the EUTM Register immediately before IP completion day, together with a representation of the mark,

(b) include the following details with regard to the decision pursuant to which the existing EUTM was revoked or declared invalid (whether wholly or partially)—

(i) the date of the decision (including any decision determined on appeal),

(ii) whether the revocation or declaration of invalidity related to all or part of the goods or services for which the existing EUTM was registered,

(iii) where the existing EUTM was revoked (whether wholly or partially) the date on which the revocation took effect,

(c) be accompanied by a copy of the decision (including any decision determined on appeal) pursuant to which the existing EUTM was revoked or declared to be invalid, and

(d) include a statement confirming that the decision pursuant to which the existing EUTM was revoked or declared invalid (whether wholly or partially) has been finally determined.

(2) Where a cancellation notice is submitted to the registrar by the proprietor of the comparable trade mark (EU) which derives from the existing EUTM, the cancellation notice must be accompanied by—

(a) a notice (a “derogation notice”) in writing to the registrar that, based upon the provisions in paragraph 21A(4) of Schedule 2A, the comparable trade mark (EU) should not be revoked or declared invalid (whether wholly or partially), and

(b) a statement of the reasons why paragraph 21A(4) of Schedule 2A applies (a “statement”) together with relevant supporting evidence (“supporting evidence”).

(3) Where the proprietor of a comparable trade mark (EU) submits a cancellation notice to the registrar but fails to send a derogation notice, a statement or supporting evidence, the registration of the comparable trade mark (EU) which derives from the existing EUTM identified in the cancellation notice must be revoked or declared invalid to the same extent as the existing EUTM, unless the registrar directs otherwise.

(4) Where the registrar receives a cancellation notice submitted by a person other than the proprietor of the comparable trade mark (EU) which derives from the existing EUTM, the registrar must as soon as reasonably practicable after receipt of the cancellation notice—

(a) send a copy of the cancellation notice to the proprietor of the comparable trade mark (EU) which derives from the existing EUTM identified in the cancellation notice, and

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(b) notify the proprietor of the comparable trade mark (EU) which derives from the existing EUTM that based upon the revocation or declaration of invalidity of the existing EUTM, the comparable trade mark (EU) will be revoked or declared invalid to the same extent as the corresponding EUTM.

(5) Where the registrar has become aware of the situation referred to in paragraph 21A(2)(a) of Schedule 2A otherwise than by a cancellation notice, the registrar must as soon as reasonably practicable after becoming aware of that situation, notify the proprietor of the comparable trade mark (EU) which derives from the existing EUTM in the terms provided in paragraph (4)(b).

(6) The proprietor of a comparable trade mark (EU) referred to in paragraph (4) and (5) must, within such period of not less than one month as may be specified in the notice referred to in paragraph (4)(b) and (5), send to the registrar a derogation notice accompanied by a statement and supporting evidence as referred to in paragraph (2), failing which the registration of the comparable trade mark (EU) must be revoked or declared invalid to the same extent as the corresponding EUTM, unless the registrar directs otherwise.

(7) The registrar must, in reaching a decision as to whether paragraph 21A(4) of Schedule 2A applies to a comparable trade mark (EU), have regard to the statement and supporting evidence filed by the proprietor of the comparable trade mark (EU) and must send written notice of the decision to the proprietor, stating the reasons for that decision.

(8) For the purposes of any appeal against a decision referred to in sub- paragraph (7), the date on which the notice is sent must be taken to be the date of the decision.

(d) in rule 47(n) (to be inserted by paragraph 11(6)), after “corresponding EUTM” insert “, and where the corresponding EUTM is subject to cancellation proceedings, that cancellation is pending”.

12. In Schedule 5 (Consequential amendments, repeals, revocations, transitional and saving provisions), in paragraph 6, in column 2 of the first entry in the Table, for “Schedule 12” substitute “Schedule 21”.

PART 5 Amendments to the Designs and International Trade

Marks (Amendment etc.) (EU Exit) Regulations 2019 13. The Designs and International Trade Marks (Amendment etc.) (EU Exit) Regulations

2019(13) are amended in accordance with this Part.

14. In the heading to regulation 4 and in regulation 4(1), for “exit day”, in each place it occurs, substitute “IP completion day”.

15. In regulation 5, for “exit day”, in each place it occurs, substitute “IP completion day”.

16. In regulation 6, for “exit day”, in both places it occurs, substitute “IP completion day”.

17. Schedule 1, Part 1 (Design Regulation and supplementary unregistered designs) is amended as follows—

(13) S.I. 2019/638. 7

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(a) in Article 1(3) of the Design Regulation (as substituted by paragraph 2), for “exit day” substitute “IP completion day”;

(b) in Article 7 of the Design Regulation (as substituted by paragraph 8), for “exit day”, in both places it occurs, substitute “IP completion day”;

(c) for paragraph 19(b) substitute— “(b) for “Community”, in the third place it appears, substitute “United Kingdom

or the European Economic Area”.”; (d) in paragraph 27(b), for “placee” substitute “place”; (e) in Article 81(2)(d) (as substituted by paragraph 29), omit “a continuing”.

18. In Schedule 1, Part 2 (2005 Regulations and the supplementary unregistered design right), in regulation 4(3) of the 2005 Regulations (as substituted by paragraph 63(b)), for “exit day” substitute “IP completion day”.

19. Schedule 2, Part 1 (Design Regulation and continuing unregistered Community designs) is amended as follows—

(a) in paragraph 5, for “exit day” substitute “IP completion day”; (b) in Article 81(2) of the Design Regulation (as substituted by paragraph 29)—

(i) in sub-paragraphs (a) to (c)— (aa) for “supplementary”, in each place it occurs, substitute “continuing”; (bb) after “unregistered”, insert “Community”;

(ii) in sub-paragraph (d)— (aa) omit “a supplementary”; (bb) after “unregistered”, insert “Community”;

(c) in Articles 82 and 83 of the Design Regulation (as substituted by paragraph 30), for “exit day”, in each place it occurs, substitute “IP completion day”.

20. In Schedule 2, Part 2 (2005 Regulations and continuing unregistered Community designs), in regulation 4(3)(a) of the 2005 Regulations (as substituted by paragraph 58(b)), for “exit day” substitute “IP completion day”.

21. Schedule 3 (Amendments to the 1949 Act to make provision for certain registered Community designs and International designs to be treated as registered under the 1949 Act from exit day and about certain applications for registered Community designs made before exit day) is amended as follows—

(a) in the heading, for “exit day”, in both places it occurs, substitute “IP completion day”; (b) in sections 12A and 12B of the 1949 Act (as prospectively inserted by paragraph 2), for

“exit day”, in each place it occurs, substitute “IP completion day”; (c) in Schedule 1A to the 1949 Act (as prospectively inserted by paragraph 3)—

(i) for “exit day”, in each place it occurs, substitute “IP completion day”; (ii) after paragraph 9 insert—

Existing registered Community design: effect of invalidity

9A.—(1) This paragraph applies where, on IP completion day, an existing registered Community design is the subject of proceedings under Article 25 (Grounds for invalidity) which have been instituted but not finally determined before IP completion day (“invalidation proceedings”).

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(2) Subject to sub-paragraph (4) where— (a) the existing registered Community design is declared invalid

(whether wholly or partly) pursuant to a decision which is finally determined, and

(b) the registrar has either— (i) received notice of the situation referred to in paragraph (a) (“an

invalidation notice”), or (ii) otherwise become aware of the situation referred to in

paragraph (a), the registration of the re-registered design which derives from the existing registered Community design must be declared invalid to the same extent as the existing registered Community design.

