Written by Ms. Hui Liu of Chofn IP
Case Study: Can post-filing of supplemental data be accepted in China？
In the Chinese pharmaceutical field, supplemental data has always been a hot topic for patent applications in China. A chemical medicine case with additional experimental data was shared by Beijing Intellectual Property Court in April of 2020.
In the case, the applicant filed a patent application for a new compound. It is described in the specification that the compound can cure many diseases, including cancer, by controlling the way of cell reproduction. Meanwhile, it is also described how to identify, prepare the compound, and how to detect cell activity, but no specific experimental data is provided in the application. Subsequently, the applicant submitted additional experimental data during the examination procedure.
According to Article 26.3 of the Chinese Patent Law, the specification shall make a clear and complete description of the invention or utility model, so that it can be achieved by those skilled in the art.
So, how to understand the phrase “it can be achieved” in this article?
According to the Chinese patent examination guideline, “it can be achieved” means that the technical solution can be implemented, the technical problem can be solved, and the expected technical effect can be produced. In this regard, this application is aimed to protect a new component, thus the applicant should disclose how to identify, to prepare the compound, and what kind of use/effect the compound has. Look back into the case, the applicant wants to prove the compound can cure many diseases(the use of the application) by disclosing the way to test the cell activity. However, it should be noted that the subject of the application is a new compound. But the specification only disclose that this compound can treat a variety of diseases. Without relevant experimental data, it is difficult for those skilled in the art to reasonably expect that this compound can achieve its claimed effect based on the specification. Therefore, the patent application as filed is not fully disclosed.
How about the post-filing data?
As a matter of fact, since the Chinese patent examination guideline was revised in 2017, to require that “the examiner shall examine the supplemental experimental data submitted after the filing date, provided that the technical effect contained in the supplemental experimental data shall be derivable by those skilled in the art from the patent application as filed”. Thus it seems possible for the applicant to supplement experimental data after the filing date. However, in practice, the standard for “derivability” is quite high and can be viewed as equivalent to “directly derivable”. if the supplemental data is submitted to overcome the obviousness rejection, it might be possible to be accepted. But if the supplemental data is aiming to overcome insufficiency of disclosure, the likelihood of being accepted is extremely low. In this case, the post-filing data cannot change the fact of insufficient disclosure, so it was not accepted by CNIPA.
Finally, the recent turn of events is quite positive for the applicants. After the negotiation of relevant contents during the China-US trade deal in January of 2020, the Supreme Chinese court firstly explicitly allows the post-filing supplemental data to be used for overcoming the insufficiency of disclosure issue. This is good news for innovative pharmaceutical companies. And it may be expected that there would be some changes in the examination of chemical medicine patent applications in China soon. In any event, such trend is good for all the applicants in a long run. If you want to know more details and updates, please feel free to contact us.