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Is Biopharma Ready For The Standards Wars?, Jorge L. Contreras Apr 2020

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 …


Mandated Disclosure In Literary Hybrid Speech, Zahr K. Said Jan 2013

Mandated Disclosure In Literary Hybrid Speech, Zahr K. Said

Articles

This Article, written for the Washington Law Review’s 2013 Symposium, The Disclosure Crisis, argues that hidden sponsorship creates a form of non-actionable influence rather than causing legally cognizable deception that mandatory disclosure can and should cure.

The Article identifies and calls into question three widely held assumptions underpinning much of the regulation of embedded advertising, or hidden sponsorship, in artistic communications. The first assumption is that advertising can be meaningfully discerned and separated from communicative content for the purposes of mandating disclosure, even when such advertising occurs in “hybrid speech.” The second assumption is that the hidden promotional aspects …