- PATENTS (AMENDMENT) ORDINANCE No. 21 of 2007 - HONG KONG SPECIAL ADMINISTRATlVE REGION
- 1. Short title
- 2. Commencement
- 3. Interpretation
- 4. Special provision regarding invention covered by 2 or more patents
- 5. Parts IXA and IXB added
- PART IXA - IMPORT COMPULSORY LICENCES FOR PATENTED PHARMACEUTICAL PRODUCTS
- 72A. Interpretation of Part IXA
- 72B. Declaration of extreme urgency forpublic heaIth problem
- 72C. Grant of import compuIsory Iicences for patented pharmaceutical products
- 72D. Terms, conditions and nature of import compulsory Iicences
- 72E. Payment of remuneration to proprietors of patents
- 72F. Notification of grant of import compulsory licences and remuneration agreed, etc.
- 72G. Termination of import compulsory Iicences
- 72H. Disposal of patented pharmaceutical products after period of extreme urgency etc.
- 72I. No infringement of patents by persons to whom patented pharmaceutical products are disposed of in accordance with import compulsory licences
- 72J. References of disputes as to import compulsory licences
- PART IXB - EXPORT COMPULSORY LICENCES FOR PATENTED PHARMACEUTICAL PRODUCTS
- 72K. Interpretation of Part IXB
- 72L. Application for export compulsory licences for patented pharmaceutical products
- 72M. Grant of export compulsory Iicences for patented pharmaceutical products
- 72N. Terms, conditions and nature of export compulsory licences
- 72O. Notification of grant of export compulsory licences
- 72P. Determination of remuneration payable to proprietors of patents
- 72Q. Termination of export compulsory licences
- 72R. References of disputes as to export compulsory licences
- 72S. Signature of documents by partnerships, companies and associations
- PART IXA - IMPORT COMPULSORY LICENCES FOR PATENTED PHARMACEUTICAL PRODUCTS
- 6. Licences granted by order of the court or Registrar
- 7. Section added
PATENTS (AMENDMENT) ORDINANCE Ord. No. 21 of 2007 ORDINANCE No. 21 OF 2007
Donald TSANG An Ordinance to amend the Patents Ordinance to implement the Protocol Amending the Agreement on Trade-Related Aspects of Intellectual Property Rights of the World Trade Organisation in relation to patents and public health; and to provide for incidental and related matters.
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Enacted by the Legislative Council,
1. Short title
This Ordinance may be cited as the Patents (Amendment) Ordinance 2007.
2. Commencement
This Ordinance shall come into operation on a day to be appointed by the Secretary for Commerce and Economie Development by notice pubIished in the Gazette.
3. Interpretation
Section 2(1) of the Patents Ordinance (Cap. 514) is amended by adding
""Doha Declaration" ({$lJ€l-'§1f» means the Declaration on the TRIPS Agreement and Public Health adopted on 14 N ovember 2001 by the Fourth WTO Ministerial Conference at Doha, Qatar;
"eligible importing member" (ۓ~~~[]pt~J!g) means "exporting member" (ili tJ Jft~:tlE.) means a WTO member country, territory or area that makes a patented pharmaceutical product for export to an eligible importing member in accordance with the General Council Decision or the Protocol;
"GeneraI Council Decision" ({~~ JJ. ~ 1tVè ~}» means the Decision adopted by the General Council of the WTO on 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration;
"patented pharmaceutical product" (~5fU~~u!MP~) means "pharmaceutical product" (~~u!M rTh) means "Protocol" ({ Bl~fl5C~~.~) means the Protocol Amending the TRIPS Agreement adopted by the GeneraI CounciI of the WTO at Geneva on 6 December 2005, the Annex to the Protocol Amending the TRIPS Agreement, the Annex to the TRIPS Agreement and the Appendix to the Annex to the TRIPS Agreement;
"reIevant instrument or Iegislation" (:tfIUJX.~1!'WU) means "TRIPS Agreement" ({~~~ilm~~) means the Agreement on TradeReIated Aspects of IntellectuaI Property Rights, being Annex lC of the World Trade Organisation Agreement;
"TRIPS CounciI" (~~~ilJJ.~1t) means the Council for Trade-ReIated Aspects of Intellectual Property Rights referred to in Article 68 of the TRIPS Agreement;
"WTO" (TItW jt~ #Ji~) means the World Trade Organisation established in Geneva on 1 January 1995 under the World Trade Organisation Agreement;".
4. Special provision regarding invention covered by 2 or more patents
Section 9 is amended by repealing "or the provisions of Part IX relating to Govemment use" and substituting ", the provisions of Part IX relating to Govemment use, an import compulsory licence having effect under Part IXA or an export compulsory licence having effect under Part IXB".