(3) Where (by virtue of sub-paragraph (2)) the registration of a re-registered design is declared invalid, the registrar must—

(a) where there is a partial declaration of invalidity, amend the entry in the register of designs;

(b) otherwise, remove the re-registered design from the register. (4) The registration of a re-registered design must not be declared invalid

under sub-paragraph (2) where the grounds on which the existing registered Community design was declared invalid (whether wholly or partly) would not apply or would not have been satisfied in relation to the re-registered Community design if—

(a) the re-registered design had been the subject of an entry on the register as at the date the invalidation proceedings were instituted, and

(b) an application for a declaration of invalidity of the re-registered design based on those grounds had been made on that date under section 11ZA.

(5) Where the registration of a re-registered design is declared invalid to any extent pursuant to this paragraph—

(a) it shall to that extent be treated as having been invalid from the date on which the rights of the proprietor of the existing registered Community design from which it derives are deemed to have ceased under the Community Design Regulation;

(b) subject to any claim for compensation for damage caused by negligence or lack of good faith on the part of the proprietor or a claim for restitution based upon the unjust enrichment of the proprietor, the invalidity of the registration of the re-registered design does not affect—

(i) a decision arising from infringement proceedings which has been finally determined and which has been enforced prior to the date of the declaration of invalidity made pursuant to sub- paragraph (2) (“the invalidity declaration date”);

(ii) any contract entered into prior to the invalidity declaration date to the extent that it has been performed prior to that date, subject to the right of a party to the contract to claim the repayment of any consideration paid under the contract where,

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having regard to the circumstances, it is fair and equitable for such repayment to be made.

(6) Where a declaration is made under sub-paragraph (2), section 11ZE(2) does not apply.

(7) An invalidation notice may be sent by any person. (8) For the purposes of this paragraph—

(a) proceedings are instituted if an application or counterclaim for a declaration of invalidity—

(i) has been filed (and not subsequently withdrawn) with the European Union Intellectual Property Office or a court designated for the purposes of Article 80, and

(ii) meets the requirements for being accorded a filing date under the Community Design Regulation and Commision Regulation (EC) No 2245/2002 of 21 October 2002;

(b) a decision is finally determined when— (i) it has been determined; and

(ii) there is no further possibility of the determination being varied or set aside (disregarding any power to grant permission to appeal out of time).

(9) An appeal lies from a declaration of invalidity under sub- paragraph (2).”;

(d) in Schedule 1B to the 1949 Act (as prospectively inserted by paragraph 3)— (i) for “exit day”, in each place it occurs, substitute “IP completion day”;

(ii) in the heading to paragraph 7, omit “registered” the first time it occurs.

22. Schedule 4 (Amendments to the 1994 Act to make provision for certain international trade marks protected in the European Union to be treated as registered trade marks and about certain applications for such marks and transformation applications) is amended as follows—

(a) in section 54A of the 1994 Act (as prospectively inserted by paragraph 2), for “exit day”, in each place it occurs, substitute “IP completion day”;

(b) in Schedule 2B to the 1994 Act (as prospectively inserted by paragraph 3), for “exit day”, in each place it occurs, substitute “IP completion day”.

23. Schedule 5, Part 1 (Fees payable in respect of a re-registered design or a re-registered international design) is amended as follows—

(a) in paragraph 1(2)— (i) omit “of six months”;

(ii) for “exit day” substitute “IP completion day”; (b) in paragraph 1(3)—

(i) for “ending” substitute “beginning”; (ii) for “exit day” substitute “IP completion day”.

24. Schedule 6 (Amendments to the Registered Designs Rules) is amended as follows— (a) in paragraph 3(a), for “exit day”, in both places it occurs, substitute “IP completion day”; (b) after paragraph 3 insert—

3A. After rule 15 insert—

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Invalidation of existing registered Community design: invalidation notice and procedure on application for derogation; Schedule 1A paragraph 9A

15A.—(1) An invalidation notice under paragraph 9A of Schedule 1A must—

(a) identify the existing registered Community design by the number under which it was registered in the RCD register immediately before IP completion day, together with a representation of the design,

(b) be accompanied by a copy of the decision (including any decision determined on appeal) pursuant to which the existing registered Community design was declared to be invalid, and

(c) include a statement confirming that the decision pursuant to which the registered Community design was declared invalid (whether wholly or partly) has been finally determined.

(2) Where an invalidation notice is sent to the registrar by the proprietor of the re-registered design which derives from the existing registered Community design, the invalidation notice must be accompanied by—

(a) a notice (a “derogation notice”) in writing to the registrar that, based upon the provisions in paragraph 9A(4) of Schedule 1A, the re- registered design should not be declared invalid (whether wholly or partly), and

(b) a statement of the reasons why paragraph 9A of Schedule 1A applies (a “statement”) together with relevant supporting evidence (“supporting evidence”).

(3) Where the proprietor of a re-registered design submits an invalidation notice to the registrar but fails to send a derogation notice, a statement, or supporting evidence, the registration of the re-registered design which derives from the existing registered Community design identified in the invalidation notice must be declared invalid to the same extent as the existing registered Community design, unless the registrar directs otherwise.

(4) Where the registrar has received an invalidation notice from a person other than the proprietor of the re-registered design which derives from the existing registered Community design, the registrar must as soon as reasonably practicable after receipt of the invalidation notice—

(a) send a copy of the invalidation notice to the proprietor of the re-registered design which derives from the existing registered Community design identified in the invalidation notice, and

(b) notify the proprietor of the re-registered design which derives from the existing registered Community design that based upon the declaration of invalidity of the existing registered Community design, the re-registered design will be declared invalid to the same extent as the existing registered Community design from which it derives.

(5) Where the registrar has become aware of the situation referred to in paragraph 9A of Schedule 1A otherwise than by an invalidation notice, the registrar must as soon as reasonably practicable after becoming aware of

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that situation notify the proprietor of the re-registered design which derives from the existing registered Community design in the terms provided in paragraph (4)(b).

(6) The proprietor of the re-registered design referred to in paragraphs (4) and (5) must, within such period of not less than one month as may be specified in the notice referred to in paragraphs (4)(b) and 5, send to the registrar a derogation notice accompanied by a statement and supporting evidence as referred to in paragraph (2), failing which the registration of the re-registered design must be declared invalid to the same extent as the registered Community design from which the re-registered design derives, unless the registrar directs otherwise.

(7) The registrar must, in reaching a decision as to whether paragraph 9A of Schedule 1A applies to a re-registered design, have regard to the statement and supporting evidence filed by the proprietor of the re-registered design and must send written notice of the decision to the proprietor, stating the reasons for that decision.

(8) For the purposes of any appeal against a decision referred to in sub- paragraph (7), the date on which the notice is sent must be taken to be the date of the decision.

(c) in rule 27(e) of the Registered Designs Rules (as prospectively inserted by paragraph 6(b)), for “exit day” substitute “IP completion day”;

(d) for paragraph 8 substitute—

8.—(1) Rule 42 (address for service) is amended as follows. (2) At the end of sub-paragraph (c) omit “, or” and substitute “;”. (3) After sub-paragraph (1)(c) insert—

“(d) a proprietor of a re-registered design who sends a derogation notice to the registrar under rule 15A.”.

(4) In paragraph (4), for “another EEA state” substitute “an EEA state”. ”; (e) after paragraph 8 insert—

9.—(1) Rule 43 (failure to furnish an address for service) is amended as follows. (2) At the end of sub-paragraph 4(c) omit “, or” and substitute “;”. (3) After sub-paragraph (4)(c) insert—

“(d) in the case of a proprietor who sends a derogation notice to the registrar, the registrar must proceed as if the proprietor had not sent a derogation notice.

