IP at the Supreme Court Series: Sandoz Inc. v. Amgen Inc.
April 26, 2017
4:30pm | Room NT01
Reception to Follow
In PIJIP’s ongoing Supreme Court Series, a panel of counsel for amici and parties will discuss the case on the afternoon following oral argument before the Court.
Panel:
- Professor Jonas Anderson, American University Washington College of Law (Moderator)
- Jennifer Thomas, Hyman, Phelps & McNamara, PC, representing Pharmaceutical Care Management Association, et al. on amicus brief
- Sara Koblitz, Hyman, Phelps & McNamara, PC, representing Pharmaceutical Care Management Association, et al. on amicus brief
- Donald Ware, Foley Hoag LLP, representing Biotechnology Innovation Organization on amicus brief
- Michael Morin, Latham & Watkins LLP, representing AbbVie Inc. on amicus brief
*This event is generously co-sponsored by the Federal Circuit Bar Association.
Issue:
(1) Whether notice of commercial marketing given before Food and Drug Administration approval can be effective; and (2) whether, in any event, it is improper to treat Section 262(l)(8)(A) – the Biologics Price Competition and Innovation Act of 2009’s “Notice of commercial marketing” provision which states that a biosimilar applicant shall provide notice to the incumbent seller of the biological product “not later than 180 days before the date of the first commercial marketing of the biological product licensed under” an abbreviated pathway for biosimilars – as a stand-alone requirement and as creating an injunctive remedy that delays all biosimilars by 180 days after approval.
UPDATE:
Decision: June 12, 2017
Argument: Transcript; Audio