It’s complicated Part 1: Amgen v. Sandoz

In Amgen v Sandoz, 582 U.S. ___ (2017) the U.S. Supreme Court [hereinafter the Court] held that an applicant need not disclose certain technical information to another company under the federal abbreviated drug approval   process. See 42 U.SC. sections 262(k) and 262(l).  The Court also held that an injunction is not available to enforce compliance with this specific federal disclosure requirement. [1] Under this abbreviated process an applicant may obtain a license for commercial marketing of its pharmaceutical product, if its pharmaceutical is (i) derived from living organisms and (ii) sufficiently similar to a licensed pharmaceutical that had undergone the traditional approval process. The traditional process requires numerous clinical tests and other technical data by a ‘sponsor,’ so there is a strong incentive for an applicant to ‘piggyback’ on the sponsor’s submissions under the abbreviated process. Also during the abbreviated process, the two companies may determine whether the sponsor’s patents would be infringed prior to the applicant’s pharmaceutical’s manufactured and sales.  The statute expressly provides a remedy of an immediate declaratory judgment to the sponsor if the applicant does not disclose its FDA licensing application and manufacturing information to the sponsor.

In the instant case, Amgen was the sponsor with a traditionally licensed protein to stimulate white blood cell production. Sandoz submitted an abbreviated approval application for a biosimilar product, but it refused to disclose its application or manufacturing information to Amgen. Thereafter Amgen filed a lawsuit against Sandoz for patent infringement, conversion and unfair competition, but the trial court dismissed these counts. The U.S. Court of Appeals for the Federal Circuit [hereinafter the Federal Circuit]  affirmed and held that Sandoz need not disclose the licensing application or manufacturing information to Amgen. It also held that there was no injunction available for compliance with this particular disclosure.

Before the Court, Amgen contended in part that the term “shall” of the statute conclusively demonstrates that disclosure of a licensing application and manufacturing information is mandatory. Amgen also contended that merely because the statute did not expressly include an injunction as a remedy did not preclude its use. However, Sandoz contended that non-disclosure was simply a conditional precedent that results in forfeiture of litigation rights to the sponsor. Sandoz further stated that injunctions were not explicitly included as a remedy for this non-disclosure, whereas in other statutory provisions an injunction was included as a remedy.

The Court agreed with Sandoz on both these points. However, it also concluded that although an injunction was not an option under the federal statute, it may be a remedy under the state law count of unfair competition. The Court then remanded the case to the Federal Circuit to determine whether Sandoz’s non-disclosure constitutes unfair competition under state law, and it so whether an injunction was possible.

© 2017 Adrienne B. Naumann, Esq. Ms. Naumann does not endorse or sponsor the advertisements at adriennebnaumann@wordpress.com

[1] Another issue before the Court was whether the applicant may provide the notice of initial commercial marketing to the sponsor prior to FDA licensing. The Court reversed the Federal Circuit which had previously held that notice must be provided only after the applicant actually receives its license. Instead the Court squarely held that notice may be  provided either before or after actual receipt of the license.

 

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