Sandoz Inc. v. Amgen Inc., Case No. 15-1039 (U.S. June 12, 2017)

On June 12, 2017, in its final patent-related decision of the October 2016 term, the U.S. Supreme Court issued a unanimous decision interpreting two disputed provisions in the Biologics Price Competition and Innovation Act of 2009, 42 U.S.C. § 262(l) (the "BPICA" or "Act").

The BPICA governs U.S. Food and Drug Administration market approval of "biosimilars," or biologic products that are highly similar to a biologic product previously approved for commercial marketing. The Act provides a framework for biosimilar applicants to "piggyback" on the application filed by an original sponsor of an approved biologic, receiving approval if the applicant can establish that a proposed biosimilar is "highly similar" to the biologic with "no clinically meaningful differences" compared to the previously-approved product. The Act also creates mechanisms requiring an applicant to disclose detailed information concerning the proposed biosimilar, and for the sponsor of the approved biologic to assert claims for patent infringement against the applicant prior to the actual sale of the biosimilar.

In this case, Amgen Inc. obtained FDA approval to market a biologic, filgrastin, under the brand name Neupogen to stimulate a patient's production of white blood cells. Sandoz Inc. filed an application under the BPICA to market a corresponding biosimilar product. Disputes then emerged concerning the parties' obligations under the BPICA machinery. Ultimately, Amgen filed an action in federal district court alleging that Sandoz failed to disclose manufacturing information concerning its proposed biosimilar as required by § 262(l)(2)(A), and seeking an injunction under the BPICA and a California statute governing unfair trade practices. In addition, Amgen argued that Sandoz failed to provide notice of its intent to market the biosimilar at least 180 days before the first commercial marketing of the product as required by the BPICA, §262(l)(8)(A), because Sandoz provided its notice before receiving an FDA license to market the biosimilar.

In a unanimous decision written by Associate Justice Clarence Thomas, the Supreme Court reversed-in-part and affirmed-in-part the U.S. Court of Appeals for the Federal Circuit. First, the Court ruled that a sponsor may not force the BPICA applicant to disclose application and manufacturing information under the Act through an injunction issued under the authority of federal law, because the BPICA provides specific, exclusive remedies that are inapplicable to such a failure. The Court noted that the BPICA only provides the biologic sponsor remedies for patent infringement, but an applicant's failure to provide technical information required under the Act is not itself an act of infringement. The Court ruled, however, that Amgen may qualify for injunctive relief under state law, including the California unfair competition statute, Cal. Bus. & Prof. Code Ann. §17205. The Court remanded for the Federal Circuit to consider whether Sandoz's failure to provide technical information under the BPICA was unlawful under state law and thus subject to state law remedies including an injunction.

Second, the Court held that a BPICA's notice provision, which requires the biosimilar applicant to provide notice to the biologic sponsor "not later than 180 days before the date of the first commercial marketing" of the approved biosimilar, allows the applicant to provide notice even before the FDA licenses such a sale. See 42 U.S.C. §262(l)(8)(A). Construing the statute narrowly, the Court reasoned that the Federal Circuit misread the statute in requiring the notice to occur both prior to commercial marketing and after FDA market approval of a biosimilar.

Justice Breyer filed a short concurring opinion inviting the FDA to promulgate regulations that potentially "would better serve the statute's objectives" than the Court's interpretation.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.