Written by Robert J. Hilton, Ph.D. and Jing Liu, Ph.D.

On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. f. 3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 f. 3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the Federal Circuit’s interpretation of certain provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

BPCIA

The BPCIA provides for an expedited process for licensing biosimilar versions of licensed biologic products. Two specific provisions of the BPCIA are at issue in this litigation. First, the BPCIA provides that the applicant “shall provide to the reference product sponsor a copy of the application submitted . . . and such other information that describes the process or processes used to manufacture the biological product.” 42 U.S.C. § 262(l)(2)(A). Second, the BPCIA 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).” 42 U.S.C. § 262(l)(8)(A).

Under the BPCIA, a biological product is a “virus, therapeutic serum, toxin antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product applicable to the prevention, treatment, or cure of a disease or condition of human beings.” 42 U.S.C. § 262(i)(1). Biological products may be licensed by two routes: first, the FDA may license a biologic if the biologic has been demonstrated to be safe, pure, and potent; and second, an abbreviated biologic license application (aBLA) may be approved if the biologic at issue is shown to be a “biosimilar” to a previously approved biologic (reference product). The act of submitting an aBLA is an act of infringement if the purpose of the submission is to obtain approval to engage in the commercial manufacture, use, or sale of a biological product claimed in a patent.

The BPCIA outlines a detailed timeline for the applicant of the aBLA and the reference sponsor to resolve patent disputes. Under this process, the applicant “shall” grant the sponsor confidential access to the aBLA application and manufacturing information no later than 20 days after the FDA accepts the application. The parties then exchange lists of patents that they believe may be asserted, including their positions regarding infringement, validity, and enforceability. The applicant must also give notice of commercial marketing to the sponsor at least 180 days prior to “commercial marketing of its product.”

Amgen v. Sandoz

Amgen markets filgrastim under the trade name Neupogen, a medication for increasing neutrophil production. Amgen has marketed the drug since 1991. The product is claimed in U.S. Patent No. 6,162,427. In May 2014, Sandoz filed an aBLA for filgrastim. On July 7, 2014, Sandoz received a notification from the FDA that it had accepted its application. On July 8, 2014, Sandoz notified Amgen of the aBLA, and that it intended to launch its product immediately upon FDA approval, which it believed would be in quarter one or two of 2015. In October 2014, Amgen sued Sandoz in the Northern District of California, alleging that Sandoz violated the BPCIA by failing to disclose the required information under § 262(l)(2)(a). The district court held that Sandoz did not violate the provision, finding that the term “shall” did not signal a requirement and Sandoz gave an effective notice of marketing. Amgen appealed to the Federal Circuit. The Federal Circuit agreed with the district court on the interpretation of the term “shall” in the statute, and concluded that Sandoz effectively followed the provisions of the BPCIA regarding the notice of the aBLA. However, the Federal Circuit disagreed that Sandoz gave proper notice of marketing, holding that the applicant must wait for product approval by the FDA before it can supply a required 180-day advance notice of commercial marketing.

Both Amgen and Sandoz appealed to the Supreme Court, which has granted certiorari for the cross-petitions after the Solicitor General recommended granting certiorari and reversing the Federal Circuit’s holding regarding the 180-day notice of commercial marketing. The issues presented to the Court, and that the Court will address are: (1) whether a biosimilar applicant is required by 42 U.S.C. § 262(l)(2)(A) to provide the reference product sponsor with a copy of its biologics license application and related manufacturing information, which the statute says the applicant “shall provide;” and

(2) whether, where an applicant fails to provide that required information, the sponsor's sole recourse is to commence a declaratory judgment action under 42 U.S.C. § 262(l)(9)(C) and/or a patent-infringement action under 35 U.S.C. § 271(e)(2)(C)(ii). CVSG: 12/07/2016.