At the end of last year, I noted that CFDA’s proposed new Drug Registration Rule could spell the end of China’s limited patent linkage regime. A new public comment draft of the Drug Registration Rule was posted on the SCLAO’s website on Feb 19, 2014, with comments due March 23, 2014.
This version of the DRR has new several references to patents, notably Article 19, which provides as follows: “第十九条 对他人已获得中国专利权的药品，申请人可以提出注册申请。国家食品药品监督管理总局按照本办法予以审查，符合规定的核发药品批准文号、《进口药品注册证》或者《医药产品注册证》，专利期满后生效.” Art 19: “An applicant can submit a drug registration application when another party has obtained a patent in China for the pharmaceutical product. CFDA’s division of Pharmaceutical Product Supervision and Management will review the application in accordance with these Rules, and if the applicant is in conformity with these Rules, the drug will be granted a drug approval number, and an “Imported Drug License” or “Drug License”, with the registration coming into effect upon expiration of the patent term.” Article 18 further requires a declaration or explanation of non-infringement by the generic applicant when there is a relevant Chinese patent relating to the drug approval, with publication of such notice on CFDA’s website. Patent disputes, according to Article 18, are to be governed by relevant patent law.
Retention of a patent linkage regime, even one that has been weak, is a positive development in China’s efforts to develop an innovative pharmaceutical industry. Equally important, this amendment shows responsiveness by CFDA to concerns about the direction of China’s innovative pharmaceutical sector. Although I have no additional information on the reasons for this change and the expectations regarding its implementation, the rumors of the death of patent linkage in China seem, at this time, to have been premature.