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Amgen, Inc. v. Sandoz Inc.: Divided Federal Circuit Holds that BPCIA § 262(l)(2) Information Exchange Is Optional, but § 262(l)(8) Notice of Commercial Marketing is Mandatory and Must Follow FDA Approval

by Alicia A. Russo; Erin J.D. Austin
July 21, 2015

On July 21, 2015, the Federal Circuit issued an opinion addressing two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). First, the Court held that 42 U.S.C. § 262(l)(2)(A) does not require a biosimilar applicant to disclose its abbreviated biologics license application (“aBLA”) and manufacturing information to the reference product sponsor (“RPS”). Second, the Court concluded that 42 U.S.C. § 262(l)(8)(A) requires the biosimilar applicant to provide notice of commercial marketing to the RPS, but that effective notice under that section of the statute can only be given after the United States Food & Drug Administration (“FDA”) licenses the aBLA product.

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Alicia Russo has extensive experience litigating and prosecuting biologics, biotechnology, bioinformatics and pharmaceutical patents. She has a B.S. in Biology and Chemistry, and an M.S. in Biomedical Sciences. Alicia has published original papers in Science, Nature, Cell and the Proceedings of the National Academia of Sciences.

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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