In a landmark ruling for the biotech and pharmaceutical industries, a unanimous Supreme Court decided Sandoz Inc. v. Amgen Inc., 582 U.S. ____, Nos. 15-1039, 15-1195 (June 12, 2017), its first biosimilar case governed by the Biologics Price Competition and Innovation Act (“BPCIA”). The case provides clarity regarding two main issues: (1) whether a court may enforce an injunction against a biosimilar applicant that “opts out” of the “patent dance” by refusing to provide its abbreviated biologics license application (“aBLA”) and manufacturing information (collectively, the applicant’s “confidential information”) to the innovator, also known as the reference product sponsor (“RPS”), and (2) whether the biosimilar applicant must obtain a license (i.e., FDA approval) before giving notice to the RPS that it plans to begin commercial marketing of its biosimilar product.

The Court answered both questions in the negative, reversing and remanding the case to the Federal Circuit for a determination of whether the RPS may rely on state law to force the applicant to comply with the confidential information exchange provision. The Court’s decision provided some muchneeded clarity around the application of the BPCIA, and it removed one obstacle for competition on biological products—the 180-day delay in biosimilar product launch after a biosimilar applicant obtains a license from FDA. The ruling, however, does not change the RPS’s ability to litigate each of its patents before that commercial launch.