CHINA revisa Ley de patentes

The country has amended a patent regulation to give a clear definition of "patented pharmaceuticals" that are subject to compulsory licensing, amid a system that allows parties to exploit patented inventions without the permission of the patent's owner.

The existing Patent Law granting a compulsory license for patented pharmaceuticals in China for the purpose of public health. It applies to manufactured products in China as well as exports to qualified countries under international treaties to which China is a member.

But the law fails to give a clear definition of "patented pharmaceuticals" that are subject to such practice.

The latest move, which was released on Jan 9 and took effect on Monday, makes it clear that "patented pharmaceuticals" are "any patented products or products 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 purpose is to make the compulsory licensing system compatible with the need to cope with public health crises," Yin Xintian, director of legal affairs department of the State Intellectual Property Office, said at a press conference on Wednesday.

China's amendment to the compulsory licensing is based on a World Trade Organization (WTO) protocol agreed in December 2005 that allows WTO members to issue compulsory licenses for the production and export of pharmaceuticals to an eligible importing member. China accepted the protocol in December 2007.

When patented foreign drugs are deemed too expensive for domestic consumers, compulsory licensing is usually adopted to help provide relatively cheaper generic counterparts.

China's newly amended law clears the way in legal issues for the use of generic versions of patented drugs domestically, but whether a mature compulsory license system is able to develop in the country relies on the specific operations of the law, said Jia Ping, founder and CEO of the China Global Fund Watch Initiative and a leading researcher on HIV/AIDS, law and human rights in China.

Más...