IP at the Supreme Court Series: Sandoz Inc. v. Amgen Inc.

Supreme Court Building
 

April 26, 2017
4:30pm | Room NT01

Reception to Follow

Webcast

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 AndersonAmerican University Washington College of Law (Moderator)
  • Jennifer ThomasHyman, Phelps & McNamara, PC, representing Pharmaceutical Care Management Association, et al. on amicus brief
  • Sara KoblitzHyman, Phelps & McNamara, PC, representing Pharmaceutical Care Management Association, et al. on amicus brief
  • Donald WareFoley Hoag LLP, representing Biotechnology Innovation Organization on amicus brief
  • Michael MorinLatham & 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: TranscriptAudio

All briefs available on SCOTUSblog: Sandoz Inc. v. Amgen Inc.