Federal Circuit IP
Regenexbio Inc., Trustees of the University of Pennsylvania v. Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC
Regenexbio Inc., Trustees of the University of Pennsylvania v. Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC
CAFC Opinion No. 2024-1408, Decided February 20, 2026
(Dyk, Hughes, Stoll; Precedential)
Overview: Naturally, genetically engineered cells are not naturally occurring.
Facts/Background
- Regenexbio filed a patent infringement suit against Sarepta asserting US Pat. 10,526,617.
- The ’617 patent is directed to host cells that have been genetically engineered to express a gene therapy vector.
- Both parties moved for summary judgment regarding patent eligibility under § 101.
- Though parties agreed that the host cells were not naturally occurring, the District Court for the District of Delaware found that individual elements of the claims were not markedly different from naturally occurring counterparts and that simply combining these elements in a cell did not render the subject matter patentable eligible.
Issue: Whether genetically engineered host cells are ineligible under § 101 when individual claim elements, when taken alone, may be considered naturally occurring.
Federal Circuit Analysis –
- Review: De novo (applying 3rd circuit law for SJ)
- Under Chakrabarty and Myriad, genetically engineered host cells are not naturally-occurring and are patent eligible under § 101:
- D.C. erred in focusing on whether individual claim components were markedly different rather than the claimed composition as a whole.
- A lab technician “unquestionably creates something new” when a recombinant nucleic acid molecule is spliced together and expressed in a host cell.
Holding: Reversed and Remanded
Takeaways
- Claimed subject matter is considered as a whole when determining whether the subject matter is markedly different from naturally occurring counterparts.
- Though not necessary for this case, consider including dependent claims directed to particular uses since Chakrabarty suggests that under some circumstances having a “significant utility” is helpful for establishing eligibility under § 101.