When Does Sharing Make Sense?: Antitrust & Risk Evaluation and Mitigation Strategies
CPI Antitrust Chronicle, Vol. 4, No. 2, April 2014
7 Pages Posted: 1 May 2014
Date Written: April 29, 2014
There exists a new front in the battle to define the circumstances under which a monopolist’s refusal to deal with a rival constitutes exclusionary conduct that violates Section 2 of the Sherman Act. The latest clash arises in the context of a brand-name drug manufacturer’s decision not to sell samples of a patented drug that is subject to certain government-mandated restricted distribution protocols to a potential generic rival seeking to use those samples to conduct bioequivalence testing necessary to develop a generic version of the product. Without access to these samples, the generic firm may be unable to sell a generic version of the drug to consumers at a significantly lower price than the branded product. Against the compelling backdrop of a health care system afflicted by rapidly rising costs, some now argue that the antitrust laws should be used to force brand-name drug companies to share samples of their products with generic rivals to further competition and reduce the cost of prescription drugs. Although ambiguity remains about the exact contours of “refusal-to-deal” law in the United States, it is unlikely for several reasons that this potential problem can or should be remedied through the blunt instrument of the antitrust laws.
Keywords: Antitrust, Competition, Risk Evaluation and Mitigation Strategies, REMS, Refusal to Deal, Trinko, Aspen Skiing, Hatch-Waxman
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