25. In Schedule 8, Part 1 (Further amendments to the 1949 Act), omit paragraph 7.

PART 6 Amendments to the Patents (Amendment) (EU Exit) Regulations 2019

26. The Patents (Amendment) (EU Exit) Regulations 2019(14) are amended in accordance with this Part.

(14) S.I. 2019/801. 12

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27. For regulation 3(a) and (b), substitute— “(a) in the heading for “EU compulsory”, substitute “Compulsory pharmaceutical”; (b) in subsection (1), for “an “EU compulsory”, substitute “a “compulsory

pharmaceutical”;”.

28. Omit regulation 4.

29. For the definition of “plant breeders’ right” substituted by regulation 7(2)(c), substitute— ““plant breeders’ right” means— (a) any right granted under, or having effect as if granted under, section 3 of the 1997 Act

(including existing rights as defined by section 40(4) of that Act); and (b) any right which by virtue of regulation 3 of the Plant Breeders’ Rights (Amendment

etc.) (EU Exit) Regulations 2019(15) is treated as if it were a plant breeders’ right granted in accordance with the 1997 Act and as if the variety were registered in accordance with regulations under section 18(1)(c) of the 1997 Act;”.

30. Omit regulation 17.

31. In the insertion after paragraph 10 of Regulation (EC) No 1610/96 made by regulation 20(3), for paragraph 12 substitute—

12. ‘court’ means— (a) as respects England and Wales, the High Court; (b) as respects Scotland, the Court of Session; (c) as respects Northern Ireland, the High Court in Northern Ireland.”.

32. Omit regulation 21.

33. In regulation 24(3), in the insertion of paragraph 8(1)(b), for “Part A section 1, points 1 to 7 or Part B, Section 1 points 1 to 5”, substitute “Part A section 1, points 1.1 to 1.7 or Part B, Section 1 points 1.1 to 1.4.3”.

34. In Regulation 52(3) in the insertion after Article 1(e) of Regulation (EC) No 469/2009— (a) for paragraph (g), substitute—

“(g) ‘court’ means— (i) as respects England and Wales, the High Court;

(ii) as respects Scotland, the Court of Session; (iii) as respects Northern Ireland, the High Court in Northern Ireland;” and

(b) in paragraph (j), after “granted” insert “or having effect as if granted”.

35. Omit regulation 53.

36. In regulation 62, omit “before”.

37. In regulation 69, for “exit day” in each place it occurs, substitute “IP completion day”.

(15) S.I. 2019/204. 13

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PART 7 Amendments to the Patents Act 1977

38. The Patents Act 1977(16) is amended as follows.

39. In Schedule A1— (a) in paragraph 1, omit the definition of “Council Regulation”; (b) in paragraph 3(3), for “Article 14(3) fourth indent of the Council Regulation”, substitute

“regulation 20A of the Plant Breeders’ Rights Regulations 1998(17)”; (c) in paragraph 4, for “Article 14(3) third indent of the Council Regulation”, substitute

“section 9(10) of the Plant Varieties Act 1997(18)”.

PART 8 Amendments to Regulation (EC) No 469/2009 and related amendments

Amendments to Regulation (EC) No 469/2009

40. Regulation (EC) No 469/2009(19) of the European Parliament and of the Council of 6th May 2009 concerning the supplementary protection certificate for medicinal products is amended as set out in the Schedule.

Amendment to Regulation (EU) No 2019/933

41.—(1) Regulation (EU) 2019/933 of the European Parliament and of the Council of 20th May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products is amended as follows.

(2) After Article 2 (entry into force), omit “This Regulation shall be binding in its entirety and directly applicable in all Member States.”.

Amendment to the Patents Rules 2007

42. In the Patents Rules 2007(20), after rule 116, insert—

Notifications relating to supplementary protection certificates

116A. Notifications under Article 5(2)(b) and (c) of the Medicinal Products Regulation must be made on Patents Form SP5.”.

Transitional provisions

43.—(1) Paragraph (2) applies where, before IP completion day, a product or a medicinal product containing that product, as defined in Article 1 of Regulation EC (No) 469/2009, is marked in accordance with that Regulation with the logo set out in Annex -I of that Regulation.

(2) That product or medicinal product containing that product so marked is not required, after these Regulations come into force, to have the words “UK export” affixed to it.

(16) 1977 c. 37. (17) S.I. 1998/1027. Regulation 20A is prospectively inserted into the1998 Regulations by S.I. 2019/204, reg 17(5). (18) 1997 c. 66. Section 9(10) is prospectively inserted into the 1997 Act by S.I. 2019/204, reg 15(2)(c). (19) OJ L152, 16.6.2009, p.1 amended by Regulation (EU) 2019/933, OJ L153, 11.6.2019, p.1. (20) S.I. 2007/3291, as amended by 2011/2052; there are other amending instruments but none are relevant.

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(3) Paragraph (4) applies where, before IP completion day, a notification is made to the Comptroller-General of Patents, Designs and Trade Marks in the form set out in Annex -Ia of Regulation (EC) No 469/2009.

(4) That notification is to be treated, on and after IP completion day, as a notification made— (a) on Patents Form SP5; and (b) on the same date as the notification made on the form set out in that Annex -Ia.

22nd September 2020

Amanda Solloway Parliamentary Under Secretary

Department for Business, Energy and Industrial Strategy

We consent to the making of these Regulations

28th September 2020

Maggie Throup Rebecca Harris

Two of the Lords Commissioners of Her Majesty’s Treasury

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SCHEDULE Regulation 40

Amendments to Regulation (EC) No 469/2009

Interpretation of Schedule

1. In this Schedule, a reference to an Article, paragraph, point or Annex is to that of Regulation (EC) No 469/2009.

Article 1: definitions

2. In Article 1, in relation to the definition of “maker”— (a) for “Union”, substitute “United Kingdom”; (b) omit “third”; (c) after “countries”, insert “outside the United Kingdom, the Isle of Man and the Member

States of the European Union”; and (d) renumber that definition as paragraph (k) and insert after the definition of “UK

authorisation(21)”.

Article 5: effects of the certificate

3. In Article 5— (a) in paragraph 2(a)—

(i) in point (i)— (aa) omit “third”; and (bb) after “countries”, insert “outside the United Kingdom, the Isle of Man and

the Member States of the European Union”; (ii) in point (ii), for “Union”, substitute “United Kingdom”;

(iii) in point (iii)— (aa) for “Member State of making”, substitute “United Kingdom”; (bb) for “Member States”, substitute “the United Kingdom, the Isle of Man or

one or more Member States of the European Union”; (iv) in point (iv), for “Union”, substitute “United Kingdom”;

(b) in paragraph 2(b)— (i) for “authority” to “take place”, substitute “comptroller”;

(ii) for “that Member State”, substitute “the United Kingdom”; (iii) for “a”, where it appears before the last occurrence of “certificate”, substitute “that”;

(c) in paragraph 2(c), for “authority referred to in Article 9(1)”, substitute “comptroller”; (d) in paragraph 2(d)—

(i) omit “third”; (ii) after “countries”, insert “outside the United Kingdom, the Isle of Man and the

Member States of the European Union”; (iii) for “a logo, in the form set out in Annex -I, is affixed”, substitute “the words ‘UK

export’ are affixed so as to be sufficiently clear and visible to the naked eye”;

(21) The definition of “UK authorisation” is inserted by S.I. 2019/801. 16

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(e) in paragraph 2(e), omit from “and” to the end of the sentence; (f) in paragraph 3, for “Union”, substitute “United Kingdom”; (g) in paragraph 5—

(i) omit point (c); (ii) in point (d), omit from “granted” the first time it appears to “making” the second

time it appears; (iii) in point (e)—

(aa) omit “third”, both times it appears; (bb) after “countries”, insert “outside the United Kingdom, the Isle of Man and

the Member States of the European Union”; (h) in paragraph 6—

(i) for “authority”, substitute “comptroller”; (ii) for “contained in Annex -Ia”, substitute “prescribed by rules made under section 123

of the Patents Act 1977”; (i) in paragraph 7—

(i) omit “third”; (ii) after “country”, the first time it appears, insert “outside the United Kingdom, the Isle

of Man and the Member States of the European Union”; (j) omit paragraph 8, including its footnote; (k) after paragraph 10, insert—

11. The Secretary of State may by regulations make further provision as to the manner and form (including design and colour) of affixing the words “UK export” to the outer packaging of the product, or the medicinal product containing that product, referred to in paragraph 2(a)(i) of this Article, and, where feasible, to its immediate packaging.

