Marilyn Neiman, a member of Cozen O’Connor’s Intellectual Property department, discusses the Biologics Price Competition and Innovation Act of 2009 (BPCIA). This act includes procedures for identifying and resolving patent disputes involving applications for licensure of biological products. In the first reported decisions on disputes concerning the BPCIA, litigants did not follow the BPCIA patent dispute procedures, as codified at 42 U.S.C. § 262(l), colloquially known as the “patent dance.” This leads to a pattern in patent litigation under the BPCIA, as seen in Amgen Inc. v. Sandoz where litigants also participated in the “patent dance.”
The Federal Circuit’s rulings have been limited to interpreting only some of the provisions of the BPCIA and only in certain contexts. As further cases under the BPCIA make their way through the court system and courts issue decisions, there will be a better understanding of the interplay of the different sections of the BPCIA and how to develop best practices and avoid pitfalls under the BPCIA.
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