The Federal Circuit decision in Cleveland Clinic Foundation v. True Health Diagnostics LLC, strikes another blow against the patent eligibility of diagnostic methods and highlights the difficulty of enforcing personalized medicine patents. The court affirmed the invalidity of claims related to a blood test for atherosclerotic cardiovascular disease, and agreed with the district court that diagnostic company True Health was not liable for contributory or induced infringement of claims directed to treating patients diagnosed by the blood test. 

The Diagnostic Patents — Ineligible

The diagnostic patents at issue were U.S. Patent No. 7,223,552, U.S. Patent No. 7,459,286, and U.S. Patent No. 8,349,581. Claim 14 of the ‘552 patent illustrates the claimed methods:

14. A method of assessing a test subject’s risk of developing a complication of atherosclerotic cardiovascular disease comprising:
determining levels of myeloperoxidase (MPO) activity, myeloperoxidase (MPO) mass, or both in a bodily sample of the test subject, said bodily sample being blood … ;
wherein elevated levels of MPO activity or MPO mass or both in the test subject’s bodily sample as compared to levels of MPO activity, MPO mass, or both, respectively in comparable bodily samples obtained from control subjects diagnosed as not having the disease indicates that the test subject is at risk of developing a complication of atherosclerotic cardiovascular disease.

Cleveland Clinic asserted the patents in the U.S. District Court for the Northern District of Ohio, which denied its motions for a temporary restraining order and preliminary injunction, and instead granted True Health’s motion to dismiss on the grounds that the patents are directed to ineligible subject matter.

The Federal Circuit upheld the district court’s findings on these patents, approving its treatment of the issues at the motion to dismiss stage, and agreeing with its determinations on the merits.

Applying step one of the Alice analysis, the Federal Circuit found:

[J]ust like Ariosa, the method starts and ends with naturally occurring phenomena with no meaningful non-routine steps in between—the presence of MPO in a bodily sample is correlated to its relationship to cardiovascular disease. The claims are therefore directed to a natural law.

Applying step two of the Alice analysis, the Federal Circuit noted that the claims do not recite the use of any new detection or analytical techniques, and found:

The claims, whether considered limitation-by-limitation or as a whole, do not sufficiently transform the natural existence of MPO in a bodily sample and its correlation to cardiovascular risk into a patentable invention. The process steps here merely tell those “interested in the subject about the correlations that the researchers discovered.” Mayo, 566 U.S. at 78.

Thus, the court “affirm[ed] the district court’s determination that the testing patents are directed to patent-ineligible subject matter.”

The Treatment Patent — Not Infringed

The method of treatment patent at issue was U.S. Patent No. 9,170,260. Independent claim 1 recites:

1. A method for administering a lipid lowering agent to a human patient based on elevated levels of myeloperoxidase (MPO) mass and/or activity comprising:
(a) performing an enzyme linked immunosorbent assay (ELISA) comprising contacting a serum or plasma sample with an anti-MPO antibody and a peroxidase activity assay to determine MPO activity in the serum or plasma sample;
(b) selecting a patient who has elevated levels of MPO mass and/or activity compared to levels of MPO mass and/or activity in apparently healthy control subjects; and
(c) administering a lipid lowering agent to the selected human patient.

The district court granted True Health’s motion to dismiss as to this patent on non-infringement grounds, finding no basis to support claims of contributory infringement or induced infringement.

The Federal Circuit upheld the district court’s treatment of this patent, agreeing that Cleveland Clinic had failed to assert facts that could support True Health’s liability for contributory infringement or induced infringement.

As to contributory infringement, the Federal Circuit agreed that True Health’s lab reports do not qualify as a “material or apparatus” that could support liability under 35 USC § 271(c).

As to induced infringement, the Federal Circuit noted

Cleveland Clinic alleges no facts that suggest any connection between True Health and doctors that may prescribe lipid lowering drugs.

Thus, the Federal Circuit agreed that Cleveland Clinic “falls short of showing ‘specific intent and action’ on behalf of True Health to induce infringement of the ’260 patent.”

Can Personalized Medicine Methods Be Protected?

Given the difficulty of patenting diagnostic methods after Mayo, many stakeholders are focusing on personalized medicine patents similar to the ‘260 patent at issue here. This case highlights challenges that may be faced when enforcing such patents–who is liable for infringement when different entities may perform the diagnosing and treating steps?

While Akamai provides some avenues for establishing liability for divided infringement, it may be difficult to establish that diagnostic companies are liable for treatment steps they do not perform. Diagnostic companies are not likely to condition their services on another party’s performance of a treatment step, or  to establish the manner or timing of that performance. Thus, they may not be liable under the Akamai paradigm.