The viability of many diagnostic method patents is in serious question after the recent Federal Circuit decision, Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015). There are four threshold requirements that must be established by a potential patentee in order to establish his or her right to a patent: (1) the invention must be directed to patent-eligible subject matter; (2) the disclosure must enable one of skill in the art to make and use the invention; (3) the invention must be novel; and (4) the invention must be non-obvious. While the focus of most patent practitioners has traditionally been on the latter two requirements, patent eligibility has become more difficult to establish in view of recent Supreme Court precedent. This article considers the state of the law for patent eligibility of diagnostic methods and compares patent eligibility in the U.S. under Ariosa to patent eligibility required under the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”). The article further explores the movement towards international patent harmonization and whether patent eligibility in the U.S. under Ariosa is in accordance with the requirements of TRIPS.

It has become increasingly difficult for the biotech industry to establish the patentability of diagnostic methods in view of the Supreme Court’s Mayo and Alice decisions. Specifically, Alice further defined Mayo’s standard for patent eligibility in announcing a two-part test: (1) determine whether the claims are directed to a patent-ineligible concept such as a law of nature, natural phenomenon or abstract idea; and (2) determine whether the claim’s other elements, considered both individually and as an ordered combination, transform the nature of the claims into a patent-eligible application, such that they are directed to an inventive concept.

In Ariosa, the Federal Circuit had the opportunity to address the patent eligibility of diagnostic method patent claims in view of Mayo and Alice. See Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015). The invention in Ariosa was related to the discovery of cell-free fetal DNA (“cffDNA”) in maternal plasma and serum. Id. at 1373. The inventors in Ariosa isolated cffDNA from the mother’s blood to detect paternally inherited cffDNA that allowed them to determine fetal characteristics such as gender. The subject claims were directed to methods for detecting and amplifying paternally inherited nucleic acid from maternal plasma or serum and methods of performing prenatal diagnosis based thereon. Id. at 1373-74.

The Federal Circuit affirmed the district court’s holding that the claims were directed to patent-ineligible laws of nature and natural phenomenon. Id. at 1378. Specifically, applying the two-part framework set forth above, the Federal Circuit found that it was undisputed that the existence of cffDNA in maternal blood is a natural phenomenon, and that “in this case, appending routine, conventional steps to a natural phenomenon, specified at a high-level of generality is not enough to supply an inventive concept. 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.” Ariosa at 1378. The Court further explained that, “The method at issue here amounts to a general instruction to doctors to apply routine, conventional techniques when seeking to detect cffDNA. Because the method steps were well-understood, conventional and routine, the method of detecting paternally inherited cffDNA is not new and useful. The only subject matter new and useful as of the date of the application was the discovery of the presence of cffDNA in maternal plasma or serum.” Id. at 1377.

A petition for rehearing en banc was denied by the Federal Circuit. However, two concurrences and one dissent were filed with the order denying the petition that questioned the restrictive Alice/Mayo framework. There has been much speculation that the Supreme Court may take up the case to provide further guidance in this area, and a petition to the Supreme Court for a writ of certiorari was filed on March 21, 2016.

The major concern for the biotech industry arising from the Alice/Mayo framework as applied in Ariosa is that many diagnostic method patents are discovery-based inventions. For example, the key to the invention in Ariosa was the discovery of cffDNA in maternal blood. That discovery allowed researchers to isolate and analyze cffDNA in a less invasive way than previous methods. However, the existence of cffDNA in a mother’s blood is a natural phenomenon, and because the steps of isolating and analyzing the cffDNA were otherwise routine and conventional, the panel concluded that this was patent ineligible subject matter. That has the possible impact of wiping out many diagnostic method patents that are based upon the use of routine and conventional methods in connection with a new biological discovery.

However, the patent eligibility of the corresponding European patent at issue in Ariosa was never disputed, and the patent itself was held unobvious in an appeal before the European Patent Office (“EPO”). As such, long­term efforts towards patent law harmonization are potentially frustrated by the patent eligibility test in the United States as applied in Ariosa as the United States is the only country that uses such a stringent standard. These harmonization efforts date back to the 1883 Paris Convention and, more recently, the development of the World Intellectual Property Organization (“WIPO”). Additionally, at least two amici have questioned whether the resulting invalidation of the patent at issue in Ariosa conflicts with the 1995 Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS”). TRIPS is administered by the World Trade Organization (“WTO”) and sets down minimum standards for many forms of intellectual property. Article 27.1 of TRIPS provides the requirements for patent eligibility under the Agreement, and it is possible that the Ariosa decision is out of line with these minimum requirements at least because of the conflicting results before the EPO.

The Ariosa decision also may conflict with congressional intent embodied in the America Invents Act (“AIA”). The AIA was passed in 2011 and is the most significant U.S. patent legislation since the Patent Act of 1952. Congress did not make any changes to the patent eligibility requirements under § 101 other than to explicitly exclude “a human organism” from patent eligible subject matter indicating an intent to maintain the status quo. Furthermore, a goal of the AIA was greater patent law harmonization. Both Mayo and Alice were decided since the enactment of the AIA, and appear to conflict with the intent of global patent law harmonization. As such, the Ariosa decision, and the Mayo and Alice decisions from which it is derived, may not be consistent with congressional intent.

The Ariosa decision may provide a significant blow to diagnostic method patents where the claims recite a naturally occurring phenomenon without any additional steps that are more than routine and conventional. The current state of the law may be out of line with the requirements of international treaties such as TRIPS and the long-standing movement towards global patent harmonization. As such, it may be time for the Supreme Court to act.