United States: Patent Law and the Supreme Court: Patent Certiorari Petitions Granted (February 21, 2017)

Questions Presented:

In the Biologics Price Competition and Innovation Act of 2009 ("BPCIA"), Congress created an abbreviated regulatory pathway for the Food and Drug Administration ("FDA") to license "biosimilar" products—i.e., products that are "highly similar" to approved biological products. 42 U.S.C. § 262(i)(2). The BPCIA's "Notice of commercial marketing" provision states that a biosimilar applicant shall provide notice to the incumbent seller of the biological product "not later than 180 days before the date of the first commercial marketing of the biological product licensed under" this abbreviated pathway. Id. § 262(l)(8)(A) (emphasis added).

The Federal Circuit concluded that a biosimilar applicant "may only give effective notice of commercial marketing after the FDA has licensed its product." App., infra, 20a (emphasis added). As the dissenting judge recognized, the Federal Circuit turned this mere notice provision into a grant of 180 days of additional exclusivity for all biological products beyond the exclusivity period Congress expressly provided—delaying the launch of all future biosimilars by six months. The Federal Circuit transformed the notice provision into a stand-alone requirement unconnected to the patent resolution provisions of the BPCIA. It also disregarded the only remedy provided by Congress—the right to initiate patent litigation—and instead created its own extrastatutory injunctive remedy to bar the launch of FDA-approved biosimilars.

The questions presented are:

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 standalone requirement and creating an injunctive remedy that delays all biosimilars by 180 days after approval is improper.

Question Presented in Conditional Cross-Petition:

Respondents Amgen Inc. and Amgen Manufacturing Limited (together, "Amgen") have today filed a Conditional Cross-Petition for a writ of certiorari to review an aspect of the Federal Circuit's decision that involves the same patent-dispute-resolution regime. Amgen's Cross-Petition presents this question: Is an Applicant required by 42 U.S.C. § 262(l)(2)(A) to provide the Sponsor with a copy of its biologics license application and related manufacturing information, which the statute says the Applicant "shall provide," and, where an Applicant fails to provide that required information, is the Sponsor's sole recourse 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. § 27l(e)(2)(C)(ii)? (Cross-Pet. at i-iii.) For the reasons set forth below, the Court should deny Sandoz's Petition. If the Court does so, it should deny Amgen's Cross-Petition too. If, however, the Court grants Sandoz's Petition, it should consider both questions regarding the patent-resolution scheme of the BPCIA by granting Amgen's Conditional Cross-Petition as well.

Cert. petition filed 2/16/16, conditional cross-petition filed 3/21/16, conference 6/16/16, CVSG 6/20/16, conference 1/13/17, cert granted 1/13/17, set for argument 4/26/17.

Merits Briefs

• Brief for Petitioner

CAFC Opinion, CAFC Argument

WilmerHale represents respondent Amgen Inc.

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