Politics Policy & Law

One year market exclusivity for generic drugs under China’s patent linkage plan

Two months after the National People’s Congress outlined a patent linkage system in proposed amendments to China’s Patent Law, regulators have drafted measures providing an incentive for generic drug developers and outlining how patent linkage might be implemented.

To provide incentives for generic drug patent challenges, the first generic to be approved would be eligible for up to one year of market exclusivity under measures released last week by the National Medical Products Administration (NMPA) and China’s National Intellectual Property Administration (CNIPA).

The measures also propose a patent linkage system intended to prevent approval of generic drugs until innovator patents expire.

Under the system, NMPA’s Center for Drug Evaluation (CDE) would establish and maintain a public database of patents on pharmaceutical active ingredients, formulations and methods of use submitted by innovators and the CDE would publicize generic drug applications and applicant declarations regarding the invalidity or termination of innovator patents

Regulators would be able to approve applications if no innovator patents are included in the database, the patents have been terminated or invalidated, or the generic is barred from the market until patent expiration. For applicants claiming to fall outside of existing patent scope or seeking to invalidate patents, innovators would be able to challenge applications via a court or CNIPA within 45 days of their publication.

The technical review of applications would continue during patent challenge and regulators would have discretion to approve the generic application if the challenge is not resolved after nine months.

Comments on the draft measures are due by Oct. 25.

China’s proposed Patent Law amendments lacked a similar incentive provision for successful challenge of innovator patents but would codify a patent linkage system and extend patent terms by up to five years for innovative drugs (see “China Moves to Deliver Patent Law Reform”).

If enacted, the measures and amendments could provide a China framework for approval of generics similar to the U.S.’s Hatch-Waxman Act, which includes a patent linkage system to protect innovators and 180 days of marketing exclusivity for first-to-file generic drug applications.

In a blog post, Mark Cohen, head of the Asia IP project at Berkeley Law, said announcing draft rules in advance of actual legislative changes could demonstrate confidence the amendments will be incorporated into law and advance discussion around key issues. Cohen is a former senior counsel at the U.S. Patent and Trademark Office (USPTO).