Integra Lifesciences v. Merck KGaA, No. 2002-1052 (Fed. Cir. 2007)
Last Friday, the Court of Appeals for the Federal Circuit decided Integra v. Merck, on remand from the Supreme Court. Click here for the opinion. The case has important implications for owners of "research tools" patents.
In the mid-1990s, Integra sued Merck KGaA (the German company) and Scripps for infringing five patents relating to peptides that contain the RGD sequence of amino acids. This suite of patents included both patents directed to RGD-containing peptide compounds and patents directed to laboratory methods (i.e., research tools) using the RGD-containing peptides.
Merck and Scripps defended their conduct by relying on the FDA safe harbor of 35 USC § 271(e)(1), which precludes liability for activities "reasonably related to the development and submission of information under [the Food, Drug and Cosmetic Act]." The FDA safe-harbor was passed as part of the Hatch-Waxman Act to permit "a limited amount of testing so that generic manufacturers can establish the bioequivalency of a generic substitute." In this sense, the safe harbor encompasses activities that develop information that will normally find its way into an FDA submission.
At the original trial in the district court, Integra argued for a narrow reading of the FDA safe harbor in three respects. First, Integra argued that the safe harbor includes only studies on the safety of administration to humans, and does not include experiments on mode of action (i.e., ADME and PK studies). Second, Integra argued that the safe harbor excludes studies on related compounds that were not the subject of any FDA submission. Third, Integra argued that the safe harbor can only include experiments complying with the FDA’s Good Laboratory Practices (GLP), since only data from GLP-compliant studies qualify for submission to the FDA.
A jury verdict and bench opinion accepted Integra's narrow reading of the safe harbor statute, and found Merck and Scripps liable for infringement. A divided panel of the Federal Circuit affirmed. The Supreme Court granted certiorari on the limited question of "whether uses of patented inventions in preclinical research, the results of which are not ultimately included in a submission to the [FDA], are exempted by [the FDA safe harbor]." The term "patented inventions" presumably included both patented compounds and patented research tools that use those compounds.