Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015), is a controversial decision of the US Federal Circuit in which the court applied the Mayo v. Prometheus test. See also Alice Corp. v. CLS Bank Int'l, 134 S. Ct. 2347, 2355 (2014) (applying the Mayo test to software implemented business method, indicating its general applicability to patent-ineligible ideas). to invalidate on the basis of subject matter eligibility a patent said to "solve ... a very practical problem accessing fetal DNA without creating a major health risk for the unborn child."Dennis Crouch, Federal Circuit Reluctantly Affirms Ariosa v. Sequenom and Denies En Banc Rehearing, (Dec. 23, 2015). The rationale for denying patent-eligibility in this case allegedly stems from claims being directed toward non-eligible subject matter (Law of Nature), "if the APPLICATION [of this discovery] merely relies upon elements already known in the art."Quotation from Mayo Collaborative Services v. Prometheus Laboratories, Inc.
In December 2015, the Federal Circuit denied a motion for en banc rehearing, with several members of the court filing opinions urging Supreme Court review. On June 27, 2016, the Supreme Court of the United States denied Sequenom's petition for a writ of certiorari.Court document supremecourt.gov
Background
Sequenom is the exclusive licensee of U.S. Patent No. 6,258,540, which claims priority to GB9704444 filed on 4 March 1997 by Oxford University Innovation Ltd. The patent describes a method of using cell-free fetal DNA (cffDNA) circulating in maternal plasma (cell-free blood) to diagnose fetal abnormalities. Claim 1 is illustrative:
The invention is based on the 1996 discovery, that fetal DNA might be floating around in the mother's blood (not just in the blood of the fetus, which was accessible only by invasive methods, such as amniocentesis, which causes numerous risks for the unborn child). Based on this finding the inventors developed (using known methods) a process to selectively amplify the fetal DNA by focusing on the paternally inherited portion of its DNA (rather than the maternally inherited DNA).
The claim itself has two simple and conventional steps: first amplifying (by polymerase chain reaction, PCR) and then detecting the paternally inherited DNA from the plasma sample. The technology for amplifying and detecting DNA was already well known and generally used to detect DNA. There was a problem, however, of how to ascertain which DNA in the sample was that of the fetus and which was the mother's (which greatly outnumbered the fetal DNA in the sample).According to the patent, fetal DNA is from 0.39% of the sample (the lowest concentration measured in early pregnancy), to as high as 11.4% (in late pregnancy).
The inventors realized that the fetus had DNA derived from the father as well as the mother, and that paternal DNA was not native to the mother's blood. So they wanted to focus on genetic fragments containing paternally inherited sequences the mother did not share, but had traveled from the fetal blood into the maternal blood through the placenta. The paternal DNA in the mother's plasma had to have come from the fetus. Then, they could reliably identify fetal DNA, which would in turn allow them to diagnose certain fetal genetic conditions. The inventors now had a test that did not require invasive and highly risky amniocentesis. Sequenom became the exclusive licensee of the patent.
After Sequenom launched its test on the market, several other companies began to market similar tests and cut prices. Sequenom sent letters to Ariosa Diagnostics, Inc., Natera, Inc. and Diagnostics Center, Inc.. threatening each of them with patent infringement suits. They responded by filing declaratory judgment actions against Sequenom.
After the district court construed the patent claims and denied a preliminary injunction, Sequenom took an interlocutory appeal. On remand to the district court, it held the patent invalid as claiming the only viable method of detecting a natural phenomenon. The district court said: "the claims at issue pose a substantial risk of preempting the natural phenomenon of paternally inherited cffDNA," which made them patent-ineligible. Sequenom then appealed to the Federal Circuit.
Ruling of the Federal Circuit
Panel decision
A three-judge panel affirmed the judgment of the district court. The majority concluded that the patent fails the two-step test that the Supreme Court developed in Mayo for determining whether a method patent impermissibly claims a natural law or phenomenon.
First, the court said, the claims "are directed to a patent-ineligible concept" because the "method begins and ends with a natural phenomenon" (i.e., cffDNA). Second, it said, the claimed method did not "'transform' the claimed naturally occurring phenomenon into a patent-eligible application"of the phenomenon.
The court reasoned that, "[f]or process claims that encompass natural phenomen[a], the process steps . . . must be new and useful." But researchers already knew how to accomplish the individual steps of (1) fractionating blood; (2) amplifying DNA; and (3) detecting characteristics in amplified DNA. Therefore, the claimed method impermissibly added only "well-understood, routine, and conventional activity" to the natural phenomenon that the inventors had discovered. That made the claimed subject matter patent-ineligible as a matter of law according to Mayo v. Prometheus precedent.
The court said that it rejected Sequenom's argument that "implies that the inventive concept lies in the discovery of cffDNA in plasma or serum." That discovery is a natural phenomenon, rather than an inventive application of a natural phenomenon. This discovery helps to meet the non-obviousness requirement, but it does not address the patentable subject matter (i.e. additional inventive concept) requirement.
