China to establish its own drug patent linkage

The Opinions on Deepening Reform of the Review and Approval System to Encourage Innovations in Drugs and Medical Devices (the opinions), jointly circulated by the General Office of the CPC Central Committee and the General Office of the State Council on 8 October 2017, shows the Chinese government’s determination to encourage innovations in drugs and medical devices. From the perspective of patent protection, the proposed exploration of a drug patent linkage, as mentioned in the opinions, is especially worthy of attention from drug companies.

Q: What is drug patent linkage? A: Derived from the well-known Hatch-Waxman Act, drug patent linkage associates the drug approval process with drug patent protection. On the one hand, it encourages generic drug producers to challenge the monopoly enjoyed by patented brand name drugs by giving certain incentives to generic drug producers, including setting up explicit “Bolar exemptions” and providing 180 days of market exclusivity to the “first” generic applicant who succeeds in challenging a listed patent.

On the other hand, however, it is also committed to protecting reasonable rights and interests of brand name drug producers particularly by providing for patent term extensions and a 30-month stay of approval that are aimed at ensuring that brand name drug producers will be provided with lawful means to maintain their exclusivity properly. Reflecting balanced interests of brand name drug producers and generic drug producers, drug patent linkage drives creation of new drugs by encouraging research and development of brand name drugs while inspiring launch of generic drugs, thus helping to lower drug prices and serve the public interest to the greatest extent.

Author: Wu Li is a senior consultant and Wang Rui is an associate at AnJie Law Firm