*AI-generated translation, for reference only.

Keywords: civil; confirmation of whether the pharmaceutical falls within the scope of patent protection; drug patent linkage; invention patent; Type 4.1 declaration; pharmaceutical use; claim construction; standing to sue

Case Facts

[REDACTED] Co., Ltd. (Japan) (hereinafter "Japan [REDACTED] Company") alleged as follows: It is the rights holder of Invention Patent No. 200480011401.1, entitled "Method for Treating Interleukin-6-Related Diseases" (hereinafter "Patent-in-Suit 1"), and Invention Patent No. 201511004468.9, entitled "Method for Treating Interleukin-6-Related Diseases" (hereinafter "Patent-in-Suit 2"). The "Tocilizumab Injection" (hereinafter the "Biosimilar-in-Suit") covered by Application No. CXSS2101056 filed by [REDACTED] Bio-Pharmaceutical Co., Ltd. (hereinafter "[REDACTED] Bio Company") was approved by the NMPA for use in combination with methotrexate (MTX) for the treatment of rheumatoid arthritis (RA). The marketing authorization holder of the originator drug at issue has registered the relevant information concerning the Patents-in-Suit on the Patent Information Registration Platform, and such information has been publicly listed. Tocilizumab is the MRA as defined in the claims of the Patents-in-Suit. [REDACTED] Bio Company will use the Biosimilar-in-Suit in combination with methotrexate and MTX, both being used for the treatment of rheumatoid arthritis, and the Biosimilar-in-Suit and the originator drug at issue share the same usage and dosage. Therefore, the technical solution of the Biosimilar-in-Suit falls within the scope of protection of claims 1 through 9 of Patent-in-Suit 1 and claims 1 through 5 of Patent-in-Suit 2. Moreover, in both the patent declaration made by [REDACTED] Bio Company on the Patent Information Registration Platform and the correspondence sent to the marketing authorization holder of the originator drug, [REDACTED] Bio Company asserted that the Patents-in-Suit should be declared invalid, *i.e.*, it acknowledged that the technical solution of the Biosimilar-in-Suit for which registration was applied fell within the scope of protection of claims 1 through 9 of Patent-in-Suit 1 and claims 1 through 5 of Patent-in-Suit 2. Japan [REDACTED] Company accordingly requested confirmation that the technical solution of the Biosimilar-in-Suit fell within the scope of protection of claims 1 through 9 of Patent-in-Suit 1 and claims 1 through 5 of Patent-in-Suit 2.

[REDACTED] Bio Company defended as follows: Neither Patent-in-Suit 1 nor Patent-in-Suit 2 is a "relevant patent" under *Article 76* of the Patent Law; Japan [REDACTED] Company therefore has no standing to bring this lawsuit under that provision, and the complaint should be dismissed.

The court found through trial as follows: Japan [REDACTED] Company registered the relevant information for Patent-in-Suit 1 on the Patent Information Registration Platform. The registered patent type was a biological product pharmaceutical use patent, and the registered claims were claims 10 through 18. Japan [REDACTED] Company registered the relevant information for Patent-in-Suit 2 on the Patent Information Registration Platform. The registered patent type was a biological product pharmaceutical use patent, and the registered claims were claims 7 through 12.

To prove that the originator drug at issue fell within the scope of protection of the Patents-in-Suit, Japan [REDACTED] Company submitted the drug label of the originator drug. The "Indications" section of the label stated: "Rheumatoid Arthritis (RA): This product is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to disease-modifying antirheumatic drugs (DMARDs). Tocilizumab is used in combination with methotrexate (MTX) or other DMARDs." The "Dosage and Administration" section stated: "The recommended adult dosage of tocilizumab is 8 mg/kg administered once every 4 weeks by intravenous infusion, and may be used in combination with MTX or other DMARDs." The "Clinical Trials" section stated: "4 or 8 mg/kg of tocilizumab or placebo was administered once every 4 weeks, together with a stable dose of MTX (10-25 mg/week)."

The Patent Information Registration Platform showed that the NMPA accepted [REDACTED] Bio Company's registration application for the Biosimilar-in-Suit on December 8, 2021, under Acceptance No. CXSS2101056, with an injection dosage form and a specification of 80 mg/4 ml, the referenced originator drug being the drug at issue. [REDACTED] Bio Company made a Type 4.1 declaration in respect of the Patents-in-Suit on the Patent Information Registration Platform.

On November 24, 2022, the Beijing Intellectual Property Court rendered Civil Judgments (2022) Jing 73 Min Chu Nos. 314 and 315, respectively, confirming that the technical solution of the "Tocilizumab Injection" biosimilar drug under Acceptance No. CXSS2101056 fell within the scope of protection of claims 1 through 9 of Patent-in-Suit 1, and within the scope of protection of claims 1 through 5 of Patent-in-Suit 2. [REDACTED] Bio Company appealed, arguing that neither claim 1 of Patent-in-Suit 1 nor claim 1 of Patent-in-Suit 2 was a "patent related to the drug for which registration is applied" under *Article 76* of the Patent Law, and that Japan [REDACTED] Company therefore had no standing to bring this lawsuit. On July 28, 2023, the Supreme People's Court rendered Civil Rulings (2023) SPC IP Civ Final Nos. 2 and 3, respectively, revoking Civil Judgments (2022) Jing 73 Min Chu Nos. 314 and 315 of the Beijing Intellectual Property Court and dismissing Japan [REDACTED] Company's complaint.

