Today, the Supreme Court granted Sandoz’s petition for certiorari and Amgen’s cross-petition in Amgen v. Sandoz, case nos. 15-1039 and 15-1195. The two cases were consolidated, and an hour was allotted for oral argument. This case will be the Supreme Court’s first to interpret the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
The Federal Circuit’s decision on appeal held that a biosimilar maker does not violate the BPCIA by failing to comply with certain information exchange provisions, known as the “patent dance.” The court also held, however, that the biosimilar maker’s notice of commercial marketing to the reference product sponsor before FDA’s licensure of the biosimilar was premature and ineffective and that post-licensure notice was mandatory. We previously covered the Federal Circuit’s decision and the procedural history in detail here. We also posted a more detailed explanation of the issues before the Supreme Court last month when the Solicitor General submitted its brief in support of Sandoz on both issues. The issues on which the Supreme Court will rule are:
(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;”
(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).
(3) Whether notice of commercial marketing given before Food and Drug Administration approval can be effective;
(4) 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.