Sandoz Inc. v. Amgen Inc. - 137 S. Ct. 1664 (2017)

Rule:

The Biologics Price Competition and Innovation Act of 2009 governs a type of drug called a biosimilar, which is a biologic product that is highly similar to a biologic product that has already been approved by the Food and Drug Administration (FDA). Under 42 U.S.C.S. § 262(l), an applicant that seeks FDA approval of a biosimilar must provide its application materials and manufacturing information to the manufacturer of the corresponding biologic within 20 days of the date the FDA notifies the applicant that it has accepted the application for review. The applicant then must give notice to the manufacturer at least 180 days before marketing the biosimilar commercially. An injunction under federal law is not available to enforce 42 U.S.C.S. § 262(l)(2)(A).

Facts:

The case involved 42 U. S. C. §262(l) which was enacted as part of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), 124 Stat. 808. The subject matter in this case concerned filgrastim, a biologic used to stimulate the production of white blood cells. Neupogen was a filgrastim product marketed by respondent Amgen Inc. It claimed to hold patents on methods of manufacturing and using filgrastim. On the other, petitioner Sandoz Inc., sought FDA approval to market a biosimilar filgrastim product under the brand name Zarxio, with Neupogen as the reference product. Day after the Food and Drug Administration informed petitioner that its application had been accepted for review, petitioner notified respondent that it had submitted an application and that it intended to market Zarxio immediately upon receiving FDA approval. It later informed respondent that it did not intend to provide the application and manufacturing information required by the law and that respondent could sue immediately for infringement. Respondent then sued petitioner for patent infringement and also asserted that the latter engaged in unlawful conduct in violation of California's unfair competition law. Respondent sought injunctions to enforce both the BPCIA requirements. Petitioner, for its part, counterclaimed for declaratory judgments that the asserted patent was invalid and not infringed and that it had not violated the BPCIA. While the case was pending, the FDA licensed Zarxio. Petitioner then provided respondent a further notice of commercial marketing. The district court granted partial judgment on the pleadings to petitioner on its BPCIA counterclaims and dismissed respondent’s unfair competition claims with prejudice. The federal circuit affirmed in part, vacated in part, and remanded. The court affirmed the dismissal of respondent’s state-law claim based on petitioner’s alleged violation of §262(l)(2)(A), holding that petitioner did not violate the BPCIA in failing to disclose its application and manufacturing information and that the BPCIA provided exclusive remedies for failure to comply with this requirement. The court also held that under §262(l)(8)(A), an applicant must provide notice of commercial marketing after obtaining licensure, and that this requirement was mandatory. Thus, petitioner was enjoined from marketing the product until 180 days after the date it provided its second notice.

Issue:

Was the requirement that an applicant shall provide its application and manufacturing information to the manufacturer of the biologic enforceable by injunction? 

Answer:

No.

Conclusion:

The court ruled that the requirement under 42 U.S.C.S. § 262(l)(2)(A) for an applicant to provide the sponsor with its application and manufacturing information was not enforceable by an injunction under federal law given that the structure of 35 U.S.C.S. § 271(e)(2)(C) did not treat an applicant's failure to provide its application and manufacturing information as an element of artificial infringement. Also, 42 U.S.C.S. § 262(l)(9)(C) excluded all other remedies, including injunctive relief. The court further held that the lower court erred in concluding that no state remedy was available since failure to comply with was not an act of artificial infringement. The court likewise held that the question of whether the challenged conduct was unlawful under state law could not be resolved by referring to federal law alone. Lastly, the court clarified that the notice required under 42 U.S.C.S. § 262(l)(8)(A) could be provided either before or after receiving FDA approval. Thus, the court’s judgment was vacated and reversed in part, and remanded.