United States: Supreme Court Rules On Patent Eligibility Of DNA Sequences

A unanimous Supreme Court held today that a claim directed to a DNA sequence defined solely by its ability to encode a protein is not patent eligible subject matter because it occurs in nature, but a claim directed to a complementary DNA (cDNA) sequence remains patent eligible because such a sequence does not occur in nature. See Association for Molecular Pathology v. Myriad Genetics, 569 U.S. ___ (2013). The claims at issue were divided into two categories - 1) claims directed to isolated DNA sequences coding for the BRCA1 or BRCA2 polypeptide sequences or one of a few specific mutant forms, and 2) claims directed to isolated cDNA sequences (i.e., a sequence that includes only the exon sequences and does not include the intron sequences present in the genomic sequence).¹ The Court affirmed in part and reversed in part the Federal Circuit's decision with respect to the patent eligibility of Myriad's composition claims. Myriad's claims directed to methods of using the sequences were not at issue in this case.

Isolated DNA

The Supreme Court noted that it has "long held that [§ 101] contains an important implicit exception [to subject matter eligibility:] Laws of nature, natural phenomena, and abstract ideas are not patentable." The Court first observed that Myriad did not create or alter any of the genetic information encoded by the BRCA1 and BRCA2 genes, or create or alter the genetic structure of the genes. Instead, the Court asserted that Myriad's principal contribution was identifying the precise location and sequence of the genes within chromosomes 17 and 13. The Court relied on Diamond v. Chakrabarty, 447 U.S. 303 (1980), noting that the composition there was patentable because it was not a naturally occurring composition of matter, but rather "a product of human ingenuity" having a distinctive name, character [and] use' and that had "markedly different characteristics from any found in nature." Id. at 309-310. The Court noted here that Myriad, by contrast, did not "create anything." Rather, Myriad found an important and useful gene and separated it from its surrounding genetic material. Also relying on Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), the Court held that Myriad's claims "fell squarely within the law of nature exception" to § 101, reasoning that the discovery of the location of the BRCA genes did not render the genes new compositions of matter. Although the Court noted that isolation of the DNA from the genome by severing the chemical bonds creates a non-naturally occurring molecule, the Court stated that this isolation was not enough to render the DNA patent eligible. The Court noted that the claims are not expressed in terms of chemical composition and instead focus on the genetic information encoded. Myriad's arguments based on J. E. M. Ag Supply, Inc. v. Pioneer Hi-Bred Int'l, Inc., 534 U.S. 124 (2001), arguing that the PTO's past practice of awarding gene patents is entitled to deference, were rejected. The Court noted that contrary to the situation in J. E. M. Ag Supply, Congress has not endorsed the views of the PTO in subsequent legislation and that in this case, the United States argued before both the Federal Circuit and the Supreme Court that isolated DNA was not patent eligible under § 101.

cDNA

By contrast to the isolated DNA claims, the Court held that the claims directed to cDNA sequences are patent eligible. In particular, the Court noted that cDNA is "an exons-only molecule that is non-naturally occurring." Because cDNA lacks the introns present in genomic DNA, the Court reasoned that cDNA is distinct from the naturally occurring DNA from which it was derived, and therefore, is not a product of nature. The Court further noted that very short sequences of cDNA may not be patent eligible because they may not have intron sequences to be removed, making them indistinguishable from "natural DNA."

The Court, however, seemed careful to narrow the scope of its holding by noting that claims to diagnostic uses of the isolated DNA molecules were not at issue in the case. As a result, diagnostic method claims should not be affected by the Court's decision, although such claims would have to pass muster in view of the Court's recent decision in Mayo v. Prometheus and the Federal Circuit's decision in the Myriad case. In addition, the Court noted that DNA molecules that have been modified from their natural state are patent eligible. Thus, a patentee or patent applicant might argue that labeled DNA molecules and expression vectors should be patent eligible because they are distinct from the naturally occurring DNA from which they were derived, and therefore, are not products of nature. The Court's decision does not directly address the issue of the patent eligibility of isolated stem cells and biological molecules such as antibodies and therapeutic proteins.

Footnotes

1. The patents also included claims to isolated DNA of at least 15 nucleotides which may fall into either of the two categories, depending on the actual sequence.

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