Exclusionary Strategies in the Hatch-Waxman Context
51 Pages Posted: 7 Jul 2009 Last revised: 28 Dec 2013
Date Written: July 5, 2009
Abstract
The intersection of patent and antitrust law has rarely been witness to a more protracted tension than that which currently resides in the pharmaceutical industry. Given the great societal need for access to affordable drugs, Congress sought to simultaneously encourage generic entry into patent-protected pharmaceutical markets, while financially rewarding those incumbents that first developed the relevant drugs. The ensuing Hatch-Waxman Act sought to balance these diametrically-opposed objectives and, in so doing, created a somewhat arcane, interwoven, and complex regulatory structure. It is within this framework that incumbent brand-name manufacturers and potential generic drug producers now operate. Given the axiomatic desire of drug companies to maximize their profits, it is unsurprising that brand-name pharmaceutical corporations have gone to some length to strategically manipulate the statutory structure to their advantage. A number of exclusionary tactics have emerged, pursuant to which incumbent drug producers have sought to discourage or even foreclose generic entry. This Article analyzes the various exclusionary phenomena that have emerged, and suggests optimal legal rules for addressing them.
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