On July 5, 2016, the Federal Circuit issued a decision interpreting the 180-day-notice-of-first-commercial-marketing provision of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). Amgen Inc. v. Apotex Inc. (Amgen II), No. 2016-1308 (Fed. Cir. July 5, 2016).  The Court held in an earlier decision that 42 U.S.C. § 262(l)(8)(A) is a standalone provision that is mandatory where the biosimilar applicant fails to participate in the so-called “patent dance,” and the clock starts running on the 180-day-notice only after FDA approval is obtained. Amgen Inc. v. Sandoz Inc. (Amgen I), 794 F.3d 1347 at 1357, 1359, 1360 (Fed. Cir. 2015). In Amgen II, the Court has now held that this provision is obligatory “regardless of whether the applicant” has participated in the patent dance. Amgen II, slip. op. at 25.

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Bob Schwartz has extensive experience litigating biotechnology and pharmaceutical patents, including those relating to antibodies, protein biochemistry, molecular biology, genomics and proteomics.  Bob has a B.S. in Biology and a Ph.D. in Biochemistry.  As a Principal Investigator of grant-funded research he published more than 40 articles in peer-reviewed publications and 7 book chapters.
Corinne Atton has experience litigating cases concerning a wide range of pharmaceuticals and biotechnology, including DNA sequences, DNA sequencing technologies, recombinant polypeptides, enzyme inhibitors, and antidiabetic drugs.  Corinne has a B.Sc. honors degree in Human Genetics.
Fred Millet has litigated a variety of patents with a focus on biotechnology, chemistry, and pharmaceuticals, in particular concerning HIV/AIDS treatments.  Fred has a B.S. degree in Chemical Engineering.                                                             
Erica Norey has experience in complex patent litigation under the Hatch-Waxman Act and interference proceedings.  Erica has a B.S. in Biology and Anthropology.                                                    


    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( 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 ( 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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