12. Those regulations are to be made by statutory instrument which is subject to annulment pursuant to a resolution of either House of Parliament.”.

Article 11: publication

4. In Article 11(4)— (a) for “authority referred to in Article 9(1)”, substitute “comptroller”; (b) for “It”, substitute “The comptroller”.

Article 21a: evaluation

5. Omit Article 21a.

Annex -I and Annex -I: logo and standard form

6. Omit Annex -I and Annex -Ia.

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EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the following statutory instruments (the “existing regulations”) which were made as a consequence of the United Kingdom exiting the European Union:

The Intellectual Property (Exhaustion of Rights) (EU Exit) Regulations 2019 (S.I. 2019/265); The Trade Marks (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/269) (“the Trade Marks Regulations”); The Intellectual Property (Copyright and Related Rights) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/605) (“the Copyright Regulations”); The Designs and International Trade Marks (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/638) (“the Designs Regulations”); and The Patents (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/801) (“the Patents Regulations”).

These Regulations substitute “IP completion day” for the various references to “exit day” in the existing regulations (“IP completion day” is defined in the European Union (Withdrawal Agreement) Act 2020 (c.1) (“the 2020 Act”) as 11pm on 31st December 2020). This will ensure that the provisions in the existing regulations will take effect by reference to IP completion day rather than exit day. The existing regulations will come into force on IP completion day by operation of paragraph 1 of Schedule 5 to the 2020 Act. These Regulations also amend certain errors contained in the existing regulations. For example, Part 2 corrects an error where a reference to Schedule ZA1 to the Copyright, Designs & Patents Act 1988 had been inadvertently retained in regulation 31(a) of the Copyright Regulations despite its deletion from that Act by another provision of the Copyright Regulations. Part 4 amends the Trade Marks Regulations to make further changes to the Trade Marks Act 1994 (“the 1994 Act”) and the Trade Marks Rules 2008 to implement Article 54(3) of the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community signed on 24th January 2020 (“the Withdrawal Agreement”), insofar as it relates to European Union trade marks. The Trade Marks Regulations provide that a European Union trade mark (“an existing EUTM”) which is registered immediately before exit day (now amended to “IP completion day”) is to be treated on and after that day as if it were a trade mark registered under the 1994 Act (“a comparable trade mark (EU)”). New paragraph 21A of Schedule 2A to the 1994 Act applies where on IP completion day an existing EUTM is the subject of revocation or invalidity proceedings, which after IP completion day results in the revocation of or a declaration of invalidity in respect of the existing EUTM. Where the registrar (as defined in the 1994 Act) receives notice or otherwise becomes aware of such revocation or declaration of invalidity, the comparable trade mark (EU) which derives from the existing EUTM must be revoked or declared invalid to the same extent as the existing EUTM and with effect from the same date except where the grounds on which the existing EUTM was revoked or declared invalid would not have applied had the proceedings been brought against the comparable trade mark (EU) under the 1994 Act. New rule 43A of the Trade Marks Rules 2008 (S.I. 2008/1797) sets out the procedural matters which apply where the registrar receives notice or otherwise becomes aware of the revocation of or declaration of invalidity in respect of an existing EUTM.

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Part 5 amends the Designs Regulations to make further changes to the Registered Designs Act 1949 (“the 1949 Act”) and the Registered Designs Rules 2006 to implement Article 54(3) of the Withdrawal Agreement insofar as it relates to registered Community designs. The Designs Regulations provide that a registered Community design (“an existing registered Community design”) which is registered immediately before exit day (now amended to “IP completion day”) is to be treated on and after that day as if it were a design registered under the 1949 Act (“a re- registered design”). New paragraph 9A of Schedule 1A to the 1949 Act applies where on IP completion day an existing registered Community design is the subject of invalidity proceedings, which after IP completion day results in a declaration of invalidity. Where the registrar (as defined in the 1949 Act) receives notice or otherwise becomes aware of such declaration of invalidity, the re-registered design which derives from the existing registered Community design must be declared invalid to the same extent as the existing registered Community design and with effect from the same date, except where the grounds on which the existing registered Community design was declared invalid would not have applied had the proceedings been brought against the re-registered design under the 1949 Act. New rule 15A of the Registered Designs Rules 2006 (S.I. 2006/1975) sets out the procedural matters which apply where the registrar receives notice or otherwise becomes aware of the declaration of invalidity in respect of an existing registered Community design. Part 6 amends the Patents Regulations to correct minor errors, to acknowledge the treatment of Community plant variety rights as plant breeders’ rights by virtue of the Plant Breeders’ Rights (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/204) (“the Plant Breeders’ Regulations”), and to update transitional provisions to refer to IP completion day. Part 7 amends the Patents Act 1977 to replace references to EU law with equivalent domestic legislation, aligning with amendments made by the Plant Breeders’ Regulations. Part 8 and the Schedule relate to supplementary protection certificates for medicinal products and arise out of changes made by Regulation (EU) 2019/933 of the European Parliament and of the Council of 20th May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products. Part 8 amends Regulation 2019/933 and the Patents Rules 2007 (S.I. 2007/3291) and contains transitional provisions. The Schedule amends Regulation (EC) No 469/2009 to address inoperabilities occurring as a result of the aforementioned changes. An impact assessment has not been produced for this instrument as no, or no significant, impact on the private, public and voluntary sectors is foreseen. An explanatory memorandum is available alongside this instrument on the Legislation UK website at www.legislation.gov.uk.

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 The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020

DExEU/EM/7-2018.2 1

EXPLANATORY MEMORANDUM TO

THE INTELLECTUAL PROPERTY (AMENDMENT ETC.) (EU EXIT)

REGULATIONS 2020

2020 No. 1050

1. Introduction

1.1 This explanatory memorandum has been prepared by the Intellectual Property Office

(IPO), an executive agency of the Department for Business, Energy & Industrial

Strategy, and is laid before Parliament by Act.

1.2 This memorandum contains information for the Joint Committee on Statutory

Instruments.

2. Purpose of the instrument

2.1 This instrument amends a number of pieces of intellectual property (IP) legislation

which were made in 2019 in preparation for a potential “no deal” exit from the EU

and the expected retention of EU law as domestic law at that point. This legislation is

listed in paragraph 6.3 and is referred to collectively as “the 2019 Regulations” in this

memorandum.

2.2 As the UK has left the EU under the terms of the Withdrawal Agreement, the retention

of EU law will now take place at the end of the transition period1. The provisions in

this instrument reflect commitments made in the Withdrawal Agreement and ensure

that the retained EU law will continue to function effectively, taking account of the

transition period. They also deal with inoperabilities arising from new EU law which

entered into force during the extended Article 50 period and correct some minor

errors in the 2019 Regulations.

Explanations

What did any relevant EU law do before exit day?

2.3 In brief, and as explained further in paragraphs 7.7, 7.11, 7.15-7.16, and 7.25, the

relevant EU law:

• provided a framework for the EU trade mark;

• established a system of EU-wide registered and unregistered designs;

• provided for a supplementary protection certificate (SPC) system for patented

pharmaceuticals and agrochemicals;

• developed the principle of a regional regime for the exhaustion of IP rights;

and

• established an IP right for databases.

