For patent disputes arising from drug registration applications filed after the implementation of the Patent Law but before the implementation of the Implementation Measures for the Mechanism for Early Settlement of Drug Patent Disputes, the parties concerned may file a lawsuit in accordance with Article 76(1) of the Patent Law. Even if the relevant transitional measures have not yet taken effect, rendering the parties objectively unable to submit the required materials, this shall not affect the People's Court's acceptance of the case in accordance with the law.
According to Article 76(1) of the Patent Law, the following conditions must be met for a party to file a drug patent linkage lawsuit: 1) the lawsuit is initiated during the review and approval process for drug marketing; 2) the plaintiff is either the drug marketing authorization applicant or the relevant patentee or an interested party; 3) the lawsuit arises from a dispute over a patent relating to the drug for which a registration application is filed; 4) the lawsuit seeks to determine whether the drug-related technical solution falls within the scope of protection of the drug patent. Additionally, patentees and interested parties filing such lawsuits must base their claims on legally valid patents.
Japan-based Corporation A filed a lawsuit, claiming to be the patentee of an invention patent for a certain drug (hereinafter referred to as “the patent”) and requested confirmation that the technical solution of a generic drug submitted by Hebei B Company (hereinafter referred to as “the generic drug”) fell within the protection scope of claims 1–9 of the patent. Although the application for the generic drug was accepted on June 30, 2021 - before the implementation of the Implementation Measures for the Mechanism for Early Settlement of Drug Patent Disputes - Japanese Corporation A had already registered the information of the patent in question on the patent information platform on June 21, 2021, and the platform disclosed the information of the patent in question for the first time on June 28, 2021. Furthermore, Hebei B Company refused to undertake to refrain from seeking marketing approval for the generic drug during the protection period of the patent, which could be construed as its assertion that the generic drug did not fall within the patent's protection scope (equivalent to submitting a Type IV declaration).
Hebei B Company argued that Japanese Corporation A’s lawsuit lacked the Type IV declaration explicitly required by laws and regulations and thus did not meet the filing conditions stipulated in the judicial interpretation on drug patent disputes, rendering the case inadmissible. Hebei B Company submitted its application for generic drug marketing approval before the implementation of the Implementation Measures for the Mechanism for Early Settlement of Drug Patent Disputes. At that time, the patent information platform was not yet officially operational and had not disclosed any patent information. Therefore, Hebei B Company was unaware of the patent and, even if it was aware of such information, it could not have made a Type IV declaration under the Measures for a patent not yet disclosed on the platform. Accordingly, under the principle of non-retroactivity of laws, the Measures should not apply to this case. Even if the Measures were applicable, since the patent information platform contained no relevant information about the patent when Hebei B Company filed its application, it was impossible for Hebei B Company to make a Type IV declaration.
After trial, the court found the following facts: Regarding the patent in question, Japanese Corporation A registered relevant information on the patent information platform on June 21, 2021. This registered information was publicly disclosed on the platform on June 28, 2021. The National Medical Products Administration (NMPA) received the registration application for the generic drug submitted by Hebei B Company on June 23, 2021. On June 30, 2021, the Center for Drug Evaluation (CDE) of the NMPA accepted the application. Concerning the patent in question, Hebei B Company did not submit any patent declaration on the registration platform. On July 14, 2021, Japanese Corporation A sent a "Patent Notice Letter" to Hebei B Company, explicitly stating that the generic drug for which Hebei B Company filed a registration application fell within the protection scope of its patent and requesting that Hebei B Company respond by July 21, 2021 and undertake not to seek marketing approval for their generic drug during the patent’s protection period. The letter further stated that if no response was received by the deadline, it would be deemed that Hebei B Company considered the generic drug not to fall within the patent’s protection scope. Hebei B Company did not respond to this notice. On May 18, 2021, the CDE published a "Notice on Public Testing of the Patent Information Registration Platform for the Mechanism for Early Settlement of Drug Patent Disputes" on its official website. On June 25, 2021, the CDE issued a "Pre-Notice on the Conclusion of Testing for China’s Patent Information Registration Platform for Marketed Drugs", along with the "User Operation Guide for China’s Patent Information Registration Platform for Marketed Drugs".
