In Search of a Compromised Solution to the Problem Arising from Patenting Biomedical Research Tools

Patents are acknowledged to be of central importance in the area of biomedical research and development. (1) 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. (2) The concern of these critics is that patents on research tools may block future biomedical research and development. (3) 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. [sections] 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. (4) 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, (5) when he found that the experimental use exception in [sections] 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. I. WHAT ARE BIOMEDICAL RESEARCH TOOLS AND HOW MIGHT THEY BE USED There are a broad range of materials that might be termed "research tools" because they can be used in the course of biomedical or biotechnological research. For example, research tools might include biochemicals, such as reagents, plasmids, antibodies and enzymes that are used to develop and test subsequent pharmaceutical end products. (6) Generally speaking, these products are used to test the efficacy or functionality of a pharmaceutical end product in a preclinical setting. It is conceivable that such research tools might also be used to produce or identify a pharmaceutical end product. Normally, such research tools would not become part of the final product, although it is possible that they may do so. Another type of research tool is a device that can be used and reused during the course of biomedical research, and often operates based on a particular methodology. Devices that run the Polymerase Chain Reaction (PCR), a technique widely used to amplify small amounts of DNA, are an example. (7) Other examples of such devices are protein and DNA sequencing instruments, (8) and microarrays (9) which allow a downstream researcher to study a great number of biological interactions at the same time, and knockout mice which provide a disease model. (10) As one can imagine, various combinations of research tools may be used when a new drug is researched, developed and tested. …