By Kevin E. Noonan --
Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (see "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)"). Last month, Sequenom filed a petition for rehearing en banc, arguing that the panel's decision in June was inconsistent with the Supreme Court's decisions in Diamond v. Diehr, 450 U.S. 175 (1981), Mayo v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), and that the panel's decision poses a threat to patent protection in multiple fields of invention. On August 27, twelve amicus curiae briefs were filed in support of Sequenom's petition for rehearing en banc. Over the past few weeks, Patent Docs has been examining these amicus briefs. Today, we review the brief submitted by JYANT Technologies, Inc.
In the brief's Statement of Interest, the amicus states that it is from Marietta, Georgia and is "an early-stage biotechnology/pharmaceutical development company" with an emphasis on companion diagnostics. Specifically, its technologies "provide ground-breaking solutions to diagnosis and treat cancers and inflammatory diseases through the use of anti-chemokine and anti-chemokine receptor antibodies." Patent protection, it says, "is critical to ensure the resources needed for its continued research and development" and the panel decision "threatens to wreak havoc on patent law."
JYANT argues that the panel decision is wrong but acknowledges that the "Supreme Court's efforts have fallen short of clear guidance for distinguishing between a patent-ineligible 'law of nature, natural phenomenon, and abstract idea' and an eligible 'new and useful process, machine, manufacture, or composition of matter.'" Nevertheless, JYANT contends that the panel decision "fundamentally misreads" the Court's precedent, from Funk Brothers Seed Co. v. Kalo Co., 333 U.S. 127 (1948), through Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013). Further, the brief asserts that the panel ignored why patent law exists in the first place: to promote progress. In this context, "progress" is in the field of diagnostic tests, and the brief argues that progress in developing a particular diagnostic test does not preempt future research for developing other tests, but rather "it encourages the dissemination of ideas and enables others to invent improved or alternative diagnostic methods" (albeit ignoring the panel's disregard for the preemption issue). Nevertheless, the brief argues that obviousness, rather than patent eligibility, is the proper patent requirement that should be applied to the question. JYANT concludes the summary of its argument by noting that should the panel decision stand, it "threatens to abolish wide swaths of existing and future intellectual property" including "[a]lmost every diagnostic test, whether medical, chemical, or agricultural, relies on some natural phenomenon" because these tests "frequently apply known tools, such as reagents or procedures, to solve a specific problem." The panel's reasoning would render all such inventions ineligible without regard to whether they are novel and non-obvious (which, it must be said, is precisely the point of this attack on the patent system).
The brief enunciates two specific arguments in support of these general themes. The first is that the panel ignored the purpose of the patent clause entirely and "contravened" precedent (which is a little harsh in view of the softness of that precedent). Specifically, the brief argues that the panel ignored the context in which the Mayo decision was reached and that this led to error in how that precedent was applied. Simply put, the brief finds no mandate in the Mayo decision, properly applied, for invalidating diagnostic methods merely because they incorporate known techniques. In making this argument, the brief characterized the Court's Myriad decision (as other amici have done) to stand for patent ineligibility of isolated genomic DNA but patent eligibility for methods "implementing" such genetic knowledge. This argument focuses (as have others' arguments) on Section III of the Myriad opinion, wherein Justice Thomas and a unanimous Court cited with approval Federal Circuit Judge Bryson's "apt observation" that Myriad had alternatives to claiming genomic DNA, because ""[a]s the first party with knowledge of the [gene] sequences, Myriad was in an excellent position to claim applications of that knowledge." Diehr contains similar reasoning, according to JYANT, focusing on the known character of each of the steps but the "patent-eligible improvement of using a particular algorithm together with known steps to achieve an improved result." This is precisely the situation here, according to the brief: the use of "known tools ["blood fractionation, PCR, and detection"] in a novel manner based on a unique scientific insight."
