Lisa M. Ferri

Lisa M. Ferri is global co-chair of the firm's Intellectual Property practice and the Life Sciences group. She serves as lead trial and appellate counsel on behalf of high-profile companies in the pharmaceutical, biotechnology and medical device industries. Lisa is a seasoned and versatile litigator having tried high-stakes cases in federal courts across the country and the International Trade Commission, argued before the Patent Trial and Appeal Board (PTAB), and the Federal Circuit Court of Appeals. She has significant expertise guiding companies through patent challenges under the Hatch-Waxman Act and Biologics Price Competition and Innovation Act (BPCIA).

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Ten Years Into the BPCIA—How Will Immunotherapy Biologics Fare?

By Lisa M. Ferri on June 8, 2020

Posted in Biologics, Biosimilars, BPCIA, IPR, Litigation, PTAB

March 23, 2020 marked the tenth anniversary of the enactment of the Biologics Price Competition and Innovation Act (BPCIA), which provided the approval pathway for biosimilar products. While it was five years before the first biosimilar—Sandoz’s Zarxio—was introduced in the United States, we now have twenty-six approvals and seventeen biosimilars on the market. With the steep increase in biologic drugs, presently accounting for 50% of sales within the pharmaceutical market, the pace of biosimilar development and approvals is increasing. Indeed, we now have multiple biosimilars competing in the same categories (e.g., five biosimilars of cancer immunotherapy drug Herceptin and six of autoimmune treatment Humira) and this occurrence will certainly reoccur.

Since BPCIA enactment, there have been numerous litigations and post-grant reviews relating to the patent portfolios of reference product sponsors (RPS). These disputes have served to clarify …
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