On September 11, 2020, the National Medical Products Administration (NMPA) and China’s National Intellectual Property Administration (CNIPA) published a draft of the Measures for Implementation of the Early Resolution Mechanism for Drug Patent Disputes, which provides an operating mechanism for the patent linkage system in China. While China’s proposed patent linkage system has adopted provisions similar to the Hatch-Waxman Act in the U.S., there are significant differences between the two systems. Some of the strategies that innovators and follow-on manufacturers have successfully employed in the U.S. may work in China, but others may not. Goodwin's recently presented webinar featured a panel discussion comparing and contrasting the new Chinese patent linkage system with the U.S. Hatch Waxman system, and discussed whether 30+ years of litigation under the U.S. system can provide insights into how innovators and biosimilar/generic manufacturers can succeed under the Chinese system.
The panel discussion covered the following topics:
- Key similarities and differences between the Chinese and U.S. linkage systems
- How will the linkage system affect costs and profits on the brand and generic/biosimilar sides?
- What types of patents will be most important to protect small molecule drugs and biologics in litigation under the patent linkage system?
- The importance of being first to file and first to market
- The significance of patent listings, stays of regulatory approval, court injunctions, joint defense groups and damages
- Patent term adjustments and extensions