On October 8, 2017, the Chinese Communist Party and the State Council jointly issued a special opinion on the reform of drug and medical device approval system (“Innovation Opinion”). The Innovation Opinion together with an earlier China Food and Drug Administration (“CFDA”) document (“Circular No. 55”) issued in May 2017 (collectively “Reform Opinion”), propose that…

Pharmaceutical polymorph patents are regarded as effective means and important secondary pharmaceutical patents to extend the life cycle of pharmaceutical patent protection. However, the inventiveness evaluation criteria for pharmaceutical polymorph patents have become much stricter in China while the amount of patent application keeps soaring. The clinical research of pharmaceutical polymorphs commenced in 1950s internationally…

A positive view is spreading on post-filing experimental data in China since the recent official post of the proposed revisions to the Guidelines for Patent Examination (the “Guidelines”) by the State IP Office (the “SIPO”) of China.  People tend to think that the window is about to open to post-filing experimental data, just like it…