Law Commons^™

Is Biopharma Ready For The Standards Wars?, Jorge L. Contreras

Utah Law Faculty Scholarship

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 …