Federal Circuit Court Invalidates Diagnostic Patent for Method of Accessing Fetal DNA

In Ariosa Diagnostics, Inc. v. Sequenom, Inc., the U.S. Court of Appeals for the Federal Circuit held that a method of diagnostic testing was not eligible for a patent.


In a cutting-edge decision at the intersection of medical testing and patent law, the U.S. Court of Appeals for the Federal Circuit affirmed a trial court decision to invalidate a patent for a method for accessing fetal tissue. The patent involved a method for non-invasively measuring “cell-free fetal DNA” (abbreviated by scientists as "cffDNA") that exists in maternal plasma and serum. The patent was challenged in a case known as Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015).

Applying the holdings of several recent U.S. Supreme Court cases, the Federal Circuit ultimately held that, even though the discovered method may have been groundbreaking, it did not meet the requirements for patent eligibility under 35 U.S.C. § 101, because it largely involved naturally occurring phenomena.

Factual Background of Ariosa Case

Ariosa Diagnostics, Inc. v. Sequenom, Inc. centered around a challenge to the validity of U.S. Patent No. 6,258,540, exclusively licensed by Sequenom, Inc., which claimed protection over methods of non-invasively measuring cffDNA in maternal plasma. Sequenom’s patent involved a technique for detecting and amplifying paternally inherited diseases contained in these prenatal materials.

Not everyone was pleased about Sequenom’s attempt to patent this method of testing. Ariosa Diagnostics, Inc., a competitor of Sequenom, sought a declaration from the U.S. District Court for the Northern District of California that Sequenom’s patent was invalid.

Such prenatal plasma materials were typically discarded as waste, as doctors were unaware of their potential. As the trial court noted, “[p]rior noninvasive DNA research had focused on detecting fetal cells in a mother's bloodstream, because the presence of cell-free fetal DNA was not known. However, these techniques were time-consuming or required expensive equipment.” Sequenom’s patent sought to capture a discovery that cffDNA is detectable in maternal plasma samples, and that “the detection rate is much higher using serum or plasma than using nucleated blood cell DNA extracted from a comparable volume of whole blood.”

In layman’s terms, Sequenom’s patent’s practical application was to use the tests to determine whether there were any abnormalities in the fetus, specifically health conditions that passed through the father’s genes.

Ariosa Diagnostics, which employed its own, similar test known as the “Harmony Test,” argued that Sequenom’s method was not eligible for a patent under controlling U.S. Supreme Court case law. Specifically, Ariosa Diagnostics argued that paternally inherited cffDNA is a natural phenomenon. Sequenom’s patent, it argued, merely described “well-understood, routine, conventional activity” for scientific researchers, which it should not have exclusive rights to control.

Sequenom countered that its patent was valid, as it employed novel uses of natural phenomenon that were previously unknown by scientists.

Relying on recent Supreme Court precedent, the trial court ultimately agreed with Ariosa Diagnostics, holding that “the only inventive concept contained in the patent is the discovery of cffDNA, which is not patentable.”

The Federal Circuit’s Opinion

In a unanimous decision issued on June 12, 2015, the U.S. Court of Appeals for the Federal Circuit (the court with jurisdiction over most patent appeals) affirmed the decision of the U.S. District Court for the Northern District of California.

Both the trial court and the Federal Circuit relied on the language of the Patent Act as well as recent Supreme Court precedent. 35 U.S.C. § 101 of the Patent Act provides: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”

In the recent case of Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), the Supreme Court interpreted this provision and cautioned that “‘[L]aws of nature, natural phenomena, and abstract ideas’… are not patentable. Thus… ‘a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc 2; nor could Newton have patented the law of gravity. Such discoveries are ‘manifestations of… nature, free to all men and reserved exclusively to none.’”

The High Court has reiterated this idea in Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) and Alice Corp. Pty. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014), disapproving of patents that give exclusive control over “[g]roundbreaking, innovative, or even brilliant” discoveries of fundamentally natural phenomena.

Because the Federal Circuit agreed that Sequenom’s testing methods amounted to basic applications of a new discovery of a natural phenomena, it was not eligible to be patented: “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 if the methods themselves are conventional, routine and well understood applications in the art.”

Conclusion and Ramifications of Ariosa Case

The Federal Circuit’s decision serves as a reminder to medical researchers and biotech developers that there are boundaries to patent-eligible subject matter. As the Supreme Court and Federal Circuit have cautioned, the Patent Act will not permit patents over naturally occurring phenomena.

Though the case is controversial among some patent scholars and scientists, the Federal Circuit’s decision is likely to stand for the foreseeable future. On June 27, 2016, the U.S. Supreme Court denied certiorari, meaning it will not hear an appeal.

Effective date: June 12, 2015