“Bleak, dismal, call it what you want, but barring a legislative fix to Section 101 from Congress, highly innovative institutions like the Cleveland Clinic will continue to be buffeted by the shrugging acquiescence of the Federal Circuit and other courts to an overly broad interpretation of Alice/Mayo Section 101 case law.”

On Monday, April 1, the Court of Appeals for the Federal Circuit issued a decision in Cleveland Clinic Foundation v. True Health Diagnostics affirming the invalidity of patents covering medical diagnostic tests for determining a patient’s risk for cardiovascular disease. The decision, which is nonprecedential and was decided along similar lines to another 2017 decision between the two parties, is yet another depressing sign that U.S. patent law is woefully inadequate when it comes to supporting important innovations in the biotech fields.

The following two Cleveland Clinic patents were affirmed as invalid in this decision:

S. Patent No. 9575065, titled Myeloperoxidase, A Risk Indicator for Cardiovascular Disease. It claims a method of detecting elevated myeloperoxidase (MPO) mass in a patient by obtaining a plasma sample from a patient having artherosclerotic cardiovascular disease (CVD) and detecting in the sample levels of MPO which are elevated compared a control MPO level in the mass population.

S. Patent No. 9581597, same title as the ‘065 patent. It claims a similar method of detecting elevated MPO levels in a CVD patient which involves contacting a plasma sample with an anti-MPO antibody and spectrophotometrically detecting MPO levels in the patient’s sample.

Cleveland Clinic II: The Latest Chapter in a Depressing Tale of Patent Eligibility

Anyone who has read the Federal Circuit’s 2017 decision in Cleveland Clinic I will observe that there is nothing new under the sun in the appellate court’s more recent decision in the case. While the recently invalidated patents are different than those invalidated in the 2017 decision, the parent patent for both the ‘065 and ‘597 patents was one of the patents involved in that earlier case. In both cases, the challenged patent claims were invalidated under 35 U.S.C. § 101 for being directed to a natural law without reciting an inventive concept beyond the natural law itself.

In the case decided on April 1, Cleveland Clinic had argued that the claims were directed to the technique of using an immunoassay to measure blood MPO levels and that the correlation of MPO levels and artherosclerotic CVD isn’t a natural law because it can only be detected using specific techniques, with prior art techniques being either too invasive or having failed to predict CVD risk. While performing an immunoassay on blood samples was known, Cleveland Clinic argued that the use of the immunoassay to detect the correlation between CVD and MPO levels provided an inventive concept. Unlike the claims in Cleveland Clinic I, which were directed to “assessing a test subject’s risk of having artherosclerotic [CVD],” Cleveland Clinic argued that the claims were rather directed to detecting elevated MPO mass, but the Federal Circuit found this to be a superficial distinction. The Federal Circuit also nixed Cleveland Clinic’s arguments that the district court improperly resolved factual disputes at the pleadings stage and that the district court should have deferred to the examiner’s decision to allow the asserted claims.

Federal Circuit: We’re Not Bound By USPTO Guidance



Of particular note is the Federal Circuit’s finding against Cleveland Clinic’s argument that the district court didn’t give appropriate deference to subject matter eligibility guidance published by the U.S. Patent and Trademark Office (USPTO) as required by the U.S. Supreme Court’s 1944 decision in Skidmore v. Swift & Co. Although this argument related to USPTO guidelines published in 2016, it would seem to call into question the USPTO’s more recent revised subject matter eligibility guidance issued earlier this year by USPTO Director Andrei Iancu. This gives voice to fears that the “Iancu Effect” on subject matter eligibility won’t matter much if the Federal Circuit and other courts don’t adhere to the USPTO’s views on patent eligibility under Section 101. The Federal Circuit’s opinion said:

“While we greatly respect the PTO’s expertise on all matters relating to patentability, including patent eligibility, we are not bound by its guidance. And, especially regarding the issue of patent eligibility and the efforts of the courts to determine the distinction between claims directed to natural laws and those directed to patent-eligible applications of those laws, we are mindful of the need for consistent application of our case law.”

