IP: Bring On The Biosimilars

A section of the Affordable Care Act could cost biosimilar manufacturers and reference sponsors significant time and money.

August 14, 2012

Despite all the headlines, there's one aspect of the Supreme Court's decision on the constitutionality of the Affordable Care Act that didn't get much coverage. The court's approval of the entire act means that the Biologics Price Competition and Innovation Act of 2009 (BPCIA) within the law now goes into full effect. BPCIA sets out a regulatory and dispute resolution framework for follow-on biologics or biosimilars inspired by the one the Hatch-Waxman Act uses for small-molecule generics. But, the fundamental differences that exist between biological products (large molecule drugs) and small molecule drugs and the process for approval and dispute resolution under the BPCIA means that reference product sponsors and biosimilar manufacturers will find themselves in uncharted and potentially time-consuming and costly waters.

Reprinted with permission from InsideCounsel. 

The articles on our website include some of the publications and papers authored by our attorneys, both before and after they joined our firm. The content of these articles should not be taken as legal advice. The views and opinions expressed in this article are those of the author(s) and do not necessarily reflect the views or official position of Robins Kaplan LLP.


Related Publications

December 8, 2022
Lessons From MMAS Research About Dispositive Pitfalls in Copyright Litigation
David Martinez, Austin Miller - Los Angeles & San Francisco Daily Journal
November 19, 2022
How to Use the USPTO Patent Public Search Tool
Miles Finn, Rajin Olson, Kelson Bain, and Ian LaForge - IPWatchdog
October 2022
In No Uncertain Terms
Bryan Mechell - The Robins Kaplan Quarterly
September 13, 2022
Patent Value: Scoring Patents Using Characteristics Of Patents In Litigation
Christopher K. Larus, Miles A. Finn, Congnan Zhan, Joseph (Yu) Chen, and Shelley Gilliss - les Nouvelles
September 2, 2022
Trade Dress Through a Trial Lens: Six Strategy Tips For Litigants
Christopher Larus, William Manske - Managing IP
Back to Top