1. “Whether the district court erred as a matter of law in holding, under 35 U.S.C. § 101, that claims to laboratory-made host cells genetically engineered to contain DNA from at least two different organisms chemically spliced together to form a recombinant nucleic acid molecule cover something that is naturally occurring, when nothing like the claimed host cells appears in nature.”
2. “Whether the district court erred as a matter of law in concluding, under 35 U.S.C. § 101, that claims to laboratory-made host cells genetically engineered to contain DNA from at least two different organisms chemically spliced together in a recombinant nucleic acid molecule are not markedly different in structure and/or function from a natural product, when no natural product has similar structural or functional characteristics.”
3. “Whether the district court failed to draw reasonable factual inferences in Appellants’ favor in granting Sarepta’s motion for summary judgment.”
1. [T]he claimed nucleic acid molecules here, although containing naturally occurring segments of DNA, are ‘not nature’s handiwork’ and ‘not . . . a hitherto unknown natural phenomenon, but . . . a nonnaturally occurring manufacture or composition of matter.’ . . . The claimed host cells are, therefore, not patent-ineligible claims to naturally occurring subject matter.”
2. “Genetically engineering two nucleic acid sequences from separate species into a single molecule and then transforming a host cell in order to incorporate that new molecule into it—thus fundamentally creating a cell containing a molecule that could not form in nature on its own—is materially different from growing more than one naturally occurring bacteria strain in a culture where none of the bacteria undergo any change from their natural state. . . . [T]he claimed host cells here contain a recombinant nucleic acid molecule that, by definition, is markedly different from anything occurring in nature.”
