Sandoz Inc. v. Amgen Inc.

Under 42 U. S. C. §262(l), an applicant for FDA approval of a biosimilar cannot be enjoined for failing to provide manufacturing information of the biosimilar, although it may under state law; and, the applicant may give the sponsor of the biosimilar notice of its application before or after receiving its FDA license.

Petitioner and Respondent market biologics, which are drug products created from animals, microorganisms, and other natural sources. Respondent sued Petitioner for patent infringement under 42 U. S. C. §262(l), for unlawfully marketing a biosimilar, which are products that are “substantially similar” to products that are already patented. Respondent sought an injunction, alleging Petitioner did not provide it with required manufacturing information, and Petitioner did not give sufficient notice prior to receiving FDA licensing. Respondent’s claims were dismissed by the district court. The Federal Circuit vacated the district court’s judgment and enjoined Petitioner from marketing the product until 180 days after the date it provided notice to Respondent. The U.S. Supreme Court determined that the appropriate remedy for failing to provide manufacturing information, under §262(l)(9)(C), was for Respondent, the “sponsor” of the biosimilar, to seek immediate declaratory judgment action against Petitioner. The Court held that Congress did not intend to allow injunctive relief, because it was not expressed by the appropriate statute. The Court also determined that the timing of the notice, provided by the applicant to the sponsor, may occur prior to or after the applicant’s licensure of the biosimilar. The Court held that §262(l)(8)(A) does not specify when notice must occur in relation to the licensure, but only that it must occur 180 days prior to marketing the product. VACATED in part, REVERSED in part, and REMANDED.