Today, the Supreme Court deferred a decision on certiorari in Amgen v. Sandoz, inviting the Solicitor General to file a brief expressing the views of the United States. Sandoz petitioned for review of one aspect of the Federal Circuit’s 2015 decision, that court’s first and so far only interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), and Amgen filed a conditional cross-petition asking for review of another aspect of the decision if Sandoz’s petition were granted. The Supreme Court’s order asks the Solicitor General to comment on both petitions.
Amgen v. Sandoz was a split decision. The issue on which Sandoz seeks is cert is when a biosimilar applicant can provide an effective “notice of commercial marketing,” which the BPCIA states must issue at least 180 days before the biosimilar enters the market. The Federal Circuit held that a biosimilar maker can only give effective notice of commercial marketing after the FDA has licensed the biosimilar product, meaning that the first sale of a biosimilar cannot be sooner than six months after the FDA’s licensing decision. In its cert petition, Sandoz contends that the Federal Circuit effectively extended the statutory exclusivity period beyond what Congress intended and awarded Amgen an inappropriate injunction.
Although Sandoz prevailed on the other significant issue in Amgen v. Sandoz, concerning whether the BPCIA’s “patent dance” procedures are mandatory or optional, Amgen did not file an opening petition on this issue. Once Sandoz filed its petition, however, Amgen filed a conditional cross-petition on the patent dance. The Federal Circuit held that an innovator’s only remedy for a biosimilar applicant’s failure to participate in the patent dance is to bring a patent infringement suit; if the applicant is willing to face such a suit, participation is optional. In the cross-petition, Amgen argues that the Federal Circuit’s decision is contrary to the plain language of the BPCIA, which states that biosimilar applicants “shall” participate in the patent dance.
Sandoz’s petition and Amgen’s cross-petition have separate docket numbers. The Supreme Court’s order calling for the views of the Solicitor General refers to both cases, indicating that the Court is asking for views on both petitions. There is no deadline for the Solicitor General to weigh in, but based on the office’s typical practices it is likely to submit a brief in August, in time for the Court to consider it at the beginning of next term.