Biosimilar Patent Litigation May Be On The Rise In 2020

Law360 (January 14, 2020, 1:24 PM EST) -- The Biologics Price Competition and Innovation Act, signed into law as part of the Affordable Care Act in March 2010, established an abbreviated regulatory pathway and unique litigation framework for biosimilars in the United States. As we begin the new year and approach 10 years since the law’s enactment, it is worth a look back at the past year and trends over the past decade as we contemplate what may lie ahead in U.S. biosimilar litigation. 

The Past Year in Biosimilar Approvals and Launches

Litigation under the BPCIA stems from the U.S. Food and Drug Administration’s acceptance of a newly submitted...

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