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

Abstract

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

Suggested Citation

Minniti, Carl, Biosimilar Litigation: The Tussle Over How to Resolve Biologic Patents (April 1, 2015). ABA SciTech Lawyer, Vol. 11, No. 3, 2015. Available at SSRN: https://ssrn.com/abstract=2620512

Carl Minniti (Contact Author)

Independent ( email )

No Address Available

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