The China National Intellectual Property Administration (CNIPA) revised the Guideline for Patent Examination, which mainly focused on the revision in the field of chemistry. The revision came into force on 15 January 2021.

The revision related to supplementary experimental data is reflected in section 3.5, Chapter X, Part II of the Guideline for Patent Examination. The purpose of the revision is to further clarify the examination criteria for supplementary experimental data.

<Contents of the revision>

3.5 Supplementary Experiment Data Submission

3.5.1 Examination Principle

The determination of sufficiency of the disclosure, is performed based upon the contents of the description and claims as originally filed.

The examiner shall examine the Supplementary experimental data submitted by the applicant after the filing date in order to meet the requirements of Article 22.3 (“inventive step” provision) and Article 26.3 (“sufficient disclosure” provision) of the Chinese Patent Law. The technical effects proved by the supplementary experimental data should be obtained by those skilled in the art from the disclosure of the patent application.

3.5.2 Supplementary experimental data of drug patent application According to the examination principles in section 3.5.1, the examination examples involving drug patent applications are given as follows.

[Example 1]

Compound A is claimed. The specification describes a method of preparing Compound A, and its effect in reducing the blood pressure, and an experimental method for measuring the activity of reduced blood pressure, but the experimental result data is not disclosed. In order to prove that the specification fully disclosed the invention, the applicant supplemented the data to show the effect of Compound A in reducing the blood pressure. For those skilled in the art, according to the original specification of the application, the effect of reducing the blood pressure of Compound A has been disclosed, and thus the technical effect shown in post-filing supplementary data is derivable from the disclosure of the patent application, and thus the supplementary data should be considered and examined.

[Example 2]

A compound of general Formula I is claimed. The specification describes the general Formula I, a method of preparing Formula I, and specific compounds A, B, and the like. The specification also describes the antitumor effect of Formula I and the experimental methods and experimental data of determining the antitumor activity. The data shows that IC is between 10-100nM. The 50 Applicant submitted supplementary experiment data to show the inventive steps, which shows that IC of 50 Compound A is 15nM and the compound in cited reference 1 is 87nM. For those skilled in the art, according to the original specification of the application as filed, compound A and its antitumor effects have been disclosed, and thus the technical effects shown in the post-filing supplementary data is derivable from the disclosure of the patent application, and thus the supplementary data should be considered and examined.

In this revision, section 3.5.2 "supplementary experimental data of drug patent application" is added to include the above two typical examples. Example 1 involves the situation that the supplementary experimental data was submitted for the purpose of proving the “sufficient disclosure”, and it also makes it clear that "the supplementary experimental data should also be examined when examining the inventive step", and Example 2 involves the situation that the supplementary experimental data was submitted for the purpose of proving the “inventive step”. According to these two cases, it further clarifies the examination criteria for the supplementary experimental data of drug patent application, explains how to comprehensively consider the contents of the application documents and the existed technical conditions, and judges whether the technical effect can be obtained by those skilled in the art from the disclosure of the patent application.

Source:https://www.cnipa.gov.cn/art/2020/12/14/art_74_155606.html