Merck v. Integra
Integra sued Merck for patent infringement for using several of Integra's "RGD peptide" patents in the course of identifying promising new drugs. Integra had offered Merck licenses on the patents but Merck had declined. At trial, Merck asserted that its use of the patents was protected by 35 U.S.C. ยง 271(e)(1), the so called "safe harbor" provision of the patent statute, which protects the use of genetic patents in work that is "reasonably related" to the development and submission of data to the Food and Drug Administration (FDA). Following a jury trial, the district court ruled that Merck infringed Integra's patents and that the safe harbor provision did not immunize Merck against liability. The Court of Appeals for the Federal Circuit affirmed, construing the safe harbor provision narrowly. To qualify for the exemption, the otherwise infringing activity must directly produce information for submission to the FDA's safety and effectiveness approval processes. In this case, Merck was not performing clinical tests to supply information to the FDA, but only general biomedical research to identify new pharmaceutical compounds. The FDA has no interest in the hunt for drugs that may or may not later undergo clinical testing for FDA approval. Thus, Merck's work was not "solely for uses reasonably related" to clinical testing for the FDA.
Question Presented:
To encourage development and expedite introduction of pharmaceuticals, Congress amended the patent laws in 1984 to insulate drug research from charges of
infringement so long as the research is "reasonably related to the development and submission of information" to the Food and Drug Administration. Did the Federal Circuit err in concluding that
this drug-research safe harbor does not protect animal studies of the sort that are essential to the development of new drugs, where the research will be presented to the FDA, and where barring the
research until expiration of the patent could mean years of delay in the availability of life-saving new drugs?
