Digest of Ariosa Diagnostics, Inc. v. Sequenom, Inc., No. 2014-1139, 2014-1144 (Fed. Cir. June 12, 2015) (precedential). On appeal from N.D. Cal. Before Reyna, Linn, and Wallach.
Procedural Posture: Defendant patent holder appealed the district court’s summary judgment of invalidity of a patent directed to methods of using cell-free fetal DNA (“cffDNA”) to determine fetal characteristics, such as gender. The district court found that the asserted claims are not directed to patent-eligible subject matter and therefore are invalid under 35 U.S.C. § 101. The Federal Circuit affirmed.
- Patent Eligibility (Section 101): Method claims are generally patent-eligible, but they, too, have to satisfy the Mayo test for patent-eligible subject matter. Here, the patent claims the method of detecting paternally inherited cffDNA, which begins with cffDNA in maternal blood and ends with paternally inherited cffDNA—both naturally occurring phenomena. Thus, the claims are directed to a patent-ineligible concept, under step 1 of the Mayo test.
- Patent Eligibility (Section 101): Where claims of a method patent are directed to an application that starts and ends with a naturally occurring phenomenon, the patent fails to disclose patent eligible subject matter under the Mayo test if the methods themselves are conventional, routine and well understood in the art. Under Mayo, the process steps themselves must be “new and useful” to transform the natural phenomenon into a patent-eligible subject matter. This particular method, consisting of the preparation and amplification of DNA sequences in plasma or serum—well-understood, routine, conventional activities performed by doctors in 1997—does not transform the manipulation of cffDNA into a patentable invention, failing step 2 of the Mayo test.
- Patent Eligibility (Section 101)/ Preemption: Claims covering the only commercially viable way of detecting a phenomenon carry a substantial risk of preempting all practical uses of it because generally one must first be able to find a natural phenomenon to use it and apply it. The Federal Circuit affirmed the principle that questions on preemption are inherent in and resolved by the Section 101 analysis.
- Patent Eligibility (Section 101): The Federal Circuit considered and rejected the patentee’s arguments that its groundbreaking invention should be patent-eligible because it “revolutionized prenatal care,” relying on the language in Myriad that “groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” The discovery regarding the cffDNA, even though a “positive and valuable contribution to science,” still can “fall short of statutory patentable subject matter.”
- Judge Linn, concurring: The finding of invalidity of all method claims containing conventional post-solution steps, bound by the Supreme Court’s “sweeping language of the test set out in Mayo,” is a “consequence—perhaps unintended—of that broad language in excluding a meritorious invention from the patent protection.” But for the law of Mayo, when a method has “effectuated a practical result and benefit not previously attained,” such as in this case, there is “no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible.”
Note: Special thanks to Na Kyung Lee, a 2015 Kenyon summer law clerk.