In June of this year, the Federal Circuit panel in Ariosa Diagnostics, Inc. v. Sequenom, Inc. invalidated a patent on the grounds of patent-ineligible subject matter. 788 F.3d 1371 (Fed. Cir. 2015). While the case is one of many since the Supreme Court’s Mayo decision involving patent invalidation under Section 101 of the Patent Act, Ariosa is unusual in that the asserted patent covered what most experts in the medical field consider to be a groundbreaking discovery; the very type of discovery that the patent system is intended to protect. In response to the panel’s decision, and perhaps encouraged by Judge Linn’s provocative concurrence, the Appellant, Sequenom, filed a petition for rehearing en banc and twelve amici curiae filed briefs in support of Sequenom’s petition. On October 19, Appellees Ariosa and Natera filed responses to Sequenom’s petition following an invitation from the Federal Circuit. While it is always difficult to predict whether the Federal Circuit will rehear a case en banc, the court’s invitation for a response from the Appellees, Linn’s concurrence, and the strong support of Sequenom’s amici curiae suggest that the prospect for Ariosa is promising.
It is an undisputed doctrine of patent law that laws of nature, natural phenomena, and abstract ideas are not eligible for patent protection. And since 2010, the Supreme Court has expanded on this doctrine, issuing four landmark rulings invalidating patents under Section 101. Bilski v. Kappos, 561 U.S. 593 (2010); Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __, 132 S. Ct. 1289 (2012); Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107 (2013); Alice Corp. v. CLS Bank International, __ U.S. __, 134 S. Ct. 2347 (2014). In each of the four cases, the Supreme Court reinforced the doctrine of patent-ineligibility as a means of invalidating patents.
The current framework for analyzing patent eligibility is a two-part test that was established by the Supreme Court in Mayo. Mayo, 566 U.S. at 1297. First, courts must determine whether the claims are generally directed to a patent-ineligible concept (i.e., a law of nature, natural phenomenon, or abstract idea). Id. If the question is answered in the affirmative, courts must then determine whether the claims contain an “inventive concept,” or “elements or a combination of elements… sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself.” Id. at 1294, 1298 (citation omitted). If not, then the subject matter is patent-ineligible.
The technology in Ariosa involves non-invasive DNA-based blood tests used for prenatal diagnostics. Plaintiffs Ariosa, Natera, and DNA Diagnostics Center, and Defendant Sequenom are competitors in the prenatal diagnostics market. Sequenom and Ariosa make and sell non-invasive diagnostic tests that are used to detect fetal chromosomal abnormalities, such as Down Syndrome and Edwards Syndrome. Natera and DNA Diagnostics Center make and sell non-invasive tests used to establish paternity of a fetal sample. Prior to the technology used in Ariosa, prenatal diagnostics could only be performed by highly invasive procedures that carry the risk of fetal injury and miscarriage, such as chorionic villi sampling (CVS) and amniocentesis. The technology in Ariosa is groundbreaking in that it enables fetal diagnostics without subjecting pregnant women and their developing fetuses to the risks associated with the traditional diagnostic methods.
The asserted patent, U.S. Patent No. 6,258,540 (“the ’540 patent”), covers methods of detecting cell-free fetal DNA (“cffDNA”) to determine fetal characteristics, such as gender, paternity, and chromosomal abnormalities. cffDNA is DNA that originates from a pregnant woman’s placenta that reflects genetic characteristics of the developing fetus. Because cffDNA circulates freely in the blood stream of pregnant women, it can be obtained from patients and used for diagnostic tests without the use of invasive procedures.
In December of 2011, Plaintiffs Ariosa and Natera filed declaratory judgment actions against Defendant Sequenom in the Northern District of California, seeking a declaration of non-infringement of the ’540 patent. Sequenom filed counterclaims alleging infringement against Ariosa, Natera, and DNA Diagnostics Center. In October 2013, the Northern District granted Ariosa’s motion for summary judgment of invalidity of the ’540 patent under Section 101.
The Federal Circuit affirmed the district court’s determination that the claimed subject matter was patent-ineligible. Applying the first step of the Mayo framework, the panel held that the claims were directed to a patent-ineligible concept. More specifically, the court found that “the claims at issue… are generally directed to detecting the presence of a naturally occurring thing or a natural phenomenon, cffDNA in maternal plasma or serum.” Ariosa, 788 F.3d at 1376. Applying the second step of the Mayo framework, the panel held that the claims did not contain an inventive concept since the additional claim elements, which were DNA amplification and detection steps, were “well-understood, routine and conventional” at time of invention. Id. at 1371. In support of that finding, the panel reasoned that in order for the additional steps in the process claim to qualify as an inventive concept, it is not enough for the steps to be used in a new application; rather, the steps must themselves be new and useful. Id. at 1377. Thus, even though the steps of DNA amplification and detection had never been performed in the context of cell-free fetal DNA, such steps did not constitute an inventive concept as methods such as PCR were widely-known and practiced at the time of invention.
Regarding the preemption issue, the Federal Circuit opted not to decide the issue on its merits, instead holding that “[w]here a patent’s claims are deemed only to disclose patent ineligible subject matter under the Mayo framework… preemption concerns are fully addressed and made moot.” Id. at 1379.
Perhaps even more interesting than the panel’s decision was Judge Linn’s concurrence. While agreeing with the majority’s application and analysis based on Mayo, Linn expressed strong disapproval at the result. He lamented: “But for the sweeping language in the Supreme Court’s Mayo opinion, I see no reason, in policy or statute, why this breakthrough invention should be deemed patent ineligible.” Id. at 1381 (Linn, J., concurring).
Linn’s concurrence explains that the problem with the Mayo framework is that the second step of the test is overly broad and consequently invalidates otherwise valid patents. Under the Federal Circuit’s interpretation of Mayo, if the “additional elements” analyzed under the second step comprise any type of “conventional activity,” then such steps do not constitute “inventive concepts.” But Linn suggests that in certain situations, such as where the conventional activity has never been performed in the context of the newly discovered phenomenon, such activity should constitute an inventive concept and therefore transform an otherwise patent-ineligible claim into a patentable one. Linn argues that such should have been the case in Ariosa, where “no one was amplifying and detecting paternally-inherited cffDNA using the plasma or serum of pregnant mothers.” Id.
On August 13, 2015, Sequenom filed a petition for rehearing en banc, and the petition was followed by twelve supporting amici curiae briefs. The petition presents two main arguments: first, that the panel’s decision is inconsistent with Supreme Court precedent, and second, that the decision greatly threatens innovation by making meritorious inventions patent-ineligible. The amici curiae similarly argue that the panel’s decision should be reversed. They further explain why the decision should not stand from both legal and policy perspectives. The petition and briefs emphasize the consequences that Ariosa will have on the life sciences industry in particular, and innovation, as a whole. New diagnostics, new uses of old drugs, new vaccines, personalized medicine applications, and indeed, any invention—no matter how groundbreaking—that uses old techniques on the discovery of a natural phenomenon, will no longer be eligible for patent protection.
On October 19, Ariosa and Natera submitted responses to Sequenom’s petition following an invitation from the Federal Circuit. History indicates that we can expect a decision within the next few months. While there is no way to predict whether the Federal Circuit will grant the rehearing en banc, it is clear through Linn’s concurrence, Sequenom’s petition, and the twelve amici curiae briefs that a decision by the Federal Circuit not to reconsider, clarify or overturn Ariosa may be an invitation for the Supreme Court’s review.