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Abstract

The saga surrounding the Integra v. Merck cases has rekindled a heated debate about the proper scope of both common law exemption and the safe harbor provision, causing significant concern for owners of research tool patents. This Article will argue that the next judicial decision addressing the question of research tool patents should clarify that they are in a safe harbor because none of the two exemptions from infringement referenced above extends to the use of research tools in experiments in order to preserve the necessary incentives for their creation in the first place. Allowing access to research tools under any of the exemptions--though arguably having a positive short term effect--would endanger the development of sufficient innovative research technologies which may have a greater negative impact on the pace of biotechnological research than an occasional lack of access to needed resources. This Article consists of nine sections. Section I will provide an introduction to the most relevant theoretical justifications of the patent system. Section II will give an overview of the development in the biotechnology sector with its competing interests. Section III will define research tools. Section IV will analyze the blocking effect of patents in the biotechnology sector. Section V will argue for a broadened common law experimental use exemption to alleviate some of the concerns among academic researchers by exempting from infringements experimentation on patented inventions. Section VI will provide an analysis of the yet unclear scope of the safe harbor provision of § 271(e)(1) with respect to research tools. Section VII will show why the use of research tools should neither be exempted under the common law exemption nor the safe harbor provision. Section VIII will address borderline cases where the distinction between "research on" and "research with" a patented research tool may arguably become blurred. Section IX will conclude with an outlook.

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