The court also rejected the argument that the patent did not preempt the entire use of cffDNA and that some uses were unpreempted. While total preemption "may signal patent ineligible subject matter," under Parker v. Flook. and other cases "the absence of complete preemption does not demonstrate patent eligibility." The fact that once a court concludes that the claims involve only natural phenomena and "conventional" techniques, "preemption concerns are fully addressed and made moot."
Senior Judge Linn concurred separately, saying that he was "bound by the sweeping language of the test set out in Mayo."788 F.3d at 1380. He explained also why he considered the Supreme Court's Mayo decision incorrect:
Judge Pauline Newman was the only dissenter in Ariosa v. Sequenom. She criticized the Federal Circuit's position on patent-eligible subject matter (claims preempting the use of the laws of nature), following the SCOTUS decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc.. Instead of inconsistent interpretation of patentable subject matter by different courts at different times (i.e. requiring additional "inventive concepts" to transform a newly discovered law of nature into a patentable claim) Newman maintains, that claims limited to a small number of routine applications of new discoveries should be allowed, because such claims do not "preempt further study of this science, nor the development of additional applications". In her opinion “the major defect is not the claims lack inventive concept but rather they are overbroad." Thus, the judge suggested narrowing a claim to cover an application actually reduced to practice.Drafting eligible biotech and immunotherapy claims. 2019. Hum Vaccin Immunother. 15/11, 2706-12. S.-J. Wang. doi: 10.1080/21645515.2019.1608746.
Gene Quinn praised Judge Newman's position in this case, stating [her] "dissent in Ariosa would be a way forward for the Federal Circuit and would be in keeping with the admonition from the Supreme Court that 101 not be used to swallow all of patent law."
Denial of rehearing en banc
Sequenom sought rehearing en banc, but in December 2015 it was denied. However, several judges who concurred in the denial wrote separately that they disagreed with the sweep of the Supreme Court's Mayo decision that had compelled the result.
Judge Lourie, joined by Judge Moore, argued that Mayo read without qualification, would not only bar the present invention but would mean that "nothing in the physical universe would be patent-eligible," and thus it was "unsound to have a rule that takes inventions of this nature out of the realm of patent-eligibility on grounds that they only claim a natural phenomenon plus conventional steps." Nonetheless, he agreed that Mayo compelled invalidation of this patent.
Judge Dyk wrote that "a problem with Mayo insofar as it concludes that inventive concept cannot come from discovering something new in nature," especially in biological sciences, is undesirable. But he insisted that "any further guidance must come from the Supreme Court, not this court."
Nonetheless, Judge Dyk offered some speculation as to how the Supreme Court might modify Mayo to accommodate biotech inventions. He suggested the possibility of rule that would exclude trolls but would admit pioneer discoveries of natural laws to a limited extent. Dyk said, "The Mayo/Alice framework works well when the abstract idea or law of nature in question is well known and longstanding, as was the situation in Mayo itself." Yet. it may not be appropriate for discoveries of previously unknown laws of nature:
Yet, "undue preemption" remains a major concern—"the fear that others' innovative future applications of the law will be foreclosed." He therefore proposes a special test for natural law cases, keeping in mind the patent ineligibility of E=mc2 and based on a requirement to keep speculator trolls out:
Dyk adds that he recognizes that the problem with the enablement and written description requirements of 35 U.S.C. § 112 is that they do not provide adequate limitations on claim scope. They "generally require only that one or a handful of representative embodiments be described" by the patent applicant, allow speculative prophesies, and thus do "not entirely prevent claims that preempt future applications of the law of nature by others," as he believes his proposal would. Finally, he said, Sequenom's claims would probably fail under the proposed test. because Sequenom claimed more than it taught: "any diagnosis of any disease, disorder, or condition. . . . impermissible attempts to capture the entire natural phenomenon of cffDNA rather than any particular applications thereof developed and actually reduced to practice by the inventors." Therefore, a future case would be a better vehicle for Supreme Court exposition of the limited, newly discovered natural law aspect of "the Mayo/Alice framework."
Judge Newman alone dissented; in her view the claimed methods were patent eligible even under Mayo because they represent "new applications" of knowledge and not a patent on the knowledge itself.
Certiorari petition
On March 21, 2016, Sequenom filed a certiorari petition.Petition. The petition raises one question only:
On June 27, 2016, the Supreme Court of the United States denied the petition for a writ of certiorari.
Commentary Chris Holman wrote, that the Federal Circuit's opinion "is indeed very bad news for the patenting of diagnostic methods, and in the life sciences generally."Chris Holman, Federal Circuit Decides Ariosa, and It's Not Good News for Innovation in the Life Sciences, (June 12, 2015). Holman said that he hoped that "the Federal Circuit can find some way to rein in the unnecessarily expansive language of Mayo." But if the Federal Circuit is as constrained by Mayo as is believed perhaps only Congress can come to the rescue. Indeed, some members of the US Congress have been trying to pass a law, overturning Mayo decision, but it has not happened as of the end of 2023.