2.4 As set out in more detail in paragraphs 7.8, 7.12, 7.17 and 7.26, these pieces of EU

law were the subject of amendments by the 2019 Regulations, which, amongst other

things:

1 This point in time is defined in s.1A of the European Union (Withdrawal) Act 2018 as “IP completion day”.

DExEU/EM/7-2018.2 2

• created comparable UK intellectual property rights in place of EU trade marks,

registered designs and unregistered designs which would have ceased to have

protection on exit day, including rights which have been protected at an

international level;

• enabled the filing of new UK applications for trade marks and designs where

EU or international applications would have still been pending on exit day

whilst retaining the relevant filing date;

• provided for the continued functioning of the SPC system;

• ensured that goods whose IP rights should be treated as exhausted remain so;

and

• limited eligibility for new database rights to UK nationals while providing for

continued protection of database rights held by EEA individuals and

businesses that were in force on exit day.

2.5 After the 2019 Regulations were made, Regulation (EU) 2019/933 amending

Regulation (EC) No 469/2009 concerning the supplementary protection certificate for

medicinal products2 introduced what is known as the “manufacturing waiver” to the

SPC system. As explained further in paragraph 7.27, this enables third parties to

manufacture SPC-protected products without requiring the consent of the SPC holder,

but only for export outside the EU or for storing in the EU for sale on the EU market

after the SPC has expired. Doing so will not infringe the SPC right.

Why is it being changed?

2.6 The 2019 Regulations do not reflect that there is now a transition period in which EU

law continues to apply in the UK - if they came into force, they would retroactively

make changes as from exit day; 31 January 2020. They also do not address the

commitments made in the Withdrawal Agreement or provide fixes to any

inoperabilities in new EU law which will be retained at the end of the transition

period.

2.7 This last point applies to the manufacturing waiver specifically. The retained EU law

would not be clear on how the waiver would apply in the UK after the transition

period; there would be uncertainty about what actions third parties could take without

infringing the SPC, and without prompting legal action from the rightsholder.

What will it now do?

2.8 For the most part, the changes ensure that the provisions of the 2019 Regulations will

apply with effect from the end of the transition period as opposed to exit day. This

will ensure that, in particular, any EU IP rights arising during that period will be

properly protected in the UK going forward.

2.9 In relation to trade marks and designs, the changes also implement commitments

contained in the Withdrawal Agreement so that, as set out in paragraphs 7.22-7.23,

certain decisions taken by EU bodies or courts on the validity of such rights are

recognised in the UK.

2.10 In relation to the manufacturing waiver, as set out in paragraph 7.29, the retained law

will allow third parties to manufacture SPC-protected products in the UK, without the

2 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2019.153.01.0001.01.ENG

DExEU/EM/7-2018.2 3

rightsholder’s consent, either for export outside of the UK or EU or for stockpiling in

the UK for sale in the UK or EU once the SPC has expired.

3. Matters of special interest to Parliament

Matters of special interest to the Joint Committee on Statutory Instruments

3.1 This instrument corrects several drafting errors identified in the 2019 Regulations. In

particular:

• regulation 3 fixes an error where a reference was retained to a schedule which

was repealed in the same instrument;

• regulation 19(b) corrects a provision where the wrong type of unregistered

design was named;

• regulation 23 fixes an error where the period in which no additional fees are

due for renewing a converted EU registered design was set to expire, rather

than begin, on a specific date; and

• regulation 25 fixes an error where a conflicting amendment was made to the

underlying Act by two different sets of amending regulations.

Other provisions fix typographical errors.

3.2 The Department and the IPO have therefore followed the requirement in paragraph

4.7.6 of Statutory Instrument Practice to consult the SI Registrar, and the free issue

procedure has been applied because of the length and mix of the new and correcting

provisions.

Matters relevant to Standing Orders Nos. 83P and 83T of the Standing Orders of the House

of Commons relating to Public Business (English Votes for English Laws)

3.3 The territorial application of this instrument includes Scotland and Northern Ireland.

3.4 The powers under which this instrument is made cover the entire United Kingdom

(see section 24(1) of the European Union (Withdrawal) Act 2018) and the territorial

application of this instrument is not limited either by the Act or by the instrument.

4. Extent and Territorial Application

4.1 The territorial extent of this instrument is all of the United Kingdom.

4.2 The territorial application of this instrument is to all of the United Kingdom.

5. European Convention on Human Rights

5.1 The Parliamentary Under Secretary of State (Minister for Science, Research and

Innovation), Amanda Solloway MP, has made the following statement regarding

Human Rights:

“In my view the provisions of the Intellectual Property (Amendment etc.) (EU Exit)

Regulations 2020 are compatible with the Convention rights.”

6. Legislative Context

6.1 These regulations are made primarily under section 8 of the European Union

(Withdrawal) Act 2018 (EUWA). This allows a Minister to make regulations to

resolve any deficiencies in law that arise as a result of the UK’s departure from the

European Union, including in EU law which continues to form part of domestic law at

DExEU/EM/7-2018.2 4

the end of the transition period under section 2 and 3 of the EUWA (namely the

saving of EU-derived domestic legislation and the incorporation of direct EU

legislation) and under section 4 (which relates to certain enforceable EU rights).

6.2 The European Union (Withdrawal Agreement) Act 2020 (WAA) amended the powers

in section 8 EUWA to include the ability to deal with any deficiencies in law which

arise as a result of the transition period. It also added section 8B, which allows a

Minister to make regulations to implement the provisions set out in Part 3 of the

Withdrawal Agreement. These Regulations are also made under section 8B.

6.3 As part of the Government’s legislative programme to prepare for a “no deal”

outcome, five statutory instruments relating to intellectual property were laid before

Parliament in 2019 and approved (the 2019 Regulations)3. These instruments, which

relied upon the power in section 8 EUWA, are:

• The Intellectual Property (Exhaustion of Rights) (EU Exit) Regulations 2019

(SI 2019/265; “the Exhaustion Regulations”),

• The Trade Marks (Amendment etc.) (EU Exit) Regulations 2019 (SI

2019/269; “the Trade Mark Regulations”),

• The Intellectual Property (Copyright and Related Rights) (Amendment) (EU

Exit) Regulations 2019 (SI 2019/605; “the Copyright Regulations”),

• The Designs and International Trade Marks (Amendment etc.) (EU Exit)

Regulations 2019 (SI 2019/638; “the Designs Regulations”), and

• The Patents (Amendment) (EU Exit) Regulations 2019 (SI 2019/801; “the

Patents Regulations”).

6.4 Parts 1 to 6 of these Regulations amend each of these instruments, whilst Parts 7 and 8

make new changes to the Patents Act 1977 and Regulation 469/2009.

7. Policy background

What is being done and why?

7.1 The UK has left the EU under the terms of the Withdrawal Agreement, and there is

now a transition period until the end of 2020 while the UK and EU negotiate

additional arrangements. The current rules on trade, travel, and business for the UK

and EU continue to apply during the transition period.

7.2 The 2019 Regulations were drafted and designed to function in the event that the UK

left the EU without an agreement being reached by exit day. They do not reflect the

legal situation that now exists following the UK’s entry into the Withdrawal

Agreement. This instrument is needed to ensure that the law properly reflects the

obligations in the Withdrawal Agreement, and to ensure that it otherwise works

effectively at the end of the transition period.

7.3 Because the 2019 Regulations take a similar approach to the arrangements set out in

the Withdrawal Agreement, the legislative gap between the two is minimal. This

instrument will ensure that the arrangements set out in the Withdrawal Agreement are

fully implemented.

3 An additional instrument, the Design Right (Semiconductor Topographies) (Amendment) (EU Exit)

Regulations 2018 (SI 2018/1052), was made in 2018, but is not amended by this draft instrument.

