Is Biopharma Ready for the Standard Wars?

Abstract

This symposium contribution sheds new light on Momenta v. Amphastar, a case in which issues relating to standardization and patent disclosure that have previously been observed in the semiconductor, computing, and telecommunications sectors found their way into a dispute between two biosimilar manufacturers. One such manufacturer, Momenta, participated in the development of a standard for testing the purity of generic enoxaparin under the auspices of the United States Pharmacopeial Convention but failed to disclose that it had applied for a patent on the testing method. When Momenta later sued Amphastar for patent infringement by using the method in accordance with the FDA’s approval of its own generic version of enoxaparin, Amphastar raised waiver and equitable estoppel as defenses, then brought antitrust claims against Momenta and its distribution partner Sandoz. Amphastar prevailed at the district court, obtaining a ruling that Momenta’s patent was unenforceable. This case demonstrates that issues surrounding the acquisition and disclosure of patents on standardized technologies have more salience in the biopharma sector than commonly believed. As such, standards organizations operating in this sector should ensure that their policies and procedures are robust enough to delineate clearly the obligations of participants with respect to patents covering standardized technologies, and organizations that participate in biopharma standards-development should heed the valuable lessons offered by more than three decades of litigation and policy making in the technology sector.