In an amicus brief co-authored by Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff LLP and Professor Adam Mossoff of George Mason University School of Law, twenty-three law professors urge the Federal Circuit to take a second look at the innovation-threatening panel decision in Ariosa v. Sequenom. They filed their amicus brief on Thursday, August 27, 2015, in support of Sequenom’s petition for rehearing en banc.
Before turning to the important points made by these amici, I’ll first explain what the Sequenom case is about and how the Federal Circuit panel reached the wrong conclusion in striking down Sequenom’s important innovation for diagnostic testing.
Ariosa v. Sequenom: What the Federal Circuit Panel Got Wrong
It’s no secret that the Section 101 jurisprudence is a mess, as novelty and obviousness inquiries are now being analyzed under the rubric of subject matter eligibility. This follows the recent quartet of Supreme Court cases—Bilski, Mayo, Myriad, and Alice—which have significantly narrowed the field of patent-eligible inventions. Making matters worse, lower courts have interpreted the “101 quartet” more broadly than necessary, invalidating many important innovations in the process. One such victim of this judicial overreach is Sequenom’s groundbreaking invention (Patent No. 6,258,540) for the noninvasive diagnosis of fetal abnormalities.
Back in the 1990s, researchers were looking for safer alternatives to invasive prenatal testing methods, such as amniocentesis. Early efforts focused on the mother’s blood, looking for traces of fetal DNA in the blood cells while discarding the blood plasma. In 1996, two doctors discovered that the blood plasma others had thrown out actually contained the fetal DNA everyone was looking for. They developed and patented a method of isolating this fetal DNA and making it suitable for prenatal genetic testing. Sequenom now owns this invention and markets it as the MaterniT21 Plus NIPT.
This past June, a panel of the Federal Circuit held that the invention is not patentable subject matter: “The method . . . begins and ends with a natural phenomenon.” Since the method “begins” with the mother’s blood and “ends” with isolated fetal DNA, the panel determined that “the claims are directed to matter that is naturally occurring.” Moreover, the panel found that there was no “inventive concept that transforms the natural phenomenon . . . into a patentable invention.” Reasoning that each step of the method was “well-understood, conventional and routine” at the time, the panel held that the method was “not new and useful” under Mayo.
The Federal Circuit panel misapplied Mayo. Even if each step, taken individually, is well-known, the question is whether the combination of steps, taken as a whole, is new. As the Supreme Court explained in Diehr:
In determining the eligibility of respondents’ claimed process for patent protection under § 101, their claims must be considered as a whole. It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis. This is particularly true in a process claim because a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made.
This directive that the patentability of a method claim turns on whether there’s a “new combination of steps” was reaffirmed in Mayo, which struck down a patent since “the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field.” The process steps at issue there were, in combination, already routine: (1) administer drug, (2) measure metabolites, and (3) adjust dosage. The insight of the patentee was in precisely defining the correlation between metabolite levels and likelihood of harm. That such a correlation existed was already well-known; it just hadn’t been precisely measured before.
However, this insight was not enough to transform the claimed method into a patent-eligible application of a law of nature. The Supreme Court found that there was no “inventive concept” because the combination of steps was previously known and the correlations were themselves laws of nature. The same is not true for Sequenom’s claimed method. At the time of the discovery, researchers were not looking for fetal DNA in the mother’s blood plasma—they looked instead in the mother’s blood cells. While the existence of fetal DNA in blood plasma is a natural phenomenon, Sequenom’s “inventive concept” was to apply that phenomenon in a combination of steps that no one had ever done before.
The Law Professors’ Amicus Brief
Written by Prof. Mossoff and Mr. Noonan, the law professors’ amicus brief provides two insights into the case—one modern and one historical. The first is that the panel’s decision threatens the very sort of modern innovation the patent system is designed to protect. As the Supreme Court reiterated in Bilski, Section 101 is a “dynamic provision designed to encompass new and unforeseen inventions.” The amici note that the “development and commercialization of prenatal genetic diagnostic tests is exactly the type of twenty-first-century innovation the patent system is designed to promote as a historically ‘unforeseen invention.’”
The research and development of modern diagnostic methods, like Sequenom’s groundbreaking process for the noninvasive prenatal testing of fetal DNA, require huge expenditures of resources. Moreover, the value of such genetic testing methods has grown dramatically in recent years as it improves patient care while decreasing the associated costs. As the amici point out: “The economics of innovative diagnostic tests reflect exactly the economic justification for the patent system: the cost of applying a genetic diagnostic test is relatively low, but the ex ante R&D cost is enormous and is not reflected in the marginal cost of the medical test itself.”
