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)

摘要

Briefly, the article proposes to have courts focus on the nature of an individualu27s use and apply the u22UARTu22 (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 researcheru27s 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 researcheru27s use of the patenteeu27s 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.