DExEU/EM/7-2018.2 5

7.4 As the 2019 Regulations were intended to take effect on exit day, they do not take

account of the transition period, or that EU law now continues to apply until the end

of that period. The WAA has deferred the coming into force of instruments made

under the EUWA, including the 2019 Regulations, by glossing their commencement

provisions so that they refer to IP completion day instead of exit day4. However, this

change does not extend to other references to exit day in the 2019 Regulations (such

as in transitional provisions). If those references are not updated when the 2019

Regulations come into force, the law will be changed retroactively and rights which

currently exist may not be properly recognised.

7.5 In addition, the 2019 Regulations could only operate on the UK and EU law as it

stood at the time they were made. Any new legislation, or any amendment to existing

legislation, since that time needs to be accounted for and, if necessary, any

inoperabilities addressed. As far as possible, the approach remains to ensure that the

law which currently applies in the UK will continue to do so at the end of the

transition period, to ensure continuity and certainty for businesses and rightsholders.

7.6 This instrument covers a number of different IP rights. The specific policy

background to each is explored in more detail in the following sections.

Copyright and database rights

7.7 Database rights are a form of IP protection unique to EU law. They give database

creators the right to prevent others copying or sharing the contents of their databases

where a substantial investment has been made in obtaining, verifying or presenting

the data. The right is automatic and unregistered; however, only databases made by

EEA nationals, residents and businesses are eligible for the right.

7.8 Among other things, the Copyright Regulations amended the retained EU law on

database rights so that only databases created by UK nationals, residents and

businesses will be eligible for the right in the UK after exit day. However, it included

a transitional provision (regulation 38) which ensured that any database rights existing

before exit day would continue to be recognised for the remainder of their duration,

including those made by EEA nationals, residents or businesses.

7.9 Article 58 of the Withdrawal Agreement requires the UK to continue to recognise any

database rights which arose before the end of the transition period. As the Copyright

Regulations only do so for database rights from EEA makers that existed before exit

day, an amendment is needed to ensure any rights arising during the transition period

are properly protected. Regulation 4 does this by changing the provision to cover any

database right existing before IP completion day.

7.10 In addition, regulation 3 corrects an error in the Copyright Regulations in relation to

orphan works (orphan works are copyright works where one or more rightsholders are

unknown or cannot be found). A reference to Schedule ZA1 to the Copyright, Designs

& Patents Act 1988 had been inadvertently retained in regulation 31(a), despite its

deletion from that Act by an earlier provision of the Copyright Regulations.

Exhaustion of rights

7.11 IP rights are said to be “exhausted” if the IP-protected product has been first sold with

the approval of the rightsholder. As a result, the rightsholder cannot use their IP rights

to prevent the product being resold. In the EU, exhaustion occurs if the product is

4 As provided in paragraph 1(1) of schedule 5 to the WAA.

DExEU/EM/7-2018.2 6

lawfully sold anywhere in the EEA; the product can be resold freely within the EEA

and the rightsholder cannot stop it moving between Member States even if they have

IP rights in a particular country. This forms part of the principle of free movement of

goods set out in the EU treaties.

7.12 The Exhaustion Regulations preserved the effect of the EEA exhaustion regime in the

UK by reference to the retention of EU law and enforceable rights in the EUWA on

exit day. This meant that the IP rights of any product lawfully sold in the EEA, either

before or after exit day, would continue to be treated as having been exhausted in the

UK.

7.13 Article 61 of the Withdrawal Agreement commits the UK and the EU to recognise that

any IP rights which are exhausted before the end of the transition period will continue

to be treated as such.

7.14 Regulation 6 replaces references to “exit day” in the Exhaustion Regulations with “IP

completion day”. This ensures that, although any products sold during the transition

period would be correctly treated as exhausted under the existing provision, the rights

which are enforceable are those which are available at the end of the transition period.

This also provides legal certainty.

Trade marks, registered designs and unregistered designs

7.15 Trade marks and designs are intellectual property rights that distinguish the goods or

services from one trader to another, or protect the appearance of a product,

respectively. EU law provides for EU-wide trade marks, registered and unregistered

designs, the first two of which are granted by the EU Intellectual Property Office

(EUIPO). These rights will cease to apply in the UK when it is no longer treated as an

EU Member State, although they continue to have effect during the transition period.

7.16 EU-wide protection of trade marks and registered designs can also be obtained by

applying through the World Intellectual Property Organisation and designating the

territories in which protection is sought. International trade marks and designs

designating the EU will also cease to apply in the UK when it is no longer treated as

an EU Member State.

7.17 The Trade Mark Regulations and the Designs Regulations provided for comparable

rights to be granted under UK law for any EU trade marks or designs, or international

rights designating the EU, that were in force on exit day. They also enabled new UK

applications to be filed where an application for an EU right was pending on exit day,

retaining the original filing date of the EU application.

7.18 Articles 54-57 and 59 of the Withdrawal Agreement require the UK to take these

measures for EU rights in force, and applications pending, at the end of the transition

period. This instrument therefore amends the Trade Mark Regulations and the

Designs Regulations so that the grant of comparable rights and the right to file

replacement applications both operate with effect from IP completion day, rather than

exit day.

7.19 Failing to do so would mean that any EU rights which were granted during the

transition period would not be converted and could potentially be lost - this could be

as many as 200,000 rights.

7.20 The amendments in Parts 4 and 5 make the necessary substitutions.

DExEU/EM/7-2018.2 7

7.21 In addition, some minor errors found in the two sets of regulations have been

corrected. Regulation 19(b) provides a fix so that UK “design courts” correctly have

exclusive jurisdiction over converted EU unregistered designs. Regulation 23 corrects

an error in the Designs Regulations so that the period where no additional fees would

be due on top of the applicable fee to renew a converted EU registered design is

correctly set at six months, instead of one day as originally, inadvertently, drafted.

Regulation 25 corrects a conflict of amendments between the Design Regulations and

the Exhaustion Regulations.

7.22 Third parties can challenge the registration of an EU trade mark or registered design at

the EUIPO, or as a counterclaim in infringement actions heard before courts

designated as EU courts in Member States; the right may be cancelled or reduced in

scope if the challenge is successful. Article 54(3) of the Withdrawal Agreement

requires the UK to honour decisions made by the EUIPO, the CJEU on appeal from

the EUIPO, or Member State courts on cancellation actions which were in progress at

the end of the transition period, and to apply the decision to the comparable UK right.

This means that successful parties will not need to launch a separate cancellation

action in the UK. There is an exception where the grounds for revocation/invalidity

would not apply if considered under UK law.

7.23 Regulations 9(b)(ii) and 11 (for trade marks) and 21(c)(ii) and 24 (for registered

designs) provide for the IPO to take account of cancellation decisions on the EU

rights, to determine if the exception applies based on evidence from the rightsholder,

and to take action on the comparable right. A right of appeal is provided against the

decision of the IPO on whether the exception applies.

Patents and supplementary protection certificates

7.24 A patent protects an invention and lets the owner of that patent take legal action

against anyone who makes, uses, sells or imports that invention without the owner’s

permission – this is known as infringement of the patent. A patent can provide such

protection for up to twenty years.

7.25 Supplementary protection certificates (SPCs) provide a period of additional protection

for patented medicines and agrochemicals, to compensate for the need for lengthy

regulatory approval procedures during the patent lifetime before the product can be

sold and research investment recouped. The SPC gives the approved product the same

rights and protection as the patent, subject to the same limitations, for up to five years

after the patent expires. SPCs are provided by EU Regulations but operate as

individual national rights.

7.26 The Patents Regulations, amongst other things, ensured that the retained EU SPC

Regulations would continue to function as domestic law, replacing references to EU

regulatory legislation with their UK equivalents and ensuring that the method for

calculation of an SPC’s duration would remain the same. The provisions of the

Patents Regulations do not, in general, refer to “exit day”, and so do not need

changing to be able to work correctly when brought into force at the end of the

transition period.

