Supreme Court Review 2017/2018 TERM
SATURDAY, NOVEMBER 25, 2017
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Issue:  “Notice of commercial marketing” provision
Consolidated With:  Amgen Inc. v. Sandoz Inc.

Sandoz Inc. v. Amgen Inc.

15-1039

QUESTION(S) PRESENTED

(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.

DECISION

Fully Briefed and Argued
Awaiting Decision

ORAL ARGUMENT

Argued April 26, 2017

Transcript
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PROCEEDING BELOW

United States Court of Appeals for the Federal Circuit
Decided July 21, 2015
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