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Rambus Redux? - Standards, Patents, and Non-Disclosure in the Pharmaceutical Sector (Momenta v Amphastar)

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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 enforcement of the patent. The alleged infringer also brought antitrust claims against the SEP holder, alleging monopolization in violation of the Sherman Act. The case is interesting because it raises issues that were seemingly settled in the information and communication technology (ICT) sector a decade ago, but in the new setting of pharmaceuticals manufacturing. As such, it may give courts an unexpected opportunity to revisit the DC Circuit’s controversial decision in Rambus v. FTC (D.C. Cir. 2008), which found no antitrust liability for an allegedly deceptive failure to disclose SEPs to an SDO.

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