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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 | 5 min read | 12.12.25

Eleventh Circuit Hears Argument on False Claims Act Qui Tam Constitutionality

On the morning of December 12, 2025, the Eleventh Circuit heard argument in United States ex rel. Zafirov v. Florida Medical Associates, LLC, et al., No. 24-13581 (11th Cir. 2025). This case concerns the constitutionality of the False Claims Act (FCA) qui tam provisions and a groundbreaking September 2024 opinion in which the United States District Court for the Middle District of Florida held that the FCA’s qui tam provisions were unconstitutional under Article II. See United States ex rel. Zafirov v. Fla. Med. Assocs., LLC, 751 F. Supp. 3d 1293 (M.D. Fla. 2024). That decision, penned by District Judge Kathryn Kimball Mizelle, was the first success story for a legal theory that has been gaining steam ever since Justices Thomas, Barrett, and Kavanaugh indicated they would be willing to consider arguments about the constitutionality of the qui tam provisions in U.S. ex rel. Polansky v. Exec. Health Res., 599 U.S. 419 (2023). In her opinion, Judge Mizelle held (1) qui tam relators are officers of the U.S. who must be appointed under the Appointments Clause; and (2) historical practice treating qui tam and similar relators as less than “officers” for constitutional purposes was not enough to save the qui tam provisions from the fundamental Article II infirmity the court identified. That ruling was appealed and, after full briefing, including by the government and a bevy of amici, the litigants stepped up to the plate this morning for oral argument....

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