Research Tool Patents after Integra v. Merck - Have They Reached a Safe Harbor?

Abstract

Biotechnology has become one of the key technologies of the 21st century. The rapid evolution of biomedical research has raised expectations of finding ever better treatment to an increased number of illnesses. Due to the complexity of biomedical research, researchers need access to numerous resources for their projects. Concerns have been expressed that increased patenting of upstream inventions, especially of research tools, has led to a situation of blocking patents and impairs research and development of new or better therapeutic products. Consequently, different ways to facilitate access to the necessary inputs have been proposed in response. The paper discusses the adequate scope of both common law experimental use exemption and of the safe harbor provision §271(e)(1), especially with regard to research tools, a discussion rekindled by the Integra v. Merck saga and causing significant concern for owners of research tool patents. Analyzing U.S. and European statutory law and practice, obligations imposed by international treaties, and especially the rationale of the patent system, this paper will argue that - to preserve the necessary incentives for the creation of research tools - the next judicial decision should clarify that neither of the two exemptions from infringement extends to the use of research tools in experiments. Allowing access to research tools under any of the exemptions - though arguably having a positive short term effect - would endanger the development of sufficient (and needed) innovative research technologies which may have a greater negative impact on the pace of biotechnological research than occasional lack of access to a needed resource.

Keywords: biotechnology, patent, infringement, defences, experimental use, research exception, research exemption, intellectual property, innovation, research tool

JEL Classification: K11, K20, O31, O33, O34