U.S. District Court Judge Susan Illston stuck again on Christmas Eve, giving the biotech patent community a rhetorical lump of coal in their stocking by invalidating on summary judgment claims directed to methods for isolating cell-free fetal DNA from maternal DNA on the grounds that they are not patent-eligible under 35 U.S.C. § 101. The author of the Ariosa v. Sequenom decision a few years ago, Judge Illston has rarely seen a patent she likes (or is not willing to invalidate), and the Supreme Court and Federal Circuit's recent § 101 jurisprudence has given district court judges the judicial discretion to invalidate patents based on their subjective determination of their eligibility.
The patents at issue, U.S. Patent Nos. 9,580,751 and 9,738,931, recite the following representative independent claims:
The '751 patent:
1. A method for preparing a deoxyribonucleic acid (DNA) fraction from a pregnant human female useful for analyzing a genetic locus involved in a fetal chromosomal aberration, comprising:
(a) extracting DNA from a substantially cell-free sample of blood plasma or blood serum of a pregnant human female to obtain extracellular circulatory fetal and maternal DNA fragments;
(b) producing a fraction of the DNA extracted in (a) by:
(i) size discrimination of extracellular circulatory DNA fragments, and
(ii) selectively removing the DNA fragments greater than approximately 500 base pairs,
wherein the DNA fraction after (b) comprises a plurality of genetic loci of the extracellular circulatory fetal and maternal DNA; and
(c) analyzing a genetic locus in the fraction of DNA produced in (b).
The '931 patent:
1. A method, comprising:
(a) extracting DNA comprising maternal and fetal DNA fragments from a substantially cell-free sample of blood plasma or blood serum of a pregnant human female;
(b) producing a fraction of the DNA extracted in (a) by:
(i) size discrimination of extracellular circulatory fetal and maternal DNA fragments, and
(ii) selectively removing the DNA fragments greater than approximately 300 base pairs,
wherein the DNA fraction after (b) comprises extracellular circulatory fetal and maternal DNA fragments of approximately 300 base pairs and less and a plurality of genetic loci of the extracellular circulatory fetal and maternal DNA fragments; and
(c) analyzing DNA fragments in the fraction of DNA produced in (b).
Both patents were subjected to rejection under § 101 and allowed upon application of U.S. Patent and Trademark Office Guidance for applying Supreme Court and Federal Circuit law to the question of subject matter eligibility relating to natural phenomena and laws of nature.
The Court, as has become district courts' wont, rendered summary judgment without a Markman hearing construing the claims, and in its opinion characterized the claimed methods for both patents as being directed to prenatal detection, fairly based on steps (c) in each patent's claims.
After setting forth the legal standards the District Court addressed the two prongs of the Alice/Mayo analysis for patent eligibility: whether the claims were "directed to" ineligible subject matter and whether they recite an inventive concept. Regarding the first, "directed to" prong, the opinion says that these claims are analogous to the claims invalidated under Federal Circuit precedent in Genetic Techs Ltd. v. Merial and, of course, Ariosa v. Sequenom. The opinion recites without contradiction Ariosa's contention that "the claimed method begins with a sample of cell-free DNA and ends with an analysis of it," which is not exactly true; in these claims the claim starts with a sample of cell-free maternal blood plasma containing cell-free fetal DNA and ends with an isolate of cell-free fetal DNA. The opinion cites a declaration, and prosecution history challenging changes in purity with change in structure. "Changing the ratio of two natural products in a mixture and analyzing one of those products does not impact whether an invention is directed towards a natural phenomenon," according to the Court's opinion. Further, the opinion states that "[b]oth patents claim results from a test of naturally occurring fetal DNA and do not transform the naturally occurring product into something new." Finally with regard to this prong, the Court rejected Illumina's assertion of the Federal Circuit's Rapid Litigation Management Ltd. v. Cellzdirect, Inc. decision, based on the distinction that frozen liver cells, the subject matter of the claims in Cellzdirect, do not occur in nature.
Regarding inventive concept, the Court relied on the recent Federal Circuit decision in Roche Molecular Systems v. Cepheid to distinguish the Cellzdirect precedent. The Court found the claims not inventive, because the method steps (extraction, size production, selective removal), taken in the abstract, are routine, conventional, and well understood. In doing so, the Court rejected the argument that applying these methods to previously unknown cell-free fetal DNA in maternal blood is not "routine, conventional, and well-understood," with some no doubt unintended irony relying on the statement from Diamond v. Diehr that "[t]he novelty of any element or steps in a process, or even the process itself, is of no relevance in determining whether the subject matter of a claim falls within the §101 categories of possibly patentable subject matter." Of course, that statement is not entirely apposite to the situation before the Court, and was made before Justice Breyer and a unanimous Court endorsed mixing novelty and obviousness considerations into the subject matter eligibility calculus in Mayo.
There was a time when patent practitioners could take some solace that the Federal Circuit would apprehend the threats to innovation that decisions such as this one pose and would act to limit their scope if not apply appropriate correction. That time, of course, is long past and it can only be hoped that recent chinks in the Federal Circuit's subject matter eligibility façade suggest members of the Court are receptive to reconsidering how Supreme Court subject matter eligibility decisions have been interpreted. This remains, of course, a hot potato issue, and whether whatever panel of the Court hears the case hews to either the Court's Cellzdirect or its Cepheid precedent is frankly a matter of chance. That biotech patenting has reached this point, particularly in view of the importance of innovation for the U.S. economy and its citizens' well-being, is disheartening. As the kids would say on social media, SMH.
Illumina, Inc. v. Ariosa Diagnostics, Inc. (N.D. Cal. 2018)
Order Granting Defendants' Motion for Summary Judgment by District Judge Illston