7.27 In July 2019 - during the extended Article 50 period - the EU introduced a new

exception to the rights provided by an SPC. This “manufacturing waiver” allows third

parties to manufacture SPC-protected medicinal products, without needing the

permission of the SPC holder. The product can only be manufactured for export to

countries outside the EU where protection does not exist or has expired, or (in the

DExEU/EM/7-2018.2 8

final 6 months of the SPC term) for storing the product in the Member State of

making (“stockpiling”), ready for sale in the EU when the corresponding SPC expires.

Acts which are necessary for the manufacture of the product, its export or storage, are

also permitted as these too would otherwise infringe the protection provided by the

SPC. The product must be specifically labelled with an “EU export” logo so it can be

identified as having been made under the waiver; this is intended to prevent illicit

diversion of the product back onto the EU market.

7.28 Article 60 of the Withdrawal Agreement requires that any applications for an SPC

which are pending at the end of the transition period should be considered in

accordance with the EU law in force at that time, and any SPC granted based on those

applications should provide for the same level of protection provided for in EU law.

This will now need to include the manufacturing waiver.

7.29 Regulations 40-43 and the accompanying Schedule make additional amendments to

Regulation 469/2009 to fix inoperabilities in the manufacturing waiver legislation and

make consequential amendments to other legislation. These maintain the scope of the

waiver so that third parties can manufacture SPC-protected products in the UK,

without the rightsholder’s consent, either for export outside of the UK or EU or (in the

final 6 months of the SPC term) for stockpiling in the UK for sale in the UK or EU

once the SPC has expired. This means that the scope of the waiver within the UK will

remain essentially unchanged at the end of the transition period.

7.30 Paragraph 3(d) of the Schedule changes the labelling requirement so that the product

must be identified with “UK export” wording; this allows it to be distinguished from

one made in the EU under its waiver. Paragraph 3(k) provides a power to further

regulate the form and manner of that wording by negative statutory instrument, whilst

a transitional provision in regulation 43 ensures that any product which has already

been manufactured under the waiver does not require relabelling. The provision also

preserves the effect of any notification of intention to use the waiver filed before the

end of the transition period; as regulation 42 amends the Patents Rules 2007 to

designate a specific form for such notifications after 1 January 2021.

7.31 Beyond the manufacturing waiver, Article 60 of the Withdrawal Agreement also

applies to applications to extend the duration of an SPC for a medicine which has

been tested for paediatric use; regulation 37 updates transitional provisions in the

Patents Regulations so that they apply to applications pending at the end of the

transition period, as well as extensions already granted.

7.32 In addition, some small changes have been made to other provisions of the Patents

Regulations, to correct minor typographical errors and update cross-references to

other domestic law. Regulation 29 ensures that plant breeders’ rights which have been

converted from Community plant variety rights are able to be cross-licensed.

Regulations 28 and 39 replace a provision which preserved pre-exit day EU

legislation with a cross-reference to equivalent domestic definitions.

8. European Union (Withdrawal) Act/Withdrawal of the United Kingdom from the

European Union

8.1 This instrument is being made using the power in section 8 of the European Union

(Withdrawal) Act 2018 in order to address failures of retained EU law to operate

effectively or other deficiencies arising from the withdrawal of the United Kingdom

from the European Union. The instrument is also made under the powers in section

8B of that Act in order to implement provisions in Part 3 of the Withdrawal

DExEU/EM/7-2018.2 9

Agreement. In accordance with the requirements of that Act the Minister has made the

relevant statements as detailed in Part 2 of the Annex to this Explanatory

Memorandum.

9. Consolidation

9.1 No consolidation of the relevant legislation is planned at present. Informal

consolidated texts of domestic intellectual property legislation are publicly available

for free on the gov.uk website5. The Intellectual Property Office is considering

whether informal consolidation of the retained EU law as amended by this instrument

will be necessary.

10. Consultation outcome

10.1 In relation to the manufacturing waiver, a public call for views was issued, seeking

feedback on draft legislation to fix the inoperabilities in the EU law in the event of a

“no deal” outcome6. The call for views was open from 5 July 2019 to 9 August 2019.

In addition, meetings were held with major representative bodies from the innovative

pharmaceutical industry, the manufacturers of generic pharmaceuticals, and the patent

attorney profession during the period to discuss the proposed draft.

10.2 Six responses were received before the call for views closed, from representative

organizations of rightsholders, pharmaceutical innovators, legal representatives, and

the generics industry. All of the respondents were in favour of ensuring the proper

functioning of the waiver and avoiding legal uncertainty. Most of the respondents

highlighted the importance of preserving the status quo regarding the territory to

which export could take place; the consultation draft would have allowed manufacture

for export to any country outside the UK. Other issues raised included the requirement

for a logo or other indication on the packaging for medicines intended for export and

the need for transitional arrangements.

10.3 In response to the feedback received, the Government made changes to the drafting of

the provisions to maintain the current markets for export and stockpiling, to provide

powers to allow for additional labelling requirements if necessary, and to include

additional transitional arrangements covering use of forms and the use of the pre-

existing labelling requirements on any products manufactured before the end of the

transition period. The drafting was then incorporated into this instrument.

10.4 The Government response to the call for views was published on 13 July 20206;

publication was initially delayed because the ratification of the Withdrawal

Agreement made it necessary to reassess the drafting of both the response and the

legislation itself. The Government’s focus on prioritising communications relating to

coronavirus necessitated a further delay.

10.5 As the other changes were largely technical and minor in nature, in line with Cabinet

Office principles on consultation, a formal public consultation was not considered to

be useful in determining the Government’s approach on drafting. Informal views on

the drafting of those changes were sought from relevant stakeholders; in particular,

the provisions on cancelling trade marks and designs were provided to representative

organisations and key users of the trade mark and design systems for comment and to

5 https://www.gov.uk/topic/intellectual-property/law-practice 6 https://www.gov.uk/government/consultations/supplementary-protection-certificate-waiver-no-deal-legislation

DExEU/EM/7-2018.2 10

familiarise them with the proposed approach. Responses generally approved of the

drafting of the legislation.

11. Guidance

11.1 Guidance was published in January 2020 on the effect of the transition period on

intellectual property rights, how the law will change at the end of that period, and

what preparations businesses may need to make7. The Intellectual Property Office

expects to update that guidance to reflect the contents of this instrument once it has

been approved by Parliament.

12. Impact

12.1 There is no, or no significant, impact on business, charities or voluntary bodies.

12.2 There is no, or no significant, impact on the public sector.

12.3 An Impact Assessment has not been prepared for this instrument because the changes

being made are largely technical in nature. The Government’s assessment is that the

combined policy impacts of this instrument fall below the threshold for a formal

impact assessment; a de minimis assessment has been carried out. The instrument will

update existing EU Exit regulations that were designed for a ‘no deal’ outcome to

account for the transition period and the obligations of the Withdrawal Agreement,

and address inoperabilities in the retained EU SPC Waiver Regulation arising as a

result of EU Exit. In both cases, the changes will ensure that existing legislation

continues to operate in the same way as before. As the status quo is being maintained,

it imposes no new obligations or burdens on private, public or third sector bodies and

does not require re-familiarisation; the changes are therefore not expected to result in

costs for businesses.

12.4 Where this instrument departs from the status quo is in implementing Article 54(3) of

the Withdrawal Agreement, under which the UK is obliged to recognise the outcome

of cancellation proceedings against EU-level registered rights that are underway as of

the end of the transition period. The impact of this is expected to be a small saving for

businesses, as separate cancellation proceedings will not need to be prosecuted in both

territories. This provision is expected to impact only around 1200 registered rights.

