martes, 13 de junio de 2017

FDA Law Blog: U.S. Supreme Court Rules in Amgen v. Sandoz; Gives a Potential Boost to the Biosimilars Industry

FDA Law Blog: U.S. Supreme Court Rules in Amgen v. Sandoz; Gives a Potential Boost to the Biosimilars Industry

Posted: 12 Jun 2017 06:50 PM PDT
By Sara W. Koblitz –

In a relatively infrequent unanimous decision, the U.S. Supreme Court this morning (June 12th) interpreted the Biologics Price Competition and Innovation Act (“BPCIA”) such that the biosimilar patent dance is not mandatory. As regular readers of the FDA Law Blog know, Amgen sued Sandoz for failure to engage in the patent dance and inadequate notice of commercial marketing for Sandoz’s ZARXIO (filgrastim-sndz), a biosimilar version of Amgen’s NEUPOGEN (filgrastim). Amgen sought injunctions to enforce the BPCIA patent dance requirements and for patent infringement while Sandoz counterclaimed for declaratory judgments that the patent was invalid and Sandoz had not violated the BPCIA.

The Supreme Court decided that Sandoz did not violate the BPCIA by failing to engage in the patent dance, as consequences for failure to do so are expressly stated in the BPCIA – meaning that failure to participate was expressly contemplated by the BPCIA. The Court explained that failing to disclose its application and manufacturing information as required under 42 U.S.C. § 262(l)(2)(A) does not constitute an act of artificial infringement, but is actionable under 42 U.S.C. § 262(l)(9)(C), which permits the sponsor to bring an immediate declaratory judgment action for artificial infringement. Therefore, failure to participate in the patent dance cedes control of patent litigation to the sponsor rather than the applicant. This, rather than injunctive relief, serves as enforcement of the disclosure requirements. The Court then remanded to the Federal Circuit to determine whether an injunction is available under California state law to enforce 42 U.S.C. § 262(l)(2)(A) based on whether noncompliance with § 262(l)(2)(A) is unlawful under California’s unfair competition statute.

The Court then examined the plain language of the 180-day notice requirement and determined that no policy argument exists that could outweigh the clear textual argument: 180-day notice of marketing is permitted before licensure.

The applicant must give “notice” at least 180 days “before the date of the first commercial marketing.” “[C]ommercial marketing,” in turn, must be “of the biological product licensed under subsection (k).” §262(l)(8)(A). Because this latter phrase modifies “commercial marketing” rather than “notice,” “commercial marketing” is the point in time by which the biosimilar must be “licensed.” The statute’s use of the word “licensed” merely reflects the fact that, on the “date of the first commercial marketing,” the product must be “licensed.” See §262(a)(1)(A). Accordingly, the applicant may provide notice either before or after receiving FDA approval.
Implicitly, the Court held that reference product manufacturers are not entitled to an additional 6 months of practical exclusivity after a biosimilar is approved. Theoretically, this should help biosimilars come to market faster.

In a Concurring Opinion, Justice Breyer, citing the Court's previous decision in National Cable & Telecommunications Assn. v. Brand X Internet Services, 545 U. S. 967 (2005), raised the possibility that notwithstanding the Court's interpretation of the BPCIA, FDA might come to a different interpretation of the statute: "if [FDA], after greater experience administering this statute, determines that a different interpretation would better serve the statute’s objectives, it may well have authority to depart from, or to modify, today’s interpretation."  It seems unlikely that FDA will depart from the Court's decision.  

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