5. Parts IXA and IXB added
The fol1owing are added immediately before Part X
"PART IXA
IMPORT COMPULSORY LICENCES FOR PATENTED PHARMACEUTICAL PRODUCTS
In this Part, unless the context otherwise requires"Director" (~{it) means the Director of Health; "import compulsory licence" (ìi 1=1 ~$fflutìt~~) means a compulsory licence
granted under section 72C; "import compulsory licensee" (ìi D 5gUIJU'l:ìt~~1~~ A) means the holder of an import compulsory licence; "proprietor" (§T~A), in relation to a patent, means the proprietor of the patent that is granted in Hong Kong. .
72B. Declaration of extreme urgency for (1) The Chief Executive in Council may, for the purposes of applying sections 72C to 72J, by notice published in the Gazette declare a period of extreme urgency whenever the Chief Executive in Council considers it to be necessary or expedient in the public interest to do so to address any public health problem or threatened public health problem in Hong Kong. 72C. Grant of import compuIsory Iicences for patented pharmaceutical products
During a period of extreme urgency declared under section 72B(l), where the Director considers that the pharmaceutical industry in Hong Kong has no or insufficient capacity to manufacture a patented pharmaceutical product to meet the needs for the product in Hong Kong, the Director may grant an import compulsory licence under the patent concerned, subject to such terms and conditions as he may impose, to a public officer or any other person to do in Hong Kong in relation to the product a1l or any of the fo1lowing which appears to the Director to be necessary or expedient in connection with the extreme urgency giving rise to the declaration 72D. Terms, conditions and nature of import compulsory Iicences
(1) The terms and conditions subject to which an import compulsory licence is granted under section 72C sha1l inc1ude 72E. Payment of remuneration to proprietors of patents section 72J(1) or (2), for the import compulsory licence in relation to the product. 72F. Notification of grant of import compulsory licences and remuneration agreed, etc.
(l) The Director shall as soon as practicabie after the grant of an import compulsory licence under section 72C (2) The Director shall 72G. Termination of import compulsory Iicences 72H. Disposal of patented pharmaceutical products after period of extreme urgency etc. (a) the Government shall pay to the import compulsory licensee a sum equivalent to the purchase price for the product paid by the licensee to the seller of the product in the exporting member; and
(b) the Director shall (4) For the avoidance of doubt, stocking of any patented pharmaceutical product which is imported under an import compulsory licence does not amount to an infringement of the patent concerned on the part of the import compulsory licensee or the Director from the termination of the period of extreme urgency by a notice under section 72B(3) until (3)(b)(i) or destroys the product under subsection (3)(b)(ii), as the case may be.
721. No infringement of patents by persons to whom patented pharmaceutical products are disposed of in accordance with import compulsory licences 72J. References of disputes as to import compulsory licences
(1) Ifthe Director and the proprietor of the patent concerned fail to agree on the amount of remuneration payable under section 72E(2), either party may, subject to subsection (5), apply to the court for an order to determine the amount of remuneration payable under that section. (6) Any person aggrieved by Cc) the apportionment of the amount of remuneration under section 72E(5); or
(d) the termination of an import compulsory licence under
section 72G(1), may, within 28 days after the date ofthe advertisement ofthe notice under section 72F(1)(b) or (2)(a)(i) or the date of the termination of the licence (as the case may be) or such further period as may be allowed by the court, apply to the court for a review of the grant of the licence, the terms or conditions of the licence, the apportionment of the amount of remuneration or the termination of the licence (as the case may be).
(7) In a review the court may
(a) confirm, vary or canee! the import compulsory licence; Cb) confirm, vary or cancel a term or condition of the import compulsory licence imposed under section 72C;
Cc) confirm or vary the apportionment of the amount of remuneration under section 72E(5);
(d) confirm or reverse the termination of the import compulsory licence under section 72G(1); or
(e) make any other order as the court thinks fit in the circumstances.
(8) The proprietor of the patent concerned may apply to the court for an order to terminate an import compulsory licence on the ground that any term or condition of the licence imposed under section 72C has been contravened.
(9) The court may, on an application under subsection (8) PART IXB
EXPORT COMPULSORY LICENCES FOR PATENTED In this Part, unless the context otherwise requires
"Director" (~-R) means the Director of Health;
"export compulsory licence" (!±ll:J 5$mHit~~) means a compulsory licence granted under section 72M;
"export compulsory licensee" (!±ll=l5$fflUtEt~~ff:fLA.)
HONG KONG SPECIAL ADMINISTRATlVE REGION
Chief Executive
29 N ovember 2007
72A. Interpretation of Part IXA
public heaIth problem
(iii) the duration of the licence;
(iii) the licence is non-assignable except with that part of the enterprise or goodwill which enjoys the use of the patent under the licence; and (c) any other terms or conditions as the Director thinks fit having regard to the public health needs in Hong Kong in the period of extreme urgency declared under section 72B(1).
PHARMACEUTICAL PRODUCTS
72K. Interpretation of Part IXB