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

Client Alert | 1 min read | 08.15.07

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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Client Alert | 3 min read | 06.03.26

Important EU Court Judgment Clarifies Rules on Interest Due in Cartel Damages Cases

In a judgment that will have direct and immediate consequences, the Court of Justice of the European Union (CJEU) has clarified that for all competition damages actions brought after 26 December 2014, interest runs from the date on which the harm occurred. The ruling addressed two important questions: (1) whether national provisions implementing Article 3(2) of the EU Damages Directive — which requires interest to run from the date harm occurred —apply to cases in which the harm preceded the adoption of those provisions; and (2) how the date of harm should be determined in cartel cases involving the purchase of goods at inflated prices....

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