Beat it! Heart disease diagnostic isn’t patent-eligible

March 21, 2018
Patterson Thuente IP

Inventors in the pursuit of “personalized medicine” patents were likely discouraged by the Federal Circuit Court of Appeals’ ruling in The Cleveland Clinic Foundation v. True Health Diagnostics LLC, which involved a diagnostic method. The court’s ruling highlights the difficulty of obtaining patents for such methods.

The heart of the matter

The Cleveland Clinic Foundation holds two patents on methods of diagnosing cardiovascular disease. The methods call for measuring the level of the enzyme myeloperoxidase (MPO) in a patient’s blood and comparing it with the level of MPO in someone who has been diagnosed as not suffering from cardiovascular disease.

The Cleveland Clinic sued True Health Diagnostics LLC for patent infringement, but the district court dismissed the case before trial. The court held that the method wasn’t eligible for a patent.

The two-part test

Under the Patent Act, natural phenomena aren’t eligible for patents. To determine whether an invention is ineligible as a law of nature or natural phenomenon, courts apply a two-step test known as the Alice test. In step one, a court considers whether the patent covers a law of nature or natural phenomenon. If it doesn’t, the inquiry ends there.

If the patent does cover such a subject, the court examines the invention’s elements to determine whether they contain an inventive concept sufficient to transform it into a patent-eligible application of the law of nature or natural phenomenon. It will look at the elements both individually and as an ordered combination to make this determination.

The court’s diagnosis

On appeal, the court found that the patents covered multistep methods of observing the law of nature that MPO correlates to cardiovascular disease. Moreover, the patent specifically states that the methods are based on the discovery that patients with cardiovascular disease have significantly higher levels of MPO — and the method doesn’t purport to alter MPO levels in any way.

The invention, therefore, comes down to “seeing” MPO that’s already present in a blood sample and correlating it with cardiovascular disease. Because the patents are based on the relationship between the disease and heightened MPO levels that exist apart from any human action, the court found they covered a patent-ineligible law of nature. The method, it said, starts and ends with naturally occurring phenomena with no meaningful nonroutine steps between. The appellate court contrasted the method with one at issue in an earlier case, noting that the patent there related to a “new and useful laboratory technique.” The Cleveland Clinic patents, on the other hand, use “well-known” techniques to execute the method.

Moving on to the second step, the court determined that the patented methods didn’t include an inventive concept that transformed the natural phenomenon of MPO being associated with cardiovascular risk into a patentable invention. It emphasized that transforming patents associated with a law of nature requires more than simply stating the law of nature in the patent language while adding the words “apply it.”

Here, the court said, the patents instructed doctors to apply routine, conventional techniques to detect and determine MPO levels. As for the comparison step, they don’t purport to derive new statistical methods to arrive at the control levels of MPO that would indicate a patient’s risk of cardiovascular disease — known statistical models can be used.

Whether considered individually or as a whole, the claimed invention’s elements were held to merely describe the correlations that the researchers discovered, the Federal Circuit said. The patents don’t extend their discovery that MPO correlates to cardiovascular disease risk; they require only conventional MPO detection methods and compare those values to predetermined values derived from conventional statistical methods.

Heartbreak could be ahead for inventors

The court’s ruling in this case sends a stinging reminder to would-be patentees. While a discovery may be groundbreaking, the court said, it can fall short of the requirements for patent eligibility. •

The Cleveland Clinic Foundation v. True Health Diagnostics LLC, No. 16-1766, June 16, 2017, Fed. Cir.

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