Decision Gives "Wide Berth" to Use of Patented Compounds in Pre-Clinical Research

Life sciences-related companies have been given more freedom to use patented compounds in pre-clinical research. On June 13, 2005, the U.S. Supreme Court decided Merck KGaA v. Integra Lifesciences I, Ltd., 2005 WL 1383624, holding that the "safe harbor" provision of 35 U.S.C. 271(e)(1) protects the otherwise infringing use of another's patented compounds in pre-clinical research. As long as there is a "reasonable basis for believing" that research using patented compounds will produce information relevant to FDA submissions, especially Investigational New Drug Applications or New Drug Applications, there is no liability for using patented compounds.

The Supreme Court stated that the statutory safe harbor provision in question "provides wide berth for the use of patented drugs in activities related to the federal regulatory process." 2005 WL 1383624 *6. This includes not only pre-clinical studies relating to drug safety in humans, but also pre-clinical studies relating to the efficacy, mechanism of action, pharmacokinetics, and pharmacology of a particular drug. The Court also made clear that the safe harbor provision may still apply to otherwise infringing use of patented compounds even if the results of the studies involving the compounds ultimately are not submitted to the FDA or the studies involve drugs that ultimately are not the focus of an FDA submission. The true focus of the analysis is whether there is a reasonable basis to believe that the research will produce the types of information relevant to FDA submissions.

It is important to note that Merck v. Integra does not support an automatic "exemption" for every use of patented compounds in research. While the practical effects of this decision have yet to unfold, the Court's opinion clarified somewhat the boundaries of 35 U.S.C. 271(e)(1)'s safe harbor provision.