*AI-generated translation, for reference only.

Keywords: Civil; Determination of whether a product falls within the scope of patent protection; Pharmaceutical patent linkage; Patentable; Types of patents; Crystal form patents

Case Facts

Swedish [REDACTED] company alleged that it is the owner of a patent titled "Invention of crystalline solvates and complexes of (1S)-1,5-dehydro-L-C-(3-((phenyl)methyl)phenyl)-D-glucitol derivatives and amino acids" (hereinafter referred to as the "Patent-in-Question"). It registered Claim 9 of the published patent grant text on the China Drug Patent Information Registration Platform (hereinafter referred to as the "Patent Information Registration Platform"),The aforementioned claim   is associated with the company's dapagliflozin tablets bearing approval numbers H20170119 and H20170120 (hereinafter referred to as   the original drug in question).A pharmaceutical company in Sichuan submitted an application for marketing authorization of the generic drug in question to the National Medical Products Administration (NMPA), designating the original drug in question as the reference drug and making a Type 4.1 declaration; the application has been accepted. Swedish [REDACTED] company believes that the generic drug in question falls within the scope of protection of claim 9 of the patent in question and requests the court to confirm that the generic drug in question falls within the scope of protection of claim 9 of the patent in question.

pharmaceutical [REDACTED] company in Sichuan argued that Claim 9 of the patent in question essentially protects a crystal form patent, which does not fall under the types of patents specified in Article 2 of the Judicial Interpretation on Pharmaceutical Patent Disputes, and that the Swedish company has no   right to file this lawsuit under Article 76 of the Patent Law.

The court found through its review that the patent in question is Patent No. 200780024135.X, titled "Crystalline solvates and complexes of (1S)-1,5-dehydro-L-C-(3-(phenylmethyl)phenyl)-D-glucitol derivatives as SGLT2 inhibitors for the treatment of diabetes" , with the patent holder being Swedish [REDACTED] company. The patent in question is currently in force, and its claims 1 and 9 read as follows: "1. A crystalline structure having formula Ia… characterized by the powder X-ray diffraction pattern shown in Figure 1." "9. The use of the crystalline structure of claim 1 in the preparation of a medicament for the treatment of diabetes, insulin resistance, hyperglycemia... or complications of diabetes in mammals."

The relevant patent claims registered by the Swedish company on the patent information registration platform are Claim 9 of the patent in question (   ), with the registered patent type being pharmaceutical [REDACTED] use patent for chemical drugs. The brand name of the original drug in question is "Andatang," the generic name is Dapagliflozin Tablets, the dosage form is tablets, and the strength is 10mg, and the marketing authorization holder is Swedish [REDACTED] company. On November 29, 2021, the National Medical Products Administration accepted the registration application for the generic drug in question submitted by pharmaceutical [REDACTED] company in Sichuan; the reference drug is the innovator drug in question, and regarding the patent in question, the pharmaceutical company in Sichuan made a Class 4.1 declaration on the patent information registration platform.

On November 18, 2022, the Beijing Intellectual Property Court issued Civil Judgment No. (2022) Jing 73 Min Chu 586, confirming that the technical solution of the generic drug "Dapagliflozin Tablets" (acceptance number CYHS2102104) falls within the scope of protection of claim 9 of invention patent No. 200780024135.X.pharmaceutical [REDACTED] company in Sichuan filed an appeal, arguing that claim 9 of the patent in question was a crystal form patent and did not fall within the category of patents subject to the drug patent linkage system. On June 14, 2023, the Supreme People's Court issued Civil Ruling No. (2023) Supreme Court IP Civil Appeal No. 7: 1. Revoke the Civil Judgment No. (2022) Jing 73 Min Chu No. 586 of the Beijing Intellectual Property Court; 2. Dismiss the lawsuit filed by Swedish [REDACTED] company.

Judge's Opinion

The court's final ruling held that a lawsuit filed by a party pursuant to Article 76, Paragraph 1 of the Patent Law must be a dispute arising from patent rights related to the drug for which registration is sought, and the patent rights upon which the party asserts its claims must be related to the drug for which registration is sought. Since, under the current system, marketing authorization holders for drugs may register on the patent information registration platform on their own, and the registered patent information has not undergone examination, the People's Court shall review this matter during the course of the proceedings if the parties dispute whether the patent in question falls within a registrable patent category, the People's Court shall examine this issue during the trial. Article 2 of the Judicial Interpretation on Drug Patent Disputes further clarifies that the types of patents eligible for registration shall be examined in accordance with the Implementation Measures for Drug Patent Disputes.

