Patent Linkage-2021 Developments and Their Impact on the Generics and Biosimilar Landscape
Patent linkage is a complex issue as it amalgamates the protection of IP with the remit of drug regulators in varying jurisdictions. The scope of this interaction varies in different countries and pharmaceutical companies need to know which jurisdictions adopt a patent linkage regime when they decide whether to adopt an enforcement strategy or seek regulatory approval for a new product.
The US is one of the key jurisdictions to have adopted patent linkage, with the Hatch-Waxman Act of 1984. On June 1, 2021 China’s patent linkage system came into effect.
The session will include:
i. A description and comparison of the two patent linkage systems with update on the current status in China
ii. Can it be predicted that strategies that work in the US system can be applied to China?
iii. What impact does patent linkage have on originators and generics? How do internal procedures need to be adapted
iv. The majority of jurisdictions do not adopt a formal patent linkage regime—how does this impact the generic and biosimilar landscape?
