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Sheila Swaroop

In 2010, Congress enacted the Biologics Price Competition and Innovation Act, which created a new pathway for regulatory approval in the United States of follow-on biologics that are “biosimilar” to or “interchangeable” with previously approved biologics. This pathway has generated tremendous interest in the biopharmaceutical industry because of the market opportunities for biologic therapies, and there have been many public announcements of biosimilar development programs and partnerships from companies such as Amgen, Baxter, Merck, and Pfizer.

Of particular significance for IP practitioners was the BPCIA’s establishment of a unique pre-litigation patent exchange between a biosimilar applicant seeking FDA approval under the BPCIA and the Reference Product Sponsor of the previously approved biologic. In this patent exchange, the parties disclose information on patents owned or licensed by the RPS that could be infringed by the biosimilar applicant, and then negotiate over which patents will be litigated prior to and after commercial launch of the biosimilar product.

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