Navigating the research exemption's safe harbor: Supreme Court to clarify scope--implications for stem cell research in California

In January 2005, the Supreme Court agreed to review the Federal Circuit's holding in Integra LifeSciences I, Ltd. v. Merck KGaA. The decision, largely seen as a victory for research tool patentees in the biotechnology sector, would if affirmed, promote cross-licensing between universities and industry, as well as discourage misappropriation of unlicensed patented tools. Pharmaceutical manufacturers argue that the decision is a limitation on drug development activities that could potentially benefit human health, and that restricting the use of tool patents in biomedical research could mean years of delay in the availability of new, life-saving drugs. The underpinnings of the Integra ruling involve federally enacted, 35 U.S.C. paragraph 271(e)(l). To encourage development and expedite the introduction of pharmaceuticals into the marketplace, Congress amended the patent laws in 1984 to insulate drug research from charges of infringement so long as such research is solely for uses reasonably related to the development and submission of information to the Food and Drug Administration (FDA). The statute renders activities that would otherwise constitute patent infringement noninfringing if they are undertaken for the purpose of developing and submitting to the FDA information necessary to obtain marketing approval for a new chemical entity, a medical device, or a food additive. Hence, the statute benefits competitors of a patentee by freeing them of liability for development work reasonably related to securing regulatory approval.