Monday, June 12, 2017

U.S. Supreme Court Holds That Federal Law Does Not Authorize Injunctions to Compel Compliance with 42 U.S.C. § 262(l)(2)(A)

The Supreme Court this morning also issued a unanimous opinion in Sandoz Inv. v. Amgen Inc., which involved two questions arising under the Biologics Price Competition and Innovation Act (BPCIA).  The proper interpretation of this extraordinarily complex statute might seem even further afield from the subject of patent remedies than is the case I mentioned earlier this morning on inter partes review, but there actually is a remedies question at issue in Amgen.  The Court holds that, when an applicant seeking FDA approval to market a biosimilar pursuant to the BPCIA's abbreviated process does not provide the sponsor (that is, the firm which was originally granted approval to market the relevant biologic) with its application materials and manufacturing information within 20 days of receipt of notification that the FDA has accepted its application for review, pursuant to 42 U.S.C. § 262(l)(2)(A), 42 U.S.C. § 262(l)(9)(C) permits the sponsor to sue the applicant for a declaratory judgment "of infringement, validity, or enforceability of any patent that claims the biological product or a use of the biological product."  In addition, the act of submitting the application constitutes an act of artificial infringement under 35 U.S.C. § 271(e)(2)(C)(ii), regardless of whether the applicant has provided the sponsor with the application and manufacturing information,  and 35 U.S.C. § 271(e)(4) authorizes the court to issue an injunction against the infringing manufacture and sale of the biologic.  Neither 35 U.S.C. § 271(e)(4) nor 42 U.S.C. § 262(l)(9)(C), however, authorize the sponsor to sue for  an injunction compelling the disclosure of the application and manufacturing informationThe Court nevertheless remands for the Federal Circuit to determine whether or not an injunction compelling disclosure of the application and manufacturing information may be available under state law, Amgen having also asserted claims for relief against Sandoz under California unfair competition law.  (The Court leaves open the possibility that the Federal Circuit may conclude that application of state law here might be preempted, though.)  The other issue in the case was whether Sandoz could provide its notice of commercial marketing to Amgen in advance of receiving a license from the FDA to market its biosimilar, or whether it had to wait until receipt of that license, the practical consequence being that Sandoz can't market its biosimilar until at least 180 days from providing the notice to Amgen.  The Court holds that the requisite notice may precede the issuance of the license, which should work to speed up the introduction of biosimilars to the market.

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