Generic Drugs

The China National Medical Products Administration (“NMPA”-China FDA) and China National IP Administration (“CNIPA”) have recently solicited public comments on the proposed rules on patent linkage system (similar to the US orange book) aiming to implement early resolution mechanisms for drug patent disputes. The proposed rules draw from the U.S. Hatch-Waxman framework for resolving patent disputes. From the direction of the current proposed rules, there are substantial implications on pharmaceutical and biotech companies doing business in China. While the Draft Measures are good news overall for innovative drug applicants, patentees and the generic drug industry in China, Innovators and pharmaceutical companies that are interested in the China drug market should evaluate their business objectives and take this opportunity to discuss with their legal counsel regarding the proposed legislation. On behalf of our pharmaceutical and biotechnology clients, we have submitted comments and proposed amendment of the law to the NMPA in response to the solicitation.