On Monday, December 12, 2016, the Supreme Court denied certiorari in Apotex v. Amgen, No. 16-332. Apotex had petitioned the Court to clarify provisions of the Biologics Price Competition and Innovation Act (BPCIA) set forth at 42 U.S.C. § 262(l)(8)(A).
The denial comes on the heels of the Solicitor General’s recommendation that the Supreme Court hear a similar case, Sandoz v. Amgen, No. 15-1039 and its cross-petition, Amgen v. Sandoz, 15-1195. Underpinning both petitions is the ruling in Amgen v. Sandoz, 794 F.3d 1357 (Fed. Cir. 2015), where the Federal Circuit considered patent infringement claims related to Sandoz’s FDA-approved biosimilar ZARXIO® and, in particular, whether the biosimilar manufacturer was required to wait 180 days post-product licensure before entering the market. Sandoz’s biosimilar, which is intended to compete with Amgen’s NEUPOGEN® for the treatment of neutropenia, launched in September 2015 at reduced costs. Notably, ZARXIO® was commercialized after a 180-day waiting period effected by the Federal Circuit in Sandoz.
Petitioner Sandoz asks the Supreme Court whether notice of commercial marketing under Subsection (l)(8)(A) is legally effective if given prior to FDA approval. If not, can the notice requirement be enforced by an injunction that delays market entry by 180 days?
In the Brief filed December 7, 2016, the Solicitor concludes that the Federal Circuit was “incorrect” when it imposed an injunction on Sandoz to enforce its reading of Subsection (l)(8)(A). Specifically, the Solicitor asserts that notice can be valid prior to approval, and no injunctive relief is available under the BPCIA. Moreover, a sponsor’s sole and proper remedy if notice is untimely is an immediate patent-infringement action. Br. 20.
According to the Solicitor, notice can be valid prior to approval because Congress specifically made submission of an aBLA an artificial “act of infringement” to facilitate patent litigation soon after submission, which necessarily occurs before the FDA can grant a license.
Addressing the statute’s use of the word “licensed” in the past tense, the Solicitor reasoned that this is most naturally read as describing the biosimilar product at the date of its first commercial marketing, and in no way implies that the biosimilar product must already be “licensed” as of the notice date.
Further, in the Solicitor’s mind, Subsection (l)(8)(A) is less about giving the sponsor time to “assess and act upon its patent rights” than it is about affording the applicant significant “control” over the pace and scope of litigation by allowing it to restrict litigation to just one patent or, conversely, to expand it to include all relevant patents. Br. 18.
Respondent Amgen cross-petitioned the Court and separately asked whether the BPCIA’s disclosure requirement in Subsection (l)(2)(A) creates a binding obligation enforceable by injunction. Here, the Solicitor concludes that the Federal Circuit was correct. In particular, the court did not require Sandoz to disclose its aBLA to Amgen (it had already been obtained during discovery), and held that the BPCIA has no provision granting a procedural right to compel compliance.
Because “[b]iologic medicines are among the most important pharmaceuticals available today” and “among the most expensive,” the Solicitor urges that the issues are sufficiently important to merit the Court’s review. While the timing of the Solicitor’s brief could, at least in theory, allow the case to be argued and decided this term, a decision on grant is expected by early- to mid-January 2017.