Editorial Note: The following post is taken from the NYIPLA amicus brief filed in Ariosa v. Sequenom. Dorothy Auth, President of the NYIPLA, as well as John Murnane, Irena Royzman, Alicia Russo, and David Ryan, and Erin Austin were authors on the brief. Charles Macedo, Irena Royzman and David Ryan are Co-Chairs of NYIPLA’s Amicus Briefs Committee and Robert Isackson is the NYIPLA Board Liaison.
The Supreme Court has long recognized that the proper test for determining patent eligibility is whether the claimed subject matter falls within one of the four statutory classes of subject matter and does not preempt what this Court has called a “fundamental principle” (i.e., abstract idea, natural phenomena or law of nature). See Diamond v. Diehr, 450 U.S. 175, 185 (1981) (citing Parker v. Flook, 437 U.S. 584 (1978); Gottschalk v. Benson, 409 U.S. 63, 67 (1972); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948)). Neither Mayo nor Alice changed this.
While Mayo and Alice presented a two-part “framework” to address when a particular claimed invention preempts a “fundamental principle,” neither case purported to have that framework replace a preemption inquiry nor authorize a court to ignore the ultimate question, i.e., does the claim preempt a fundamental principle instead of merely claim a practical application of such a principle?
The claims in Sequenom’s U.S. Patent No. 6,258,540 (“the ‘540 patent”) are directed to noninvasive detection of paternally inherited cell-free fetal DNA (“cffDNA”) in the blood or plasma of pregnant women, allowing for early detection of certain genetic traits without the serious risks posed by prior procedures, such as amniocentesis. Sequenom offered evidence that there are other uses of cffDNA other than those claimed in the ‘540 patent and thus, preemption did not exist.
In this case, the Panel held that several claims in the ‘540 patent were invalid because they were not directed to patent-eligible subject matter under the Mayo framework. The Panel further concluded that “[w]here a patent’s claims are deemed only to disclose patent ineligible subject matter under the Mayo framework, as they are in this case, preemption concerns are fully addressed and made moot.” Op. at 14-15 (emphasis added). The Panel did so while acknowledging that “[t]he Supreme Court has made clear that the principle of preemption is the basis for the judicial exceptions to patentability.” Id. at 14 (citing Alice, 134 S. Ct. at 2354). Amicus Curiae respectfully submits that the Panel’s conclusion is clear error and needs to be corrected.
The Panel erroneously applied the Mayo framework in a mechanical manner (much like the machine or transformation test, Friedman-Walter-Abele and technological arts tests had been applied in the past), ignoring the goal of the inquiry—to determine if the claim includes enough “something more” to avoid preempting the fundamental principle in question. This type of rigid analysis of prior Supreme Court patent-eligibility frameworks was rejected in Bilski v. Kappos, 561 U.S. 593 (2010) and is likewise incorrect here.
It is well-settled that the proper test for determining patent eligibility is whether the claimed subject matter falls within one of the four statutory classes of subject matter and does not preempt a so called fundamental principle. Diehr, 450 U.S. at 185. In Diehr, the Supreme Court acknowledged these as “long- established standing principles.” Id. (referring to Parker, 437 U.S. 584 and Gottschalk, 409 U.S. 63).
The Supreme Court has also made clear that patents that “pose no comparable risk of pre-emption … remain eligible for the monopoly granted under our patent laws”:
In applying the § 101 exception, we must distinguish between patents that claim the “‘buildin[g] block[s]'” of human ingenuity and those that integrate the building blocks into something more, Mayo 566 U.S., at ___, 132 S. Ct. at 1303, thereby “transform[ing]” them into a patent-eligible invention, id., at ___, 132 S. Ct. at 1294. … The latter pose no comparable risk of pre-emption, and therefore remain eligible for the monopoly granted under our patent laws.
Alice, 134 S. Ct. at 2354-55 (emphasis added).
The failure to consider preemption has resulted in courts and the PTO over-using §101 in a gatekeeper or threshold fashion for which it was never intended to be used, either as enacted by Congress or as interpreted by the Supreme Court. Cf. Dann v. Johnston, 425 U.S. 219, 221 (1976) (avoiding a §101 determination in favor of a §103 analysis).
Accordingly, Amicus Curiae respectfully submits that the Panel should have considered preemption when applying the framework of Mayo. The full Court should grant rehearing to correct this legal error en banc.