Amgen Inc. v. Sandoz Inc.

Questions presented

SCOTUS records, cert granted 13 Jan 2017

The Biologics Price Competition and Innovation Act of 2009 (the "BPCIA"), see Pub. L. No. 111-148, §§ 7001-7003, 124 Stat. 119, 804-21, created a new regulatory pathway, 42 U.S.C. § 262(k), by which the FDA could approve a biologic product as "biosimilar to" a "reference product" that was itself approved under the full, traditional pathway of 42 U.S.C. § 262(a). "[B] alancing innovation and consumer interests," Pub. L. No. 111-148 § 7001(b), Congress established procedures to control and streamline patent litigation between the biosimilar applicant (the "Applicant") and the reference product sponsor (the "Sponsor" or "RPS"), see 42 U.S.C. § 262(l), triggered by the filing of an application under the new abbreviated pathway, see id. § 262(l) (1)(B)(i). Amgen Inc. and Amgen Manufacturing Limited (together, "Amgen") respectfully file this Conditional Cross-Petition for a writ of certiorari to review the judgment of the United States Court of Appeals for the Federal Circuit regarding its interpretation of one part of the integrated patent- litigation procedures in subsection 262(l). Specifically, subparagraph 262(l) (2)(A) requires that, within 20 days of the FDA accepting its biologics license application for review under the new, abbreviated regulatory pathway, the Applicant "shall provide" the Sponsor with a copy of that biologics license application and related information about the manufacture of its proposed biosimilar product. Despite the statute's use of the mandatory verb "shall" and the centrality of the biologics license application and manufacturing information to many of the steps of the patent-dispute-resolution procedures, the Federal Circuit held that an Applicant is not required to provide that information to the Sponsor and that a court cannot compel an Applicant to provide that information. The question presented by this Conditional Cross-Petition is: Is an Applicant required by 42 U.S.C. § 262(l)(2)(A) to provide the Sponsor with a copy of its biologics license application and related manufacturing information, which the statute says the Applicant "shall provide," and, where an Applicant fails to provide that required information, is the Sponsor's sole recourse to commence a declaratory-judgment action 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)? Cross-Respondent Sandoz Inc. ("Sandoz") has already filed a petition ("Sandoz's Petition"), which has been docketed as No. 15-1039, asking for this Court to review the Federal Circuit's interpretation of another component of the patent-dispute-resolution procedures of subsection 262(l), the notice of commercial marketing required by subparagraph 262(l)(8)(A). There, consistent with this Court's statutory-interpretation precedent, the Federal Circuit held that the verb "shall" is mandatory. Notably, Sandoz argues in its petition that subparagraph

Opinion summary

Etalia.ai summary of the majority opinion

The case centered on the interpretation of the Biologics Price Competition and Innovation Act (BPCIA), specifically regarding biosimilar products. Amgen Inc., a biotechnology company, sued Sandoz Inc., alleging that Sandoz violated provisions of the BPCIA by not providing Amgen with its application and manufacturing information for a biosimilar version of Amgen's Neupogen. The Supreme Court addressed two main issues: whether notice is required after FDA approval or can be given before, and if an injunction to enforce disclosure requirements is available under federal law. The Court ruled unanimously that biosimilar applicants may provide notice either before or after receiving FDA approval, thus allowing earlier market entry post-approval. Additionally, it held that federal law does not authorize an injunction to compel compliance with the disclosure requirement but leaves room for state-law remedies.