Safe Harbor for Preclinical Use of Patented Inventions in Drug Research and Development: Merck KGaA v. Integra Lifesciences I, Ltd.
Publication Date: October 2005
Publisher(s): Library of Congress. Congressional Research Service
In Merck KGaA v. Integra Lifesciences I, Ltd., __ U.S. __, 125 S. Ct. 2372 (2005), the United States Supreme Court unanimously held that the preclinical use of patented inventions in drug research is exempted from patent infringement claims by the "safe harbor" provision of the Patent Act, 35 U.S.C. Section 271(e)(1). (Merck KGaA is a German company unaffiliated with the U.S.-based pharmaceutical company Merck & Co.) This decision potentially may help expedite the development of new medical treatments and lower the cost of some drugs for consumers.
In 2003, the U.S. Court of Appeals for the Federal Circuit had narrowly construed the safe harbor provision as protecting only clinical research activities that produce information for submission to the Food and Drug Administration (FDA) in the regulatory process. In vacating that decision, the U.S. Supreme Court ruled that the exemption applies to all uses of patented inventions that are "reasonably related" to the process of developing any information for FDA submission. The Court explained that, under certain conditions, the safe harbor provision is even "sufficiently broad" to protect the use of patented compounds in experiments that are not ultimately submitted to the FDA or drug experiments that are not ultimately the subject of an FDA submission. Finally, the scope of the exemption is not limited only to preclinical studies pertaining to a drug's safety in humans, but also includes preclinical data regarding a drug's efficacy, mechanism of action, pharmacokinetics, and pharmacology.
However, the Court cautioned that the exemption does not reach all experimental activity that at some point, however attenuated, may lead to an FDA approval process. For example, the safe harbor provision does not embrace basic scientific research performed on a patented compound without the intent to develop a particular drug or without a reasonable belief that the compound will cause a particular physiological effect that the researcher desires. In addition, because the matter was not at issue in the case, the Court expressly declined to decide whether or to what extent the exemption applies to patented "research tools" that are often used to facilitate general research in developing compounds for FDA submissions.