In a case concerning a dispute over confirmation of whether a product falls within the protection scope of a patent, the Supreme People's Court determined that: patents for a compound of crystalline structure do not belong to a patent type eligible for registration stipulated in the Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes. A summary of the case is as follows:
Company A is the right holder of an invention patent (hereinafter referred to as the “patent”) and the holder of an originator drug approved for marketing (hereinafter referred to as the “originator drug”). It registered claim 9 of the patent on the China Marketing Authorization Holders Patent Information Registration Platform (hereinafter referred to as the “Patent Information Registration Platform”). Company A filed a lawsuit with the original first-instance court to confirm that the generic drug (classified as chemical drug category 4) for which Company B applied for marketing authorization (hereinafter referred to as the “generic drug”) fell within the protection scope of claim 1 of the patent.
Company B argued that: claim 9 of the patent essentially seeks protection for patent for a crystalline form, which does not belong to the patent type stipulated in Article 2 of the Judicial Interpretation on Drug Patent Disputes, and therefore, Company A has no right to file this lawsuit under Article 76 of the Patent Law.
The first-instance court held that: claim 9 of the patent, as a use claim, includes not only crystalline form characteristics but also use characteristics within its protection scope; and therefore, this claim does not belong to a patent for crystalline form and should be recognized as a patent for use under the aforementioned article. Accordingly, it rendered a civil judgment: confirming that the technical solution of the generic drug fell within the protection scope of claim 9 of the invention patent.
Company B appealed on the grounds that claim 9 of the patent is a patent for crystalline form, which does not fall within the patent type subject to trial in drug patent linkage cases. The Supreme People's Court issued final ruling: 1. revoking the civil judgment of the first-instance court; and 2. dismissing the lawsuit filed by the Company A.
The Supreme People's Court held that: 1) Article 5 of the Measures for the Implementation of the Early Resolution Mechanism for Drug Patent Disputes stipulates: “The patent types belonging to the drug patent linkage system are: a patent for a compound of an active pharmaceutical ingredient of a chemical drug, a patent for a pharmaceutical composition comprising an active ingredient, and a patent for medical use." The scope covered by these three types of registrable patents stipulated in this Article should be determined comprehensively. Firstly, this Article indicates that not all patents for a pharmaceutical compound or a pharmaceutical composition are eligible for registration. Given the limitations imposed on the patent for a pharmaceutical compound and the patent for a pharmaceutical composition, if no limitation is imposed on the “patent for medical use”, it would lead to a situation where a patent for medical use corresponding to an unregistrable pharmaceutical compound or pharmaceutical composition could nonetheless be registered. This clearly does not conform to the original intent of limiting the first two types of patents, nor does it conform to the drafting logic of normative documents. “Patent for medical use” should be understood in light of the overall meaning of this provision, interpreted as a patent for medical use of a compound of an active pharmaceutical ingredient, or a patent for medical use of a pharmaceutical composition comprising an active ingredient.
Secondly, the early resolution mechanism for drug patent disputes is not the only way to resolve such disputes. In principle, the scope of drug patents applicable to this special mechanism cannot be arbitrarily expanded through interpretation. Patents for a compound that further characterizes a crystal structure based on an existing compound expressed by molecular structures, using features such as crystal unit cell parameters and space groups, crystal XRPD patterns (data), solid-state NMR patterns (data), should not be included in the scope of registrable patents. Finally, the Policy Interpretation of the Measures for the Implementation of the Early Resolution Mechanism for Drug Patent Disputes (Trial), issued by the national administrative authority responsible for formulating the Measures, emphasizes in reverse that “relevant patents do not include patents for intermediates, metabolites, crystalline forms, preparation methods, testing methods, etc.”, which can serve as an important reference for interpreting the types of registrable patents.
In this case, claim 1 of the patent seeks protection for a crystalline structure, the specific technical features of which are clearly defined by the powder X-ray diffraction pattern shown in Fig. 1. Claim 9 discloses the specific use of this crystalline structure, rather than a patent for medical use corresponding to a patent for a compound of an active pharmaceutical ingredient or a patent for a pharmaceutical composition comprising an active ingredient. Therefore, the claim registered by Company A is not one of the three patent types stipulated in Article 5 of the Measures for the Implementation of the Early Resolution Mechanism for Drug Patent Disputes. Company A has no right to file this lawsuit under Article 76 of the Patent Law, and its lawsuit should be dismissed.
Through the aforementioned ruling, the Supreme People's Court indicated that: patents for a compound characterizing a crystal structure do not belong to the patent types eligible for registration stipulated in the Measures for the Implementation of the Early Resolution Mechanism for Drug Patent Disputes.
(2023) Zui Gao Fa Zhi Min Zhong No. 7
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