Effective January 15, 2021, China National Intellectual Property Administration (CNIPA) will allow submission of data after filing date. This is particularly important to pharmaceutical patent applicants.

According to amended Examination Guideline (EG), submission of additional experimental data is allowed for the purpose of (1) proving sufficiency of the disclosure or (2) proving inventiveness.

The sufficiency of disclosure is determined by the original specification and claims, according to EG 3.5.1. However, later submitted data should be considered and the technical effects proved by the supplementary experimental data should be obtainable by those skilled in the art from the disclosure of the original patent application.

In addition, the supplementary experimental data can be submitted to prove inventiveness. Similarly, the technical effects proved by the supplementary experimental data should be obtainable by those skilled in the art from the disclosure of the original patent application.

Example 1:

Compound A is claimed, and the specification describes the preparation example of compound A, the blood pressure lowering effect and the experimental method for determining the blood pressure lowering activity, but the experimental result data is not recorded. In order to prove that the specification is fully disclosed, the applicant supplemented the blood pressure lowering effect data of Compound A. For those skilled in the art, according to the original application documents, the blood pressure-lowering effect of Compound A has been disclosed, and the technical effects to be proved by the supplementary experimental data can be obtained from the disclosure of the patent application documents. It should be noted that the supplementary experimental data should also be reviewed when reviewing creativity.

Example 2:

The compound of general formula I is claimed. The specification describes the general formula I and its preparation method, the preparation examples of a number of specific compounds A, B, etc. in the general formula I and also records the anti-tumor effect of general formula I and the determination of anti-tumor effects. The experimental method and experimental result data of tumor activity, the experimental result data is recorded as the IC50 value of the compound of the example on tumor cells is in the range of 10-100 nM. In order to prove the inventiveness of the claims, the applicant submitted comparative experimental data, which showed that the IC50 value of compound A was 15nM, while the compound of comparative document 1 was 87nM. For those skilled in the art, according to the original application documents, Compound A and its anti-tumor effects have been disclosed, and the technical effects to be proved by the supplementary experimental data can be obtained from the disclosure of the patent application documents. It should be noted that at this time, the examiner also needs to further analyze whether the technical solution requested by the claim meets the requirements of creativity in conjunction with the supplementary experimental data.

In summary, submission of supplementary experimental data is allowed and applicant should take advantage of this procedure to better protect their intellectual property rights in China.