January 18, 2017
On January 13, 2017, the U.S. Supreme Court granted a petition for writ of certiorari in two companion cases, Amgen v. Sandoz and Sandoz v. Amgen, which the Court has consolidated. It will be the first time the Court has considered a case involving the Biologics Price Competition and Innovation Act of 2009, which created an approval pathway for biosimilar and interchangeable biological products.
The issues the Court will consider follow:
Amgen v. Sandoz
(1) Whether a biosimilar applicant is required by 42 U.S.C. § 262(l)(2)(A) to provide the reference product sponsor with a copy of its biologics license application and related manufacturing information, which the statute says the applicant “shall provide;” and (2) whether, where an applicant fails to provide that required information, the sponsor’s sole recourse is to commence a declaratory judgment under 42 U.S.C. § 262(l)(9)(C) and/or a patent-infringement action under 35 U.S.C. § 271(e)(2)(C)(ii).
Sandoz v. Amgen
(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.
Fitch Even attorneys are monitoring this case and will report once the Court has issued its decision.
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