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.
Insights
Client Alert | 3 min read | 11.21.25
On November 7, 2025, in Thornton v. National Academy of Sciences, No. 25-cv-2155, 2025 WL 3123732 (D.D.C. Nov. 7, 2025), the District Court for the District of Columbia dismissed a False Claims Act (FCA) retaliation complaint on the basis that the plaintiff’s allegations that he was fired after blowing the whistle on purported illegally discriminatory use of federal funding was not sufficient to support his FCA claim. This case appears to be one of the first filed, and subsequently dismissed, following Deputy Attorney General Todd Blanche’s announcement of the creation of the Civil Rights Fraud Initiative on May 19, 2025, which “strongly encourages” private individuals to file lawsuits under the FCA relating to purportedly discriminatory and illegal use of federal funding for diversity, equity, and inclusion (DEI) initiatives in violation of Executive Order 14173, Ending Illegal Discrimination and Restoring Merit-Based Opportunity (Jan. 21, 2025). In this case, the court dismissed the FCA retaliation claim and rejected the argument that an organization could violate the FCA merely by “engaging in discriminatory conduct while conducting a federally funded study.” The analysis in Thornton could be a sign of how forthcoming arguments of retaliation based on reporting allegedly fraudulent DEI activity will be analyzed in the future.
Client Alert | 3 min read | 11.20.25
Client Alert | 3 min read | 11.20.25
Client Alert | 6 min read | 11.19.25
