CHINA Law and Practice Contributed by: Hans She, Muran Sun, Andy Zhu and Ray Cao, Fangda Partners
4. Patent Term Extensions for Pharmaceutical Products 4.1 Supplementary Protection Certificates In China, the availability of a patent term exten - sion for pharmaceutical products is specifically governed by Article 42.3 of the Patent Law. This provision allows the patent administrative department of the State Council to grant an extension, not exceeding five years, upon the request of the patentee. The purpose is to com - pensate for the time required for the assessment and approval of a new drug’s marketing. The total effective term of the patent, after approval for marketing, must not exceed 14 years. Invention patents related to new drugs include new drug product patents, preparation method patents and pharmaceutical use patents that meet specific requirements found in the Patent Examination Guidelines (2023). The application for the extension should be filed by the patentee; and if the patentee is inconsistent with the holder of the drug marketing authorisation, the written consent of the holder of the drug marketing authorisation should be obtained. For a patent to be granted the extension, it is also a prerequisite that it has not been granted an extension previ - ously. According to the newly amended Detailed Rules for the Implementation of the Patent Law (2023) and the Patent Examination Guidelines (2023), for different products but the same pat - ent, the applicant can only apply for extension for one drug product. For one product protected by a number of patents, the patentee can only apply for extension for one patent. Where the patent(s) belong(s) to multiple patentees, and no patent agency has been engaged, the applica - tion shall be handled by their representative.
tion of the listed patent. This suspension applies throughout the entire marketing approval pro - cess, whether within or beyond the nine-month stay period.
3. Biosimilar Market Entry 3.1 Infringing Acts
Lawsuits concerning biologics and biosimilar patents will follow the same procedural rules as indicated in 2.1 Infringing Acts . 3.2 Data and Regulatory Exclusivity The details discussed in 2.2 Regulatory Data and Market Exclusivity will not differ in relation to biologics and biosimilars, except that there will be no 12-month market exclusivity period for biosimilar applicants. 3.3 Acceptable Pre-Launch Preparations The details discussed in 2.3 Acceptable Pre- Launch Preparations do not differ where the litigation concerns biologics or biosimilars. 3.4 Publicly Available Drug and Patent Information The details discussed in 2.4 Publicly Available Drug and Patent Information will not differ where the litigation concerns biologics or biosimilars. 3.5 Reimbursement and Pricing/Linkage Markets The details discussed in 2.5 Reimbursement and Pricing/Linkage Markets will not differ where the litigation concerns biologics or bio - similars, except that there will be no nine-month stay period for marketing approval in the sce - nario of litigation or administrative adjudication for applications of biosimilars.
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