CFDA’s new draft policy introduces the Chinese version of patent linkage

On May 12, Chinese Food and Drug Administration (CFDA) issued Policy Notice No. 55, entitled “Policies Relevant to the Protection of the Rights and Interests of Innovators for the Encouragement of Innovation in Drugs and Medical Devices”, for public comments.  The commenting period ends on June 10.  In the Notice, CFDA, for the first time, outlines the patent linkage scheme, which requires a generic applicant to make a non-infringement declaration against the innovator’s patent portfolio and notify the innovator within 20 days of the generic drug application.  The innovator then has 20 days to institute a patent infringement suit to be eligible for a stay of the generic approval of up to 24 months.  To encourage generics to challenge the innovator’s patent, the first successful challenger will be eligible for 18 months exclusivity (presumably against other generic filers).

If this policy is implemented as proposed, it may cause a flood of pharmaceutical patent litigation.  In addition, many high profile pharmaceutical patent litigations may happen first in China due to the relatively shorter patent terms in China for pharmaceuticals.

For further details, please refer to the translation of the Notice available in our e-alert.