In drug patent linkage dispute cases, when the parties concerned have a disagreement over whether the patent in question falls within the types of patents that can be registered, the people’s court shall examine the issue. The lawsuit filed by a party pursuant to Article 76(1) of the Patent Law must be a lawsuit arising from a dispute related to a patent concerning the drug for which marketing authorization is being sought. If the patent claimed by a party does not fall within the types of patents eligible for registration as provided in the Implementation Measures for the Mechanism for Early Settlement of Drug Patent Disputes, the people’s court shall rule to dismiss the lawsuit.
According to the Implementation Measures for the Mechanism for Early Settlement of Drug Patent Disputes, the types of patents that can be registered for chemical medicinal products are: pharmaceutical active ingredient compound patents, patents for pharmaceutical composition containing active ingredients, and patents for medical use of the foregoing two types. Patents for crystalline compounds characterized by crystal cell parameters, which are based on a prior disclosed compound defined by its molecular structure; composition patents containing such crystalline compounds; and medical use patents for these two categories, do not yet fall within the types of patents eligible for registration under the Measures.
Company A filed a lawsuit, claiming to be the holder of an invention patent for a certain drug used to treat diabetes (hereinafter referred to as the patent-in-suit). It has registered Claim 9 as published on the grant announcement on the Patent Information Registration Platform for Medicinal Products Marketed in China (hereinafter referred to as the Patent Information Registration Platform), and this claim was linked to its approved original drug (hereinafter referred to as the original drug). Company B submitted an application to the National Medical Products Administration for marketing authorization of a generic drug referencing the original drug as the reference registered drug, and made a Type 4.1 declaration, i.e. the patent linked to the original drug that had been registered on the Patent Information Registration Platform should be announced invalid; the application has been accepted. Company A believed that the generic drug fell within the scope of protection of Claim 9 of the patent-in-suit, and requested the court to confirm such.
Company B argued: Claim 9 of the patent-in-suit essentially protected a polymorph patent, which did not fall within the types of patents specified in Article 2 of the Judicial Interpretation on Drug Patent Disputes, and therefore Company A had no right to file the lawsuit under Article 76 of the Patent Law.
Upon trial, the court found the following: The patentee of the invention patent-in-suit is Company A, and the patent is currently valid. The contents of Claims 1 and 9 are as follows:
“1. A crystalline structure of a compound of formula Ia… wherein its powder X-ray diffraction pattern is as shown in FIG. 1.”
“9. The use of the crystalline structure according to Claim 1 in the preparation of a medicament for treating diabetes, insulin resistance, hyperglycemia… or diabetic complications in mammals.”
The relevant patent claim registered by Company A on the Patent Information Registration Platform is Claim 9 of the patent-in-suit, and the type of patent registered is a chemical medical product patent for medical use. Company A holds the marketing authorization for the original drug. On November 29, 2021, the National Medical Products Administration accepted Company B’s registration application for the generic drug, for which the original drug is the reference registered drug. For the patent-in-suit, Company B made a Type 4.1 declaration on the Patent Information Registration Platform.
The court of first instance rendered a civil ruling confirming that the technical solution of the generic drug fell within the scope of protection of Claim 9 of the patent. Company B appealed on the grounds that Claim 9 of the patent-in-suit constitutes a polymorph patent, which did not fall within the types of patents that can be adjudicated under drug patent linkage cases. On June 14, 2023, the Supreme People’s Court issued its final ruling: 1) The civil ruling of the first instance court is revoked; 2) Company A’s lawsuit is dismissed.
The court’s effective judgment held that a lawsuit filed under Article 76(1) of the Patent Law must be a dispute arising from a patent related to the drug for which marketing authorization is being sought, and the patent claimed by the party must be relevant to the drug registration application. Since, under the current system, a marketing authorization holder can independently register patent information on the Patent Information Registration Platform, and the registered patent information is not subject to examination, the people’s court shall examine whether the patent-in-suit falls within the patent types eligible for registration during the course of hearing the case if the parties dispute this issue. Article 2 of the Judicial Interpretation on Drug Patent Disputes further clarifies that the determination of registrable patent types should be conducted in accordance with the Implementation Measures for the Mechanism for Early Settlement of Drug Patent Disputes.
Article 5 of the Implementation Measures for the Mechanism for Early Settlement of Drug Patent Disputes stipulates that: “The types of patents falling under the drug patent linkage system are patents for the active pharmaceutical ingredient (API) compound of chemical drugs, patents for drug compositions containing the active ingredient, and medical use patents.” The scope covered by these three registrable patent types should be comprehensively determined: First, this article indicates that not all compound patents and composition patents are registrable. If the “medical use patent” is interpreted without any limitation while the chemical compound and composition patents are subject to restrictions, it would lead to a situation where a medical use patent corresponding to a non-registrable chemical compound or drug composition could nonetheless be registered. This clearly runs counter to the intent of restricting the first two patent types and is also inconsistent with the drafting logic of the normative document. Interpreted in light of the overall wording, the types of patents that may be registered under the Measures should be: patents for active pharmaceutical ingredient compounds, patents for drug compositions containing the active ingredient, and medical use patents for these two categories. Second, the early resolution mechanism for drug patent disputes is not the sole pathway for resolving such disputes, and the scope of drug patents applicable to this special mechanism should not, in principle, be expanded by broad interpretation. Patents for crystalline compounds, which are further characterized by crystal cell parameters, space groups, crystal XRPD patterns (data), solid-state NMR spectra (data), and so forth, based on a prior disclosed compound expressed in terms of its molecular structure, as well as composition patents containing such compounds, should not be included within the scope of patents for patents for the active pharmaceutical ingredient compounds or drug compositions containing the active ingredient as specified in the Measures. Lastly, the Interpretation of the Implementation Measures for the Mechanism for Early Settlement of Drug Patent Disputes (Trial) published by the national administrative authority that formulated the Measures explicitly states that “relevant patents do not include patents for intermediates, metabolites, polymorphs, methods of preparation, testing methods, etc.” This can serve as an important reference for interpreting the types of patents that may be registered.
In this case, Claim 1 of the patent-in-suit seeks to protect a crystalline structure whose specific technical features are defined by the powder X-ray diffraction pattern shown in Figure 1. The content of Claim 9 is the specific use of this crystalline structure, and does not constitute a medical use patent for an API compound or a drug composition containing the active ingredient. Therefore, the claim registered by Company A does not fall within the three types of patents specified in Article 5 of the Implementation Measures for the Mechanism for Early Settlement of Drug Patent Disputes, and Company A has no standing to file the present lawsuit under Article 76 of the Patent Law. Accordingly, the lawsuit should be dismissed.
(2023) Zui Gao Fa Zhi Min Zhong No. 7
If you have any question about the protection of intellectual property rights, please feel free to send us emails. For patent-related matters, please send to info@afdip.com. For trademark/ litigation/ legal matters, please send to info@bhtdlaw.com.
