*AI-generated translation, for reference only.

[Keywords]

Civil; Confirming whether to fall within the protection scope of the patent right; Drug patent linkage; Declaration information; Basis of comparison; Registration; Declaration of Type 4.2; Independent claims

[Case Facts]

The Appellant, Japan [REDACTED] Co., Ltd., is the patentee of Chinese invention patent No. 200580009877.6, titled "ED-71 Preparation" (hereinafter referred to as the patent-in-question). Japan [REDACTED] Co., Ltd. holds the marketing authorization for the corresponding brand-name drug and has registered the aforesaid drug and patents on the China Listed Drug Patent Information Registration Platform (hereinafter referred to as the Registration Platform). The Appellee, Wenzhou [REDACTED] Pharmaceutical Co., Ltd., applied to the National Medical Products Administration (NMPA) for marketing authorization for a generic version of the above-mentioned brand-name drug and made a relevant declaration, stating that its generic drug did not fall within the protection scope of the patent rights related to the brand-name drug as included in the Registration Platform. Japan [REDACTED] Co., Ltd. filed a lawsuit with the Beijing Intellectual Property Court, requesting a judgment confirming that the technical solution of the generic drug in question fell within the protection scope of the claims of the patent-in-question.

The Beijing Intellectual Property Court rendered a civil judgment (2021) Jing 73 Min Chu No. 1438 on April 15, 2022, dismissing Japan [REDACTED] Co., Ltd.'s claims. Dissatisfied, Japan [REDACTED] Co., Ltd. appealed. The Supreme People's Court rendered a civil judgment (2022) SPC IP Civil Final No.905 on August 5, 2022, dismissing the appeal and upholding the original judgment.

[Judge's Opinion]

The effective judgment of the court holds: According to Article 6 of the Implementation Measures for the Mechanism for Early Settlement of Medicinal Product Patent Disputes (for Trial Implementation), an applicant for a chemical generic drug, when submitting an application for drug marketing authorization, shall make a declaration against each relevant drug patent pertaining to the brand-name drug, by reference to the patent information already made public on the Registration Platform. The generic drug applicant is responsible for the authenticity and accuracy of the relevant declaration. This provision only sets forth requirements for the patent against which the generic drug applicant must make a declaration; it does not specify the particular patent claims against which the declaration should be made. When making a declaration, a generic drug applicant should typically consider the correspondence between the brand-name drug and the patent claims disclosed on the Registration Platform, i.e., whether the brand-name drug implements the technical solutions of the patent claims disclosed on the Registration Platform.

For a Type 4.2 declaration, the core purpose is to state that the technical solution of the generic drug applied for by the applicant does not fall within the protection scope of the patent right of the brand-name drug. To ensure the authenticity and accuracy of the declaration, the generic drug applicant should, in principle, make the declaration on the Claim corresponding to the imitated drug with the largest scope of protection. Since the scope of protection of an independent claim is the broadest, if the brand-name drug corresponds to an independent claim, as long as the generic drug's technical solution does not fall within the scope of the independent claim, it necessarily does not fall within the scope of any dependent claims. However, if the generic drug's technical solution does not fall within the scope of a dependent claim, it does not automatically lead to the conclusion that it does not fall within the scope of the patent right. Therefore, for a Type 4.2 declaration of non-infringement, if the brand-name drug corresponds to an independent claim, the generic drug applicant should make the declaration against that independent claim; when there are two or more independent claims corresponding to the claim with the broadest scope of protection for the brand-name drug, the generic drug applicant must make a declaration against those two or more independent claims to ensure the authenticity and accuracy of the declaration.

After the patentee registers information on the Registration Platform, it is possible for the patentee to amend the claims of the registered patent during invalidation proceedings. However, regardless of the method of amendment, the final accepted examination text must not broaden the scope of protection of the original claims. Therefore, as long as the generic drug applicant makes a Type 4.2 declaration against the claim with the broadest scope of protection corresponding to the brand-name drug at the time of filing the generic drug application, any subsequent amendment of the claims by the patentee during invalidation proceedings will not affect the authenticity and accuracy of the declaration.

