Amgen, Sandoz Both Winners And Losers At Federal Circuit
Law360, New York ( July 21, 2015, 9:13 PM EDT) -- The Court of Appeals for the Federal Circuit on July 21 rendered its decision on the applicability and interpretation of two key provisions of the Biologics Price Competition and Innovation Act. The court ruled that: (1) the BPCIA does not require biosimilar applicants to turn over their application and manufacturing information to the reference product sponsor (RPS), making it "optional" to take part in the so-called patent dance; and (2) biosimilar applicants can only comply with the obligation to give notice of commercial marketing by giving "notice" once the U.S. Food and Drug Administration has licensed the biosimilar product for commercial marketing. The decision was not unanimous, however, with Judge Alan Lourie the only member in the majority on both issues and Judges Pauline Newman and Raymond Chen dissenting on issues one and two, respectively....
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