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.
- Brief of Petitioner Sandoz, Inc.
- Opening and Response Brief for Amgen, Inc.
- Brief amicus curiae of Adello Biologics, LLC
- Brief amici curiae of Pharmaceutical Care Management Association, et al.
- Brief amici curiae of Apotex Inc. and Apotex Corp.
- Brief amicus curiae of Biosimilars Council
- Brief amicus curiae of America’s Health Insurance Plans
- Brief amicus curiae of United States
- Brief amici curiae of AARP Foundation, et al.
- Brief amicus curiae of Coherus Biosciences, Inc.
- Brief amicus curiae of Mylan, Inc.
- Brief amicus curiae of AbbeVie Inc.
- Brief amicus curiae of Janssen Biotech, Inc.
- Brief amicus curiae of Biotechnology Innovation Organization
- Brief amicus curiae of Genentech, Inc.