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The Impact of Ariosa Diagnostics v. Sequenom on the Patent Eligibility of Biomarker Detection Methods

Posted in Development & Commercialization of Technology, Intellectual Property, Patent Counseling & Strategies, Patent Law, Patent Prosecution

Under the Patent Act, one can patent “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”[1] Common exceptions to what can be patented include laws of nature, natural phenomena, and abstract ideas[2]. In a recent decision in Ariosa Diagnostics v. Sequenom (Sequenom), The United States Court of Appeals for the Federal Circuit held that a patent covering methods of detecting cell-free fetal DNA is not eligible for patenting because it pertains to nothing more than a natural phenomenon[3]. Unless this decision is reversed by the Supreme Court, it could adversely affect the patentability of some biomarker detection methods.

The patent at issue in Sequenom pertained to a method of detecting cell-free fetal DNA (cffDNA), a non-cellular DNA that floats freely in the blood stream of pregnant women[4]. The detection methods involved amplifying segments of the cffDNA by various methods, such as the polymerase chain reaction[5].

In reaching its decision, the Court reasoned that the patent at issue is not eligible for patenting because it “starts and ends with a naturally occurring phenomenon” (i.e., cffDNA)[6]. Moreover, the Court reasoned that the cffDNA amplification step did not make the invention eligible subject matter because the amplification methods were “conventional, routine and well understood applications in the art.”[7] In particular, the Court indicated that, “[b]ecause the method steps were well-understood, conventional and routine, the method of detecting …cffDNA is not new and useful.”[8] The Court also stated that “appending routine, conventional steps to a natural phenomenon, specified at a high level of generality, is not enough to supply an inventive concept.”[9]

The full impact of Sequenom remains to be determined. It is doubtful that the ruling in Sequenom will affect the patentability of all biomarker detection methods. For instance, biomarker detection methods that utilize “unconventional” detection methods may still be eligible for patenting in view of Sequenom. However, the ruling in Sequenom may affect the patentability of diagnostic methods that rely on the amplification of naturally occurring biomarkers through “conventional” and “routine” techniques. Furthermore, terms such as “unconventional”, “conventional” and “routine” may become subject to different interpretations.

[1] 35 U.S.C. § 101

[2] Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014)

[3] Ariosa Diagnostics, Inc. v. Sequenom, Inc., 2014-1139, 2014-1144, (Fed. Cir. 2015)

[4] Id. at page 3

[5] Id.

[6] Id. at page 13

[7] Id.

[8] Id. at page 11

[9] Id. at page 13