The Federal Circuit has reversed a district court’s grant of summary judgment in a patent infringement case, finding that the patent claims weren’t ineligible as directed to a natural phenomenon.
REGENXBIO Inc. and The Trustees of the University of Pennsylvania (collectively, “REGENXBIO”) filed a patent infringement suit against Sarepta Therapeutics, Inc. and Sarepta Therapeutics Three, LLC for allegedly infringing certain claims of U.S. Patent No. 10,526,617.
Both parties moved for summary judgment re patent eligibility under 35 U.S.C. § 101, disagreeing about whether the claims disclose natural products.
The district court granted Sarepta’s motion and held the claims ineligible under § 101 as directed to a natural phenomenon.
As the court explained,
Genetic disorders—like cystic fibrosis, hemophilia, and sickle cell anemia—are caused by mutations or deletions in the sequences of nucleotides in one’s DNA. Gene therapy allows the use of modified virus “vectors” to deliver a new therapeutic gene (a “transgene”) that replaces the defective or missing gene, treating or possibly even curing the disease by addressing the underlying genetic disorder. Host cells can be engineered to contain plasmids, where a plasmid is a circular piece of DNA that is separate from the chromosomes of the host cell, and the plasmid has the desired transgene within it. A host cell can make multiple copies of the plasmid and also proliferate to make more host cells. Plasmids can contain a capsid sequence, where a capsid is the outer shell of a vector. These plasmids can be purified, collected, and introduced into a mammalian host cell, along with other plasmid DNA, to generate a gene therapy vector.
The ’617 patent is titled “Method of Detecting and/or Identifying Adeno-Associated Virus (AAV) Sequences and Isolating Novel Sequences Identified Thereby,” and is directed to genetically engineered host cells that contain adeno-associated virus rh.10 sequences.
The court noted, quoting the US Supreme Court, that
“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” 35 U.S.C. § 101. “Laws of nature, natural phenomena, and abstract ideas,” in contrast, “are not patentable.”
The key question, said the Federal Circuit, was whether the claimed host cells have “markedly different characteristics” and have “the potential for significant utility” from that which is naturally occurring.
The court found, again quoting an earlier Supreme Court decision, that
the 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 court noted that “the claims here are not merely directed to repackaging products of nature.”
Said the court:
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.
The court concluded that
the claimed host cells here contain a recombinant nucleic acid molecule that, by definition, is markedly different from anything occurring in nature. The claimed host cells are, therefore, not patent-ineligible claims to naturally occurring subject matter.
The court thus reversed the district court’s summary judgment of ineligibility under 35 U.S.C. § 101 and remanded for further proceedings consistent with the opinion.
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