Judge's Opinion

The court's effective ruling held as follows: At this second-instance stage, the court must first examine whether Japan [REDACTED] Company had standing to bring this lawsuit under *Article 76* of the Patent Law. A lawsuit brought by a party pursuant to *Article 76(1)* of the Patent Law must be a lawsuit arising from a dispute concerning patent rights related to the drug for which registration is applied. This type of lawsuit does not resolve infringement disputes in the general sense; its purpose is to resolve, in advance during the drug marketing review and approval stage, patent disputes that may arise between originator drug patent holders and chemical generic drug, biosimilar, or traditional Chinese medicine same-name same-formula drug applicants once the drugs enter the market for production and commercial operations. Only where the technical solution of the originator drug itself falls within the scope of protection of the patent claims can the lawsuit brought by the rights holder or an interested party be regarded as having a standing basis consistent with *Article 76(1)* of the Patent Law, which is the natural corollary of this type of lawsuit provided for under the Patent Law.

*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 Applications Have Been Filed* (hereinafter the "Judicial Interpretation on Drug Patent Disputes") further provides: "'The relevant patent' as referred to in *Article 76* of the Patent Law means a patent to which the specific implementation measures, formulated by the relevant administrative departments of the State Council, for resolving patent disputes at the stages of drug marketing authorization approval and drug marketing authorization application apply." The *Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)* (hereinafter the "Drug Patent Dispute Early Resolution Measures") are the "specific implementation measures" referred to in that provision.*Article 2(1)* of the Drug Patent Dispute Early Resolution Measures provides that what a drug marketing authorization holder registers on the Patent Information Registration Platform shall be information on patents related to drugs registered and marketed in China; the Drug Patent Dispute Early Resolution Measures may not be applied where no relevant patent information has been registered on the Patent Information Registration Platform. *Article 4(1)* provides that the specific contents of the registration include "the correspondence between drugs and the relevant patent claims." It is thus evident that the "relevant patent" under *Article 76(1)* of the Patent Law is predicated upon registration on the Patent Information Registration Platform; patents registered on the Patent Information Registration Platform shall be patents related to drugs registered and marketed in China, and the registration contents shall include the correspondence between the drugs and the relevant patent claims. In other words, under the specific provisions of the Judicial Interpretation on Drug Patent Disputes and the Drug Patent Dispute Early Resolution Measures, the condition that the originator drug's technical solution falls within the scope of protection of the patent claims is also a necessary prerequisite for the rights holder or interested party to bring a lawsuit under *Article 76* of the Patent Law. However, neither the Patent Law nor the Judicial Interpretation on Drug Patent Disputes treats the filing of an objection to the patent registration information as a necessary precondition for bringing a lawsuit under *Article 76* of the Patent Law.

Given that under the current system, drug marketing authorization holders may register patent information on the Patent Information Registration Platform on their own initiative without the registered patent information undergoing review, the People's Court shall, in the course of trial, examine whether the originator drug's technical solution falls within the scope of protection of the patent rights at issue whenever the parties dispute that question; where the originator drug's technical solution does not fall within the scope of protection of the patent claims asserted by the rights holder or interested party, the complaint shall be dismissed by ruling. In this case, [REDACTED] Bio Company had expressly raised at first instance the defense that the originator drug's technical solution did not fall within the scope of protection of claims 1 through 9 of Patent-in-Suit 1 and claims 1 through 5 of Patent-in-Suit 2; accordingly, the court must examine this issue in order to determine whether the lawsuit brought by Japan [REDACTED] Company satisfied the conditions for filing.

Claim 1 of Patent-in-Suit 1 should be construed as the use of MRA and methotrexate in the preparation of a pharmaceutical combination product in a specific packaging form for the treatment of rheumatoid arthritis. The originator drug product at issue is tocilizumab injection, and the drug label merely states that it may be used in combination with methotrexate — *i.e.*, it involves only a single substance and does not constitute a pharmaceutical combination product in a specific packaging form; therefore, it necessarily does not fall within the scope of protection of claims 1 through 9 of Patent-in-Suit 1. The phrase in claim 1 of Patent-in-Suit 2 — "use of a recombinant humanized anti-human interleukin-6 receptor monoclonal antibody MRA and methotrexate MTX for the preparation of a combination of MRA and MTX for treating rheumatoid arthritis" — should be construed as the use of MRA and MTX in the preparation of a pharmaceutical combination product in a specific packaging form for the treatment of rheumatoid arthritis. The originator drug product at issue is tocilizumab injection, and the drug label merely states that it may be used in combination with MTX — *i.e.*, it involves only a single substance and does not constitute a pharmaceutical combination product in a specific packaging form; therefore, it necessarily does not fall within the scope of protection of claims 1 through 5 of Patent-in-Suit 2. Accordingly, Japan [REDACTED] Company's complaint does not satisfy the conditions set forth in *Article 76(1)* of the Patent Law and should be dismissed.

Judgment Digest

In drug patent linkage lawsuits, where the parties dispute whether the originator drug's technical solution falls within the scope of protection of the patent claims at issue, the People's Court shall examine the issue; where the originator drug's technical solution does not fall within the scope of protection of the patent claims asserted by the rights holder or an interested party, the complaint shall be dismissed by ruling.

Related Index

*Article 76(1)* 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 Applications Have Been Filed* (Fa Shi [2021] No. 13)

*Articles 2(1) and 4(1)* of the *Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)*

First Instance: Beijing Intellectual Property Court, Civil Judgments (2022) Jing 73 Min Chu Nos. 314 and 315 (November 24, 2022)

Second Instance: Supreme People's Court, Civil Rulings (2023) SPC IP Civ Final Nos. 2 and 3 (July 28, 2023)