*AI-generated translation, for reference only.

[Keywords] Civil, confirmation of whether it falls within the protection scope of a patent right, drug patent linkage, transition period, conditions for filing an action, Type 4.2 Declaration

Case Facts

[REDACTED] Pharmaceutical Co., Ltd. alleged: It is the patentee of the invention patent titled "Prodrug of Substituted Polycyclic Carbamoyl Pyridone Derivative" and requests a confirmation that the technical solution of the Type 4 chemical generic drug "Baloxavir Marboxil Tablets" (20 mg) (hereinafter referred to as the generic drug in question) with acceptance number CYHS2101377 submitted by [REDACTED] Pharmaceutical Co., Ltd. falls within the protection scope of Claims 1-9 of the patent in question. Although the application for the generic drug in question was accepted on June 30, 2021, before the issuance of the Implementing Measures for the Early Resolution Mechanism of Pharmaceutical Patent Disputes (Trial), [REDACTED] Pharmaceutical Co., Ltd. had already registered the patent information of the patent in question on the Patent Information Registration Platform as early as June 21, 2021, and the platform first published the patent information in question on June 28, 2021. Furthermore, [REDACTED] Pharmaceutical Co., Ltd. refused to commit to not seeking marketing approval for the generic drug in question within the term of protection of the patent in question. This can be deemed as [REDACTED] Pharmaceutical Co., Ltd. considering that the generic drug in question does not fall within the scope of protection of the patent in question (equivalent to its having submitted a Type 4.2 declaration).

 [REDACTED] Pharmaceutical Co., Ltd. argued in its defense: The lawsuit filed by [REDACTED] Pharmaceutical Co., Ltd. lacked the Type 4.2 declaration explicitly required by laws and regulations, and thus did not meet the conditions for filing a lawsuit under the Judicial Interpretation on Pharmaceutical Patent Disputes and should not be accepted. The act of [REDACTED] Pharmaceutical Co., Ltd. in submitting the application for marketing authorization for the generic drug occurred before the Implementing Measures for the Early Resolution Mechanism of Pharmaceutical Patent Disputes took effect. At that time, the Patent Information Registration Platform was not yet officially operational and had not disclosed any patent information. [REDACTED] Pharmaceutical Co., Ltd. was not aware, and even if it had been aware, it could not have made a Type 4.2 declaration under the said Measures for a patent not yet disclosed on that platform. Therefore, according to the principle of non-retroactivity of laws, the Implementing Measures for the Early Resolution Mechanism of Pharmaceutical Patent Disputes (Trial) should not apply to this case. Even if the said Measures were to apply, the Patent Information Registration Platform did not contain the relevant patent information at the time [REDACTED] Pharmaceutical Co., Ltd. filed the registration application for the generic drug in question. Therefore, it was impossible for [REDACTED] Pharmaceutical Co., Ltd. to make a Type 4.2 declaration.

The court ascertained through trial: With respect to the patent in question, [REDACTED] Pharmaceutical Co., Ltd. registered the relevant information on the Patent Information Registration Platform on June 21, 2021. The said registration information was published on the Platform on June 28, 2021. The National Medical Products Administration received the registration application for the chemical Type 4 generic drug "Baloxavir Marboxil Tablets" filed by [REDACTED] Pharmaceutical Co., Ltd. on June 23, 2021. On June 30, 2021, the Center for Drug Evaluation of the National Medical Products Administration (hereinafter referred to as the CDE) accepted the application. With respect to the patent in question, [REDACTED] Pharmaceutical Co., Ltd. made no patent declaration on the Platform. On July 14, 2021, [REDACTED] Pharmaceutical Co., Ltd. sent a "Patent Notification Letter" to [REDACTED] Pharmaceutical Co., Ltd., clearly informing it that the generic drug it applied for registration fell within the scope of protection of the patent in question, and requested [REDACTED] Pharmaceutical Co., Ltd. to reply before July 21, 2021, and commit to not seeking marketing approval for the generic drug in question within the term of protection of the patent in question. If [REDACTED] Pharmaceutical Co., Ltd. failed to reply by that date, it would be deemed as [REDACTED] Pharmaceutical Co., Ltd. considering that the generic drug in question does not fall within the scope of protection of the patent in question. [REDACTED] Pharmaceutical Co., Ltd. did not reply to the Patent Notification Letter. On May 18, 2021, the CDE published on its official website (https://www.cde.org.cn/) the "Notice on Matters Concerning the Public Testing of the Patent Information Registration Platform Related to the Early Resolution Mechanism of Pharmaceutical Patent Disputes." On June 25, 2021, the CDE published on its official website the "Pre-Notice on Ending the Testing Work of the China Listed Drug Patent Information Registration Platform," and also published the "User Operation Guide for the China Listed Drug Patent Information Registration Platform."