The brief further supports this argument in a creative way, by noting that the Court in Funk Brothers v. Kalo affirmed earlier precedent (Cameron Septic Tank Co. v. Village of Saratoga Springs, 159 F. 453 (2d Cir. 1908)) supporting the argument that claims should considered as a whole:
Claim 1 in Cameron Septic Tank covered a "process of purifying sewage, which consists in subjecting the sewage under exclusion of air, of light and of agitation to the action of anaerobic bacteria until the whole mass of solid organic matter contained therein becomes liquefied, and then subjecting the liquid effluent to air and light." The Second Circuit explained that neither the individual steps nor the anaerobic bacteria used in the process were new [internal citations omitted].
What the Cameron Court recognized, and the Supreme Court in Funk Bros. affirmed, according to the brief, was the "particular implementation of old steps to achieve a new result" as the "innovative feature" of the invention. By necessity (and aided by the Second Circuit's rejection in Cameron of the defendant's argument that the claims were patent ineligible for being a "process of nature"), the brief argues that the Funk Bros. Court's approval of the precedent means the Court "necessarily agreed that conventional tools, employed in a novel combination configured to utilize a natural phenomenon, can be patent-eligible."
With regard to this argument the brief also asserts that Sequenom's claims "do not present the preemption risk of which the Supreme Court has frequently warned" because the claims are sufficiently limited with regard to the methods steps recited therein that the "law of nature" (the existence of paternally derived cffDNA in maternal blood) could be detected using other, unclaimed methods. The "ultimate utility" of the invention is to use a blood test to "determine characteristics of the fetus, such as gender, Rh type, and certain genetic abnormalities." The brief distinguishes Sequenom's methods from Myriad's claims to genomic DNA because in the Myriad case this patenting "might have tied up the basic informational building blocks of the human genome" (honesty would require "might" to be emphasized).
Finally in this section, the brief identifies as a "further flaw" by the panel substituting the eligibility question for obviousness; obviousness has the advantage of "provid[ing] an analytical framework with which a court can objectively determine whether a claimed diagnostic test is a significant enough advance so as to warrant patent protection," citing Graham v. John Deere Co., 383 U.S. 1, 17 (1966). Obliquely, this section of the brief illustrates the negative consequences of this substitution by reminding the Court that "patent protection creates the necessary incentive to develop and disseminate groundbreaking diagnostic technologies" and that the proper distinction between Section 101 and 103 is that "the obviousness inquiry ensures the proper balance of patent protection to provide the necessary incentive for continued innovation."
In the brief's second argument, JYANT argues that the panel decision also "threatens to undermine patent protection for a wide variety of inventions, including diagnostic tests" and "decimate the very legal protection that incentivizes the development of so many useful tools that improve the human condition." What follows is an explication of how patenting has fostered "the development of medical diagnostic tests of all types" and thereby "improv[ed] the standard of care in the vast majority of medical decisions." Because "[a]ll of these tests, at their base, are specific applications relying on some natural phenomenon," the brief argues that the panel decision would make companies "less inclined to invest in research for diagnostic tests." And this section of the brief contends that, using the panel's reasoning, even the polymerase chain reaction itself would not have been patent eligible (noting the Nobel Prize-winning nature of PCR, albeit forgetting how little weight courts are giving inventions of this quality).
JYANT Technologies was represented on the brief by Matthew J. Dowd, Robert A. Gutkin, and Sushila Channana of Andrews Kurth LLP.
For additional information regarding this topic, please see:
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: NYIPLA," September 28, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Novartis AG," September 23, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Paul Gilbert Cole," Setember 22, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Bioindustry Association," September 20, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: WARF, Marshfield Clinic, and MCIS, Inc.," September 17, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: BIO and PhRMA," September 16, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Amarantus Bioscience Holdings, Personalis, Inc., and Population Diagnostics, Inc.," September 15, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Coalition for 21st Century Medicine," September 14, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: IPO," September 8, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Professors Lefstin and Menell," September 6, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: 23 Law Professors," September 3, 2015
• "Amici Support Sequenom's Petition for Rehearing En Banc," August 28, 2015
• "Sequenom Requests Rehearing En Banc," August 18, 2015
• "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015), June 22, 2015