Patent Claims for Prenatal Diagnostic Method Invalidated as Ineligible Subject Matter

November 8, 2013

Method Claims Applying Conventional Techniques to a Natural Phenomenon Held to be Patent Ineligible Subject Matter

By Ali Shalchi

The U.S. District Court for the Northern District of California found Sequenom's patent claims on a prenatal diagnostic method to be invalid and not infringed by Arisoa Diagnostic's Harmony Test product, because the asserted claims were directed at patent ineligible subject matter. Ariosa Diagnostics, Inc. v. Sequenom, Inc., No. 3:11-cv-06391-SI (N.D. Cal. Oct. 30, 2013). The court, applying relevant Supreme Court cases, including Prometheus and Myriad Genetics, found that the patent claims were based on a routine and conventional use of natural phenomenon and were therefore patent ineligible. See Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012) and Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013).

Sequenom is the exclusive licensee of the patent at issue, U.S. Patent No. 6,258,540 ("'540 patent"), which it licensed from Isis Innovation Limited. The '540 patent is directed at non-invasive prenatal detection methods that are performed on a maternal serum or plasma sample to detect a paternally-inherited nucleic acid of fetal origin. The prenatal diagnosis may include sex determination, blood typing and other genotyping, as well as detection of pre-eclampsia in the mother. The '540 patent is based on the discovery in 1996-1997 that cell-free fetal DNA ("cffDNA") is detectable in maternal serum or plasma samples, such that the process of isolating fetal cells was no longer needed.

The litigation was initiated by Ariosa's filing of a declaratory relief action Sequenom, seeking a judgment that its Harmony Test product did not infringe the '540 patent. Sequenom counterclaimed for infringement of the '540 patent and a preliminary injunction. The court denied Sequenom's preliminary injunction upon finding that Ariosa had raised a substantial question regarding the patent's validity. Both parties moved for summary adjudication as to whether certain claims of the '540 patent were drawn to patent-eligible subject matter.

The Court cited the traditionally broad scope of subject matter eligibility under ยง 101 of the Patent Act ("[w]hoever 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") while noting the important exception to that statutory scope, i.e. that laws of nature, natural phenomena, and abstract ideas are not patentable (citing See Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012)).

On summary judgment, it was undisputed that the cffDNA was a natural phenomenon and that neither it, nor its discovery, were patentable. Ariosa argued that certain claims of the '540 patent were directed at patent ineligible subject matter because paternally inherited cffDNA is a natural phenomenon and the claims of the patent merely add well-known, routine activity in the field to that natural phenomenon. Sequenom countered that the claims are patentable because they provide a novel use of the natural phenomenon. Thus, the issue before the Court was whether the steps of the claimed methods, as applied to the natural phenomenon of cffDNA in maternal plasma or serum, are sufficient to render the claims patentable.

Echoing the opinions in Prometheus and Myriad, the court noted that while a process or method is not unpatentable simply because it contains a law of nature, a natural phenomenon, or an abstract idea, to be patentable there must be some "inventive concept" at work beyond the application of "well-understood, routine, and conventional activity." The court also likened the case to Parker v. Flook, 437 U.S. 584 (1978), which involved claims for a three-step method of updating alarm systems that were held not patent-eligible because the only novel feature was a mathematical formula.

The court rejected Sequenom's argument that although the cffDNA is not patentable, the use of cffDNA was patentable:

The Supreme Court has never stated that any use of a natural phenomenon is patentable. To the contrary, the Supreme Court has held that "simply appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable." Prometheus, 132 S. Ct. at 1300. It is only an innovative or inventive use of a natural phenomenon that is afforded patent protection. See Myriad, 133 S. Ct. at 2119 ("Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent."); Flook, 437 U.S. at 594 ("[A]n inventive application of the principle may be patented."). Sequenom attempts to argue that its patent claims an inventive method of using cffDNA. But, based on the undisputed facts before the Court, the only inventive part of the patent is that the conventional techniques of DNA detection known at the time of the invention are applied to paternally inherited cffDNA as opposed to other types of DNA.

Sequenom's argument that its use of cffDNA was inventive because no one had previously started with the mother's plasma or serum to detect paternally inherited fetal DNA, was similarly unavailing in light of the innovation requirement. Thus, the court was unconvinced that there was sufficient novelty or innovation in Sequenom's use of the natural phenomena. Importantly, Ariosa presented evidence, including the specification and prosecution history of the '540 patent and the testimony of Sequenom's own expert, to show that the amplification and detection of DNA sequences in plasma was well known at the time of the invention.

In determining patentability, the court also found that the claims posed a substantial risk of preempting a natural phenomenon. citing Prometheus, 132 S. Ct. at 1294 (stating that Supreme Court case law "warn[s] against upholding patents that claim processes that too broadly preempt the use of a natural law."). The court based this finding on evidence that the claimed method was the only commercially viable method of cffDNA detection:

It is important to note that the '540 patent does not merely claim uses or applications of cffDNA, it claims methods for detecting the natural phenomenon. Because generally one must be able to find a natural phenomenon to use it and apply it, claims covering the only commercially viable way of detecting that phenomenon do carry a substantial risk of preempting all practical uses of it.

Accordingly, upon finding the claims at issue to be patent ineligible, the court granted Ariosa's motion for summary judgment and denied Sequenom's motion for summary judgment.