Data supplementation for chemical and biotech patents

Q: What is the State Intellectual Property Office’s (SIPO) position on post-filing supplementary data for the chemistry and biotech patents? A: It had long been criticized that in the chemical and biotech sectors, China’s SIPO was too stringent in accepting supplementary data post a filing for patent. The amended SIPO’s Patent Examination Guideline, which took effect on 1 April 2017, seemingly provided an answer to such criticisms, according to which supplementary data submitted after the filing date should be accepted and the technical effects to be testified by such supplementary data should be taken into consideration, on the condition that such technical effects are obtainable to a person skilled in the art, based on the original disclosure of the patent application.

However, taking a closer look, many commentators are concerned that such amendments will only lead to a vicious circle: the supplementary data can only be accepted if the technical effects it intends to testify on have already been disclosed, yet they offer no definite guidelines for the applicant or the patentee to figure out when or how such technical effects to be testified on by the post-filing supplementary data can be deemed as disclosed in the original disclosure.

Q: Can you introduce some typical cases in this regard? A: Novartis’ Chinese patent related to the blockbuster drug “Entresto” was invalidated by the SIPO for lack of inventiveness, and it provided a vivid example of why commentators would have concerns.

Wu Li is a senior consultant and Wang Rui is a senior associate at AnJie Law Firm