Are Patented Research Tools Still Valuable? Use, Intent, and a Rebuttable Presumption: A Proposed Modification for Analyzing the Exemption from Patent Infringement under 35 USC 271 (E) (1)


Vihar R. Patel


Briefly, the article proposes to have courts focus on the nature of an individual's use and apply the "UART" (Use As a Research Tool) factors to determine if a patented invention is being used as a research tool. If a patented invention is being used as a research tool, then the court is to presume that the activities are not covered by the FDA exemption. However, this presumption can be rebutted by a researcher's demonstration of the research tool owner using his patent to block efforts to develop a competing product. If the presumption is rebutted, then the court applies the current version of the FDA exemption analysis to determine, if a researcher's use of the patentee's invention is reasonably related to FDA approval. The paper also proposes allocations of burdens of production and proof to help the court balance competing interests and apply the FDA exemption to research tools. This is a brief summary of the attached paper.


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Date of this Version

July 2006