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KMID : 1142220140090020063
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Regulatory Research on Food, Drug & Cosmetic
2014 Volume.9 No. 2 p.63 ~ p.70
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Understanding the Hatch-Waxman Act: Overview of the Statutory and Regulatory Scheme
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Choe So-Heui
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Abstract
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The Hatch-Waxman Act was enacted to (1) facilitate and streamline the process of low-cost genetic entry into a market, and (2) to induce the development of pioneering innovator drug and the patent protection. First, the Hatch-Waxman Act authorizes the establishment of the Abbreviated New Drug Application (ANDA) and simplifies the ANDA requirements for FDA approval. Thus, the genetic company is permitted to rely on the safety and efficacy testing data of the new drug application and is not required to submit the preclinical and clinical testing data in the ANDA. Further, the Hatch-Waxman Act codifies the “safe harbor” provision that the genetic company is immune from the infringement for all uses of the patented invention to prepare the testing data for FDA drug approval process. Second, the Hatch-Waxman Act provides the extension of the term of a patent covering the NDA invention for the innovator drug company to make up for patent life lost during the lengthy FDA approval process. The Hatch-Waxman Act also creates a set of the market exclusivity and data exclusivity to incentivize the innovator drug company. The Hatch-Waxman establishes the framework for patent challenges
and patent litigation procedure between the genetic drug company and the innovator drug company, which are distinct from the other patent infringement disputes. This paper is intended to present the statutory and regulatory scheme of the Hatch-Waxman Act relevant to drug approval-patent linkage and provide the understanding of the Hatch-Waxman Act.
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KEYWORD
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Hatch-Waxman Act, Genetic, New drug, Drug approval-patent linkage
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