China FDA Proposes Hatch-Waxman-Like Regulatory Framework Linking Drug Approval to Patent Rights

China pharma

Recently, the China Food and Drug Administration (CFDA) issued a policy proposal linking drug approval to patent rights.1 The proposal is intended to promote innovation in the development of both drugs and medical devices and to protect innovators’ rights. It also encourages generics to challenge patent rights. If enacted, the proposal should benefit innovator pharmaceutical patent holders in China, as well as first-filing generic challengers. In this WSGR Alert, we present a brief summary of the CFDA’s proposal, which has some similarities to the U.S. Hatch-Waxman framework that governs interactions between generics, 505(b)(2) new drug application filers, and branded pharmaceuticals for (primarily) small-molecule drugs.

Drug-Patent Linkage

The CFDA’s proposal plans to link new drug approval to patent rights. That is, when filing an application for drug approval, the drug applicant (e.g., a generic drug applicant) will have to declare whether the drug product violates the intellectual property rights of others.2 To challenge relevant patents, the applicant must declare non-infringement and put the patentee on notice within 20 days after the application is filed.3 If the patentee (innovator) disagrees with the declaration, the patentee must bring a patent infringement suit and inform the CFDA within 20 days after receipt of the notice.4 The CFDA can stay the market approval up to 24 months from the date of receiving proof of court acceptance of the suit.5 During the stay, the CFDA will continue its technical review of the generic drug application and decide on market approval based on the outcome of the patent litigation (or a settlement agreement) between the parties. If no court decision or settlement is reached within the stay period, the drug application may be approved by the CFDA.6

Data Protection

Innovator drug applicants can submit a request for protection of the data included in a drug application when filing the application. The period of protection ranges from 1.5 years to 10 years starting from the date of the market approval. For example, innovative drugs, or New Chemical Entities (NCEs), will receive six years of data exclusivity, and NCEs that are also orphan drugs will receive 10 years of data exclusivity.7,8,9 Innovative biologics will receive 10 years of data exclusivity.10 During the data protection period, the CFDA may not approve other applications for the same drug, except with data created by the same applicant.11

Catalog of Marketed Drugs in China

Similar to the U.S. FDA Orange Book, a catalog (drug patent registry) will list the drugs approved for marketing in China and include information about their active ingredients, dosages, specifications, marketing authorization holders, and exclusive rights related to patents, monitoring periods, and data protection.12


The proposal includes new guidelines to enforce confidentiality obligations for the CFDA staffs.


If enacted, the CFDA’s proposed patent linkage regulatory framework should benefit innovator pharmaceutical patent holders in China. It will also benefit successful first-filing generic patent challengers.

For questions regarding the proposal, please contact Lou Lieto, Vern Norviel, David Hoffmeister, Karen Wong, or any member of Wilson Sonsini Goodrich & Rosati’s patents and innovation strategies or FDA/life sciences practices.

Shan Liu, Richard Wang, and Charles Andres contributed to the preparation of this alert.

About the Author

Related Posts

Leave a Reply