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Rambus Redux? – Standards, Patents And Non-Disclosure In The Pharmaceutical Sector (Momenta V. Amphastar), Jorge L. Contreras
Rambus Redux? – Standards, Patents And Non-Disclosure In The Pharmaceutical Sector (Momenta V. Amphastar), Jorge L. Contreras
Utah Law Faculty Scholarship
Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. (D.Mass 2) involves the alleged deception of a standards-development organization (SDO) by the holder of a patent essential to a standard relating to the manufacture of the drug enoxaparin. The SDO's rules regarding disclosure of standards-essential patents (SEPs) were found to be ambiguous, yet, as in Qualcomm v. Broadcom (Fed. Cir. 2008), the district court held that participant expectations created an affirmative obligation to disclose SEPs. Following the SEP holder's assertion of the undisclosed patent against a competing generic manufacturer of enoxaparin, the alleged infringer successfully raised defenses of waiver and estoppel against …