Article 5 of the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" provides that

"The types of patents covered by the pharmaceutical patent linkage system include patents for active pharmaceutical ingredients (APIs) of chemical drugs   , patents for drug compositions containing active ingredients, and patents for pharmaceutical uses." The scope of the three types of registrable patents specified in this provision   should be determined comprehensively:First, this provision   makes clear that not all compound patents and composition patents are eligible for registration. Given that it imposes restrictions on pharmaceutical compound patents   and pharmaceutical composition patents, if no restrictions are placed on "pharmaceutical use patents,"   a situation would arise where pharmaceutical use patents corresponding to pharmaceutical compounds and compositions—which are otherwise ineligible for registration—could be registered. This clearly contradicts the original intent of restricting the first two types of patents   and is inconsistent with the logical structure of the regulatory document.When interpreted in light of the overall context, the "Implementation Measures for the Early Resolution Mechanism for Pharmaceutical Patent Disputes (Trial)" stipulates that the types of patents eligible for registration should be patents for active pharmaceutical ingredient compounds, patents for pharmaceutical compositions containing active ingredients, and medical use patents for the former two.Second, the early resolution mechanism for pharmaceutical patent disputes is not the sole avenue for resolving such disputes   , and the scope of pharmaceutical patents applicable to this special mechanism should not, in principle, be interpreted broadly   . Beyond existing compounds expressed in molecular structure, further characterization of crystal structure through parameters such as unit cell dimensions and space groups, crystal X-ray diffraction (XRPD) patterns (data),solid-state NMR spectra (data), and other characteristics to characterize the crystal structure, as well as patents for compositions containing such compounds, should not be included within the scope of patents for active pharmaceutical ingredient compounds or patents for drug compositions containing active ingredients as defined in the "Implementation Measures for the Early Resolution Mechanism for Pharmaceutical Patent Disputes (Trial)" .Finally, the provision in the "Policy Interpretation of the 'Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)'" issued by the national administrative authority that formulated the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" regarding "relevant patents do not include patents for intermediates, metabolites, crystal forms, preparation methods, detection methods, etc." may serve as an important reference for interpreting the types of registered patents.

In this case, Claim 1 of the patent in question seeks protection for a crystalline structure, the specific technical features of which are defined by the powder X-ray diffraction pattern shown in Figure 1. The content set forth in Claim 9 describes a specific use of this crystalline structure, rather than a patent for pharmaceutical [REDACTED] active ingredient compound or pharmaceutical [REDACTED] use patent for a drug composition containing the active ingredient. Therefore, the claims registered by Swedish [REDACTED] company   do not fall under any of the three patent types specified in Article 5 of the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)"   . The company lacks the right to file this lawsuit under Article 76 of the Patent Law, and the lawsuit should be dismissed.

Judgment Digest

1. In cases involving disputes over pharmaceutical patent rights, where the parties dispute whether the patent in question falls within a registrable patent category, the People's Court shall review the matter. A lawsuit filed by a party pursuant to Article 76, Paragraph 1 of the Patent Law must be a dispute arising from patent rights related to the pharmaceutical product for which registration is sought. If the patent upon which the party bases its claim does not fall within the registrable patent categories specified in the Implementation Measures for the Early Resolution Mechanism for Pharmaceutical Patent Disputes, the People's Court shall issue a ruling dismissing the action.`

2. The types of chemical drug patents eligible for registration under the Implementation Measures for the Early Resolution Mechanism for Pharmaceutical Patent Disputes shall be patents for active pharmaceutical ingredient compounds, patents for pharmaceutical compositions containing active ingredients, and patents for the medical uses of the former two.Compound patents that further characterize the crystal structure based on crystal cell parameters, etc., on the basis of existing compounds expressed in molecular structure, patents for compositions containing such compounds, and patents for the medical uses of the former two do not yet fall within the types of registrable patents specified in the Implementation Measures for the Early Resolution Mechanism for Pharmaceutical Patent Disputes.

Related Index

Article 76, Paragraph 1 of the Patent Law of the People's Republic of China

Article 2, Paragraph 1 of the "Provisions of the Supreme People's Court on Several Issues Concerning the Application of Law in Civil Cases Involving Disputes Over Patent Rights Related to Drug Registration Applications"

Article 5 of the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)"

First Instance: Beijing Intellectual Property Court Civil Judgment No. (2022) Jing 73 Min Chu 586 (November)

Appeal: Supreme People's Court Civil Ruling No. (2023) Supreme Court IP Civil Appeal No. 7 (June 14, 2023)