Measures for Granting Compulsory License for Exploitation of
Public Health Related Patents



On November 29, 2005, China's State Intellectual Property Office (SIPO) issued the Measures for Granting Compulsory License for Exploitation of Public Health Related Patents. The measures were promulgated in accordance with the WTO Doha Declaration on TRIPS and Public Health.

According to the measures, a compulsory license may be granted to exploit the patents relating to pharmaceutical products, which have effects for the treatment of some infectious diseases. The infectious diseases include AIDS/HIV, pulmonary tuberculosis and malaria. For the purpose of granting a compulsory license, the patents can be product patents covering the pharmaceutical products, or process patents for producing the pharmaceutical products. The patents for producing the active ingredients of the pharmaceutical products, and those for producing the diagnosis reagents used for application of the pharmaceutical products are also subject to a compulsory license.

According to the Regulations on Compulsory License for Exploitation of Patents issued by the SIPO in 2003, only the governmental authorities, instead of any corporations, are qualified to request the SIPO to issue a compulsory license. A compulsory license may be issued to produce the pharmaceutical products in China, or to import the products. At the request of another country, the SIPO may also issue a compulsory license to produce the pharmaceutical products in China and to export the products to the country. Noticeably, parallel importation of products having effects for the treatment of the infectious diseases is allowed, without granting a compulsory license.

The measures will come into effect on January 1, 2006.