The particularity of this case lies in the fact that the generic drug applicant, Wenzhou [REDACTED] Pharmaceutical Co., Ltd., did not make a declaration against the independent claim corresponding to the brand-name drug before amendment, but only made a declaration against the original dependent claim 2. In this regard, during invalidation proceedings, a patentee's amendment of claims does not necessarily lead to a change in the examination text. The earliest point at which an amended examination text is accepted and published by the China National Intellectual Property Administration (CNIPA) is during the oral proceedings. When the NMPA accepted Wenzhou [REDACTED] Pharmaceutical Co., Ltd.'s registration application for the generic drug in question on August 16, 2021, CNIPA had not yet held oral proceedings for the invalidation request concerning the patent-in-question. Therefore, Wenzhou [REDACTED] Pharmaceutical Co., Ltd.'s application for marketing the generic drug and its Type 4.2 declaration occurred before CNIPA's oral proceedings. At the time Wenzhou [REDACTED] Pharmaceutical Co., Ltd. made its Type 4.2 declaration, it failed to make a declaration against the independent claim with the broadest scope of protection corresponding to the brand-name drug at that time, making a declaration only against a dependent claim with a narrower scope of protection. This action lacked justification, suggesting an attempt to evade the main issue, and its propriety is questionable. Wenzhou [REDACTED] Pharmaceutical Co., Ltd. claimed it had applied to the NMPA to amend its declaration, but this fact arose after Japan [REDACTED] Co., Ltd. filed the instant lawsuit, making it difficult to prove the propriety of Wenzhou [REDACTED] Pharmaceutical Co., Ltd.'s actions.

During the process of drug marketing review and approval, disputes between a drug marketing authorization applicant and a relevant patentee or interested party concerning patents related to the drug under application represent merely a special form of dispute between the parties regarding relevant patent rights, commonly referred to as drug patent linkage disputes. For chemical generic drugs, the drug regulatory authority of the State Council conducts marketing review and approval based on the application dossiers submitted by the generic drug applicant and decides whether to suspend approving the relevant drug's marketing within a specified period based on effective judgments of the people's court concerning such disputes. Therefore, when determining whether a generic drug's technical solution falls within the patent's protection scope, the comparison and evaluation should, in principle, be conducted based on the generic drug applicant's application dossiers. If the technical solution actually implemented by the generic drug applicant is inconsistent with the applied technical solution, the applicant must bear legal responsibility according to relevant drug regulatory laws and regulations. If the patentee or interested party believes the technical solution actually implemented by the generic drug applicant constitutes infringement, they may also file a separate lawsuit for patent infringement. Consequently, whether the technical solution actually implemented by the generic drug applicant is the same as that in the application dossiers generally does not fall within the scope of review in a lawsuit for confirming whether it falls within the protection scope of a patent right. In this case, whether Wenzhou [REDACTED] Pharmaceutical Co., Ltd.'s declaration of an antioxidant registered as an active pharmaceutical ingredient as an excipient for the generic drug in question complies with relevant regulations falls within the review scope of the drug regulatory authority of the State Council and does not affect this court's confirmation of the authenticity of the application dossiers or the subject of comparison in this case. Furthermore, Japan [REDACTED] Co., Ltd. has no other evidence proving that the basis for the drug regulatory authority of the State Council's review and approval of the antioxidant in the generic drug in question has changed.

[Judgment Digest]

1. Where an applicant of a generic drug makes a declaration, in accordance with Article 6 of the Implementation Measures for the Mechanism for Early Settlement of Medicinal Product Patent Disputes (for Trial Implementation), that the technical solution of the generic drug does not fall within the protection scope of the patent of the brand-name drug in question, the applicant should, in principle, make its declaration vis-a-vis the patent claim of the broadest protection scope corresponding to the brand-name drug, so as to ensure the authenticity and accuracy of such declaration. Where two or more independent claims corresponding to the brand-name drug are disclosed on the patent information registration platform for listed drugs in China, the applicant of the generic drug should make its declaration for such two or more independent claims.

2. In drug patent linkage litigation, when determining whether the technical solution of a generic drug falls within the protection scope of the involved patent, people’s courts shall in principle decide according to the comparison on the basis of the application materials submitted by the generic drug applicant; whether the technical solution embodied by the generic drug applicant in fact is the same as that in the application materials generally does not fall within the scope of judicial review in drug patent linkage litigation.

[Related Index]

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

First Instance: Civil Judgment of Beijing Intellectual Property Court, (2021) Jing 73 Min Chu No. 1438 (April 15, 2022).

Second Instance: Civil Judgment of the Supreme People's Court, (2022) SPC IP Civil Final No.905 (August 5, 2022).