In drug patent linkage litigation cases, if the parties are in dispute over whether the technical solution of the originator drug falls within the protection scope of the relevant patent claims, the People’s Court shall examine the issue. If the court determines that the technical solution of the originator drug does not fall within the protection scope of the patent claims asserted by the patentee or an interested party, it shall rule to dismiss the case.
Corporation A filed two lawsuits, claiming its ownership of two invention patents (hereinafter "Patent 1" and "Patent 2"). It accused that: the "Tocilizumab Injection" (hereinafter the "Disputed Biosimilar"), for which Company B filed a registration application, was approved by the National Medical Products Administration (NMPA) for use in combination with methotrexate (MTX) to treat rheumatoid arthritis (RA). The marketing authorization holder of the Disputed Originator Drug had registered and publicly disclosed the relevant patent information of the Disputed Patents on the Patent Information Registration Platform for Marketed Drugs, wherein tocilizumab is the medical reference product (MRA) specified in the claims of the Disputed Patents. Company B used the Disputed Biosimilar in combination with MTX for RA treatment, and the Disputed Biosimilar shared identical dosage and administration with the Disputed Originator Drug. Therefore, the technical solution of the Disputed Biosimilar fell within the protection scope of Claims 1–9 of Patent 1 and Claims 1–5 of Patent 2. Furthermore, in both its patent declaration on the Patent Information Registration Platform for Marketed Drugs and its email correspondence with the originator drug’s marketing authorization holder, Company B contended that the Disputed Patents should be declared invalid; in other words, Company B admitted that the technical solution of its Disputed Biosimilar for which registration was sought fell within the protection scopes of Claims 1–9 of Patent 1 and Claims 1–5 of Patent 2. Accordingly, Corporation A requested the court to determine that the Disputed Biosimilar’s technical solution fell within the protection scopes of Claims 1–9 of Patent 1 and Claims 1–5 of Patent 2.
Company B contended that neither Patent 1 nor Patent 2 qualified as a "relevant patent" under Article 76 of the Patent Law and thus Corporation A lacked standing to bring the lawsuits pursuant to said provision, and the lawsuits should be dismissed.
Upon trial, the court found that Corporation A had registered the relevant information of Patent 1 on the Patent Information Registration Platform for Marketed Drugs. The type of patent registered was “biologic product patent for medical use”, and the registered claims were claims 10–18. For Patent 2, Corporation A had also completed registration on the Patent Information Registration Platform for Marketed Drugs. The type of patent registered was “biologic product patent for medical use”, and the registered claims were claims 7–12.
To demonstrate that the Disputed Originator Drug fell within the protection scopes of the Disputed Patents, Corporation A submitted the drug's prescribing information.
In the “Indications” section, the following was stated:
"Rheumatoid Arthritis (RA): For treatment of moderate to severe active RA in adult patients with inadequate response to disease-modifying antirheumatic drugs (DMARDs). Tocilizumab is to be used in combination with methotrexate (MTX) or other DMARDs."
In the “Dosage and Administration” section, the following was stated:
"The recommended adult dosage of tocilizumab is 8mg/kg administered by intravenous infusion every 4 weeks, which may be used in combination with MTX or other DMARDs."
In the “Clinical Trials” section, the following was stated:
"Patients received either tocilizumab or placebo at 4 or 8mg/kg every 4 weeks, in combination with a stable dose of MTX (10-25mg weekly)."
According to the Patent Information Registration Platform for Marketed Drugs, the NMPA accepted Company B’s application for registration of the Disputed Biosimilar on December 8, 2021. The product was filed as an injectable formulation (80mg/4ml), with the Disputed Originator Drug designated as its reference listed drug. In relation to the Disputed Patents, Company B submitted a Type 4.1 Declaration on the Patent Information Registration Platform for Marketed Drugs.
The court of first instance confirmed in its civil rulings that the technical solution of the Disputed "Tocilizumab Injection" Biosimilar fell within the protection scopes of Claims 1–9 of Patent 1 and Claims 1–5 of Patent 2. Following the rulings, Company B filed two appeals, arguing that: Claim 1 of Patent 1 and Claim 1 of Patent 2 did not qualify as "patents related to a drug pending registration" under Article 76 of the Patent Law. Corporation A therefore lacked standing to bring the lawsuits. On July 28, 2023, the Supreme People’s Court issued two civil judgments, overturning the first-instance rulings and dismissing Corporation A’s lawsuits.
