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Expert Analysis

Post-Merck Debate Over Research Exemption For Infringement

Law360, New York (April 11, 2013, 12:44 PM EDT) -- Patent protection is a critical driver of value for the biotech industry. One of the unique aspects of biotech patents, however, is that many otherwise infringing activities are exempt from claims of patent infringement when those activities are "reasonably related to the development and submission of information" to the U.S. Food and Drug Administration.[1] The scope of this exemption has been hotly contested since the passage of the Hatch-Waxman Act in 1985.[2]...

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