In a July 29, 2011 opinion authored by Judge Lourie for the majority, the Court of Appeals for the Federal Circuit held in the Myriad gene patenting case that composition claims directed to "isolated" DNA molecules are patent-eligible subject matter under 35 U.S.C. § 101. The court’s slip opinion, captioned Association of Molecular Pathology v. U.S. Patent and Trademark Office, appears at www.cafc.uscourts.gov/images/stories/opinions-orders/10-1406.pdf.
Myriad, as defendant in a declaratory judgment suit, appealed a decision of the U.S. District Court for the Southern District of New York that composition claims to isolated DNA molecules in several patents it owned were invalid. The district court had ruled for the plaintiffs, including several medical organizations, researchers, genetic counselors, and patients, who argued that the composition of matter claims were directed to "products of nature", which are patent ineligible subject matter. The claims pertained to isolated DNAs of the human genes coding for the BRCA1 and BRCA2 polypeptides and gene mutations associated with a predisposition to breast and ovarian cancers. Slip. Op. at 8-9.
The Federal Circuit noted that in Diamond v. Chakrabarty (447 U.S. 303 (1980)) the Supreme Court held that bacteria genetically engineered with naturally occurring DNA plasmids to enable the breakdown of multiple components of crude oil qualified as patentable subject matter. No single naturally occurring bacterium could break down the multiple crude oil components. The Court noted that the claims to the genetically engineered bacteria were "not to a hitherto unknown natural phenomenon, but to a non-naturally occurring manufacture or composition of matter - a product of human ingenuity 'having a distinctive name, character [and] use.'" Slip. Op. at 8-9.
The Federal Circuit then contrasted the isolated DNA claimed by Myriad with DNA in its native form in the human body. The court observed that the BRCA1 gene in its native state is a contiguous part of a DNA molecule having about 80 million nucleotides, while the isolated DNAs of claims 5 and 6 of Myriad's U.S. Patent 5,747,282 have as few as fifteen nucleotides of a BRCA sequence. The Federal Circuit indicated that the nucleotide sequences of the isolated DNAs, when found in the native state, are covalently bonded to other nucleotides. As such, the court found that the isolated DNAs are different chemical entities than the native DNAs. Slip. Op. at 42 and 47.
The plaintiffs had argued that because the claimed isolated DNAs included the same nucleotide sequence as native DNA, and, therefore, included similar information content, the isolated DNAs did not have "markedly different" characteristics than the native DNA. The Federal Circuit refuted this argument on the basis that the isolated DNAs are "materials having a chemical nature ... best described in patents by their [chemical] structures rather than their [informational] functions." Slip. Op. at 44-45.
The Federal Circuit noted that its decision upholding the patent eligibility of isolated DNA is consistent with the practice of the U.S. Patent and Trademark Office in issuing patents claiming "isolated DNA" since the Chakrabarty decision. In the Federal Circuit's view, a change in the law by Congress would be required to exclude DNA inventions from patentability under 35 U.S.C. § 101. Slip. Op. at 48.
Judge Bryson dissented, arguing that Myriad's claims to BRCA gene fragments were not patent eligible. The dissent focused on the function of genes as directing protein synthesis, and considered the isolation of DNA from the larger DNA molecules on which the genes reside to be an "extract[ion]" that does not alter the natural character of the genes. Judge Bryson reconciled his dissent with the Chakrabarty decision by reasoning that Myriad's claims, unlike Chakrabarty’s, were directed to the genetic coding material, which is structurally and functionally the same in both the native gene and the isolated form of the gene. Slip. Op. at 2, 8-11, and 13.
This case may be addressed further, either in an en banc hearing before the Federal Circuit or before the Supreme Court. Myriad represents another iteration in the ongoing debate between those who seek to maintain or expand the patent eligibility of subject matter in the life sciences and those who seek to curtail it.