Diagnostic tests require the investment of many tens of millions of dollars to produce, and the patent system exists to promote such investment by granting exclusive property rights to inventors. The amici explain the negative consequences of the panel’s reasoning:
The panel decision . . . threatens to preclude many genetic and other diagnostic tests from the ambit of patent protection. It disincentivizes making the massive R&D investments required to create this new innovation in the twenty-first century. This is neither hyperbole nor conjecture. For example, Accelerate Diagnostics recently warned its investors that it “incurred significant costs in connection with the development and commercialization of [its] [diagnostic testing] technology” and “[i]f we are unable to effectively protect our . . . intellectual property, our business would be harmed.”
The historical insight of the amici is the fact that the panel’s reasoning casts “serious doubt about classic nineteenth-century patented innovation either validly issued under the patent laws or sustained by the Supreme Court.” For example, the amici point to the O’Reilly v. Morse opinion from 1853, where the Supreme Court upheld several of Samuel Morse’s method claims relating to his invention of the telegraph. Claim 1 of Morse’s patent, which the Court held patentable, provided in relevant part:
First. . . . what I specially claim as my invention and improvement, is making use of the motive power of magnetism, when developed by the action of such current or currents substantially as set forth in the foregoing description of the first principal part of my invention, as means of operating or giving motion to machinery which may be used to imprint signals upon paper or other suitable material, or to produce sounds in any desired manner, for the purpose of telegraphic communication at any distances.
As the amici elucidate, this claimed method would likely be patent-ineligible subject matter under the panel’s decision:
Claim 1 recites conventional activity for the art in his time. First, Morse acknowledges in his specification that “it had been essayed to use the currents of electricity or galvanism for telegraphic purposes” before his invention, and he even acknowledges later in Claim 1 that “[t]here are various known methods of producing motion by electro-magnetism.”
Second, the steps he states in Claim 1 of “operating or giving motion to machinery,” “imprinting signals upon paper or other suitable material,” and “produc[ing] sounds,” when assessed individually were undeniably routine and conventional in the 1830s when Morse invented his electro-magnetic telegraph.
Accordingly, the Ariosa panel’s application of the Mayo test, if applied to Claim 1 of Morse’s patent in the same way the panel applied it to Sequenom’s patent, leads to the conclusion that Morse’s Claim 1 is arguably unpatentable subject matter. But this directly contradicts the Supreme Court’s analysis and decision in Morse that Claim 1 is valid.
Likewise, the amici look at Claim 5 of Alexander Graham Bell’s patent for the telephone. Though it merely recited a natural phenomenon and well-known steps to apply it, the Supreme Court upheld the claim in 1888. The amici also point to the very first patent, issued in 1790 to Samuel Hopkins, for his method of making potash. All of the individual steps in the claimed method were well-known at the time, and his innovation was the development of a new combination of steps that no one had done before. Under the panel’s reasoning, the very first patent would probably fail because this new combination would not qualify as an “inventive concept” under its version of the Mayo analysis.
More importantly, the amici note the historical significance of Hopkin’s patented method:
Hopkins’ patent was signed by Thomas Jefferson as Secretary of State and as a member of the committee created under the 1790 Patent Act who reviewed Hopkins’ application. Jefferson was both a drafter of some of the early patent laws and has long been known for his views that patents should be severely restricted in their issuance to inventors. Moreover, Hopkins’ patent was issued under the 1790 Patent Act, which was drafted by many of the original Framers of the Constitution who were then serving in Congress.
Justices and constitutional scholars recognize legislation from the First Congress as having significant import as to the meaning of the Constitution. This includes the Copyright and Patent Clause’s authorization for Congress to secure an “exclusive Right” to “Inventors” for their “Discoveries” in order to advance the “progress of . . . useful Arts.” Thus, when a contemporary court reaches a decision that calls into question a patent validly issued under the 1790 Patent Act and signed by Jefferson himself, it is cause to question whether this court has applied the law correctly.
As the amici correctly argue, the panel’s decision striking down Sequenom’s noninvasive prenatal test strikes at the very heart of the patent system. Revolutionary diagnostic testing methods that cost tens of millions of dollars to produce should be the flagship of the modern patent system. But the panel’s misapplication of Mayo calls into doubt many meritorious inventions that benefit us all. Moreover, the panel’s reasoning simply cannot be squared with several innovations that the Supreme Court has historically upheld as proper statutory subject matter. Hopefully the entire Federal Circuit will agree to take up this important case so that vital innovations such as Sequenom’s patented method continue to be produced.