*AI-generated translation, for reference only.

Keywords: civil; confirmation of whether the pharmaceutical falls within the scope of patent protection; drug patent linkage; related patent; dosage form; dosage strength; specification difference

Case Facts

 [REDACTED] LLC (hereinafter "[REDACTED] Company") is the patent holder of Invention Patent No. 03802556.6, entitled "2-(Pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-one" (hereinafter the "Patent-in-Suit"). The scope of protection of the Patent-in-Suit covers all dosage forms of pharmaceutical products containing the active ingredient palbociclib, including palbociclib capsules and palbociclib tablets.

On June 30, 2021, [REDACTED] Company registered the Patent-in-Suit on the China Marketed Drug Patent Information Registration Platform (hereinafter the "Patent Information Registration Platform") as a related patent for palbociclib capsules in three specifications (75 mg, 100 mg, and 125 mg), registering claims 1 through 4. The originator drug palbociclib tablets in 25 mg and 125 mg specifications (dosage form: tablets) was approved for marketing in China on August 10, 2022. On September 6, 2022, [REDACTED] Company further registered the Patent-in-Suit on the Patent Information Registration Platform as a related patent for palbociclib tablets in two specifications (25 mg and 125 mg), likewise registering claims 1 through 4.

On April 12, 2022, the National Medical Products Administration (NMPA) accepted the generic drug registration application for palbociclib tablets filed by [REDACTED] Pharmaceutical Co., Ltd. (hereinafter "[REDACTED] Pharmaceutical Company"), covering three specifications (75 mg, 100 mg, and 125 mg) in tablet dosage form. With respect to the Patent-in-Suit, [REDACTED] Pharmaceutical Company made a Type 1 declaration on the Patent Information Registration Platform, *i.e.*, declaring that there was no patent information relating to the generic drug in the Patent Information Registration Platform.

 [REDACTED] Company alleged as follows: The Type 1 declaration made by [REDACTED] Pharmaceutical Company was false and inaccurate; [REDACTED] Pharmaceutical Company had previously filed an invalidation petition against the Patent-in-Suit, and its true intent was therefore a Type 4.1 declaration. [REDACTED] Company requested confirmation that the technical solution of the generic drug for which [REDACTED] Pharmaceutical Company had applied for registration fell within the scope of protection of claims 1 through 4 of the Patent-in-Suit.

 [REDACTED] Pharmaceutical Company defended as follows: For the 75 mg and 100 mg specifications of palbociclib tablets covered by its application, there were no corresponding originator drugs and patent information for the same publicly listed on the Patent Information Registration Platform.

For the 125 mg specification, the patent information publicly registered and listed on the Patent Information Registration Platform was posted after [REDACTED] Pharmaceutical Company had made its declaration. Its invalidation petition and administrative litigation concerning the Patent-in-Suit were both commenced before the implementation of China's drug patent linkage system and before the date of its generic drug application; accordingly, [REDACTED] Company's argument that [REDACTED] Pharmaceutical Company should have made a Type 4.1 declaration was without foundation.

On April 26, 2023, the Beijing Intellectual Property Court rendered Civil Rulings (2022) Jing 73 Min Chu No. 1210 and (2023) Jing 73 Min Chu Nos. 189 and 191, dismissing [REDACTED] Company's complaint. [REDACTED] Company appealed. On September 20, 2023, the Supreme People's Court rendered Civil Rulings (2023) SPC IP Civ Final Nos. 1233, 1234, and 1235, dismissing the appeal and affirming the original ruling.

