Claims Directed to Methods of Detecting Cardiovascular Disease Risk Found Not Patent-Eliegible Subject Matter

August 2017

 

Cleveland Clinic v. True Health Diagnostics LLC 2016-1766 (Fed. Cir. June 16, 2017)

In Cleveland Clinic, the Federal Circuit held that claims directed to a method for detecting risk of cardiovascular disease in a patent were not directed to patent-eligible subject matter.  The claims covered a natural relationship between enzyme released by the body and the incidence of cardiovascular disease, and solely relied on well-known methods to detect the enzyme and draw comparisons.

The Cleveland Clinic Foundation was the owner of three patents directed to methods of measuring risk of developing cardiovascular disease by detecting the presence of myeloperoxidase, an enzyme released when an artery is damaged or inflamed, in the blood.  True Health Diagnostics had contracted with the Cleveland Clinic to perform MPO diagnostic testing, but in 2015 it opted to begin performing its own testing.

The Cleveland Clinic sued.  True Health moved to dismiss the complaint on the basis that the claims were allegedly directed to patent-ineligible subject matter.  The district court granted the motion to dismiss, and the Cleveland Clinic appealed.

Patent-Eligible subject matter is determined through a two-part test.  First, the court considers whether the claims are directed to illegible subject matter, such as a law of nature.  If so, the court proceeds to step two to determine whether the claims as a whole contain an inventive concept capable of transforming the natural phenomenon into a patent-eligible application.

The Federal Circuit affirmed the district court’s dismissal of the Cleveland Clinic’s complaint.  In step one, the court determined that the claims were directed to observing a law of nature that MPO correlates with cardiovascular disease.  In step two, the court found that the claims as a whole relied on well-known and customary techniques for measuring MPO levels, and fundamental statistics techniques for performing the comparison.  Thus, the patents were invalid.

The Federal Circuit also affirmed the propriety of several procedural issues common to patent-eligibility questions.  It held that it was proper to raise subject matter eligibility issues at the motion to dismiss stage.  Claim construction and discovery are not always required in order to determine whether the patents claim patentable subject matter.  The court also held that it was appropriate for the district court to only examine representative claims, rather than all of the claims of the patents-in-suit.  Where the claims are substantially similar and linked to the same natural law, analyzing representative claims is proper.

Key Takeaway:  Claims directed to methods of determining risk, that do no more than use conventional laboratory and statistical techniques to observe a naturally occurring biological correlation, are not patent-eligible.  Patent eligibility may further be determined at the motion to dismiss stage, and a district court may rely on representative claims where the claims are similar and directed to the same underlying concept.