Federal Circuit Clarifies Patent-Eligibility Under 35 U.S.C. § 101 For Claims Covering Recombinant DNA Molecules

On February 20, 2026, in REGENXBIO Inc. et al. v. Sarepta Therapeutics Inc., et al., No. 2024-1408, the Federal Circuit reversed a district court decision which held that claims covering a cultured host cell containing a recombinant nucleic acid molecule were patent ineligible under 35 U.S.C. § 101. The Federal Circuit held that the claimed host cells are “markedly different from anything occurring in nature” and therefore not directed to patent-ineligible natural phenomena.... By: White & Case LLP