Guest Post by Jeffrey Lefstin, Ph.D., Professor of Law at the University of California Hastings College of the LawAfter the Supreme Court decided Mayo v. Prometheus, the Court vacated and remanded the Federal Circuit’s initial AMP v. Myriad opinion for reconsideration in light of Mayo. Despite the Supreme Court’s hint, the Federal Circuit’s opinion on remand begins by dismissing Mayo as irrelevant – at least to those claims drawn to isolated and purified BRCA DNA. Composition of matter claims, according to Judge Lourie, are governed not by Mayo, but primarily by Chakrabarty, which suggests that a composition of matter is patent eligible if it is “markedly different” than a natural product, or if the transformation of the natural product yields “a distinctive name, character, and use.”
There are a number of problems with Judge Lourie’s premise. The subject matter eligibility question in Myriad turns on whether the DNA claims are drawn to “products of nature.” But Chakrabarty is about the patentability of living things, not products of nature. In fact, Chakrabarty’s discussion of the “product of nature” doctrine is entirely dictum. Although Chakrabarty’s claims to genetically engineered bacteria were originally rejected as “products of nature,” that rejection was not sustained by the Board of Appeals. And while the CCPA considered the issue in connection with the related Bergy appeal, in Chakrabarty the Solicitor expressly disowned the “product of nature” rejection in his argument before the Court.
So why did the Chakrabarty court discuss the “product of nature” doctrine at all? The “product of nature” discussion seems to have arisen because Chakrabarty’s brief mentioned Funk Brothers, the Court’s 1948 case denying patentability to a mixture of nitrogen-fixing bacteria. Chakrabarty suggested that if living things were not patent-eligible, the Court would have said so in Funk. The Solicitor’s reply denied that the claims in Funk were drawn to living things, but neither Chakrabarty nor the government argued the “product of nature” issue in their briefs.
Even if the Court’s discussion were more than dictum, Chakrabarty hardly establishes “markedly different” or “distinctive name, character, and use” as definitive standards. “Markedly different” is an offhand comment by the Court, and “distinctive name, character, and use” derives from the Court’s 1931 opinion in American Fruit Growers – which looked to Customs law for the meaning of “manufacture” in the patent statute. (The acquisition of a distinctive name, character, and use is now known as the “substantial transformation” test, and is used to establish the country of origin for imported products).
But most significantly, while the Federal Circuit’s opinion makes passing reference to Funk Brothers, it overlooks the point that Mayo’s analytical framework – asking whether the patentee’s application of a law of nature goes beyond the conventional and obvious – is nothing more than Funk Brothers redux. In Mayo, the Court’s requirement that a claim must embody an “inventive concept” beyond the natural law was drawn from Parker v. Flook. In turn, Flook’s approach was expressly grounded in Funk. And a reading of Funk makes clear that Mayo’s requirement of “natural law plus more than conventional activity” is simply the analysis employed in Funk:
Discovery of the fact that certain strains of each species of these bacteria can be mixed without harmful effect to the properties of either is a discovery of their qualities of non-inhibition. It is no more than the discovery of some of the handiwork of nature and hence is not patentable. The aggregation of select strains of the several species into one product is an application of that newly-discovered natural principle. But however ingenious the discovery of that natural principle may have been, the application of it is hardly more than an advance in the packaging of the inoculants.
If the Mayo Court truly revived the Funk analysis, the implications for Myriad (and subsequent cases) are substantial. Funk dealt with a composition of matter: bacteria. So if Mayo’s framework draws from Funk, that framework is clearly applicable to a composition of matter such as DNA. And under the reasoning of Funk, it seems not to matter whether the process of arriving at the claimed subject matter is inventive; the Funk court conceded that the discovery leading to the claimed invention might have been “ingenious.” What matters is whether there is “something else” in the claims, other than conventional or obvious activity routine in the art.
Even more so than in Mayo, of the Myriad composition claims seem to lack “something else” beyond the natural phenomenon: the natural sequence of the BRCA genes. For the Federal Circuit, the structural differences between the natural genes and the isolated products were the key to patent-eligibility. But under Mayo and Funk, the question is whether those transformations of the natural sequence represent something more than conventional or obvious activity.
Taking the identification of the natural sequence as a given – as Mayo and Funk appear to demand – the patent-eligibility of Myriad’s composition claims is in serious doubt. The “something else” in Myriad’s claims is the separation of that natural sequence from the genomic context, or the embodiment of that sequence in a cDNA. However ingenious the discovery of the BRCA loci may have been, the embodiment of the BRCA sequences in isolated DNA molecules was either conventional in the art, or, in the case of the removal of non-coding information from the mRNA transcripts that gave rise to the cDNAs, performed automatically by the cell.