There appear to be some serious discussion of late regarding China using its IP laws to encourage more innovative drugs. One significant advance was the recent amendments to China’s Patent Examination Guidelines to permit post-filing supplementation of data in certain circumstances.
In addition to this reform, there is also talk of China addressing issues involving data exclusivity, lack of patent term extension and patent linkage.
CFDA Commissioner Bi Jingquan noted some of these developments at a press conference at the time of the NPC Meeting on February 27，2017:
We want to study the policy of encouraging drug innovation, improve patent linkage and the data protection system, and to achieve domestic and international clinical data mutual recognition, reducing the cost of R &
Commissioner Bi also made a similar point in an interview on October 31, 2016:
…efforts should be made to… research clinical trial management, data protection, patent linkage and other policies closely related to innovation, to promote regulatory innovation to promote the transformation and upgrading of the pharmaceutical industry and supply side of the structural reform.
One pharma company ( 天士力) CEO also made a case for patent term extension at the NPC meetings, due to regulatory delays.
None of these pharmaceutical IP issues are totally new to China. Hopefully, their endorsement by industry and government leaders will help speed their consideration and implementation.
Categories: CFDA, China IPR, Data Supplementation, NPC, patent linkage, Pharmaceutical Patents
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