THE CLEVELAND CLINIC FOUNDATION, CLEVELAND HEARTLAB, INC., v. TRUE HEALTH DIAGNOSTICS LLC: No. 2016-1766; June 16, 2017. Before Lourie, Reyna, and Wallach.

Takeaway:

  • Patent claims directed to observing a law of nature are patent-ineligible subject matter even if based on a valuable discovery.
  • Service providers cannot be liable for contributory infringement if they do not provide a material or apparatus.

Procedural Posture:

Cleveland Clinic and Cleveland Heartlab (collectively, “Cleveland”) appealed from a judgment by the Northern District of Ohio which found the asserted claims of three medical testing patents were not patent-eligible subject matter and that Cleveland failed to state a claim for contributory or induced infringement of a fourth patent. The CAFC affirmed.

Synopsis:

  • Subject Matter Eligibility: The Northern District of Ohio found the asserted claims of three medical testing patents, U.S. Patent Nos. 7,223,552; 7,459,286; and 8,349,581, were directed to patent-ineligible subject matter under § 101 for observing a law of nature. Under the first step of the Alice analysis, the CAFC found the testing patents to claim a natural relationship between myeloperoxidase (“MPO”) values and the risk of cardiovascular disease that exists apart from human action. Under Alice step two, the CAFC held nothing in the claims sufficiently transformed the law of nature into a patentable invention, because the claimed methods required only well-known MPO detection methods and the comparison of the obtained values to control values derived from conventional statistical methods. The CAFC noted that even groundbreaking and valuable contributions can fall short of patentable subject matter, citing Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015).
  • Contributory Infringement: Cleveland alleged that True Health contributorily infringed a fourth patent, U.S. Patent No. 9,170,260, directed to a method of treating a patient at risk of cardiovascular disease by administering a lipid lowering drug. Contributory infringement may occur if a party sells, or offers to sell, a material or apparatus for use in practicing a patented process, but the CAFC ruled a party that provides only a service, and no “material or apparatus,” cannot be liable under § 271(c). Since True Health provides only MPO testing services, the district court properly dismissed Cleveland’s cannot be liable for contributory infringement claim.
  • Induced Infringement: Cleveland also accused True Health of inducing infringement of the ’260 patent. Cleveland asserted True Health generated lab reports that would create a reasonable inference that a doctor would rely on the results to administer a lipid lowering agent, but the CAFC ruled Cleveland failed to allege any facts that supported the specific intent or action on behalf of True Health to induce infringement as required by § 271(b). Accordingly, the CAFC affirmed the district court’s dismissal Cleveland’s induced infringement claims.