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** DISTRICT COURT 101 ANALYSIS FAILED TO CONSIDER CLAIMED COMPOSITION AS A WHOLE
REGENXBIO Inc. v. Sarepta Therapeutics, Inc., 24-1408 — On Friday in an opinion by Judge STOLL, the Federal Circuit reversed a district court summary judgment that REGENXBIO’s patent for genetically engineered host cells containing adeno-associated virus sequences was invalid under 35 U.S.C. § 101. REGENXBIO argued the district court erred in finding its patent was directed to a natural phenomenon.
The Federal Circuit agreed. To meet the claim limitations, nucleic acid sequences from at least two different species had to be spliced together via human intervention to create a recombinant nucleic acid molecule that “does not and cannot exist in nature.” The district court took “too narrow” an approach to analyzing the claims by focusing on whether the claim’s individual components were “markedly different from what is naturally occurring” and did not consider whether the composition as a whole occurred in nature. It was also undisputed that the claimed composition had “the potential for significant utility” and benefit to gene therapy patients.
(1 to 4 stars rate impact of opinion on patent & trademark law)
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