CHINA Law and Practice Contributed by: Hans She, Muran Sun, Andy Zhu and Ray Cao, Fangda Partners
The Mechanism Under Chinese law, a drug marketing authorisa - tion holder must register essential information within 30 days of obtaining the drug registration certificate. This includes details such as: • drug name;
Generic drug applicants must notify the market - ing authorisation holder via paper or email, with the declaration being publicly accessible on the platform (Article 6). Given the absence of specific timing require - ments in current regulations, regular monitoring of the Platform for Marketed Drugs is advised for drug marketing authorisation holders. 2.5 Reimbursement and Pricing/Linkage Markets China’s Patent Linkage System China’s patent linkage system for generic drugs is primarily governed by three legal frameworks: • the Implementation Measures for the Early Settlement Mechanism of Drug Patent Dis - putes (for Trial Implementation) jointly issued by the Centre for Drug Evaluation, NMPA and CNIPA (the “Implementation Measures”); • the Administrative Adjudication Measures for Early Resolution of Drug Patent Disputes issued by the CNIPA (the “Administrative Adjudication Measures”); and • the Provisions of the Supreme People’s Court on Several Issues Concerning the Applica - tion of Law in the Trial of Civil Cases Involving Patent Disputes Related to Drugs Applied for Marketing Authorisation (the “Provisions of the SPC”). As outlined in Article 5 of the Implementation Measures, pertinent patents for chemical drugs encompass: • the compound patent of the pharmaceutical active ingredient; • the composition patent containing active
• dosage form; • specifications;
• marketing authorisation holder; • related patent information; and • contact details.
The Platform for Marketed Drugs, managed by the Centre for Drug Evaluation, NMPA, makes this information publicly available. Generic drug applicants must, upon submitting a marketing authorisation application, declare one of four options regarding listed patents. Within ten working days of application acceptance, the Centre for Drug Evaluation, NMPA publicly dis - closes the application details and corresponding declarations. Simultaneously, the generic drug applicant informs the marketing authorisation holder via paper and email. In the case of objections to a Type (4) declara - tion, the patentee or interested party may file a lawsuit with the Beijing Intellectual Property Court or seek administrative adjudication with the CNIPA within 45 days of the Type (4) dec - laration being disclosed on the platform. If liti - gation or administrative adjudication is initiated, the Centre for Drug Evaluation, NMPA imposes a non-renewable nine-month stay period on the generic drug registration application (Article 8). Marketing approval suspension for the generic drug occurs only if the court judgment or admin - istrative adjudication decision determines that the application falls within the scope of protec -
pharmaceutical ingredients; and • the medical indication patent.
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