On November 25, 2022, the court of first instance rendered a civil judgment, confirming that the technical solution of the generic drug fell within the protection scope of claims 1–9 of the invention patent in question. Following the judgment, Hebei B Company appealed, arguing that: Applying the drug patent linkage system to this case violated the principle of non-retroactivity of laws; the first-instance judgment’s determination that the case was equivalent to a Type IV declaration was evidently unfair; the request for Hebei B Company to undertake to refrain from infringement during the patent’s term lacked legal basis. On March 14, 2023, the Supreme People’s Court issued a final judgment, dismissing the appeal and upholding the original ruling.
The court's legally effective judgment held that:
(1) Regarding Legal Basis for Filing the Lawsuit in This Case
Article 76 of the Patent Law does not stipulate that the application of Paragraph 1 is contingent on the implementation of the specific transitional measures mentioned in Paragraph 3. In the absence of such stipulation, the effective date of the law should govern the effective date of its specific provisions. Furthermore, Paragraph 1 of Article 76 grants parties the right to sue, while Paragraph 3 pertains to the transitional measures linking drug marketing approval procedures with patent dispute resolution. Whether these transitional measures have been formulated and implemented should not affect the parties’ right to sue. Although Article 76 alone does not fully establish the drug patent linkage system, the completeness of the system does not impede the law’s application once it takes effect. When applying the law in specific cases, courts shall adhere to legislative intent and purpose, respecting the litigation rights granted to parties by law. In principle, the effective date of the law should not be de facto altered on these grounds. Therefore, for generic drugs registered after the Patent Law took effect but before the implementation of the Implementation Measures for the Mechanism for Early Settlement of Drug Patent Disputes, parties may file lawsuits under Article 76(1) of the Patent Law, irrespective of whether the Measures have been implemented or the conditions stipulated therein have been met.
(2) Regarding Specific Conditions for Filing the Lawsuit in This Case
Although Japanese Corporation A filed this lawsuit after the judicial interpretation on drug patent disputes (the “Interpretation”) took effect, the materials required for filing the lawsuit under the Interpretation were all formed according to the transitional measures. As previously stated, for patent disputes arising from drug registrations filed after the Patent Law took effect but before the implementation of the Measures, parties may sue under Paragraph 1 of Article 76. If parties were objectively unable to submit materials formed according to the so-called transitional measures because such measures had not yet taken effect, their right to sue should not be affected. Otherwise, the effective date of Paragraph 1 of Article 76 would be de facto postponed until after the Interpretation took effect. Thus, in such cases, whether the lawsuit meets the stipulated filing conditions should be assessed under Article 76(1) of the Patent Law and Article 122 of the Civil Procedure Law. Moreover, since generic drug applicants had no statutory obligation to make declarations regarding the referenced patents under such circumstances, the concept of a "Type IV declaration" should not be introduced when determining whether the lawsuit meets filing conditions.
According to the provisions of Article 76(1) of the Patent Law, a lawsuit must meet the following conditions: 1) the lawsuit is initiated during the review and approval process for drug marketing; 2) the plaintiff is either the drug marketing authorization applicant or the relevant patentee or interested party; 3) the lawsuit arises from a dispute over a patent relating to the drug for which a registration application is filed; 4) the lawsuit seeks to determine whether the drug-related technical solution falls within the scope of protection of the drug patent. Additionally, patentees and interested parties filing such lawsuits must base their claims on legally valid patents. Regarding the condition of "dispute over a patent relating to the drug for which a registration application was filed", since Article 76(1) explicitly states that the litigation for such dispute shall seek to determine whether the technical solution related to a drug for which a registration application is filed falls within the drug patent’s protection scope, such dispute naturally refers to a disputes over whether the technical solutions related to the drug for which a registration application is filed fall within the protection scope of a drug patent. However, where a declaration mechanism for generic drug applicants has not yet been established, patentees or interested parties may file lawsuits under Article 76(1) of the Patent Law for such disputes without requiring prior expression of intent by the generic drug applicant. Whether an actual dispute exists between the parties regarding whether the product falls within the protection scope of the drug patent is a matter for examination during the substantive trial phase.
In this case, the patent in question was valid, and Japanese Corporation A, as the patentee, filed the lawsuit during the generic drug’s review and approval process, seeking confirmation that the generic drug’s technical solution fell within the patent’s protection scope. This met the filing conditions under Article 76(1) of the Patent Law. Additionally, the lawsuit filed by Japanese Corporation A complied with the requirements of Article 122 of the Civil Procedure Law.
(2023) Zui Gao Fa Zhi Min Zhong No. 4
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.
