Preparing for Uncertainties in Biosimilars Litigation

Financier Worldwide
January 2011

Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”) to facilitate marketing of “follow-on,” or “biosimilar,” versions of biologic drugs. The BPCIA includes a complex framework for patent litigation between innovators and biosimilar applicants. The BPCIA’s complex provision may contain hidden advantages and potential pitfalls for future litigants. Thus, before engaging in litigation under the BPCIA, members of the biologics industry must be familiar with the intricacies of its litigation provisions and must be prepared for the uncertainties in its interpretation.

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