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Abstract

Support for new drug development has taken some interesting turns in current patent law jurisprudence. Beginning with the severe curtailment of scope of the common law experimental use doctrine in Madey v. Duke University, and culminating with the recent Supreme Court decision in Merck KGaA v. Integra Lifesciences I, Ltd., broadening the scope of the statutory research exemption, the freedom to conduct experimental research using another's patented inventions becomes dependent in part on the purpose of the research. That the patent at issue in Merck was characterized by the Federal Circuit as being directed to a research tool raised the question of the extent of protection that should be afforded to such inventions. In other words, as new drug development necessarily involves some degree of exploratory research, research tools are often employed to facilitate the search for new drugs. Consequently, patents on such inventions provide an interesting anomaly to the innovation incentive argument for patent rights. The question of whether patents on research tools retard rather than enhance innovation have been discussed at length without any clear conclusion. Interestingly, the patent code, which in its present form was promulgated in large part through heavy lobbying by the pharmaceutical companies, now serves as a sword of Damocles hanging over these companies' research activities using patented research tools. The environment for drug development by large pharmaceutical companies is changing. Previously chemistry dictated new development by defining new structures or active isomers of chemical compounds. The focus has now shifted to biology as targeted treatments are taking the forefront in drug development. The shift can be credited in large part to the success of the Human Genome project, which served to redefine medical research by fusing biological systems with advances in information technology. Pharmacogenomics, as it is termed, describes the science behind targeted pharmaceuticals, which serves as a novel business model for the pharmaceutical industry[...] Targeted treatments could be the next generation of "blockbuster pharmaceuticals" the industry has been waiting for, in that it will shift the focus from traditional blockbuster one-for-all medications to more selective products. However, much of the success of these drugs depends on the discovery and validation of new targets using existing and developing research tools. One noteworthy example of the importance of research tools in developing targeted treatments is the discovery of gene slicing by RNA interference (RNAi), which offers a promising possibility for treating AIDS and other diseases. The FDA also jumped on the bandwagon criticizing the disparity between advances in the understanding of diseases and the dearth of new pharmaceutical products. As a result, the clinical diagnostics business will play an important role in developing targeted treatments. Moreover, legislation facilitating overt and explicit contact between scientific discovery and product development has created changes that has led many commentators, both critics and advocates, to agree that there is something significant occurring. The scientific lab is now directly linked with commercial outlets through a systematic infrastructure of the venture capital market, the insurgence of biotechnology start up companies, and the convergence of university and industry. Due to the complexity of pharmacogenomics, access to many proprietary research tools is necessary to conduct research in this field. Thus the significance of the availability of research tools becomes apparent. However, broad patents on upstream products arguably adversely affect innovation in this area. This article will address the limitations on the use of research tools and propose a means to ensure its continued accessibility to promote innovation in pharmacogenomics. Part I will address the development of biotechnology in the United States and the legislation that has helped spur innovation in the field. Part II will discuss the arguments put forth in support of open science and the legal issues surrounding access to patented tools for research purposes. Part III will discuss the current literature on research tools, including the economics and legal policies relating to patents on research tools and alternatives to patenting. Finally, Part IV will propose a policy incorporating licenses of right to ensure continued accessibility of patented research tools developed using NIH funding.

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