In order to resolve patent disputes related to pharmaceutical registration and marketing, China has begun to explore the establishment of a pharmaceutical patent linkage system since 2017. China and the United States signed the “phase one” economic and trade agreement on January 15, 2020, which includes establishing an early settlement mechanism for pharmaceutical patent disputes in China. On September 11, 2020, the China National Medical Products Administration and the China National Intellectual Property Administration (CNIPA) jointly issued the "Implementing Measures for a Pharmaceutical Patent Dispute Early Resolution Mechanism (Trial for Implementation) (Draft for Public Opinions) " (referred to as the "Draft Implementation Measures"). On October 17, 2020, China made amendments to the Patent Law, stipulating the establishment of an early resolution mechanism for pharmaceutical patent disputes in China, which will take effect on June 1, 2021.
The Draft Implementation Measures include provisions that would provide a “patent linkage” system (drawing from the U.S. Hatch-Waxman Act) for the early resolution of patent infringement disputes before competitor pharmaceuticals may be launched. The newly revised Patent Law only provides principles for the early resolution of pharmaceutical patent disputes, and the detailed implementation measures have not yet been officially issued.
The newly added Article 76 of Patent Law provides as follows:
“In the process of marketing review and approval of new pharmaceuticals, where a dispute arises due to the patent right concerning the pharmaceutical in the application for registration, between the applicant for pharmaceutical marketing authorization and the concerned patentee or interested party, any of the parties may institute legal proceedings in the people’s court, requesting for a judgement whether the technical solutions related to the pharmaceutical applying for registration fall within the protection scope of the other party’s pharmaceutical-related patent right. Within the stipulated time limit, the pharmaceutical administration department under the State Council may make a decision on whether to suspend the approval of marketing of the concerned pharmaceutical according to the effective judgement made by the people’s court.
Applicant for pharmaceutical marketing authorization and related patentee or interested party may also request the patent administration department under the State Council for administrative adjudications as to the dispute arisen due to the right of patent concerning the pharmaceutical in the application for drug registration.
The pharmaceutical administration department under the State Council, jointly with the patent administration department under the State Council, shall formulate specific measures for the connection between approval of pharmaceutical marketing authorization and the resolution of disputes of patent right arisen during the application stage for pharmaceutical marketing authorization, which shall be implemented upon approval of the State Council.”
According to the linkage mechanism determined in Article 76 and the "Implementing Measures for a Pharmaceutical Patent Dispute Early Resolution Mechanism (Trial for Implementation)", the patentee or the interested party shall submit the judgment or report within ten days of receiving the judgment to the National Pharmaceutical Evaluation Agency. During the period of administrative examination and approval, the State Pharmaceutical Administration will deal with it according to the different judgment of the people’s court.
Article 76 contains three parts and provides that:
1) During the drug marketing authorization ("MA") review period, if there is patent dispute between the MA applicant and the patentee/interested party related to the drug, which is the subject matter of the MA application, the relevant party may file court proceedings, requesting a judgment on whether the drug falls within the patent protection scope.
2) The National Medical Products Administration ("NMPA") may, within the prescribed time limit, decide whether or not to stay the MA approval based on the effective court judgment. The MA applicant and the patentee/interested party may also request an administrative ruling on the patent dispute from the China National Intellectual Property Administration ("CNIPA").
3) NMPA and CNIPA will formulate the specific patent linkage measures and report to the State Council for approval for implementation.
Article 76 of the Patent Law provides the legal basis for pharmaceutical patent disputes, so that the patentee of the original research pharmaceutical and the applicant for the listing of generic pharmaceuticals have a law to resolve patent infringement disputes before the listing of generic pharmaceuticals. Accordingly, the patentee of the original research pharmaceutical and the applicant for the listing of generic pharmaceuticals have two paths for "resolve beforehand":
1. Judicial path
In accordance with the provisions of Article 76, paragraph 1, and in conjunction with the " Draft Regulations on Several Issues Concerning the Application of Law in the Trial of Civil Cases Involving Patent Linkage (Draft for Comments)" promulgated by the Supreme People’s Court on October 29, 2020, please note: 1) the "people's court" in the first paragraph refers exclusively to the Beijing Intellectual Property Court; 2) the second is to strictly limit the scope of the basis for the right to sue, the “relevant patents” in the first paragraph only refer to the patents related to the generic pharmaceuticals registered and marketed in China registered on the Chinese listed pharmaceutical patent information registration platform; 3) clarifing the scope of the subject of the prosecution, in which the "interested party" not only refers to the licensee of the above-mentioned registered pharmaceutical patent, but also includes the registered pharmaceutical marketing license holder, and they all have the right to file a patent related to pharmaceutical marketing approval to the court Dispute litigation; 4) the conclusion of the judgment is of a certain degree of particularity, the court will respectively determine in the main article of the judgment that some of the pharmaceutical-related technical solutions applied for registration fall in the scope of the relevant patent protection, and the determination will be clearer.
2. Administrative path
According to the second paragraph of Article 76, applicants for pharmaceutical marketing authorization and relevant patentees or interested parties may also request administrative rulings from the Patent Administration Department of the State Council for disputes over patent rights related to the pharmaceuticals applied for registration. In other words, in addition to stipulating that the People's Courts accept such cases, the Patent Law also gives the State Intellectual Property Office the power to make administrative rulings on such cases.
As a comprehensive system, the early settlement mechanism of pharmaceutical patent disputes requires close cooperation of multiple departments and organic coordination of different systems. Its establishment is an important practice for my country's pharmaceutical innovation and development and patent law entering the "new era".
2021-04-28
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