Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”) in 2009 in an effort to bring biosimilar drug products to market. Nevertheless, no biosimilar application had been filed with the FDA before July 2014, when Sandoz sought to market a biosimilar version of the protein filgrastim, sold by Amgen under the brand name NEUPOGEN®. Sandoz and Amgen had differing interpretations of the BPCIA, with Sandoz believing that the aBLA disclosure and patent exchange provisions (the so-called “patent dance”) are optional, and that the 180-day “notice of commercial marketing” provision can occur at any time, not necessarily after approval of the application. On July 21, 2015, a seriously fractured Federal Circuit panel agreed with Sandoz that the patent dance was not mandatory, but disagreed with regard to the 180-day notice period. This webinar will review the history of the BPCIA and the Amgen v. Sandoz case, including the potential implications of the Federal Circuit’s recent decision. Topics will include: Presenters: MBHB partners Kevin E. Noonan, Ph.D. and Andrew W. Williams, Ph.D. Access an archived audio version of this webinar here. NOTE: MCLE credit is not available for this archived recording. McDonnell Boehnen Hulbert & Berghoff LLP is committed to educating clients and friends of the firm with respect to significant developments and trends in the areas of intellectual property law.
The statutory framework of the BPCIA
The Sandoz application and subsequent litigation
Statutory construction at the district court and Federal Circuit
Prospects for Supreme Court review
Consequences of the Federal Circuit decision