April 26: SCOTUS Series – Sandoz Inc. v. Amgen Inc.

 

4:15 PM Registration | 4:30 PM Panel | Room NT01 (Ceremonial Classroom)
American University Washington College of Law
4300 Nebraska Ave., NW, Washington DC, 20016
Registration | Logistics and Directions

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.

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.

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 Ware, Foley Hoag LLP, representing Biotechnology Innovation Organization on amicus brief

Michael MorinLatham & Watkins LLP, representing AbbVie Inc. on amicus brief

Briefs:

*This event is generously co-sponsored by the Federal Circuit Bar Association.

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