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ARTICLE · 13 MAY 2004

Integra v Merck: Is There A Safe Harbor For Research

Intellectual property lawyers frequently encounter scientists who believe their work cannot infringe another’s patent because they only do "research".

United StatesGovernment, Public Sector
Cathryn Campbell, Ph.D.
Cathryn Campbell, Ph.D.
Mauricio Flores
Mauricio Flores
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Intellectual property lawyers frequently encounter scientists who believe their work cannot infringe another’s patent because they only do "research." This position is contrary to the statutory definition of infringement, which specifically includes making and using a patented invention within the definition of infringing acts.1 There are only two potential exceptions for research: the common-law "Experimental Use Exception" and the statutory "U.S. Food and Drug Administration (FDA) Exemption."2 Both are circumscribed in their applicability, however, and recent case law has further limited their application.

The common law Experimental Use Exception derives from the 19th century case of Wittamore v. Cutter, which stated that "it could not have been the intention of the legislature to punish a man" who constructed a patented device "merely for philosophical experiments."3 Recently, the U.S. Court of Appeals for the Federal Circuit, in Madey v. Duke University,4 considered the

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