Entry into force of the Protocol Amending the TRIPS Agreement
(Agreement on Trade-Related Aspects of Intellectual Property Rights)
1. The Protocol Amending the TRIPS Agreement entered into force on January 23 (local time) through acceptance by 110 member countries (including Japan), which corresponds to two thirds of the WTO Members, pursuant to the provision of the Agreement Establishing the World Trade Organization (hereinafter reffered to as “WTO Agreement”).
2. Concerning Article 31 of the TRIPS Agreement that defines criteria for patent “compulsory licenses” (note 1), the Protocol Amending the TRIPS Agreement adds Article 31bis after Article 31 and also adds Annex to the TRIPS Agreement, which exempt the obligations of a member country under Article 31 (f) in certain conditions (note 2). The aim of this amendment is to enable parties other than patent holders to produce pharmaceutical products related to infectious diseases and export these products to relevant developing countries in order to address public health problems of these countries.
3. It is expected that entry into force of the Protocol Amending the TRIPS Agreement will provide legal certainty for production and export of pharmaceutical products for addressing public health issues related to AIDS, tuberculosis, malaria and other infectious diseases in countries with limited or no pharmaceutical production capacity.
(Note 1) Compulsory licenses
When a patent has been granted, parties other than the patent holder may not engage in production, sales or import of products related to the patent invention without a license from the patent holder as a general rule. However, a government may allow a third party to utilize a patent invention even without approval of the patent holder under certain conditions, and this is known as a compulsory license. Article 31(f) of the TRIPS Agreement allows compulsory licenses “predominantly for the supply to the domestic market.”
(Note 2) Content of amendment
(1) Countries with limited or no pharmaceutical production capacity must rely on imports of pharmaceutical products from other countries to address public health issues related to HIV and other infectious diseases. However, countries with pharmaceutical production capacity were at risk of violating Article 31(f) of the TRIPS Agreement, which requires predominantly for the supply to the domestic market, in granting compulsory licenses for production of pharmaceutical products with patent rights in their own countries for export to the above countries.
(2) The amendment adds a provision (Article 31bis) not to apply a part of the provision related to “compulsory licenses” under the TRIPS Agreement in order to address public health issues of infectious diseases and the like in developing countries.
(Reference 1] Protocol Amending the TRIPS Agreement
(1) The WTO Ministerial Meeting held on November 14, 2001 adopted the “Declaration on the TRIPS Agreement and Public Health” (Doha Declaration).
(2) The WTO General Council adopted the Protocol Amending the TRIPS Agreement following the Doha Declaration on December 6, 2005.
(3) Japan accepted the Protocol Amending the TRIPS Agreement on August 31, 2007.
(4) The Protocol Amending the TRIPS Agreement enters into force for Members that accepted it upon acceptance by two thirds of member countries pursuant to paragraph 3 of Article 10 of the WTO Agreement, and it subsequently enters into force for other Members when they accept it.
(Reference 2) Paragraph 3 of Article 10 of the WTO Agreement
Amendments to provisions of this Agreement, or of the Multilateral Trade Agreements in Annexes 1A and 1C, other than those listed in paragraphs 2 and 6, of a nature that would alter the rights and obligations of the Members, shall take effect for the Members that have accepted them upon acceptance by two thirds of the Members and thereafter for each other Member upon acceptance by it. (abbreviated)