"Elevidys represents both the remarkable promise and the profound access tension at the heart of gene therapy patents. The underlying technology was developed in the laboratory of Dr. James M. Wilson at the University of Pennsylvania, supported in substantial part by more than $105 million in NIH funding over Wilson's career, and then exclusively licensed to REGENXBIO Inc."
"On February 20, 2026, the Federal Circuit reversed a Delaware district court's grant of summary judgment of ineligibility under 35 U.S.C. § 101, holding that the claimed genetically engineered host cells are not directed to a natural phenomenon. The reversal applies settled doctrine that traces Diamond v. Chakrabarty through Myriad's cDNA holding and Diamond v. Diehr's prohibition on dissecting claims into old and new elements."
"Representative claim 1 covers a cultured host cell containing a recombinant nucleic acid molecule encoding an AVV capsid protein having a sequence 95% identical to that listed. The molecule also includes a heterologous non-AAV sequence."
Elevidys, priced at $3.2 million per dose for treating Duchenne muscular dystrophy, exemplifies tensions between gene therapy innovation and access. The underlying technology was developed at the University of Pennsylvania with over $105 million in NIH funding and exclusively licensed to REGENXBIO. In REGENXBIO v. Sarepta, the Federal Circuit reversed a district court's summary judgment of patent ineligibility, holding that genetically engineered host cells containing recombinant nucleic acid molecules are not directed to natural phenomena. The decision applies established doctrine from Diamond v. Chakrabarty and Myriad, distinguishing biotechnology patents from software and diagnostic method claims that have faced consistent ineligibility challenges.
#gene-therapy-patents #patent-eligibility #biotechnology #duchenne-muscular-dystrophy #federal-circuit-decision
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