The court's final judgments held that: the second-instance proceedings should first examine whether Corporation A had the legal standing to initiate the lawsuits under Article 76 of the Patent Law. Litigation filed pursuant to Article 76(1) must concern disputes arising from patents related to a drug pending registration. Such litigation does not address ordinary infringement disputes; rather, its purpose is to proactively resolve potential patent conflicts between originator drug patent holders and applicants for generic chemical drugs, biosimilars, or traditional Chinese medicine equivalents during the drug review and approval stage, before commercial production and marketing might lead to patent disputes. Only when the technical solution of the originator drug itself falls within the protection scope of the patent claims, can litigation initiated by the patentee or interested parties be deemed as having a proper right basis under Article 76(1) of the Patent Law. This is the legislative intent underlying this type of litigation as provided for in the Patent Law.
Rule 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 of Which Applications for Registration are Filed (hereinafter referred to as the Judicial Interpretation of Patent Disputes Related to Drugs) further stipulates:
“For the purposes of Article 76 of the Patent Law, ‘relevant patent’ means a patent subject to the specific connection measures issued by the relevant administrative department under the State Council for the resolution of patent disputes during drug marketing approval and drug marketing application.”
And, Measures for the Implementation of the Mechanism for Early Settlement of Drug Patent Disputes (Interim) (hereinafter referred to as the Measures) are the “specific connection measures” referred to in the above provision.
Rule 2(1) of the Measures stipulates that: the marketing authorization holder of a drug shall register on the Patent Information Registration Platform for Marketed Drugs the relevant patent information for drugs that are registered and marketed within China; and these Measures shall not apply to drugs for which relevant patent information has not been registered on the China’s Patent Information Registration Platform for Marketed Drugs. ”
Rule 4(1) of the Measures further specifies that the content for registration shall include “correspondence between the drug and relevant patent claims.”
It is thus clear that the “relevant patent” as referred to in Article 76(1) of the Patent Law presupposes registration on the Patent Information Registration Platform for Marketed Drugs, and the patents registered on the Patent Information Registration Platform for Marketed Drugs must be patents related to drugs that are registered and marketed within China, and the registered content shall include the correspondence between the drug and the relevant patent claims. In other words, according to the specific provisions of the Judicial Interpretation of Patent Disputes Related to Drugs and the Measures, the fact that the originator drug’s technical solution falls within the protection scope of the patent claims is also a necessary condition for the patentee or an interested party to file a lawsuit under Article 76 of the Patent Law. However, neither the Patent Law nor the Judicial Interpretation of Patent Disputes Related to Drugs stipulates that raising an opposition against the registered patent information is a necessary condition for bringing a lawsuit under Article 76 of the Patent Law.
Since, under the current system, the marketing authorization holder of a drug may independently register patent information on the Patent Information Registration Platform for Marketed Drugs, and the registered patent information is not subject to examination, when there is a dispute between the parties as to whether the technical solution of the originator drug falls within the protection scope of a patent in dispute, the People’s Court shall examine this issue during the trial. If it is determined that the technical solution of the originator drug does not fall within the protection scope of the patent claims asserted by the patentee or an interested party, the court shall rule to dismiss the lawsuit. In these two cases, Company B clearly argued in the original trial that the technical solution of the Disputed Originator Drug did not fall within the protection scope of Claims 1–9 of Patent 1 or Claims 1–5 of Patent 2. Therefore, this should be examined to determine whether the lawsuits filed by Corporation A met the conditions for filing.
Claim 1 of Patent 1 should be interpreted as defining the use of MRA and methotrexate (MTX) for the production of a specifically packaged drug combination product for the treatment of rheumatoid arthritis. However, the Disputed Originator Drug is a tocilizumab injection, and only in its prescribing information was it stated that it may be used in combination with methotrexate; that is, it involves only a single substance and does not constitute a specifically packaged drug combination product. Therefore, it certainly did not fall within the protection scope of Claims 1–9 of Patent 1. The “use of a recombinant humanized anti-human interleukin-6 receptor monoclonal antibody MRA and methotrexate (MTX) for the production of a combination of MRA and MTX for treating rheumatoid arthritis” in Claim 1 of Patent 2 should likewise be interpreted as defining the use of MRA and MTX for the production of a specifically packaged drug combination product for the treatment of rheumatoid arthritis. However, the Disputed Originator Drug is a tocilizumab injection, and only in its prescribing information was it stated that it may be used in combination with MTX; that is, it involves only a single substance and does not constitute a specifically packaged drug combination product. Therefore, it certainly did not fall within the protection scope of claims 1–5 of Patent 2. Accordingly, Corporation A’s lawsuits did not comply with the provisions of Article 76(1) of the Patent Law and shall be dismissed.
(2023) Zui Gao Fa Zhi Min Zhong Nos. 2 and 3
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