The Beijing Intellectual Property Court rendered the civil judgment (2022) Jing 73 Min Chu No. 14 on November 25, 2022: confirming that the technical solution of "Baloxavir Marboxil Tablets" with acceptance number CYHS2101377 falls within the protection scope of Claims 1-9 of Invention Patent No. 201180056716.8. After the judgment was pronounced, [REDACTED] Pharmaceutical Co., Ltd. filed an appeal on the grounds that applying the drug patent linkage system to this case violated the principle of non-retroactivity of laws, that the determination by the first-instance judgment that the case was deemed to involve a Type 4.2 declaration was manifestly unfair, and that requiring [REDACTED] Pharmaceutical Co., Ltd. to commit to not committing infringement within the patent validity period lacked legal basis. The Supreme People's Court rendered the civil judgment (2023) SPC IP Civil Final No. 4 on March 14, 2023, dismissing the appeal and upholding the original judgment.

Judge's Opinion

The effective judgment of the court holds that:

I. Regarding the Legal Basis for Filing a Lawsuit under the Circumstances of this Case

Article 76 of the Patent Law does not specifically stipulate that the effectiveness of the provisions in Paragraph 1 is conditioned upon the prior implementation of the specific linkage measures provided for in Paragraph 3. In the absence of special provisions, the effective date of the law should be taken as the effective date of its specific provisions. Second, Article 76, Paragraph 1 of the Patent Law already grants parties the right of action, while Paragraph 3 addresses the linkage measures between the approval of drug marketing authorization and the resolution of patent disputes. Whether the specific linkage measures between the two procedures are formulated and implemented should not affect the parties' right of action. Furthermore, although the provisions of Article 76 of the Patent Law alone are insufficient to fully establish the drug patent linkage system, the perfection of the relevant system does not affect the law's effectiveness after it comes into force. When applying the law in specific cases, the legislative intent and purpose shall be followed, the right of action granted to the parties by law shall be respected, and in principle, the effective date of the law should not be effectively altered on this ground. Therefore, for generic drugs for which registration applications were filed after the Patent Law came into effect but before the Implementing Measures for the Early Resolution Mechanism of Pharmaceutical Patent Disputes (Trial) came into effect, the parties may file a lawsuit under Article 76, Paragraph 1 of the Patent Law, without the prerequisite of the implementation of the said Implementing Measures and the satisfaction of the conditions stipulated therein.

II. Regarding the Specific Conditions for Filing a Lawsuit under the Circumstances of this Case

Although the time when [REDACTED] Pharmaceutical Co., Ltd. filed this lawsuit was after the Judicial Interpretation on Pharmaceutical Patent Disputes came into effect, the materials required to be submitted when filing a lawsuit under the said Judicial Interpretation are all materials generated under the so-called linkage measures. As mentioned above, for patent disputes arising from the registration of drugs applied for after the Patent Law came into effect but before the Implementing Measures for the Early Resolution Mechanism of Pharmaceutical Patent Disputes (Trial) came into effect, the parties may file a lawsuit under Article 76, Paragraph 1 of the Patent Law. If the parties are objectively unable to submit materials generated under the so-called linkage measures because the said measures have not yet been implemented, their right of action should not be affected; otherwise, the effective date of Article 76, Paragraph 1 of the Patent Law would be effectively postponed to after the Judicial Interpretation on Pharmaceutical Patent Disputes came into effect. Therefore, under such circumstances, whether a party's lawsuit meets the conditions for filing should be determined in accordance with Article 76, Paragraph 1 of the Patent Law and Article 122 of the Civil Procedure Law. Furthermore, since the generic drug applicant has no statutory obligation to make a declaration regarding the patent related to the referenced drug under these circumstances, the concept of a "Type 4.2 declaration" should not be introduced when specifically applying the law to determine the conditions for filing a lawsuit.

