Although Amgen originally did not petition the Supreme Court for certiorari to review the first Federal Circuit decision interpreting the BPCIA framework for resolving biosimilar patent disputes, Amgen now has filed a “Conditional Cross-Petition” for certiorari. Amgen urges the Court to deny Sandoz’s petition for certiorari, but asks the Court to grant its Conditional Cross-Petition if the Court decides to grant Sandoz’s petition. The gist of Amgen’s position seems to be that the 180-day pre-marketing notice issue raised by Sandoz is not ripe for review, but if the Court decides to review that aspect of the Federal Circuit decision, it should consider it in the context of the statutory framework as a whole, including the “requirement” that the biosimilar applicant provide a copy of its application to the reference product sponsor, and review the Federal Circuit’s decision that that “requirement” is optional.
The Federal Circuit decision at issue interpreted two provisions of the Biologics Price Competition and Innovation Act (BPCIA), 42 USC § 262(l)(2) and 42 USC § 262(l)(8)(A)
42 USC § 262(l)(2) provides:
(2) Subsection (k) application information
Not later than 20 days after the Secretary notifies the subsection (k) applicant that the application has been accepted for review, the subsection (k) applicant−
(A) shall provide to the reference product sponsor a copy of the application submitted to the Secretary under subsection (k), and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application; and
(B) may provide to the reference product sponsor additional information requested by or on behalf of the reference product sponsor.
42 USC § 262(l)(8)(A) provides:
(8) Notice of commercial marketing and preliminary injunction
(A) Notice of commercial marketing
The subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).
(B) Preliminary injunction
After receiving the notice under subparagraph (A) and before such date of the first commercial marketing of such biological product, the reference product sponsor may seek a preliminary injunction prohibiting the subsection (k) applicant from engaging in the commercial manufacture or sale of such biological product until the court decides the issue of patent validity, enforcement, and infringement with respect to any patent that is [included in either of the first lists but not included on the agreed upon list or the second lists].
The Federal Circuit held that the “shall provide” in § 262(l)(2) is optional, while the “shall provide” in § 262(l)(8)(A) is mandatory. You can read more about the Federal Circuit decision in this article.
Sandoz petition for certiorari raised two questions:
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.
Sandoz’s main argument is that the Federal Circuit’s interpretation of this provision effectively “grant[s] a 180-day ‘exclusivity windfall’ to reference product sponsors” that is not supported by the language or purpose of the statute, and that “will delay the availability of all biosimilars for 180 days more than Congress intended—even if the sponsor has no valid patent claims and even if the sponsor already has had the opportunity to pursue any valid claims.”
You can read more about Sandoz’s petition for certiorari in this article.
Amgen filed a brief in opposition to Sandoz’s petition, urging the Court to decline to review the Federal Circuit decision. Amgen’s brief sets forth three main arguments:
As noted above, Amgen’s Conditional Cross-Petition urges the Court to deny Sandoz’s petition for certiorari , but asks the Court to grant its Conditional Cross-Petition if the Court decides to grant Sandoz’s petition, so that the Court can consider both statutory provisions in context. With regard to the Federal Circuit’s interpretation of § 262(l)(2), Amgen provides several reasons why the court erred by interpreting “shall” as “may” instead of “must.”
Other biosimilar cases that may be making their way to the Supreme Court include Amgen v. Apotex, relating to Apotex’s proposed biosimilar of Amgen’s Neulasta® (pegfilgrastim) product. Apotex has appealed the district court’s application of § 262(l)(8)(A), arguing that that requirement to give 180-day pre-marketing notice does not apply if the biosimilar applicant has provided a copy of its application in accordance with § 262(l)(2). The Federal Circuit heard oral arguments in that case on April 4, 2016.
Janssen Biotech, Inc. v. Celltrion Healthcare Co., relating to Celltrion’s biosimilar of Janssen’s Remicade® (infliximab) product, which was approved by the FDA on April 5, 2016, may raise similar and/or different questions under § 262(l), such as whether § 262(l)(2)(A) permits a biosimilar applicant to provide a copy of its application but not information regarding its manufacturing process; whether a biosimilar applicant can circumvent the negotiation procedures of § 262(l)(4) and (5) by consenting to the reference product sponsor’s patent list, and whether providing notice of commercial marketing before a product is approved accelerates the time in which the reference product sponsor must bring suit.
Other biosimilar disputes are bound to raise other issues, as parties try to operate under (or around) the complex provisions of § 262(l). The question is how long the Supreme Court will wait to weigh in, and how parties will adapt to evolving understandings of the statute in the meantime.