Cleveland Heart: Patents *Not* Valid....Oops!

Interesting, so Cleveland Heart's been saying they have exclusives on this test....now the court says it's not even patent-worthy.


Fed. Circ. Nixes 3 Cleveland Clinic Test Patents Under Mayo

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Law360, New York (June 16, 2017, 7:13 PM EDT) -- The Federal Circuit on Friday upheld a lower court’s decision invalidating three Cleveland Clinic patents on cardiovascular disease tests, ruling that they claim only patent-ineligible laws of nature in a decision that clears accused infringer True Health Diagnostics LLC.

The appeals court held that a federal judge in the famed hospital’s hometown of Cleveland correctly ruled last year that the three patents are invalid under the U.S. Supreme Court’s Mayo ruling because they cover nothing more than the natural correlation between a certain enzyme and an increased risk of heart disease.

The high court’s 2012 Mayo decision also invalidated medical diagnostic tests that were based on a natural correlation and emphasized that natural laws are not patent-eligible. The Federal Circuit said that Cleveland Clinic’s patent claims were similar.

“Because the testing patents are based on the relation between cardiovascular disease and heightened [enzyme] levels that exists in principle apart from human action, they are directed to a patent-ineligible law of nature,” the appeals court wrote, paraphrasing language from the Mayo decision.

The Federal Circuit also affirmed the lower court’s ruling that True Health did not infringe a fourth Cleveland Clinic patent.

True Health is a diagnostic laboratory that purchased the assets of Health Diagnostics Lab, which had contracted with Cleveland Clinic to perform cardiovascular disease testing. True Health ended the relationship and began performing its own tests, leading Cleveland Clinic to file suit in November 2015.

Just over three months later, Judge Patricia A. Gaughan of the Northern District of Ohio granted True Health's motion to dismiss the suit, ruling that Cleveland Clinic's patents are invalid.

Cleveland Clinic's tests involve detecting the enzyme myeloperoxidase, or MPO, which is released when an artery is damaged and indicates a risk of cardiovascular disease. The patents describe using "any of a variety of standard methods known in the art" to detect MPO, then correlating the test results to cardiovascular disease risk using statistical methods.

The Federal Circuit ruled that since the patents use standard testing techniques and known statistical methods, they "merely tell those interested in the subject about the correlations that the researchers discovered," which the Supreme Court held in Mayo is not patent-eligible.

While Cleveland Clinic argued that it had made "groundbreaking" discoveries about the relationship between MPO and cardiovascular disease, the Federal Circuit said even such "valuable contributions" may not be patent-eligible.

On that point, the court quoted a closely watched 2015 decision known as Ariosa v. Sequenom, which invalidated prenatal DNA test patents for claiming only a natural phenomenon. It said it saw little difference in Cleveland Clinic's claims.

"Just like Ariosa, the method starts and ends with naturally occurring phenomena with no meaningful nonroutine steps in between — the presence of MPO in a bodily sample is correlated to its relationship to cardiovascular disease," it said. "The claims are therefore directed to a natural law."

True Health said in a statement Friday that it was pleased the court invalidated Cleveland Clinic’s patents, calling the hospital’s infringement suit a “misguided effort to besmirch our reputation.”

“True Health remains undeterred in our mission to change health care by helping to detect chronic disease earlier and providing patients with a better experience,” it said.

A representative of Cleveland Clinic declined to comment on the decision.

The patents-in-suit are U.S. Patent Numbers 7,223,552; 7,459,286; 8,349,58; and 9,170,260.

Judges Alan Lourie, Jimmie Reyna and Evan Wallach sat on the panel for the Federal Circuit.

The Cleveland Clinic is represented by Lawrence Rosenberg and Susan Gerber of Jones Day.

True Health is represented by Adam Marchuk, Michael Osterhoff, Mark Smith, Caroline Teichner and Dan Bagatell of Perkins Coie LLP.

The case is the Cleveland Clinic Foundation et al. v. True Health Diagnostics LLC, case number 2016-1766, in the U.S. Court of Appeals for the Federal Circuit.

--Editing by Aaron Pelc.