American Journal of Law & Medicine

Declining to Immunize Prior Anticompetitive Acts, First Circuit Limits Application of Noerr-Pennington Doctrine

A recent decision by the First Circuit may mark a changing tide for pharmaceutical firms that have grown reliant on the immunity granted under the Noerr-Pennington doctrine. (1) In modern antitrust enforcement actions, the Noerr-Pennington doctrine is frequently employed by brand-name pharmaceutical firms to shield their anticompetitive actions against generic competitors from antitrust liability. (2) Based in First Amendment protections, the doctrine immunizes a defendant company from antitrust liability when it attempts to influence government officials to adopt laws or policies that may have anticompetitive consequences. (3) Efforts to obstruct generic competitors from diluting a branded drug's market share are often employed as part of "product life-cycle management" (4) schemes, which have come under sharp criticism for allowing firms to keep drug prices artificially high in the absence of competition. (5)

In Amphastar Pharmaceuticals, Inc. v. Momenta Pharmaceuticals, Inc., the First Circuit reversed the dismissal of Amphastar Pharmaceuticals Inc.'s complaint alleging that defendant Momenta Pharmaceuticals engaged in a series of anticompetitive acts to frustrate Amphastar's efforts to market a generic form of the anticoagulant drug enoxaparin. (6) Momenta's alleged course of anticompetitive conduct began in 2009, when the Food & Drug Administration (FDA) adopted a required testing standard for enoxaparin. At the time the testing requirements were being proposed, Momenta failed to disclose to an independent standard-setting organization that the proposed testing method may have been covered by Momenta's pending patent application. (7) Once the FDA adopted the requirement, Momenta was able to assert its patent rights against competitors such as Amphastar who would need to use the method to obtain FDA approval for its generic enoxaparin. (8) In a suit for patent infringement, Momenta obtained a court order to enjoin Amphastar from marketing Amphastar's generic product. (9) Amphastar later sought damages from Momenta to recover lost profits during the injunction period, claiming that Momenta's conduct constituted a violation of federal antitrust laws. (10) The district court, finding that Amphastar's injury was a result of the FDA's adoption of the testing requirements, dismissed the suit under the Noerr-Pennington doctrine. …

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