Supreme Court to Review BPCIA -- Amgen v. Sandoz Petitions for Writs of Certiorari Granted

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On Friday, the Supreme Court granted both petitions for writs of certiorari and consolidated the Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195) appeals.  Sandoz had petitioned the Court on February 16, 2016 for a writ of certiorari to review one of the issues decided by the Federal Circuit's July 21, 2015 opinion, 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.

Amgen filed a brief in opposition on March 21, but at the same time 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.  As Amgen put it, both questions related to the "patent-resolution scheme of the BPCIA."  Specifically, the question posed in Amgen's 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)?

The grant of certiorari in this case on both questions was not necessarily a surprise move, because as we reported last month, the Solicitor General recommended that the Court do so.  It is possible, however, that the Court took this case because its resolution will not necessarily follow partisan lines.  Before the incoming President has an opportunity to appoint someone to fill Justice Scalia's seat (a nominee whose confirmation may be further delayed in the Senate by opposition from the Democrats), every case the Supreme Court hears faces a potential 4-4 split.  Correspondingly, any decision rendered before the Court is constituted with nine members may come under increased scrutiny.  While the potential for lower biosimilar drug products is certain to be of interest to the general public, the nuances of the interpretation of a statute that intersects FDA and patent law is not likely to engender diametrically opposed views across party lines.  In some ways, therefore, the Court may be playing it safe by taking this case now.

With that said, it is difficult to foresee how the Court will resolve the case.  Unlike most cases in which the Court reviews decisions by the Federal Circuit (which are generally reversed), this case has four potential outcomes:  the Court could affirm or deny the entirety of the Federal Circuit's decision, or it could affirm one holdings and deny the other.  What is clear is that we could see resolution of this case by the end of the current term in June.  One needs only look to the schedule of the Cuozzo v. Lee case for comparison -- certiorari was granted in that case almost exactly a year ago, and the decision was handed down last June.  Patent Docs will continue to monitor this case and provide updates as necessary.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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