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Vice President Biden and Pharmaceutical Innovation
3 months ago
Innovative pharmaceutical companies have been facing a number of challenges in obtaining or maintaining patents in China. One of these issues has involved progressively more restrictive interpretations of Art. 26.3 of the Patent Law (enablement or sufficiency of data disclosure). This issue has been previously highlighted here ).
In addition to these challenges, pharmaceutical companies had been unable to supplement data, the Patent Examination Guidelines have been applied in a retroactive manner to impose new and unanticipated burdens on applicants who were previously granted patents, and the actual standard of sufficiency of data disclosure appears to have been raised in successive editions of the Examination Guidelines.
Here are comparison chartsthat I prepared on some of the progressively higher burdens being imposed in the Examination Guidelines.
Now we have a statement in the Joint Fact Sheet from the Vice President on his recent trip to China (December 5, 2013) that addresses some of these issues.
Of particular importance is SIPOs public recognition as a result of the Vice Presidents visit that its Examination Guidelines are governed by Article 84 of the Law on Legislation, which limits their retroactive effect.
This can have important consequences beyond Article 26.3, and should require limit SIPOs discretion in applying different versions of the Examination Guidelines to previously granted patents:
China affirms that the Chinese Patent Examination Guidelines permit patent applicants to file additional data after filing their patent applications, and that the Guidelines are subject to Article 84 of the Law on Legislation, to ensure that pharmaceutical inventions receive patent protection.
China affirms that this interpretation is currently in effect.Attached are English and Chinese versions of a speech by USPTO Acting Director Teresa Rea that was first delivered at China Pharmaceutical University earlier this month.
The speech underscores the challenges for innovative pharmaceutical companies in China's current IP environment. Although China has ambitious goals to develop an innovative pharmaceutical industry, certain aspects of IP protectionAs noted previously in this blog, the death of patent linkage which had been heralded by draft Drug Registration Rules appears to be premature.
In fact, the China Food and Drug Administration has stated that it is interested in developing a more robust patent linkage system.
On May 12, 2017,There have been several important developments in recent weeks involving pharmaceutical IP protection in both mainland China and Taiwan. Based on these developments, mainland China appears to be slowing its momentum to afford better IP protection to innovative pharmaceutical products (perhaps as a negotiating position in the Trade War), while
Mark Allen Cohen (??} is a Distinguished Senior Fellow, Director and Lecturer of the Asia IP Project at the Berkeley Center for Law and Technology at the University of California, Berkeley.
In total, he has nearly 40 years of private sector, public sector, etc., in-house and academic experience on IPR issues in China, including numerous publications and awards.
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