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.
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.
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.
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.
has experience in complex patent litigation under the Hatch-Waxman Act and interference proceedings. Erica has a B.S. in Biology and Anthropology.