Abstract

     Patents are acknowledged to be of central importance in the area of biomedical research and development. At the same time, however, many commentators have expressed concern about there being too much patenting in this area, particularly in the area of biomedical research tools. The concern of these critics is that patents on research tools may block future biomedical research and development. This paper argues that, while patenting of such tools is desirable and thus should not be obliterated, some legal limitations on the ability of patent owners to enforce their biomedical research tool patents should exist. That is, certain users and uses of research tools should be exempted from patent infringement and limits should be imposed on amounts and types of royalties that a patent owner can collect from their research tool patents.
     Part I of this paper is devoted to defining the term ‘biomedical research tool” and what it encompasses, as well as exploring how such tools might be used. In Part II, we develop an understanding of the problem associated with the patenting of biomedical research tools. In this context, we trace what essentially is the demise of the common law experimental use exception, and how this development has contributed to the urgency of the research tools problem. Part III considers the link between the statutory experimental use exception  pursuant to 35 U.S.C. § 271(e)(1) and biomedical research tools. Section 271(e)(1) originally was intended to benefit generic pharmaceutical companies who manufacture “copycat” drugs based on original, patented drugs. That is, this exception was intended to give these companies a safe harbor from infringing the original drug’s patent while they conducted the necessary experiments to obtain FDA approval on their copycat drug. However, both U.S. courts and the many players in the biomedical research community have interpreted the provision much more broadly. Recently, Judge Rader deviated sharply from this broad interpretive approach in Integra Lifesciences I, Ltd. v. Merck KGaA, when he found that the experimental use exception in § 271(e)(1) cannot be extended to render non-infringing a company’s otherwise infringing use of a patented research tool. Part III explores the effects of this decision on the patent problem relating to biomedical research tool patents. Finally, Part IV proposes a solution for addressing the problem arising from patents on biomedical research tools.