According to Article 76, Paragraph 1 of the Patent Law, a party's lawsuit shall meet the following conditions: 1. The lawsuit is filed during the process of drug marketing review and approval; 2. The plaintiff is the drug marketing authorization applicant or the relevant patentee or interested party; 3. The lawsuit is filed due to a dispute arising from the patent rights related to the drug applied for registration; 4. The content of the claim is to confirm whether the technical solution related to the drug applied for registration falls within the protection scope of the drug patent right. Furthermore, such a lawsuit filed by the patentee or an interested party shall also be based on a lawfully valid patent right. Regarding the condition "a dispute arising from the patent rights related to the drug applied for registration," because Article 76, Paragraph 1 of the Patent Law already explicitly stipulates that the content of the claim in such a dispute shall be to confirm whether the technical solution related to the drug applied for registration falls within the protection scope of the drug patent right, such a dispute naturally refers to a dispute concerning whether the technical solution related to the drug applied for registration falls within the protection scope of the drug patent right. However, under circumstances where the generic drug applicant declaration mechanism has not yet been established, a patentee or interested party filing a lawsuit over such a dispute under Article 76, Paragraph 1 of the Patent Law does not need to be premised on the expression of will by the generic drug applicant. Whether an actual dispute between the parties concerning falling within the protection scope of the drug patent right exists should be examined during the substantive trial stage.

In this case, the patent right in question is valid. [REDACTED] Pharmaceutical Co., Ltd., as the patentee of the patent in question, filed the lawsuit during the review and approval process of the generic drug in question, seeking confirmation that the technical solution of the generic drug in question falls within the scope of protection of the patent in question. This satisfies the conditions for filing a lawsuit under Article 76, Paragraph 1 of the Patent Law. Furthermore, the lawsuit filed by [REDACTED] Pharmaceutical Co., Ltd. also satisfies the conditions stipulated in Article 122 of the Civil Procedure Law.

Judgment Digest

I. For a patent dispute arising from the registration of a drug applied for after the Patent Law came into effect but before the Implementing Measures for the Early Resolution Mechanism of Pharmaceutical Patent Disputes came into effect, the parties may file a lawsuit under Article 76, Paragraph 1 of the Patent Law. Even if the parties are objectively unable to submit relevant materials because the relevant linkage measures have not yet been implemented, this does not affect the people's court's acceptance of the case in accordance with the law.

II. According to Article 76, Paragraph 1 of the Patent Law, a party filing a drug patent linkage action shall meet the following conditions: the lawsuit is filed during the process of drug marketing review and approval; the plaintiff is the drug marketing authorization applicant or the relevant patentee or interested party; the lawsuit is filed due to a dispute arising from the patent rights related to the drug applied for registration; the content of the claim is to confirm whether the technical solution related to the drug applied for registration falls within the protection scope of the drug patent right. Furthermore, such a lawsuit filed by the patentee or its interested party shall also be based on a lawfully valid patent right.

Related Index

Article 76, Paragraph 1, Paragraph 3 of the Patent Law of the People's Republic of China

First Instance: Civil Judgment (2022) Jing 73 Min Chu No. 14 of the Beijing Intellectual Property Court (November 25, 2022)

Second Instance: Civil Judgment (2023) SPC IP Civil Final No. 4 of the Supreme People's Court (March 14, 2023)

The text of this case has been adjusted as of February 26, 2024