On March 6, the federal Food and Drug Administration licensed the first-ever U.S. biosimilar drug, Sandoz’s Zarxio, a version of Amgen’s Neupogen (filgrastim). Less than two weeks later, the U.S. District Court for the Northern District of California denied Amgen’s motion for a preliminary injunction against Sandoz’s Zarxio launch, removing the final barrier to consumers being able to obtain the drug.
In its ruling, the court held (1) that the information exchange procedures laid out in §262(l)(2)-(8) of the Biologics Price Competition and Innovation Act (BPCIA), known as the “patent dance,” are optional; and (2) that a biosimilar applicant may properly give the 180-day notice of commercial marketing required by §262(l)(8)(A) before obtaining its FDA license to sell its product. This ruling is the first to interpret these two key provisions of the BPCIA and, if upheld on appeal, will have a tremendous impact on the patent litigation strategies of both reference product sponsors and biosimilar applicants going forward.
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