Judge's Opinion

The court's effective ruling held as follows: First, from the perspective of systematic interpretation, 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 *Article 2(1)* of the Judicial Interpretation on Drug Patent Disputes. *Article 2* 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." *Article 4(1)* provides that the specific contents of registration include "the correspondence between drugs and the relevant patent claims." It is thus evident that the patents registered pursuant to the Drug Patent Dispute Early Resolution Measures should correspond to drugs already marketed in China. *Article 6(1)* of the Drug Patent Dispute Early Resolution Measures further provides that "when submitting a drug marketing authorization application, a chemical generic drug applicant shall, by reference to the patent information publicly listed on the China Marketed Drug Patent Information Registration Platform, make a declaration in respect of each relevant drug patent for the generic drug." In interpreting "each relevant drug patent for the generic drug" in this article, the understanding should follow that in the preceding provisions: the "generic drug" and the "relevant drug patent" should satisfy the requirement, set forth in *Article 4(1)*, that a correspondence exists between the generic drug and the relevant patent claims, and the patent claims with such correspondence must have been registered on the Patent Information Registration Platform. Hence, the "generic drug" referred to herein should be understood as a generic drug that is already marketed in China, and the "relevant drug patent" should be understood as a patent registered on the Patent Information Registration Platform in correspondence with a generic drug already marketed in China.

Second, from the perspective of purposive interpretation, the drug patent dispute early resolution mechanism established by *Article 76* of the Patent Law and the Drug Patent Dispute Early Resolution Measures is a special mechanism designed to balance the interests of originator drug patent holders, generic drug applicants, and the public interest. The drug patent dispute early resolution mechanism is not the sole means of resolving drug patent disputes, and the scope of drug patents to which this special mechanism applies should not, as a matter of principle, be arbitrarily expanded through interpretation. If the understanding advanced by [REDACTED] Company were adopted, interpreting "relevant patent" as potentially encompassing any patent appearing on the Patent Information Registration Platform, it would unduly increase the burden on generic drug applicants in determining the category of their declarations and would compromise the stable and effective operation of the mechanism.

Finally, [REDACTED] Pharmaceutical Company's invalidation petition and administrative litigation concerning the Patent-in-Suit were both commenced before the implementation of China's drug patent linkage system and before the date of its generic drug application; accordingly, such actions cannot be interpreted, by applying subsequently enacted laws, judicial interpretations, or administrative rules, as a Type 4.1 declaration in respect of the Patent-in-Suit.

In summary, the "relevant patent" under *Article 76(1)* of the Patent Law should be understood as a patent registered on the Patent Information Registration Platform in correspondence with the generic drug already marketed in China. Given that the Patent-in-Suit was not registered as a patent corresponding to the palbociclib tablets already marketed in China, it does not constitute a "relevant patent" with respect to palbociclib tablets. Accordingly, [REDACTED] Company's complaint does not satisfy the conditions set forth in *Article 76* of the Patent Law and should be dismissed.

Furthermore, although under China's current drug regulatory regime, chemical drugs that differ only in specification are also required to file separate registration applications and obtain separate batch numbers, a generic drug in the same dosage form may use originator drugs of different specifications as reference listed drugs and may rely on quality and efficacy equivalence data with respect to such reference listed drugs as the basis for its registration application. Therefore, where an originator drug that differs from the generic drug only in specification has a patent registered on the Patent Information Registration Platform, the generic drug applicant should, in principle, make its declaration by reference to the relevant patents registered under the other specifications of the generic drug as listed on the Patent Information Registration Platform.

Judgment Digest

1. A patent registered on the Patent Information Registration Platform in correspondence with a generic drug already marketed in China constitutes a "relevant patent" under *Article 76(1)* of the Patent Law.

2. Where an originator drug that differs from the generic drug only in specification has a relevant patent registered on the Patent Information Registration Platform, the generic drug applicant shall, in principle, make its declaration by reference to the registered relevant patent of the originator drug with such registered information.

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, 4(1), and 6(1)* of the *Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)*

First Instance: Beijing Intellectual Property Court, Civil Rulings (2022) Jing 73 Min Chu No. 1210, and (2023) Jing 73 Min Chu Nos. 189 and 191 (April 26, 2023)

Second Instance: Supreme People's Court, Civil Rulings (2023) SPC IP Civ Final Nos. 1233, 1234, and 1235 (September 20, 2023)