Pharmaceutical Patents: The Judicial Practice of the Supreme People's Court of China Regarding Supplementary Experimental Data
Date: 18 October 2024
【Volume 144】
The handling of supplementary experimental data in pharmaceutical patent cases by the Supreme People's Court reflects shifts in judicial standards in China. Article 10 of the “Provisions (I) of the Supreme People's Court on Several Issues concerning the Application of Law in the Trial of Administrative Cases Involving the Grant and Confirmation of Patents” of China stipulates: “When a pharmaceutical patent applicant submits supplementary experimental data after the application date and claims reliance on such data to prove that the patent application complies with the Paragraph 3 of Article 22, Paragraph 3 of Article 26, and other relevant provisions of the Patent Law, the People's Court shall conduct examination.” On the other hand, the 2023 edition of China's Patent Examination Guidelines (hereinafter referred to as “the Guidelines) has relaxed the regulations on submitting supplementary experimental data (Section 3.5, Chapter 10, Part II of the Guidelines: “For experimental data submitted after the application date to meet the requirements of Paragraph 3 of Article 22, Paragraph 3 of Article 26 and so forth of the Patent Law, the examiner shall review it. The technical effects demonstrated by the supplementary experimental data must be those that a person skilled in the art can derive from the content disclosed in the patent application”). 1 2
In order to identify the court's criteria for judgment, we have compiled and prepared the following table based on court rulings by the Supreme People's Court Intellectual Property Tribunal involving supplementary experimental data for pharmaceutical patents:
| Case Name | Case No. | Judgment Date |
Acceptance Criteria |
Acceptance | Reasons |
| “Ticagrelor” Case of Crystal Form Patents | (2019) SPC IP Admin. Final 33 | October 26, 2020 | The original patent application documents have clearly described or implicitly contain the to-be-confirmed technical effects that are intended to be directly proved by the supplementary experimental data. | O | The original patent application documents described a technical effect of “a surprisingly high metabolic stability and bioavailability” that the supplementary experimental data are intended to directly prove. |
| “Entresto” Case of Pharmaceutical Compositions Patents | (2019) SPC IP Admin. Final 235、 | June 30, 2021 | The original patent application documents have clearly described or implicitly contain the to-be-confirmed technical effects that are intended to be directly proved by the supplementary experimental data. | X | The court presumes that the patent holder completed the experiments before the application date, and the patent holder should provide experimental data before the application date. However, the patent holder did not provide such data nor explain the reason for this omission. The supplementary experimental data were obtained after the application date, and some of the experimental conditions, such as the animal models used, differ from those described in the patent specification. The patent holder also failed to provide a reasonable explanation for these discrepancies. |
| Patent Application Rejection Decision for “Stable aqueous solution of recombinant human interleukin-11, and preparation method thereof” | (2020) SPC IP Admin. Final 100 | November 25, 2020 | The original patent application documents have clearly described the to-be-confirmed technical effects that are intended to be directly proved by the supplementary experimental data. | X | The technical effects that the supplementary experimental data aim to prove are not explicitly described in the original patent application documents. |
| Patent Application Rejection Decision for “Method for determining nucleic acids by real-time polymerase chain reaction and a device for the implementation thereof” | (2020) SPC IP Admin. Final 501 | December 31, 2020 | The premise for accepting supplementary experimental data is that the data must be directed towards the technical effects explicitly described in the original patent application documents. | X | The technical effects that the supplementary experimental data aim to prove are not explicitly described in the original patent application documents. |
| Patent Application Rejection Decision for “Composition comprising a peptide and an inhibitor of viral neuraminidase” | (2020) SPC IP Admin. Final 297 | July 9, 2021 | The technical effects demonstrated by the supplementary experimental data must be those that a person skilled in the art can understand from the disclosure at the time of the patent application. Otherwise, the supplementary data should not be accepted. | X | The technical effects that the supplementary experimental data aim to prove are not disclosed in the original patent application documents. |
Based on the table above, we conclude the following comments and suggestions:
1.The patent specification should clearly describe the technical effects that the supplementary experimental data aim to prove, and a qualitative description without supporting data is sufficient, such as “surprisingly high metabolic stability and bioavailability”.
However, it is still recommended that applicants provide as detailed a description of the invention's technical effects as possible when drafting the specification. Additionally, for supplementary experimental data, it is advisable to use the experimental conditions and methods described in the specification (or those commonly known in the art) to increase the likelihood of the supplementary data being accepted.
2.It is important to ensure the relevance among the evidence, supplementary experimental data, and the patent holder's claims. The form of the evidence should be as thorough as possible, such as the inclusion of statements or affidavits from the experimenters, accompanied by notarization. Only when the evidence meets the requirements of legality, relevance, and authenticity can the supplementary experimental data be accepted and trusted.
However, the acceptance of evidence or supplementary experimental data does not necessarily lead to the approval of the patent holder's claims. Therefore, the patent holder must convince the court to accept not only the evidence and supplementary experimental data but also the credibility of the supplementary data which sufficiently proves the patent in question achieving the technical effects as described therein.
3. Referring to past court rulings, such as the (2018) Administrative Rulings of Case No. 3961 and (2018) Administrative Rulings of Case No. 4176, in cases where only qualitative descriptions of technical effects are provided without supporting data, the court deemed them as “assertive statements” and did not recognize them, thereby rejecting the patent holder's supplementary data.
However, starting with (2019) SPC IP Admin. Final 33, the Supreme People's Court Intellectual Property Tribunal began to accept qualitative descriptions of technical effects without requiring supporting data. This note-worthy shift indicates a trend of the Chinese courts becoming more lenient in accepting supplementary experimental data.
[1 ] For an introduction to supplementary experimental data, please refer to Wisdom News Vol. 54: https://www.wisdomlaw.com.tw/m/405-1596-104026,c12252.php?Lang=en
[ 2 ] For the administrative practices of the China National Intellectual Property Administration (CNIPA) regarding the acceptance of supplementary experimental data, please refer to Wisdom News Vol. 127: https://www.wisdomlaw.com.tw/m/404-1596-117797.php?Lang=en
