On June 1 2018, the Supreme People’s Court of China (SPC) issued the draft judicial interpretation on patent validity and examination cases for public comments. Article 13 deals with data supplementation for chemical invention patents and has drawn widespread attention from the industry.
The SPC seems to have adopted a double standard in Article 13 according to the purpose of the data supplementation – whether for enablement purposes (Article 26.3 of the Chinese Patent Law) or for the question of inventive step (Article 22.3 of the Chinese Patent Law). It appears that the SPC applies an even tougher standard for submitting data in the context of inventiveness.
The first paragraph of Article 13 states that the court shall examine supplementary data when such data is used to demonstrate technical effects that have been sufficiently disclosed (enablement issue), and the technical effects can be confirmed (que ren) by a person having ordinary skill in the art according to the specification, drawings and common knowledge on the application date.
In the second paragraph of Article 13, it states that the court shall examine the supplementary data when it is used to demonstrate that the claimed invention has different technical effects from prior art (inventiveness) and the technical effects can be confirmed (que ren), directly and unambiguously, by a person having ordinary skill in the art from the specification.
The draft Article 13 is slightly confusing as the SPC appears to have adopted different standards depending on the purpose of the data supplementation. The SPC uses the word “confirm (que ren)” in both paragraphs in Article 13, but when it comes to inventiveness, the SPC requires that the confirmation must be done “directly and unambiguously” from the specification. The emphasis on “directly and unambiguously” does not exist in the first paragraph which deals with the issue of enablement.
It makes us wonder if the SPC allows a more lenient test for the use of supplementary data to prove the enablement issue. In other words, does it mean that the court allows an applicant to use the supplementary data to prove that certain technical results have been sufficiently disclosed, as long as such technical results can be “indirectly derived or confirmed by the person having ordinary skill in the art”?
The different standard is somewhat confusing. It is difficult to ascertain the true intention of the SPC. The cases regarding data supplementation, which have been adjudicated by the SPC in recent years, indicated that the SPC’s standard for data supplementation has undergone a change.
In Takeda Pharmaceutical Company Limited v PRB ((2012) Zhi Xing Ti Zi No. 41), the SPC was of the opinion that, if the patent applicant or patentee submitted experimental data to prove inventiveness, the technical effects must be explicitly described in the original application. The
standard for accepting the data is quite high, which means the technical effects shall be both described and confirmed in the specification.
In Warner-Lambert Company LLC v PRB ((2014) Xing Ti Zi No. 8), the SPC’s attitude towards data supplementation appeared to have softened to some extent. In this judgment, the SPC was of the opinion that, with respect to the experimental data for proving enablement, if there was evidence showing that the person having ordinary skill in the art, based on knowledge level and cognitive capability at the application date, could carry out the invention from the contents disclosed by the specification, such data should be considered. The SPC did not require that the disclosure must be explicitly made in the specification.
Notably, the SPC’s positions with respect to data supplementation have not been in-keeping with those of Beijing Higher People’s Court, which often renders the final decision on patent validity matters. In China, Beijing Higher People’s Court, as the appellate court, reviews the decisions of the Beijing IP Court regarding any appeals concerning the Patent Re-examination Board’s decision, while the SPC has to grant petition for retrials on selected cases.
The Beijing Higher People’s Court has been insisting on a standard of explicit teaching or disclosure. In its own local guidelines issued in 2017, it clearly stated that, the technical effects proved by the supplementary experimental data should be explicitly described in the original patent application.
Such local guidelines were underlying several cases that came before the Beijing Higher People’s Court, for example, Celgene v PRB ((2017) Jing Administrative Final No. 1642), and Gilead v PRB ((2017) Jing Administrative Final No. 1806). The standards for the Beijing Higher People’s Court to accept data supplementation are that, firstly, the supplementary experimental data is obtained by using the experimental method available prior to the application date and secondly, the technical effects proved by the supplemented experimental data are explicitly described in the original patent application.
If the draft JI is issued as it stands, Article 13 would be quite close to what the Beijing Higher People’s Court has been doing, at least with respect to the inventiveness issue, offering no clear progress with respect to the data supplementation issue.
It is hoped that the SPC will continue reviewing the data supplementation rule.