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Norway

NO061

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Patent Regulations No. 1162 of December 20, 1996 (Extract)

Pursuant to sections 49 and 69 of the Act of 15 December 1967 No. 9 relating to patents, the Ministry of Justice and the Police laid down the following regulations by Royal Decree of 14 May 2004:

I

The Regulations of 20 December 1996 No. 1162, which have been issued pursuant to the Patents Act, shall be amended as follows:

New section 107 shall read as follows:

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.
2.

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.

New section 108 shall read as follows:

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

1.
2.
3.
4.

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.
2.
3.

New section 109 shall read as follows:

Section 109. The competent court or the Competition Authority shall make a notification to the Council for TRIPS concerning the compulsory licence in accordance with the General Council Decision, paragraph 2(c). States that are not party to the WTO Agreement shall make a notification to the Norwegian Ministry of Foreign Affairs.

The holder of a compulsory licence shall post information on its website in accordance with the General Council Decision, paragraph 2(b)(iii).

II

These regulations enter into force on 1 June 2004.