Analysis of Solicitor General’s Brief in Sandoz v. Amgen

Amgen v. Sandoz (filgrastim)  •  BPCIA and Related U.S. Statutes

As we posted earlier this week, the Acting Solicitor General (“SG”), on December 7th,  filed an amicus brief in which it (a) recommended that the Supreme Court grant Sandoz’s cert petition and Amgen’s conditional cross-cert petition regarding how to interpret important provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), and (b) sided with Sandoz with respect to the remedies available for non-compliance of 42 U.S.C. § 262(l)(2)(A), and the latitude granted to biosimilar applicants in the 180-day “notice of commercial marketing” provision in 42 U.S.C. § 262(l)(8)(A).

The BPCIA establishes an expedited process for licensing “biosimilar versions of licensed biologic products” (“reference products”).  42 U.S.C. § 262(k).  Subsection (l)(2)(A) states that the applicant “shall provide to” the sponsor a copy of the biosimilar application and information about the product’s manufacturing processes.  If the applicant timely provides the sponsor with appropriate disclosures, neither the sponsor nor the applicant may bring a declaratory-judgment action until the applicant provides advance notice of the first commercial marketing of its biosimilar.  Subsection (l)(8)(A) states that the 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).”  The SG states that BPCIA provisions control the timing and scope of resulting patent-infringement claims by allowing an applicant to postpone litigation if proper disclosures are provided to the sponsor  (explaining that “[t]he proper interpretation of [these] provisions has a significant impact on the operation of the BPCIA and the ability of aBLA applicants promptly to bring their biosimilars to the public”).

In Amgen v. Sandoz, the Federal Circuit held:

  • with respect to § 262(l)(2)(A), an applicant can elect not to disclose a copy of the biosimilar application and information about the product’s manufacturing processes, subject only to patent-litigation consequences specified in the BPCIA; and
  • with respect to § 262(l)(8)(A), an applicant can only provide 180-day advance notice of the date of first commercial marketing under § 262(l)(8)(A) only after FDA approval and that pre-approval notice is ineffective.

The Federal Circuit also imposed an injunction to enforce the notice requirement of  § 262(l)(8)(A).  Sandoz petitioned for cert on February 16, 2016 and Amgen conditionally cross-petitioned on March 21, 2016.

The SG sided with Sandoz across the board, disagreeing with the Federal Circuit’s interpretation of § 262(l)(8)(A) and agreeing with the Federal Circuit’s interpretation of § 262(l)(2)(A).  In particular, the brief stated that:

  • notice of commercial marketing before FDA approval is consistent with § 262(l)(8)(A);
  • injunctive relief is not available for a failure to furnish notice under § 262(l)(8)(A) because nothing in the BPCIA creates a cause of action to enforce the notice provision; and
  • if an applicant fails to provide information under § 262(l)(2)(A), a sponsor’s recourse is to commence a patent-infringement action.

First, the SG states that the text and purpose of § 262(l)(8)(A) permits the applicant to give advance notice of commercial marketing before the FDA has licensed the biosimilar.  Also, if a sponsor is provided notice at the outset under § 262(l)(2), the applicant will no longer be able to control the pace and scope of the patent litigation because the sponsor may immediately bring suit on the relevant patents.  Second, the SG states that a private cause of action for patent infringement does not provide for enforcement of § 262(l)(2)(A) because while Congress did specify the availability of injunctive relief for a violation of confidentiality rules in § 262(l)(1), Congress only provided for infringement actions in § 262(l)(2)(A).  As the SG stated in its amicus brief, the interpretation of these provisions will have a significant impact on the BPCIA’s operation and when applicants can bring their biosimilar products to the market.

As we posted earlier this week, Amgen’s supplemental brief in response will be due December 21.  The Court will consider the petition at its private conference on January 6, and a cert grant could be announced as soon as that afternoon.  The Acting Solicitor General’s recommendation that the Court grant cert is a very strong indicator that the Court will grant the petition and cross-petition.  The case is expected to be briefed in early 2017, argued in April, and decided by the end of June.

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