The Precedent: Federal Circuit Upholds Gene Therapy Host Cell Claims Under 35 U.S.C. § 101 in Regenxbio Inc., Et Al. v. Sarepta Therapeutics, Inc., Et Al.

The Federal Circuit reversed a district court’s summary judgment, ruling that gene therapy host cell claims in Regenxbio Inc., et al. v. Sarepta Therapeutics, Inc., et al. are patent-eligible under 35 U.S.C. § 101. The court determined that the claimed host cells, containing recombinant nucleic acid molecules, are “markedly different” from anything found in nature, aligning with the Chakrabarty decision. This ruling emphasizes that human-engineered biological inventions incorporating naturally occurring sequences can be patent-eligible if the composition as a whole is nonnaturally occurring and possesses distinct characteristics and utility.