Vice President Biden and Pharmaceutical Innovation

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 (https://chinaipr.com/tag/enablement-requirement/). 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 charts that 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 SIPO’s public recognition as a result of the Vice President’s 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 SIPO’s 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.”

See Joint Fact sheet: http://www.enewspf.com/latest-news/latest-national/latest-national-news/48457-joint-fact-sheet-on-strengthening-u-s-china-economic-relations.html?tmpl=component).

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