Guangdong Zhong* Pharmaceutical Co., Ltd. v. China National Intellectual Property Administration and Can* Co., Ltd.: Patent Administrative Adjudication Case

— The Impact of Amendments to Claims on the Trial of Drug Patent Linkage Cases

Keywords: administrative; patent-related administrative case; patent administrative adjudication; drug patent linkage; amendment of claims; patent information registration

Basic Facts

Can* Co., Ltd. (hereinafter "Can*") is the patentee of the invention patent titled "Ophthalmic oil-in-water type emulsion with stable positive zeta potential" (Patent No. 2005******329.6) (hereinafter the "Patent in Suit"). The originator drug corresponding to the Patent in Suit is "Weikasi" Ciclosporin Eye Drops (III). On May 26, 2022, Can* registered the Patent in Suit on the China Marketed Drug Patent Information Registration Platform (hereinafter the "Registration Platform"), with registered claims 1-10, 12, 14, 15, 20-24, 27, 28, 31, 33 and 34 (hereinafter the "Claims").

On June 22, 2022, the National Medical Products Administration accepted the marketing authorization application filed by Guangdong Zhong* Pharmaceutical Co., Ltd. (hereinafter "Zhong*") for the generic drug in suit. Zhong* made a Category 4.1 declaration on the Registration Platform, i.e., that the relevant patent rights of the originator drug listed on the Registration Platform should be declared invalid.

On August 5, 2022, based on the Patent in Suit, Can* filed a request for administrative adjudication of a drug patent dispute with the China National Intellectual Property Administration (CNIPA), naming Zhong* as the respondent, and requested confirmation that the technical solution of the generic drug in suit fell within the scope of protection of the claims of the Patent in Suit. On May 7, 2023, CNIPA made an administrative adjudication on the drug patent dispute (hereinafter the "Challenged Adjudication"), confirming that the technical solution of the generic drug in suit fell within the scope of protection of the claims of the Patent in Suit. Dissatisfied, Zhong* filed a lawsuit with the Beijing Intellectual Property Court, requesting that the Challenged Adjudication be revoked and that CNIPA be ordered to make a new administrative adjudication.

During the trial of that lawsuit, on May 22, 2024, Zhong* filed a request for invalidation of the Patent in Suit with CNIPA. On June 27, 2024, Can* amended the claims on the basis of original claim 1 and others, and the amendment was accepted by CNIPA. One of the amendments was to further incorporate into claim 1 the technical feature in claim 18, "the ophthalmic oil-in-water submicron emulsion comprises tyloxapol as a non-ionic surfactant". On December 6, 2024, CNIPA issued Decision on Request for Invalidation No. 5832**, maintaining the validity of the Patent in Suit on the basis of the amended claims submitted by Can* on June 27, 2024. Meanwhile, Zhong* expressly stated in this case that it did not agree to the amended claims serving as the basis for the trial.

On July 23, 2024, the Beijing Intellectual Property Court rendered Administrative Judgment (2023) Jing 73 Xing Chu No. 19399: (1) the relevant administrative adjudication on the drug patent dispute made by CNIPA is revoked; and (2) CNIPA shall make a new administrative adjudication.

After the judgment was pronounced, both CNIPA and Can* were dissatisfied and filed separate appeals. On December 24, 2024, the Supreme People's Court rendered Administrative Judgment (2024) Zui Gao Fa Zhi Xing Zhong No. 931: (1) item 1 of Administrative Judgment (2023) Jing 73 Xing Chu No. 19399 of the Beijing Intellectual Property Court is upheld; (2) item 2 of Administrative Judgment (2023) Jing 73 Xing Chu No. 19399 of the Beijing Intellectual Property Court is revoked; (3) the other appeal requests of CNIPA are dismissed; (4) the other appeal requests of Can* are dismissed; and (5) the other claims of Zhong* are dismissed.

Reasons for the Judgment

The issue in dispute in this case is: what impact the patentee's amendment of the claims has on a pending case concerning a dispute over confirmation of whether a product falls within the scope of protection of a drug patent (a drug patent linkage dispute).