13. Regulating small business

13.1 The legislation applies to activities that are undertaken by small businesses.

13.2 No specific action is proposed to minimise regulatory burdens on small businesses.

13.3 The basis for the final decision on what action to take to assist small businesses is that,

as the principal purpose of the instrument is to maintain the status quo, it introduces

no new burdens to small businesses that need to be mitigated.

14. Monitoring & review

14.1 The approach to monitoring of this legislation is to assess the effect of the changes

being made as part of the course of normal departmental business.

14.2 As this instrument is made under the EU Withdrawal Act 2018, no review clause is

required.

7 https://www.gov.uk/government/news/intellectual-property-and-the-transition-period

DExEU/EM/7-2018.2 11

15. Contact

15.1 Michael Warren at the Intellectual Property Office, Telephone: 01633 813988 or

email: Michael.Warren@ipo.gov.uk can be contacted with any queries regarding the

instrument.

15.2 James Porter, Deputy Director at the Intellectual Property Office can confirm that this

Explanatory Memorandum meets the required standard.

15.3 Amanda Solloway MP, Parliamentary Under Secretary of State at the Department for

Business, Energy & Industrial Strategy can confirm that this Explanatory

Memorandum meets the required standard.

DExEU/EM/7-2018.2 12

Annex Statements under the European Union (Withdrawal) Act

2018

Part 1

Table of Statements under the 2018 Act

This table sets out the statements that may be required under the 2018 Act.

Statement Where the requirement sits To whom it applies What it requires

Sifting Paragraphs 3(3), 3(7) and

17(3) and 17(7) of Schedule

7

Ministers of the Crown

exercising sections 8(1), 9 and

23(1) to make a Negative SI

Explain why the instrument should be

subject to the negative procedure and, if

applicable, why they disagree with the

recommendation(s) of the SLSC/Sifting

Committees

Appropriate-

ness

Sub-paragraph (2) of

paragraph 28, Schedule 7

Ministers of the Crown

exercising sections 8(1), 9 and

23(1) or jointly exercising

powers in Schedule 2

A statement that the SI does no more than

is appropriate.

Good Reasons Sub-paragraph (3) of

paragraph 28, Schedule 7

Ministers of the Crown

exercising sections 8(1), 9 and

23(1) or jointly exercising

powers in Schedule 2

Explain the good reasons for making the

instrument and that what is being done is a

reasonable course of action.

Equalities Sub-paragraphs (4) and (5)

of paragraph 28, Schedule 7

Ministers of the Crown

exercising sections 8(1), 9 and

23(1) or jointly exercising

powers in Schedule 2

Explain what, if any, amendment, repeals

or revocations are being made to the

Equalities Acts 2006 and 2010 and

legislation made under them.

State that the Minister has had due regard

to the need to eliminate discrimination and

other conduct prohibited under the

Equality Act 2010.

Explanations Sub-paragraph (6) of

paragraph 28, Schedule 7

Ministers of the Crown

exercising sections 8(1), 9 and

23(1) or jointly exercising

powers in Schedule 2

In addition to the statutory

obligation the Government has

made a political commitment

to include these statements

alongside all EUWA SIs

Explain the instrument, identify the

relevant law before exit day, explain the

instrument’s effect on retained EU law and

give information about the purpose of the

instrument, e.g., whether minor or

technical changes only are intended to the

EU retained law.

DExEU/EM/7-2018.2 13

Criminal

offences

Sub-paragraphs (3) and (7)

of paragraph 28, Schedule 7

Ministers of the Crown

exercising sections 8(1), 9, and

23(1) or jointly exercising

powers in Schedule 2 to create

a criminal offence

Set out the ‘good reasons’ for creating a

criminal offence, and the penalty attached.

Sub-

delegation

Paragraph 30, Schedule 7 Ministers of the Crown

exercising sections 10(1), 12

and part 1 of Schedule 4 to

create a legislative power

exercisable not by a Minister

of the Crown or a Devolved

Authority by Statutory

Instrument.

State why it is appropriate to create such a

sub-delegated power.

Urgency Paragraph 34, Schedule 7 Ministers of the Crown using

the urgent procedure in

paragraphs 4 or 14, Schedule

7.

Statement of the reasons for the Minister’s

opinion that the SI is urgent.

Explanations

where

amending

regulations

under 2(2)

ECA 1972

Paragraph 14, Schedule 8 Anybody making an SI after

exit day under powers outside

the European Union

(Withdrawal) Act 2018 which

modifies subordinate

legislation made under s. 2(2)

ECA

Statement explaining the good reasons for

modifying the instrument made under s.

2(2) ECA, identifying the relevant law

before exit day, and explaining the

instrument’s effect on retained EU law.

Scrutiny

statement

where

amending

regulations

under 2(2)

ECA 1972

Paragraph 15, Schedule 8 Anybody making an SI after

exit day under powers outside

the European Union

(Withdrawal) Act 2018 which

modifies subordinate

legislation made under s. 2(2)

ECA

Statement setting out:

a) the steps which the relevant authority

has taken to make the draft instrument

published in accordance with paragraph

16(2), Schedule 8 available to each House

of Parliament,

b) containing information about the

relevant authority’s response to—

(i) any recommendations made by a

committee of either House of Parliament

about the published draft instrument, and

(ii) any other representations made to the

relevant authority about the published draft

instrument, and,

c) containing any other information that

the relevant authority considers appropriate

in relation to the scrutiny of the instrument

or draft instrument which is to be laid.

DExEU/EM/7-2018.2 14

Part 2

Statements required when using enabling powers

under the European Union (Withdrawal) 2018 Act

1. Appropriateness statement

1.1 The Parliamentary Under Secretary of State (Minister for Science, Research and

Innovation), Amanda Solloway MP, has made the following statement regarding use

of legislative powers in the European Union (Withdrawal) Act 2018:

“In my view the Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020

do no more than is appropriate”.

1.2 This is the case because the changes ensure compliance with the specific provisions of

the Withdrawal Agreement, and only correct deficiencies to the extent necessary to

maintain the continued functioning of the intellectual property system at the end of

the transition period.

2. Good reasons

2.1 The Parliamentary Under Secretary of State (Minister for Science, Research and

Innovation), Amanda Solloway MP, has made the following statement regarding use

of legislative powers in the European Union (Withdrawal) Act 2018:

“In my view there are good reasons for the provisions in this instrument, and I have

concluded they are a reasonable course of action”.

2.2 These are: that it is critical to implement the commitments agreed in the Withdrawal

Agreement and to ensure that EU law retained at the end of the transition period

functions effectively as domestic law.

3. Equalities

3.1 The Parliamentary Under Secretary of State (Minister for Science, Research and

Innovation), Amanda Solloway MP, has made the following statement(s):

“The draft instrument does not amend, repeal or revoke a provision or provisions in

the Equality Act 2006 or the Equality Act 2010 or subordinate legislation made under

those Acts.”.

3.2 The Parliamentary Under Secretary of State (Minister for Science, Research and

Innovation), Amanda Solloway MP, has made the following statement regarding use

of legislative powers in the European Union (Withdrawal) Act 2018:

“In relation to the draft instrument, I, Amanda Solloway have had due regard to the

need to eliminate discrimination, harassment, victimisation and any other conduct that

is prohibited by or under the Equality Act 2010.”.

4. Explanations

4.1 The explanations statement has been made in section 2 of the main body of this

explanatory memorandum.


立法 修正 (8 文本) 修正 (8 文本) 实施 (3 文本) 实施 (3 文本) 世贸组织文件号
IP/N/1/GBR/86
IP/N/1/GBR/C/6
IP/N/1/GBR/D/39
IP/N/1/GBR/P/14
IP/N/1/GBR/T/54
无可用数据。

WIPO Lex编号 GB384