Sandoz Requests U.S. Supreme Court Interpretation Of The Biologics Price Competition And Innovation Act In Amgen Inc. V. Sandoz Inc.

As many expected, Sandoz Inc. filed a petition for a writ of certiorari asking the Supreme Court to review the Federal Circuit's decision in Amgen Inc. v. Sandoz Inc.1,2 Amgen will have an opportunity to not only oppose Sandoz's petition but also to file a conditional cross petition.3 Amgen is the first Federal Circuit decision to substantively interpret the Biologics Price Competition and Innovation Act of 2009 ("BPCIA"), so whether the Court decides to hear the case will be closely monitored by the biologics industry because it will have a significant economic impact on both reference product sponsors and biosimilar applicants, as well as the general public.4

In its fragmented July 21, 2015 opinion that generated two different dissents, the Federal Circuit held that: (1) a biosimilar applicant does not have to participate in the elaborate patent exchange procedure contemplated by § 351(l) of the PHSA;5 and (2) a biosimilar applicant must provide the reference product sponsor with 180 days' notice of commercial marketing that is not effective until after the FDA licenses the biosimilar application.6

Sandoz's petition challenges the Federal Circuit's second holding relating to notice of commercial marketing. Sandoz contends that a biosimilar applicant can provide the reference product sponsor with notice of commercial marketing prior to the FDA's licensure of the proposed biosimilar application. Sandoz phrased the question presented as:

Whether notice of commercial marketing given before FDA approval can be effective and whether, in any event, treating Section 262(l)(8)(A) [of Title 42 of the United States Code] as a stand-alone requirement and creating an injunctive remedy that delays all biosimilars by 180 days after approval is improper.7

Pursuant to Supreme Court Rule 15.3, Amgen may file a brief opposing Sandoz's petition "within 30 days after the case is placed on the docket." Moreover, Amgen has the same timeframe to file a conditional cross petition pursuant to Supreme Court Rule 12.5. Absent an unduly long extension being granted to Amgen, we expect that the Court will rule on whether to hear the case before its summer recess. If Sandoz's petition is granted, oral argument will likely be heard during the Court's October Term 2016, and a decision will not be rendered until 2017.

1. Without An Amgen Cross Petition, Biosimilar Applicants Are Not Required To Participate In The Patent Exchange Procedure

   Absent a conditional cross petition by Amgen that is granted by the Court, the Federal Circuit's holding in Amgen relating to the patent exchange procedure will continue to control the procedures under the BPCIA. As such, biosimilar applicants may elect to not participate in the patent exchange procedure...