[Ip-health] Invalidation made final for 3TC patent in China

Joan-Hu-Yuanqiong joan_hu_msf at yahoo.com
Wed Apr 13 20:38:18 PDT 2011

Information sources confirmed an invalidation decision has been finalized on an unpublished invalidation dispute between anonymouse Chinses generic company and GSK (designated to IAF as defendant) over a process patent on 3TC. 

3TC first introduced to China in early 1990s, but only in the formulation treating Hepatitis B. Though Chinese patent law only started granting product patent on medicines from 1992, 3TC got a set of special protections under SFDA against the background of US-China biletral interllectual property negotiation, and obtained market monopoly since then without any single produt patent in China. The legal status of 3TC resulted the large constraints for the HIV/AIDS treatment in China, as under the government free ARV scheme started from 2003, the only channel to get 3TC is relying on conditional donation from GSK. 

A number of the special protections have expired over 3TC in 2007, but GSK claimed its process patent to covering ALL producte related to 3TC on its website publically: http://www.gsk-china.com/asp/News/client/newconten/515200784150.htm

Among the claim patents, the CN99126580.7 is the core patent blocking local prodution and importation. However, CN99126580,7 is only a divisional patent of a process patent, and will expire by end of April 2011. 

In 2010, patent attorney presenting anonymous Chinese generic company filed an invalidation case before the national patent reexmination office to invalidate this patent for the reason of lacking novelty. IAF instead of GSK itself was presented in the first trial. The first trial was not in favor of the Chinese plantiff due to nortorization issues on the evidence. After Chinese appeal, the final tril by the committee made the invalidation decision by the end of December 2010. According to Chinese law, the defendant has 3 months time unpon the invalidation decision by the committee to sue to the court for further trail. Until the end of March, no court case was brought by either IAF or GSK, which means the invalidation on 3TC patent is made final. 

Although people in China only got a slim margin of victory after many years battel, because the patent will expire anyway by end of April, the symbolic and precedence value of this case is large which could trigger a deeper debate and action on patent criteria and practice over medicines in China.  


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