Guangdong Zhongmou Pharmaceutical Co., Ltd. v. China National Intellectual Property Administration and Shenmou Co., Ltd. (Patent Administrative Adjudication)

— Effects of amending patent claims on the adjudication of pharmaceutical patent linkage cases

Keywords: administrative; patent-related administrative cases; patent administrative adjudication; pharmaceutical patent linkage; claim amendment; patent information registration

Basic facts

Shenmou Co., Ltd. (“Shenmou”) is the patentee of the invention patent entitled “Oil-in-water emulsion for ophthalmic use having a stable positive zeta potential” (patent No. 2005******329.6) (the “Patent”). The corresponding original drug is “Restasis” cyclosporine ophthalmic emulsion (III). On 26 May 2022, Shenmou registered the Patent on the China Marketed Drug Patent Information Registration Platform (the “Platform”), registering claims 1-10, 12, 14, 15, 20-24, 27, 28, 31, 33 and 34 (the “Claims”).

On 22 June 2022, the National Medical Products Administration accepted the marketing authorization application filed by Guangdong Zhongmou Pharmaceutical Co., Ltd. (“Zhongmou”) for the corresponding generic drug. Zhongmou made a Category 4.1 declaration on the Platform, i.e. that the relevant patents of the original drug recorded on the Platform should be declared invalid.

On 5 August 2022, based on the Patent, Shenmou filed a request with the China National Intellectual Property Administration (“CNIPA”) for administrative adjudication of a pharmaceutical patent dispute against Zhongmou, seeking confirmation that the technical solution of the generic drug fell within the protection scope of the Patent claims. On 7 May 2023, CNIPA rendered a pharmaceutical patent dispute administrative adjudication (the “Challenged Decision”), confirming that the technical solution of the generic drug fell within the protection scope of the Patent claims. Zhongmou disagreed and sued before the Beijing Intellectual Property Court, seeking revocation of the Challenged Decision and an order that CNIPA remake the administrative adjudication.

During that litigation, on 22 May 2024 Zhongmou filed a request with CNIPA to invalidate the Patent. On 27 June 2024, Shenmou amended the claims on the basis of original claim 1 and others; the amendment was accepted by CNIPA. One of the amendments further limited into claim 1 the technical feature in claim 18 that “the oil-in-water submicron emulsion for ophthalmic use comprises tyloxapol as a non-ionic surfactant.” On 6 December 2024, CNIPA issued Invalidation Decision No. 5832**, maintaining the Patent valid on the basis of the amended claims submitted by Shenmou on 27 June 2024. In the present case, Zhongmou expressly stated that it did not agree to continue the proceedings on the basis of the amended claims.

On 23 July 2024, the Beijing Intellectual Property Court rendered Administrative Judgment (2023) Jing 73 Xing Chu No. 19399: (1) revoking the relevant pharmaceutical patent dispute administrative adjudication made by CNIPA; and (2) ordering CNIPA to remake the administrative adjudication.

After pronouncement, CNIPA and Shenmou both appealed. On 24 December 2024, the Supreme People’s Court rendered Administrative Judgment (2024) Zui Gao Fa Zhi Xing Zhong No. 931: (1) affirming item 1 of the Beijing Intellectual Property Court judgment; (2) setting aside item 2 of that judgment; (3) dismissing CNIPA’s other appeal requests; (4) dismissing Shenmou’s other appeal requests; and (5) dismissing Zhongmou’s other claims.

Reasons for the decision

The issue in dispute was what effect a patentee’s amendment of claims has on a pending dispute concerning confirmation of whether a drug falls within the protection scope of a pharmaceutical patent (a pharmaceutical patent linkage dispute).

Article 76 of the Patent Law of the People’s Republic of China provides that, during drug marketing review and approval, where a dispute arises between a marketing authorization applicant and the relevant patentee or interested party concerning a patent related to the drug for which registration is sought, the relevant party may sue before the people’s court and seek a judgment on whether the technical solution of the drug related to the application for drug registration falls within the protection scope of the relevant patent right. The party may also request the patent administration department under the State Council to make an administrative adjudication.

Where, in a pharmaceutical patent linkage dispute, the patentee amends the claims and the amendment is accepted by CNIPA, such that the amended claims cannot be regarded as the “relevant patent right” under Article 76(1) of the Patent Law, and the generic applicant also disagrees to continue the proceedings on the basis of the amended claims, the case no longer has a basis for continued adjudication. Questions such as whether the technical solution of the generic drug falls within the protection scope need to be reconfirmed. Zhongmou also expressly disagreed to continue on the amended claims. In those circumstances, the amended claims could not be used to confirm whether the generic technical solution fell within the patent protection scope. The second-instance court therefore revoked the Challenged Decision already made, but did not order CNIPA to remake an administrative adjudication.

Holding

In pharmaceutical patent linkage litigation, where the patentee amends the claims and the amendment is accepted by CNIPA, with the result that the amended claims cannot be regarded as the “relevant patent right” under Article 76(1) of the Patent Law, and the generic applicant also disagrees to continue on the basis of the amended claims, the pharmaceutical patent linkage dispute no longer has a basis for continued adjudication. In that situation, if the pharmaceutical patent linkage dispute was brought directly as a civil case before a people’s court, the court shall lawfully dismiss the claims; if, after requesting administrative adjudication from the patent administration department under the State Council, a case is brought against that adjudication, the people’s court need only revoke the administrative adjudication and need not order that a new adjudication be made.

Related references

Article 76 of the Patent Law of the People’s Republic of China; Article 2(1) of the Provisions of the Supreme People’s Court on Several Issues Concerning the Application of Law in the Trial of Civil Cases Involving Patent Disputes Related to Drugs for Which Registration Is Sought (Fa Shi [2021] No. 13); Article 2(2) of the Measures for Early Resolution Mechanisms for Pharmaceutical Patent Disputes (Trial).

First instance: Beijing Intellectual Property Court Administrative Judgment (2023) Jing 73 Xing Chu No. 19399 (23 July 2024). Second instance: Supreme People’s Court Administrative Judgment (2024) Zui Gao Fa Zhi Xing Zhong No. 931 (24 December 2024).

Attachment: Judgment PDF

Source：Intellectual Property Court of the Supreme People’s Court；2026-10-20；https://ipc.court.gov.cn/zh-cn/news/view-6180.html