The Supreme People's Court (2024) Judgment No. 931 of the Supreme People's Court (Administrative) clearly establishes: in a drug patent linkage lawsuit, where the patentee amends the claims and the amendment is accepted by the China National Intellectual Property Administration, such that the amended claims no longer constitute the "relevant patent right" referred to in Article seventy-six, paragraph one of the Patent Law, and the generic drug applicant does not agree to use them as the basis for trial, the case loses its basis for continued trial—if it is a civil case, the claims are dismissed by judgment; if it is an administrative adjudication case, only the adjudication is revoked, without an order to re-decide.
The patent at issue is "Ophthalmic oil-in-water emulsion with stable positive zeta potential" (Patent No. 2005329.6), the patentee being Canmou Co., Ltd., corresponding to the original drug "Vicas" cyclosporine ophthalmic emulsion. In 2022, 6, Guangdong Zhongmou Pharmaceutical filed a marketing application for a generic drug and made a Category 4.1 declaration on the registration platform, asserting that the registered patent right should be declared invalid. In 8 of the same year, Canmou Company requested an adjudication from the China National Intellectual Property Administration; in 2023, 5, it obtained support, and the generic drug technical solution was found to fall within the scope of protection. Zhongmou Company was dissatisfied and sued in the Beijing Intellectual Property Court.
During the litigation, Zhongmou Company filed an invalidation request on 2024, 5, 22. On 6, 27, Canmou Company amended its claims and the amendment was accepted, one of which incorporated the feature in claim 18 that "the ophthalmic oil-in-water submicron emulsion comprises tyloxapol as a nonionic surfactant" into claim 1—while claim 18 had never been registered on the registration platform. Zhongmou Company expressly stated that it did not agree to use the amended claims as the basis for trial.
On 2024, 7, 23, the Beijing Intellectual Property Court in the first instance revoked the challenged adjudication and ordered that it be re-decided. The China National Intellectual Property Administration and Canmou Company were both dissatisfied and appealed separately. On 12, 6 of the same year, the China National Intellectual Property Administration maintained the patent as valid on the basis of the amended claims; on 12, 24, the Supreme People's Court in the final instance upheld the "revocation" part and revoked the "order to re-decide" part.
The starting point of the Supreme People's Court's reasoning is: drug patent linkage is procedurally based on the patent information on the registration platform and the declaration of the generic drug applicant. Article 2, Paragraph 1 of Judicial Interpretation No. 2021 13 limits "relevant patent" to patents to which the linkage measures apply, while Article 2, Paragraph 2 of the Measures for the Implementation of the Early Resolution Mechanism for Drug Patent Disputes (Trial) clearly provides that where patent information has not been registered on the registration platform, these Measures do not apply. Once claims are amended and the amendment is accepted, the original claims are deemed abandoned, the registration information changes accordingly, and the basis for trial is thereby shaken.
In this case, the amendment incorporated features of the unregistered claim 18 into claim 1, the originally registered claims no longer exist, and continuing the trial based on the original claims can no longer achieve the purpose of "early resolution of disputes"; the amended claims also require re-confirmation of whether the original drug technical solution falls within the scope of protection. Therefore, the second instance revoked the challenged adjudication and did not order that it be re-decided. ——————————————————————————————————————————————————— Source: Reference case in the People's Court Case Database (database entry No. 2026-13-3-024-013); first instance Beijing Intellectual Property Court (2023) Jing 73 Xing Chu 19399 (2024, 7, 23); second instance Supreme People's Court (2024) Supreme People's Court (Administrative) Final No. 931 (2024, 12, 24).
Note: This article is compiled based on public information and is for informational reference only; it does not constitute legal or other professional advice. For specific conclusions, please refer to official publications and the actual circumstances of individual cases.
Prepared by Liangma Legalmark Trademark Team from public industry information for general information only. It is not legal advice on a specific matter. Editorial standards ↗
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