In a case concerning a dispute over whether a technical solution falls within the protection scope of a patent, the Supreme People’s Court provided definitions and comments on “generic drugs” and “relevant patents”. The facts of the case are summarized as follows.
Company A is the patentee of an invention patent. Company A filed a lawsuit with the court of first instance, requesting the court to determine that the technical solution of the generic drug for Xmg dosage (the generic tablet at issue) applied for registration by Company B falls within the protection scope of the claims of its invention patent, and asserting that the Type 1 Declaration made by Company B was false and inaccurate.
Company B argued that, when it submitted the registration application for the generic tablet at issue, there was no patent information registered for the generic drug on the Chinese Marketed Drug Patent Information Registration Platform (hereinafter referred to as the Patent Information Registration Platform).
Therefore, it made a Type 1 Declaration, namely that there was no relevant patent information for the generic drug on the Patent Information Registration Platform, and that Company A’s lawsuit did not meet the statutory conditions related to Type 4 Declaration.
The court of first instance ascertained the following facts.
(1) Prior to the effective date of the current Patent Law and the Implementing Measures for the Drug Patent Disputes, Company B had already initiated invalidation proceedings and subsequent administrative litigation against the invention patent at issue, and those proceedings had concluded.
(2) The generic drug, i.e., a certain tablet with an Xmg dosage, had not yet been marketed in China.
(3) Prior to Company B’s filing of the registration application for the generic tablet at issue, Company A had registered the invention patent at issue as a relevant patent for a certain capsule on the Patent Information Registration Platform.
(4) The National Medical Products Administration accepted Company B’s registration application for the generic drug at issue, and Company B made a Type 1 Declaration on the Patent Information Registration Platform.
(5) After Company B filed the registration application for the generic tablet at issue, Company A registered the invention patent at issue as a relevant patent for two dosages, Ymg and Zmg, of a certain tablet on the Patent Information Registration Platform.
(6) Company B acknowledged that the generic tablet at issue falls within the protection scope of the patent at issue.
The court of first instance held as follows.
(1) The core considerations of the early resolution mechanism for drug patent disputes include both patent-related factors and drug-related factors. For a drug that has not been registered or marketed in China, even if its relevant patent has been granted in China and other drugs covered by the patent have been marketed in China, such drug still does not satisfy the prerequisites for protection under the early resolution mechanism for drug patent disputes. For a drug that has not been marketed in China, namely a certain tablet with an Xmg dosage, the generic drug applicant can only make a Type 1 Declaration, and thus the Type 1 Declaration made by Company B complies with the above provisions.
(2) The timing of Company B’s initiation of invalidation proceedings and subsequent litigation was earlier than the effective date of the current Patent Law and the Implementing Measures for the Drug Patent Disputes. Therefore, Company B’s conduct cannot be interpreted, under the current Patent Law and the Implementing Measures for the Drug Patent Disputes, as constituting a Type 4 Declaration. In conclusion, this case falls under a situation in which a Type 1 Declaration should be made. Given that a Type 4 Declaration is one of the conditions for accepting cases involving disputes over determination of whether a technical solution falls within the protection scope of a patent, Company A’s lawsuit did not meet the conditions for acceptance.
Dissatisfied with the ruling of the court of first instance, Company A appealed to the Supreme People’s Court.
The Supreme People’s Court, as the court of second instance, held as follows.
(1) The “generic drug” should be understood as the drug that has already been marketed in China, and the “relevant drug patent” should be understood as the patent registered on the Patent Information Registration Platform corresponding to such marketed generic drug.
(2) The early resolution mechanism for drug patent disputes is not the only avenue for resolving drug patent disputes, and the scope of drug patents to which this special mechanism applies should, in principle, not be expansively interpreted at will. If “relevant patent” were to be interpreted as potentially including any patent on the Patent Information Registration Platform, this could unduly increase the burden on generic drug applicants when determining the type of declaration, and could adversely affect the stable and effective operation of the mechanism.
(3) The dates on which Company B filed requests for invalidation and subsequent administrative litigation against the patent at issue were all earlier than the implementation date of China’s patent linkage system and earlier than the filing date of the registration application for the generic drug at issue. Accordingly, such conduct cannot be interpreted, under subsequently enacted laws, judicial interpretations and administrative regulations, as constituting a Type 4.1 Declaration for the patent at issue. In summary, the Type 1 Declaration made by Company B complies with the provisions of the Implementing Measures for the Drug Patent Disputes and is not improper, and Company A’s lawsuit does not satisfy the conditions prescribed by the relevant provisions. In addition, where the originator drug that differs from the generic drug only in terms of dosage has already had its patent registered on the Patent Information Registration Platform, the generic applicant, in principle, should make its declaration with reference to the relevant patents registered under other dosages of the same generic drug on the Patent Information Registration Platform. On this point, the findings of the court of first instance was inappropriate and is hereby corrected by the Supreme Court.
Through the above ruling, the Supreme People’s Court clarified that, in order to utilize the early resolution mechanism for drug patent disputes to resolve patent disputes, the following requirements must be satisfied:
(1)The generic drug must have been marketed in China,
(2) The patent corresponding to the generic drug must have been registered on the Patent Information Registration Platform.
At the same time, where the only difference between the generic drug and the generic drug lies in drug dosage, the generic applicant, in principle, should make its declaration with reference to the relevant patents registered under other dosages of the generic drug on the Patent Information Registration Platform.
(2023) Zui Gao Fa Zhi Min Zhong Nos. 1233, 1234, 1235
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