After what seemed like an eternity, the epic saga known as AMP v. Myriad Genetics has finally come to a close. On June 13, 2013, the Supreme Court ruled (1) that isolated genomic DNA (gDNA) is not patent-eligible under section 101 of the...
After what seemed like an eternity, the epic saga known as AMP v. Myriad Genetics has finally come to a close. On June 13, 2013, the Supreme Court ruled (1) that isolated genomic DNA (gDNA) is not patent-eligible under section 101 of the Patent Act, but (2) cDNA is. For once, what the Justices said at oral argument gave accurate clues to what they really thought, and the result was what almost every observer (including this one) had predicted.
The opinion—by Justice Thomas—was unanimous and brief: 18 pages. Justice Scalia wrote a one-paragraph concurrence in which he said only that he didn’t know enough to sign on to the Court’s recitation of “the details of molecular biology,” though he agreed with the decision. The 9-0 decision reflects a recent trend in patent decisions (see Mayo v. Prometheus and last month’s Monsanto opinion), and may represent a reaction to the derision that greeted the fractured, multi-opinion mess that was Bilski v. Kappos, the Court’s 2010 business methods case. Beyond the surface unanimity, the Myriad opinion has a no-brainer quality—that is, the opinion does not give any sense of wrestling with a difficult issue, giving the impression that the outcome was so clear that reasonable minds couldn’t possibly differ. Consistent with this approach, the Court cited only the lower court opinions and briefs in the case, a few of its own patent decisions, and a single scientific text (Watson’s Molecular Biology of the Gene). No amicus briefs (except the government’s, to confirm that the Department of Justice had thrown the USPTO under the bus), no scientific or law review articles.
The strict legal significance of the decision is pretty straightforward. The Court struck down patent claims on genomic DNA that has been merely “isolated” from the body, where “isolated” means, well, “isolated”—removed and separated from its natural environment in the cell. More specifically, the Court held that genomic DNA does not meet the threshold test of patentable subject matter under section 101. It upheld the subject matter status of cDNA, which it defined as “synthetically created DNA . . . which contains the same protein-coding information found in a segment of natural DNA but omits portions within the DNA segment that do not code for proteins [introns].” Every patent drafted like Myriad’s first and broadest claim—“an isolated DNA coding for [a specified protein]”—is now invalid. Conversely, claims limited to cDNA versions of genes continue to pass the threshold test, though they are still subject to scrutiny under all the other patentability requirements (more on that below).
The cDNA/gDNA distinction has its roots in the Federal Circuit’s 1991 decision in Amgen v. Chugai. That case turned on a priority-of-invention contest: who got the rights to the human EPO gene. But the case did, at least implicitly, establish the subject matter status of cDNA. The broadest claim upheld in that case was: “A purified and isolated DNA sequence consisting essentially of a DNA sequence encoding human erythropoietin.” The court treated this as a claim to the cDNA version of the gene, interpreting “purified” as meaning something like “only the coding regions.” It commented that “[i]t is important to recognize that [neither competing inventor] invented EPO or the EPO gene. The subject matter [of this claim] was the novel purified and isolated sequence which codes for EPO.”
Thereafter, two things happened. First, the subject matter eligibility of cDNA was never again challenged, until now. And understandably so, if DNA is viewed as a chemical for patent law purposes. cDNA is, in a literal sense, a substance not found in the body; it contains the same coding information as the mature RNA transcript, but it is a different chemical: and, with the noncoding regions excised, it is not exactly replicated in natural DNA. The second thing was less predictable. Amgen set up one of those slippery slopes that lawyers are always talking about. The USPTO
