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Legislative Implementation of Flexibilities - Norway

Title:Sections 45-50a and 107 of the Patent Act No. 9 of 15/12/1967 (as last amended by Act No.80 of 29/06/2007) and Sections 107-108 of the Patent Regulations No. 1162 of 20/12/1996 (as last amended by Royal Decree of 14/05/2004)
Field of IP:Patents
Type of flexibility:Compulsory licenses and government use
Summary table:PDF

Provisions of Law

Section 45. Where three years have elapsed from the grant of the patent and four years from the filing of the patent application without the invention being worked in this country to a reasonable extent, anyone who wishes to work the invention in this country may obtain a compulsory licence for that purpose, provided there is no legitimate reason for the failure to work the invention.For the purpose of the first paragraph, utilization of the invention shall, in contracting states in the WTO treaty or the EEA, be given equal status as utilization within this country, provided that the patent rights do not prevent national imports. The same applies for utilization in other states, to the extent it complies with a reciprocal duty following an international treaty.

Section 46. The holder of a patent for an invention, the use of which is dependent on a patent owned by someone else, may obtain a compulsory licence to use the invention protected by the latter patent provided that the former invention involves an important technical advance of considerable economic significance in relation to the latter invention.The holder of the patent for the invention to which the compulsory licence applies shall be entitled to obtain a compulsory licence on reasonable terms to use the other invention.

Section 46 a. Where a breeder cannot acquire or exploit a plant variety right without infringing a prior patent, he may, subject to payment of an appropriate royalty, apply for a compulsory licence for non-exclusive use of the invention protected by the patent inasmuch as the licence is necessary for exploitation of the plant variety to be protected. A compulsory licence will only be granted where the applicant can demonstrate that the plant variety constitutes significant technical progress of considerable financial interest in relation to the invention.If a patent holder has been granted a compulsory licence for the exploitation of a protected plant variety according to Act No 32, March 12, 1993 about Plant variety protection Section 28 second paragraph, the holder of the plant variety right is entitled to a compulsory licences of the patented invention on reasonable terms.

Section 47. Any person who wants to exploit an invention commercially, which has been patented by someone else, may be given a compulsory licence

- when required by important public interests.

- when the patent rights are exploited in a way that significantly limits competition.

Section 48. Anyone who, at the time a patent application was made available to the public, was commercially exploiting the invention for which a patent is applied for in this country, may, if the application results in a patent, obtain a compulsory licence for the exploitation of the invention, provided that special circumstances make it desirable, and that he had no knowledge of the application and could not reasonably have obtained such knowledge. Such right shall also, on similar conditions, be enjoyed by anyone who has made substantial preparations for commercial exploitation of the invention in this country. The compulsory licence may also comprise the time preceding the grant of the patent.

Section 49. A compulsory licence may only be granted to someone who has made efforts to obtain a licence on reasonable business terms by agreement, without achieving it in reasonable time, and may be presumed able to exploit the invention in a manner which is acceptable and which is in compliance with the terms of the licence. A compulsory licence shall not prevent the patent holder from exploiting the invention himself or from granting licences. A compulsory licence shall only be assignable in conjunction with the enterprise where it is exploited or in which the exploitation was intended. Furthermore, a compulsory licence obtained according to the first paragraph of section 46 may only be assigned in conjunction with the dependent patent.In the case of semi-conductor technology, compulsory licences shall only be granted for public non-commercial use or to remedy practice determined after judicial or administrative process to be anti-competitive or based on section 47 nr.2.A compulsory licence shall mainly be given with the aim of supplying the domestic market. The King may, by regulation, determine provisions which depart from this.

Section 50. The court shall grant a compulsory licence in accordance with this section, and the Norwegian Competition Authority in accordance with section 50 a. In a decision considering a compulsory licence, the court shall also determine to what extent the invention may be exploited and stipulate the compensation and the other terms of the licence. The compensation shall be appropriate, taking into account the circumstances in each case. The value of the licence shall be taken in consideration when assessing the compensation. If circumstances should change considerably, the court may, at the request of either party, cancel the licence or stipulate new terms. In a decision granting or extending a compulsory licence, the court may find that the owner of the compulsory licence shall have the right to exploit the invention in accordance with the decision during the period prior to the decision becoming legally binding. Motion for preliminary enforcement has to be put forward prior to the judge's final deliberations on the merits of the case. If the compulsory licence is cancelled because the decision is opposed before becoming legally binding, the owner of the compulsory licence shall be obliged to pay compensation for the loss caused by the exploitation, to an extent considered reasonable. The third sentence shall apply correspondingly if restrictions are imposed on the compulsory licence. In a decision under the first sentence, the court may instruct the licensee to furnish security for liability under the third and fourth sentences. If a decision granting or extending a compulsory licence is opposed before becoming legally binding, the court to which the decision is brought, may make or reverse a decision under the first and fourth sentences. The decision is made by a ruling or by the final decision in the matter, cf. the second sentence. A ruling under the sixth sentence may only be opposed in connection with an appeal of the final decision in the matter.

