The US Supreme Court has laid down the law – again. When it comes to patents in life sciences, many claims for innovation will not be eligible for intellectual property protection.

Patent applications that involve DNA techniques can be too basic for protection. That’s according to a ruling by the US Supreme Court on June 27, which denied a writ of certiorari in Ariosa Diagnostics, Inc. v Sequenom Inc., concerning patentability in life sciences. The court upheld a Federal Circuit decision from last year, which refused to review Sequenom’s appeal on the rejection of their patent involving methods for detecting cell-free fetal DNA (cffDNA). In doing so, the stringent framework for patent eligibility established in Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2010) remains the standard by which scientific subject matter is judged.

The Framework

35 USC §101 defines patentable subject matter as "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." Historically, this definition set a low bar for the protection of intellectual property. Yet, judicially created exceptions do exist, and they apply to abstract ideas, laws of nature and natural phenomena. Mayo involved one of these very exceptions. The Mayo ruling held that a method for relating the effectiveness of medical treatment to an administered drug’s metabolite is a law of nature not subject to legal protection. This Supreme Court decision provided a two-part framework for assessing the eligibility of scientific claims. Claims must first be evaluated according to judicial exceptions. Then, any applications directed at patent ineligible concepts, such as a law of nature, must be geared at "significantly more" than that natural law or phenomena. If they fail to do so, these claims are refused.

The Case

Sequenom received a patent for their methods of measuring cffDNA in maternal plasma. Intrusive prenatal diagnostic processes are replaced through these techniques of detecting, isolating and amplifying cffDNA. In 2015, the company sued Ariosa for patent infringement. In turn, Ariosa challenged the validity of Sequenom’s patent, arguing that cffDNA is a phenomenon of nature, exempt from legal protection. Using Mayo protocol, the district court agreed, ruling that cffDNA fit the judicial exception, and the steps used to measure it did not constitute "significantly more" than the phenomenon itself. Rather, the court viewed these steps as "well-understood, routine, and conventional," a far cry from ingenuity worthy of patenting.

Sequenom appealed, maintaining that their procedures are patent eligible "applications" of a natural phenomenon. Since "no one was using the plasma or serum of pregnant mothers to amplify and detect paternally-inherited cffDNA" prior to Sequenom, the company reasoned that the methods being employed surpassed the mere "conventional" title given by the court.

The Mayo Effect

By forgoing a review of Sequenom’s case, the Supreme Court has held the Mayo test as a standard by which claims in the life sciences are adjudicated. While this rejection of certiorari translates into a victory for defendants challenging method claims levied against them, increased scrutiny befalls those seeking patent claims for technologies in this field, leading to uncertainty over the validity of many applications. One such claim, similar to the DNA methods of Sequenom’s discovery, was rejected this April. In Genetic Techs. Ltd. v. Merial L.L.C. the Circuit deemed that a method of detecting a coding region allele was applied through "routine" steps of detecting DNA, and as such, was ineligible for protection. Although guidelines set by Mayo and the United States Patent and Trademark Office (UPSTO) do not categorically refuse subject matter eligibility when it comes to life science-based technologies, courts have provided little guidance over the elements that allow a claim to be directed to "significantly more" than the judicial exception it concerns. In Mayo, the Supreme Court warned, "too broad an interpretation of this exclusionary principle could eviscerate patent law." Circuit Judge Linn echoed this apprehension in his opinion, calling Ariosa a "consequence" flowing from "that broad language [in Mayo] in excluding a meritorious invention from the patent protection it deserves and should have been entitled to retain."

Going Forward

The impact of denying Sequenom’s petition is unclear. Lower courts will likely continue to invalidate certain claims in the life sciences without Supreme Court guidance. That does not suggest the Court won’t revisit the Mayo framework in the future. For now, clients making claims in the life sciences should consider these decisions and the nature of their innovation’s adherence to Mayo protocol in order to avoid patent refusal. Plaintiffs like Ariosa, seeking to skirt charges of infringement, have a new tool at their disposal. Whether such rulings encourage or hinder advancements in the diagnostic and life science realm remains to be seen.