By Andrew Williams --
In other Supreme Court news from Monday, June 20, 2016, the Court invited the Solicitor General to file briefs in the Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195) appeals to express the views of the United States. As we previously reported, Sandoz petitioned the Court on February 16 for a writ of certiorari to review one of the issues decided by the Federal Circuit on July 21, 2015, specifically:
Whether notice of commercial marketing given before FDA approval can be effective and whether, in any event, treating Section 262(l)(8)(A) as a stand-alone requirement and creating an injunctive remedy that delays all biosimilars by 180 days after approval is improper.
Since that time, Amgen filed a brief in opposition on March 21 asking the Court to deny Sandoz's petition. At the same time, Amgen filed a conditional cross-petition asking the Court for a writ of certiorari to review a second question in the event it granted the Sandoz Petition, because both questions relate to the "patent-resolution scheme of the BPCIA." Specifically, the question posed in the conditional cross-petition was:
Is an Applicant required by 42 U.S.C. § 262(l)(2)(A) to provide the Sponsor with a copy of its biologics license application and related manufacturing information, which the statute says the Applicant "shall provide," and, where an Applicant fails to provide that required information, is the Sponsor's sole recourse to commence a declaratory-judgment action under 42 U.S.C. § 262(l)(9)(C) and/or a patent-infringement action under 35 U.S.C. § 271(e)(2)(C)(ii)?
Nevertheless, Amgen stressed that this petition was expressly conditional on the grant of Sandoz's petition, and that it ultimately urged the Court to deny both petitions.
The Supreme Court's action on Monday can be seen as a delay tactic on the part of the Court. Obviously, no decision on whether the Court will hear this case will be made before the Court's next term. Moreover, the Solicitor General does not have a deadline for expressing the views of the United States. Nevertheless, this still can be seen as a positive for Sandoz. It would not have been surprising for the Court to deny the petition outright; especially considering the Federal Circuit opinion was the first significant interpretation of the BPCIA by a Court of Appeals. In fact, Amgen argued in its opposition brief that this case was a poor vehicle for review because the issues are still be developed by the lower courts. However, the Supreme Court did not wait for the case law to develop at the PTAB and the Federal Circuit regarding the new IPR proceedings, but instead took up the first appeal it could, which culminated in the Court's opinion in Cuozzo v. Lee on Monday. As a result, a lot could hinge on the views of the United States, which we will likely see later this year. Patent Docs will continue to monitor this case and provide updates as necessary.