News

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.

Download PDF

 

 

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.                                                    

Methodology

Information contained in the Venable Fitzpatrick 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 Fitzpatrick BiologicsHQ database.

Disclaimer

The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

Subscribe for Future Updates

captcha