The recent history of subject matter eligibility in the life sciences before the Court of Appeals for the Federal Circuit has been fraught with uncertainty, and the most recent decision, in Illumina, Inc. v. Ariosa Diagnostics, Inc., illustrates this uncertainty nicely (particularly because a divided panel of the Court held that the claims were eligible for patenting.
The claims at issue fell into the third "bucket" of eligibility, being neither diagnostic method claims (always ineligible at the Federal Circuit) nor method of treatment claims (eligible, at least for now, because the Supreme Court denied review of Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals), but rather (as denoted in the majority opinion), method of preparation claims, a philosophical cousin to the claims in Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc. As an added bonus, Judge Reyna dissented in a manner that illustrates his thinking on patent eligibility of inventions involving natural phenomena (and natural products).
The case arose over U.S. Patent No. 9,580,751 (the '751 patent) and U.S. Patent No. 9,738,931 (the '931 patent), directed to the solution of an unexpected difficulty in detecting cell-free fetal DNA (cffDNA):
[T]he major proportion (generally >90%) of the extracellular DNA in the maternal circulation is derived from the mother. This vast bulk of maternal circulatory extracellular DNA renders it difficult, if not impossible, to determine fetal genetic alternations [sic] . . . from the small amount of circulatory extracellular fetal DNA.
The inventors found that cffDNA was significantly smaller (300-500 bp) than the "interfering" maternal DNA, and thus using admittedly conventional techniques of size separation the cffDNA could be isolated and rendered detectable.
Claim 1 from the ’751 patent recited the claimed method of preparing a DNA-containing fraction from blood of a pregnant woman, by extracting extracellular circulatory fetal and maternal DNA fragments from blood plasma or blood serum of the pregnant woman and then further fractionating the DNA fragments by removing fragments larger than 300-500 basepairs.
The District Court held these claims to be ineligible for patenting, and the Federal Circuit reversed, in an opinion by Judge Lourie joined by Judge Moore; Judge Reyna (the author of the Court's Ariosa Diagnostics Inc. v. Sequenom, Inc. decision) dissented. Judge Lourie got right to the point, stating "[t]his is not a diagnostic case. And it is not a method of treatment case. It is a method of preparation case." The opinion acknowledged the consistent precedent post-Mayo that diagnostic method claims are ineligible, and method of treatment claims are eligible. The majority appreciated a distinction lost on the dissent: "[h]ere, it is undisputed that the inventors of the '751 and '931 patents discovered a natural phenomenon. But at step one of the Alice/Mayo test, 'it is not enough to merely identify a patent-ineligible concept underlying the claim; we must determine whether that patent-ineligible concept is what the claim is 'directed to," citing Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc.
The majority understood the natural phenomenon underlying the claimed invention to be "that cell-free fetal DNA tends to be shorter than cell-free maternal DNA in a mother's bloodstream" despite some apparent inconsistencies in how at least Roche enunciated its interpretation. The critical question as understood by the majority was "whether the claims are 'directed to' that natural phenomenon." The majority held that the claims were not directed to the natural phenomenon but rather were directed to "a patent-eligible method that utilizes it." In support of this conclusion, Judge Lourie wrote regarding the specificities of the claims, including "specific process steps—size discriminating and selectively removing DNA fragments that are above a specified size threshold" that increased the relative amount of cffDNA in the processed sample compared to maternal DNA. The claimed method "change[d] the composition of the mixture" and produced a DNA-containing fraction that was different from what naturally occurs in maternal blood. This was what distinguished, for the majority, what was claimed from merely "observing that fetal DNA is shorter than maternal DNA or detecting the presence of that phenomenon."
The panel majority analogized this case to the Cellzdirect precedent, by noting that those inventors did not "invent" hepatocytes, but rather invented a method for making preparations of them that relied on the hepatocytes natural ability to be subjected to multiple rounds of freezing and thawing unappreciated in the prior art. For the majority, the '751 and '931 patents similarly do not claim (and the inventors do not assert they had invented) cffDNA or even the differential size distribution between maternal and fetal DNA in maternal blood. The panel majority recognized that the inventors here relied on this natural phenomenon to invent a method of separating cffDNA into an enriched fraction by "physical process steps" that "selectively remove some maternal DNA in blood to produce a mixture enriched in fetal DNA."
The majority summarized its opinion as follows:
The inventors here patented methods of preparing a DNA fraction. The claimed methods utilize the natural phenomenon that the inventors discovered by employing physical process steps to selectively remove larger fragments of cell-free DNA and thus enrich a mixture in cell-free fetal DNA.
Judge Reyna dissented, his dissent nicely setting forth the philosophical differences between the members of this Court (as well as the Supreme Court) for whom the eligibility/ineligibility dichotomy is categorical: once a "natural phenomenon" is identified, the invention cannot be patented (despite Judge Reyna's protestations at the end of his dissent that "process claims that involve naturally occurring phenomena from beginning to end could be directed to patent eligible subject matter, but this is not such a case" -- there will never be such a case).
The dissent recites the conventional view that applying routine, well-understood, and conventional methods to a newly discovered natural phenomenon is enough, per se, to preclude patent eligibility. What Judge Reyna continues to refuse to acknowledge (and he is not alone in this particular brand of short-sightedness) is that there is nothing routine, well understood, and conventional (and cannot be) in using old techniques in new ways. Indeed, there would be very little patenting if the use of older technology could not be a part of innovation; after all, the goal of building a better mousetrap would be considerably more difficult if the existence of a mousetrap itself preluded patenting a better one.
Kevin Noonan is a partner with the law firm McDonnell Boehnen Hulbert & Berghoff LLP and represents biotechnology and pharmaceutical companies on a myriad of issues. A former molecular biologist, he is also the founding author of the Patent Docs weblog, https://patentdocs.typepad.com/.
