China 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 China Daily reports.

The existing patent law grants a compulsory license for patented pharmaceuticals in China for public health, and applies to products made 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.”

The amendment states 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, told the paper this week.

China’s amendment to compulsory licensing is based on a World Trade Organization protocol that allows WTO members to issue compulsory licenses to make and export drugs to an eligible importing member. China’s newly amended law clears the way for 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, according to 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.

“Demand for HIV/AIDS, cancer, hepatitis and cardiovascular diseases drugs are currently high in China, but patents of most major drugs are held by a number of international manufacturers, which push domestic ones downstream in the industrial chain,” Jia tells the paper. “The standard patent protection period is 20 years. When the deadline approaches, the companies patent an improvement on the drug - sometimes just a small step - which grants another 20 years.”

So far, compulsory licenses have never been issued in China, leading to a lack of generic versions of these drugs. “Take HIV/AIDS as an example. China is highly dependent on government procurements and internationally donated drugs,” Jia tells China Daily. “Two years ago, there was an outcry demanding more lamivudine around the country. To fulfill domestic needs, local production of such drugs under compulsory licensing is necessary.”