Is Biopharma Ready for the Standards Wars?
38 Pages Posted: 1 Apr 2020 Last revised: 11 Feb 2021
Date Written: March 7, 2020
This symposium contribution sheds new light on Momenta v. Amphastar, a recent federal 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 infringement based on its use of that testing method, Amphastar raised defenses of waiver and equitable estoppel, then brought antitrust claims against Momenta and its distribution partner Sandoz. Amphastar prevailed at the district court on all three theories, 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.
Keywords: biologic, generic, patent, standards, USP, enoxaparin, deception, Qualcomm
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