Big Molecule Watch
September 9, 2015

Amgen v. Sandoz: Final Round of En Banc Briefing Has Been Filed, Vote Expected Soon

In their reply briefs, Amgen and Sandoz further sharpened their arguments in opposition to the en banc review sought by the other.

Sandoz continued to emphasize that the text of the BPCIA and 35 U.S.C. § 271(e)(2)(c)(ii) support the panel majority’s holding that a biosimilar applicant may “opt out” of the patent dance by refusing to provide its biosimilar application. Sandoz reiterated that the remedy specified by the statutes—granting the patentee an option to bring an immediate patent infringement action—would be superfluous if the patentee could bring a suit to compel compliance with the dance. Sandoz also reiterated that the panel was correct to deny Amgen the right to force Sandoz to dance, since 35 U.S.C. § 271(e)(4) makes clear that it alone provides the remedies open to a patentee like Amgen for an act of infringement under § 271(e)(2)(c)(ii), and thus “the BPCIA expressly precludes state-law remedies as well as any implied federal remedy.

Sandoz also asserted that the panel’s position made eminent sense on policy grounds. According to Sandoz, the overall goal of the BPCIA is to resolve patent disputes quickly and efficiently so that “biosimilars can be available to patients as soon as possible.” A biosimilar applicant should have the choice to forego the “incentives” provided by the BPCIA to follow the dance, says Sandoz, where those incentives are outweighed by disadvantages, such as the delay necessitated by the dance, confidentiality concerns, or its belief that no relevant patents exist.

For its part, Amgen refined its arguments in support of the panel majority’s holding that, when a biosimilar applicant refuses to dance, the 180-day notice of commercial marketing may only be given after FDA has approved—“licensed”—the biosimilar. Amgen continued to emphasize the majority’s view that only upon licensure will the parties know the final composition and approved uses of the biosimilar, and thus only then will the patent dispute be sufficiently “crystallized” for a preliminary injunction motion. Amgen likened the 180-day notice period to the 30-month stay in Hatch-Waxman litigation, asserting that both periods “give the district courts time, and authority, to determine whether, on a motion for preliminary injunction, the status quo should be maintained until the outcome of patent litigation.”

We expect the Federal Circuit to vote on whether to grant en banc review shortly.  Stay tuned to Big Molecule Watch for continuing coverage and analysis.