Pharmaceutical Patent Linkage in Drug Registration Rule

A new public comment draft of the Drug Registration Rule (DRR) was posted on the Legislative Affairs Office of the State Council of China’s website on Feb 19, 2014, with comments due March 23, 2014.   

It has references to patents, which particularly provides in Art 19: An applicant can submit a drug registration application when another party has obtained a patent in China for the pharmaceutical product.  China Food and Drug Administration (CFDA) 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 Patent disputes, according to Article 18, are to be governed by relevant patent law.

(Source: China Law)