Last week, the United States Supreme Court granted certiorari review of the Amgen v. Sandoz decision. Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1351 (Fed. Cir. 2015), cert. granted, (U.S. Jan. 13, 2017). In Amgen v. Sandoz, the Federal Circuit interpreted provisions of the Biologics Price Competition and Innovation Act (BPCIA), which it described as a “riddle wrapped in a mystery inside an enigma.” Id. The BPCIA, which in part provides a framework for biosimilar applicants to engage with reference product sponsors to clear patent disputes, has only begun to be construed by the courts and has serious implications for the emerging biosimilar industry. In its July 2015 decision, the Federal Circuit held that the patent dance provisions of the BPCIA are optional (specifically, that a biosimilar applicant does not have to provide a copy of its aBLA and other material under 262(l)(2)(A)) and that 180-day advance notice of first commercial marketing of a biosimilar under Section 262(l )(8)(A) is only effective after FDA has licensed that biosimilar. The Federal Circuit also held that a court may enforce Section 262(l )(8)(A) by enjoining the applicant from such marketing until 180 days after the applicant provides effective notice.
The Federal Circuit’s decision was thus a mixed bag for biosimilar applicants. The decision gave biosimilar applicants the ability to opt out of the exchange of confidential information and the patent dance, but biosimilar applicants decried the decision for effectively giving the reference product sponsor an extra 180 days of exclusivity. Applicants would have to wait for FDA approval, and only then provide notice under 262(l)(8)(A) and start the 180-day clock to commercial marketing, or face a potential injunction. Because of these potential ramifications, Sandoz asked the Supreme Court to review the Federal Circuit’s interpretation of notice of commercial marketing under 262(l)(8)(A). Amgen filed a conditional cross-petition on the Federal Circuit’s ruling that the BPCIA patent dance procedures were not mandatory.
The Supreme Court’s decision to hear the case comes just about a month after the Solicitor General recommended the Court grant certiorari. In its brief, the Solicitor General largely agreed with Sandoz’s positions at the Federal Circuit. The Solicitor General stated the Federal Circuit “erred in interpreting Subsection (l)(8)(A) [in holding that notice was effective only after FDA licensure], but correctly construed Subsection (l)(2)(A) [in clarifying the optional nature of the patent dance].” (Solicitor’s brief at 12-13.) The Solicitor General also argued that an injunction is not proper to enforce Section 262(l)(8)(A). Instead, according to the Solicitor General, a sponsor’s sole recourse if a biosimilar applicant fails to provide information under (l)(8)(A) is commencement of a patent infringement action. The Solicitor also made other recommendations that aligned with Sandoz’s positions, namely, that the Court should reverse the Federal Circuit with respect to the timing of the 180-day notice, arguing that notice is valid if given pre-licensure. With respect to the disclosure requirement in Subsection (l)(2)(A), the Solicitor recommended that the Court adopt the Federal Circuit’s holding that a biosimilar manufacturer is not required to disclose its aBLA application and manufacturing process information to start the patent dance. Thus, should the Supreme Court wholly adopt the Solicitor General’s recommendations, it would be a major win across the board for the biosimilar industry.
The Supreme Court also invited Apotex, whose certiorari petition on similar issues was denied in December, to submit amici briefing on the issues.
Last year, the Supreme Court granted certiorari in January 2016 to eight cases, with briefing in seven of those cases completed by April and decisions rendered in June and July. This means biologic manufacturers and biosimilar applicants can likely expect more guidance regarding the BPCIA enigma by early summer 2017.
Authors: Jenny Shmuel, Tasha Francis
The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.
Dr. Jenny Shmuel represents clients on a range of intellectual property matters, with an emphasis on medical device and pharmaceutical technologies. She has extensive experience in pre-suit diligence, case management, expert and fact discovery, and brief writing, and has examined and...