Biosimilar Litigation: The Tussle Over How to Resolve Biologic Patents
ABA SciTech Lawyer, Vol. 11, No. 3, 2015
5 Pages Posted: 20 Jun 2015
Date Written: April 1, 2015
Both the first biosimilar applications and litigation under the Biologics Price Competition and Innovation Act of 2009 have finally arrived. With introduction of biosimilars estimated to save the US market more than $44 billion over the next decade, all stakeholders will be interested in how these drugs are approved. Notably, the resolution of patent disputes will play a major role in promoting the confidence biosimilar makers have in their investment. This article discusses early trends in the interpretation of the BPCIA’s patent resolution provisions thus far.
Keywords: biosimilar, BPCIA, Biologics Price Competition and Innovation Act
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