Maybe Biosimilar Applicants Should Dance After All [Biosimilar Development]

Blake Coblentz and Aaron Lukas wrote an article about the Biologics Price Competition and Innovation Act and the issues applicants face whether to go through the patent dance. Ten years after the enactment of the Biologics Price Competition and Innovation Act (BPCIA), one of the thorniest questions facing biosimilar applicants is whether to go through the patent dance. The issue arises immediately after an aBLA has been filed, and it can have far-reaching consequences for a biosimilar applicant. As one of the first law firms to direct a biosimilar applicant through the patent dance, we can unequivocally tell you that the answer is not an easy one. Indeed, there are a myriad of factors to weigh, and each biosimilar applicant should carefully consider the option that best fits its biosimilar development and marketing strategy.

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W. Blake Coblentz

Chair, Hatch-Waxman & Biologics Litigation

wcoblentz@cozen.com

(202) 912-4837

Aaron Lukas, Ph.D.

Member

alukas@cozen.com

(202) 912-4823


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