Federal Circuit Interprets Biosimilars Law in Amgen v. Sandoz

McDonnell Boehnen Hulbert & Berghoff LLP
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In a seriously fractured decision, the Federal Circuit construed the provisions of the Biologics Price Control and Innovation Act (BPCIA or Act) in Amgen Inc. et al. v. Sandoz Inc. In doing so, the court limited the information available to biologic drug makers regarding a competitor’s application for a biosimilar product (adopting Sandoz’s argument). On the other hand, the decision extended the statutory exclusivity period enjoyed by innovator biologic drug makers relating to when the biosimilar applicant can enter the marketplace (as Amgen argued).

The BPCIA is a component of the Patient Protection and Affordable Care Act commonly known as “Obamacare” and provides for the first time in the U.S. an abbreviated pathway for FDA approval of so-called “biosimilar” drugs, generic versions of biologic drugs. The Act contains complicated litigation provisions that have come to be termed the “patent dance” that prescribe how the parties (termed the “reference product sponsor” and the “biosimilar applicant”) decide which patents will be litigated during the time prior to FDA approval.

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