“CVD is the number-one killer of both men and women in the United States.” Thus reads paragraph 14 of an amended complaint for patent infringement filed by Cleveland Clinic in February 2017 in the Eastern District of Virginia, the district court that invalidated the ‘065 and ‘597 patents. And Cleveland Clinic’s innovations in the field of diagnosing CVD, as covered by those now invalidated patents, were groundbreaking and lifesaving, according to an October 2018 article written by former USPTO Director David Kappos and former Chief Judge of the Federal Circuit Paul Michel, and published by Morning Consult. After discovering that elevated MPO levels were an early warning sign for CVD, Cleveland Clinic launched Cleveland HeartLab to commercialize its innovations in determining biomarkers for CVD; Cleveland HeartLab was then sold to Quest Diagnostics in late 2017.

Yet, as Kappos and Michel point out, despite the fact that lifesaving discoveries are worthy of patent protection and despite the importance of Cleveland Clinic’s discovery of MPO as a biomarker for the number one killer of Americans, jurisprudence on Section 101 has effectively chilled investment into research and development in the diagnostics sector. An interview with Rep. Steve Stivers (R-OH) with IPWatchdog Founder Gene Quinn published in May discussed the fact that Cleveland Clinic has stopped investing in diagnostics because of the patent eligibility issues in the sector, and that investment into research has been going to Asia and especially China. In Stivers’ words:

“To say a diagnostic is unpatentable is perplexing to me, because that is going to drive personalized health. I think diagnostics are going to be a bigger part of health going forward and to take that out of the United States’ economy and away from America and lose those jobs because those inventions can’t be patented here but can be in other countries is pretty silly.”

A Bleak and Dismal View

If an inability to protect medical diagnostics discoveries with a patent is “pretty silly,” then it was downright foolish of the Supreme Court to deny a writ of certiorari last June that terminated an appeal of Cleveland Clinic I. In Cleveland Clinic II, decided April 1, a group of six patent law professors filed an amicus brief to argue that Eastern Virginia’s invalidation of the asserted patents was a misapplication of the Alice/Mayo framework. As the professors wrote:

“Patent claims on diagnostic methods, including the specialized laboratory methods at issue here, present a particularly salient concern. Such claims are easy to analytically dissect and overgeneralize into individual foundational laws of nature or natural phenomenon, or restate at such a high level of generalization to be regarded as conventionally-known techniques in the art. That is not because such inventions comprise laws of nature or natural phenomena themselves, but because all diagnostic method claims seek to discover information about a subject, including those seeking to diagnose conditions in humans.”

If this was the end of the patent eligibility issues to be faced by the Cleveland Clinic, that would be enough of a quagmire in and of itself. However, this March the Cleveland Clinic announced the launch of a Center for Clinical Artificial Intelligence which will focus on research into AI and machine-learning technologies and clinical applications for those technologies in the medical field. Patent applications for AI technologies have been facing tremendous patent eligibility issues under Section 101 , and while the 2019 revised subject matter eligibility guidelines have aided the prospects of patent applications in that sector, there’s no guarantee that AI patents will be respected by the courts, especially given what the Federal Circuit said about the USPTO’s subject matter guidelines in the recent Cleveland Clinic decision. Bleak, dismal, call it what you want, but barring a legislative fix to Section 101 from Congress, highly innovative institutions like the Cleveland Clinic will continue to be buffeted by the shrugging acquiescence of the Federal Circuit and other courts to an overly broad interpretation of Alice/Mayo Section 101 case law.

Industry Reaction



Adam Mossoff, a law professor at George Mason University Antonin Scalia Law School and one of the professors contributing to the aforementioned brief in Cleveland Clinic, said that the recent decision shows the necessity for Congressional action on Section 101 patent eligibility:

“Cleveland Clinic is the latest in a series of court decisions that have made it impossible to obtain reliable and effective patents for diagnostic tests or methods of treatment. These patented innovations are the result of millions in R&D and represent cutting-edge applications in science and biotech—the ‘useful Arts’ the patent system is supposed to be promoting and securing to the benefit of everyone. Congress should act quickly to fix patent eligibility doctrine and get U.S. innovation policy back on track.”

Dr. Robert Sahr, Counsel at Choate Hall & Stewart, says that the recent Federal Circuit decision in Cleveland Clinic delivers a blow to life sciences companies seeking patent protection for diagnostic tests: