The Evanescent Experimental Use Exemption from United States Patent Infringement Liability: Implications for University and Nonprofit Research and Development
64 Pages Posted: 14 Apr 2005
In marked contrast with all leading foreign patent law regimes, no statutory provision in the U.S. Patent Act provides a general exemption from infringement liability for unlicensed use of patented inventions in contexts such as scholarly research and scientific experimentation. Early U.S. judicial decisions spoke approvingly of a common law-based doctrine that would exempt unlicensed uses of patented technology for purposes of scientific experimentation or purely personal use. More recently, the U.S. Court of Appeals for the Federal Circuit, which since 1982 has exercised exclusive nationwide jurisdiction over patent-based appeals, has also recognized the experimental use exemption. The court interprets the exemption so narrowly, however, that for all practical purposes it has become a nullity. In Madey v. Duke University (2002) and Integra Lifesciences I, Ltd. v. Merck KgaA (2003), the Federal Circuit severely constrained the already limited reach of the experimental use doctrine. The court in Madey mapped an exceedingly limited role for the experimental use defense through a distorted application of the "legitimate business" criterion of Pitcairn v. United States (Ct. Cl. 1976) to basic research conducted by university researchers. By narrowly construing the issues on appeal, the panel majority in Integra ducked the important questions raised by the Integra dissent's strong defense of the experimental use doctrine. Despite the Federal Circuit's seeming discomfort with the experimental use exemption, a narrowly defined but practically meaningful experimental use exemption is long overdue for the U.S. patent system. Without such an exemption, scientific research functions that require the use of patented inventions are more likely to be shifted offshore to legally hospitable forums. The patent system's goal of technology dissemination must, of course, be balanced against the incentivizing function of patents. An experimental use exemption, like any incursion on the exclusivity of the patent owner's right to exclude others from her invention, must therefore be carefully defined and judiciously applied so as not to significantly compromise incentives for innovation. This Article calls for the congressional enactment of a limited but balanced experimental use exemption in patent law, just as Congress did in enacting the Copyright Act's fair use provision in 1976. The Article proposes and applies a set of factors for inclusion in a legislative codification of the experimental use exemption.
Keywords: experimental use, research exception, research exemption, patent, infringement, defenses, intellectual property, university, nonprofit
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