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06 November 2012
China’s recent amendments to the patent law’s implementing regulations came into effect February 1.
The Decisions of the State Council to Amend the Implementing Regulations of the Patent Law of the People’s Republic of China make a number of modifications to the patent law’s previous implementing regime, according to a statement from Lehman, Lee & Xu, adding nine new rules, removing five previous rules, and amending 47 remaining rules.
“One area the amended regulations expand upon and clarify is the issues surrounding compulsory licensing located under Article 50 of the Act,” the firm noted.
Article 50 states that for the purpose of public health, the patent administrative department of the State Council may grant a compulsory license for a patented pharmaceutical so as to produce and export it to the country or region which conforms to the provisions of the relevant international treaty to which China has acceded.
The proviso outlines that a compulsory license would allow the State to be exempt from China’s patent law where a public health issues arises. The Act, however omits from providing details or definitions as to what constitutes a patented pharmaceutical. The amended regulations fill in the void in accordance with the WTO’s Protocol Amending the TRIPS Agreement, which China ascended to in December 2007, and defines patented pharmaceuticals as “any patented product or product directly obtained according to patented processes in the medical and pharmaceutical field to address public health issues, including patented active ingredients needed in the production of the product and diagnostic supplies necessary for the application of the product.”
The amended regulations go on to state that the granting of compulsory licenses under Article 50 of the Act, should conform with various issues outlined under international agreements China are a binding signatory to.
Edward Lehman, managing director of Lehman, Lee & Xu, welcomed the amendments. “Previous to the amendments coming into effect, there was potential for the exploitation of patents without express permission, through the wide scope of Article 50 under the PRC’s Patent Law,” he said. “With the implementation of these amendments, the remit of Article 50 is clarified, and China’s commitment to strengthening its domestic IPR regime has once again been highlighted.”
