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Abstract

Congress enacted the Hatch-Waxman Act to address rising healthcare costs, while further encouraging pharmaceutical innovation.  The Act allows generic drug manufacturers to bypass the lengthy and costly FDA approval process by relying on FDA approved brand name pharmaceuticals.  As a result, brand name pharmaceutical manufacturers have engaged in certain acts, such as reverse payment settlements, to maintain market control pursuant to their exclusive patent rights.  Therefore, this Act has resulted in a clash between brand name and generic pharmaceutical companies, which is harming consumers and implicating anti-trust concerns.  Accordingly, this Comment proposes that Congress enact legislation, so that pharmaceutical patents—as for design and plant patents—will have their own set of rules to address all the current issues surrounding the pharmaceutical patents.

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