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Safe Harbor of 271(E)(1) Broadly Applied


On remand from the Supreme Court, a Federal Circuit panel in Integra Lifesciences v. Merck KGaA, (Nos. 02-1052 and -1065; July 27, 2007) explores whether the FDA Exemption from infringement (or “safe harbor”) established by 35 U.S.C. § 271(e)(1) applies to research conducted by Merck and Scripps on certain peptides useful for inhibiting angiogenesis. Concluding that the FDA Exemption applies, the panel reverses the district court’s judgment of infringement. In reaching this conclusion, the panel relied on the Supreme Court explanation that § 271(e)(1) “exempted from infringement all uses of patented compounds ‘reasonably related’ to the process of developing information for submission” to the FDA. The Supreme Court had also explained that the phrase “reasonably related” includes uses in research that are conducted after the biological mechanism and physiological effect of a candidate drug have been recognized, such that if the research is successful it would appropriately be included in a submission to the FDA.

Applying this standard, the Federal Circuit determines (i) that Integra conceded that the experiments were conducted after it had been discovered that a particular class of peptides shrank tumors in an animal model and (ii) that Integra did not dispute that that the accused experiments yielded data relating to efficacy, mechanism of action, pharmacology, or pharmacokinetics. The Federal Circuit expressly rejects Integra’s arguments that experiments involving compounds that were not taken to clinical trials were infringing; that the FDA Exemption applies only to experiments to show that a candidate drug can safely be administered to humans in clinical trials; and that the FDA Exemption is limited to experiments that are entirely routine. Instead, the panel determines that the experiments meet the criteria of being reasonably related to research that, if successful, would be appropriate to include in a submission to the FDA. Accordingly, the research falls within the safe harbor.

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