Article 76 of the Patent Law of the People's Republic of China provides: "Where, during the review and approval of a drug marketing application, a dispute arises between the drug marketing authorization applicant and the relevant patentee or interested party over a patent right related to the drug applied for registration, the relevant party may file a lawsuit with a people's court, requesting a judgment on whether the technical solution related to the drug applied for registration falls within the scope of protection of another person's drug patent right. The drug regulatory authority under the State Council may, within the prescribed time limit, decide whether to suspend the approval of the marketing of the relevant drug according to the effective judgment of the people's court. The drug marketing authorization applicant and the relevant patentee or interested party may also request administrative adjudication from the patent administration department under the State Council concerning a patent right dispute related to the drug applied for registration..." Article 2, paragraph 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 Disputes over Patent Rights Related to Drugs Applied for Registration (Fa Shi [2021] No. 13) provides: "The related patents referred to in Article 76 of the Patent Law refer to patents to which the specific linkage measures of the relevant administrative department under the State Council for the resolution of patent right disputes at the stages of drug marketing authorization approval and drug marketing authorization application (hereinafter the 'Linkage Measures') apply." Article 2, paragraph 2 of the Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial) provides: "These Measures do not apply where the relevant patent information has not been registered on the China Marketed Drug Patent Information Registration Platform." Accordingly, China's early resolution mechanism for drug patent disputes (i.e., the drug patent linkage system) only targets disputes arising, during drug review and approval, over patent rights related to drugs applied for registration, and takes as the basis for initiating the procedure the patent information registered on the Patent Information Registration Platform by the marketing authorization holder of the originator drug and the declaration made by the generic drug applicant in respect of the registered patent information. If the patentee amends the claims and the amendment complies with the provisions of the Patent Law, the patentee shall be deemed to have abandoned the original claims. Such an amendment may affect the patent information on the Registration Platform and the declaration made by the generic drug applicant in respect of the registered patent information, thereby affecting the basis for the trial of the case concerning a dispute over confirmation of whether a product falls within the scope of protection of a drug patent. In such circumstances, factors such as the impact of the relevant changes on the substantive and procedural rights of the parties, the realization of the purpose of the early resolution mechanism for drug patent disputes, and the parties' willingness to resolve drug patent disputes through the early resolution mechanism shall be considered to determine whether the relevant drug patent linkage dispute case should continue to be tried. Where the patentee amends the claims and the amendment is accepted by CNIPA, so that the amended relevant claims cannot be regarded as the "related patent rights" provided in Article 76, paragraph 1 of the Patent Law, and the generic drug applicant does not agree to continue the trial on the basis of the amended claims, the drug patent linkage dispute case no longer has a basis for continued trial. In this case, if the drug patent linkage dispute case is a civil case filed directly with a people's court, the people's court shall render a judgment dismissing the claims in accordance with the law; if it is a case in which a lawsuit is filed against an administrative adjudication after administrative adjudication was requested from the patent administration department under the State Council, the people's court only needs to revoke the administrative adjudication, without ordering a new administrative adjudication to be made.

In this case, Can* amended the claims, one of the amendments being to further incorporate into claim 1 part of the technical features of original claim 18, which had not been registered on the Registration Platform, and the amendment was accepted by CNIPA. As a result of the above amendment, the originally registered claims no longer exist, and continuing to try this case on the basis of the originally registered claims cannot achieve the purpose of resolving in advance patent disputes that may arise after the generic drug is approved for marketing. Meanwhile, the amended claims require issues such as whether the technical solution of the originator drug falls within the scope of protection of the patent right to be confirmed anew. Zhong* also expressly stated that it did not agree to the amended claims serving as the basis for continuing the trial. In such circumstances, it is not possible to confirm on the basis of the amended claims whether the technical solution of the generic drug in suit falls within the scope of protection of the patent right. Therefore, the court of second instance revoked the Challenged Adjudication that had been made, but did not order CNIPA to make a new administrative adjudication.

Gist of the Judgment

In drug patent linkage litigation, where the patentee amends the claims and the amendment is accepted by CNIPA, so that the amended relevant claims cannot be regarded as the "related patent rights" provided in Article 76, paragraph 1 of the Patent Law, and the generic drug applicant does not agree to continue the trial on the basis of the amended claims, the drug patent linkage dispute case no longer has a basis for continued trial. In this case, if the drug patent linkage dispute case is a civil case filed directly with a people's court, the people's court shall render a judgment dismissing the claims in accordance with the law; if it is a case filed against an administrative adjudication after administrative adjudication was requested from the patent administration department under the State Council, the people's court only needs to revoke the administrative adjudication, without ordering a new administrative adjudication to be made.

Related Index

Article 76 of the Patent Law of the People's Republic of China

Article 2, paragraph 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 Disputes over Patent Rights Related to Drugs Applied for Registration (Fa Shi [2021] No. 13)

Article 2, paragraph 2 of the Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)

First instance: Administrative Judgment (2023) Jing 73 Xing Chu No. 19399 of the Beijing Intellectual Property Court (July 23, 2024)

Second instance: Administrative Judgment (2024) Zui Gao Fa Zhi Xing Zhong No. 931 of the Supreme People's Court (December 24, 2024)

Attachment: Gist of the case (PDF, Chinese original)

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