Section 50 a. A request for a compulsory licence made to the Norwegian Competition Authority, shall state the grounds for the request and provide details of the circumstances referred to in section 49 first paragraph. The claim shall set out the scope of the licence and compensation and any further conditions the party considers reasonable. A prescribed fee shall be paid. If the application does not fulfil these requirements, The Norwegian Competition Authority shall grant a reasonable period of time for rectification. The demand shall be rejected if the deficiency in the request is not rectified within the time limit, unless the Norwegian Competition Authority finds reasons to grant a new period of time for rectification.

The Norwegian Industrial Property Office, Board of Plant Varieties, or any other public agency shall, upon request from the Norwegian Competition Authority or the Board of Appeals, provide an opinion on the case within 6 weeks from the date of the request.Anyone can provide the Norwegian Competition Authority or the Board of Appeals with the information these authorities require in connection with cases concerning compulsory licences. The Norwegian Competition Authority may summon the parties to an oral hearing if necessary. The King may, by regulation, determine specific rules for the procedures.The regulation in section 50 third paragraph apply correspondingly for cases under this section, nevertheless the Norwegian Competition Authority or the Board of Appeals do not have the authority to cancel or amend a licence which has been granted or tried by a court of law.

For implementation of an administrative decision, the Public Administration Act section 42 applies. If the compulsory licence is cancelled or limited following a challenge or a lawsuit filed within two months of the Norwegian Competition Authority's or the Board of Appeals' decision, the licensee is obliged to pay reasonable compensation for the economic loss the exploitation has caused. The Norwegian Competition Authority or the Board of Appeals may in the decision concerning the compulsory licence require as a condition that the licence holder provide security for the liability, in accordance with this paragraph's second sentence.In a lawsuit the court has full judicial power to review all aspects of the Norwegian Competition Authority's or the Board of Appeals' decision in accordance with this paragraph. A lawsuit may not be filed on the grounds that the decision on a compulsory licence has been dismissed summarily or rejected. A lawsuit, filed by the patent holder in accordance with this paragraph, must be brought against the holder of the compulsory licence.

Regulations

Section 107. When the requirements set out in section 108 have been complied with, a producer of pharmaceutical products in Norway shall be granted on application a compulsory licence pursuant to section 47 of the Patents Act to manufacture pharmaceutical products for export to an eligible importing State that has requested the producer to supply the products. For the purpose of these regulations, an eligible importing State is a State or a customs territory that:

1.at the time in question has been designated by the UN as a least developed country or customs territory, or that has insufficient manufacturing capacity in accordance with the Annex to the decision of the WTO General Council of 30 August 2003 (the General Council Decision), and

2.has made a notification to the Council for TRIPS in accordance with the General Council Decision, paragraphs 1(b) and 2(a).

States that are not party to the WTO Agreement shall make the notification referred to in the first paragraph (2) above to the Norwegian Ministry of Foreign Affairs.

Section 108. A compulsory licence may only be granted pursuant to section 107 if

1.the producer has tried to obtain a licence by agreement in Norway insofar as this is required pursuant to section 49, first paragraph, of the Patents Act,

2.the product is covered by paragraph 1(a) of the General Council Decision,

3.the product is only to be produced for export to the eligible importing State in order to cover the said State's current need for the product for health purposes, as described in the notification mentioned in section 107, and

4.the invention is not protected by a patent in the eligible importing State, or the eligible importing State has granted a compulsory licence or legal proceedings to obtain such a licence have been initiated pursuant to Article 31 of the Agreement of 15 April 1994 on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement) and the General Council Decision.

When assessing what are reasonable commercial terms and conditions pursuant to section 49, first paragraph, of the Patents Act, and when determining the remuneration pursuant to section 50, second paragraph, of the Patents Act, account shall be taken of the economic value to the importing State of the use of the invention.

More detailed requirements for granting a compulsory licence may be imposed in the decision to grant such a licence, cf. section 50, first paragraph, of the Patents Act. These shall include the following requirements

1.the packaging and container shall be distinct from those of products being offered for sale in Norway or in another state by the patent-holder himself or with his consent,

2.the products shall be labelled so as to clearly indicate that the pharmaceutical product has been manufactured under compulsory licence in Norway for export to a specified importing state in accordance with the General Council Decision, and

3.the manufacture and export shall cease if the licence-holder learns the products are being used to an appreciable degree for purposes that are not in accordance with the conditions for granting the licence, cf. first paragraph (3).

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