IP Law Daily Testing methods for heart-disease warning sign were directed to ‘law of nature’
Friday, June 16, 2017

Testing methods for heart-disease warning sign were directed to ‘law of nature’

By Thomas Long, J.D.

Three patents claiming methods of testing for the enzyme myeloperoxidase (MPO) were not directed to patent-eligible subject matter, the U.S. Court of Appeals for the Federal Circuit has held, affirming a decision of the federal district court in Cleveland finding the patents invalid under 35 U.S.C. §101. The patents merely claimed a law of nature—specifically, the correlation between MPO and cardiovascular disease. In addition, patent-holders The Cleveland Clinic Foundation and Cleveland Heartlab, Inc. (together, "CCF") failed to state claims of contributory or induced infringement against laboratory company True Health Diagnostics LLC, with respect to a fourth patent for a treatment method involving administration of a lipid-lowering agent (The Cleveland Clinic Foundation v. True Health Diagnostics LLC, June 16, 2017, Reyna, J.).

Patents-in-suit. In 2003, researchers at CCF developed a test that assessed a patient’s risk for cardiovascular disease that by analyzing inflammation of the blood vessels, as indicated by levels of MPO. The body releases MPO when an artery is damaged or inflamed; therefore, its presence is an early symptom of cardiovascular disease, or of the risk of developing the disease. CCF’s U.S. Patent Nos. 7,223,552 ("the ’552 patent"), 7,459,286 ("the ’286 patent"), and 8,349,581 ("the ’581 patent") (together, the "testing patents") taught a method of analyzing MPO biomarkers in a patient’s blood sample to predict a patient’s potential for cardiovascular disease. U.S. Patent No. 9,170,260 ("the ’260 patent") built on the first three patents by adding a treatment method.

Prior art testing methods required either invasive surgery, or yielded results that were not predictive of cardiovascular disease. The inventors of the patents-in-suit purportedly discovered how to "see" MPO in blood and correlate that to the risk of cardiovascular disease. The patents disclosed that MPO activity "may be determined by any of a variety of standard methods known in the art." The patents also disclosed MPO detection kits that differed from commercially available kits with respect to cut-offs and sensitivities, as well as instructions and other printed material for characterizing risk based on test results. The ’260 patent disclosed a method for administered a lipid-lowering agent to a patient at risk of cardiovascular disease.

True Health purchased the assets of another lab that had contracted with CCF to perform MPO testing. Rather than continue the relationship with CCF, True Health opted to perform its own MPO testing. CCF sued True Health, asserting infringement of the patents-in-suit. True Health moved to dismiss the lawsuit on the grounds that (1) the three "testing patents" were invalid under Section 101 because their claims were directed to a patent-ineligible law of nature and (2) CCF failed to state a claim for infringement of the ’260 patent. The district court granted the motion to dismiss, and CCF appealed to the Federal Circuit.

Invalidity. The Federal Circuit affirmed the district court’s finding that the "testing patents" were directed to patent-ineligible subject matter. The patents recited the relationship between MPO levels in the bloodstream and the risk of having or developing cardiovascular disease. These claims were held to be directed to a natural law—the fact that MPO correlated to cardiovascular disease. The invention involved "seeing" MPO already present in a sample and correlating that to cardiovascular disease.

A patent directed to ineligible subject matter may still be valid if it contains an "inventive concept" that renders the otherwise-ineligible claimed natural phenomenon patentable. Here, however, the "testing patents" did not include inventive concepts. Transforming claims that are directed to a law of nature requires more than simply stating the law of nature while adding the words "apply it," the Federal Circuit said. The ’552 patent and the ’581 patent contained a "determining" step that called for determining the MPO mass or activity level from the blood sample by whatever method the user chooses. The patents acknowledged that such well-known techniques existed. Therefore, the determining step did not add an inventive concept. The process steps merely told those "interested in the subject about the correlations that the researchers discovered."

CCF argued that its invention was narrowly preemptive and thus should be patent eligible. However, the court said, when a patent’s claims are deemed only to disclose patent-ineligible subject matter, preemption concerns were fully addressed and made moot. Accordingly, the Federal Circuit affirmed the determination that the three "testing patents" were invalid under Section 101.

The district court did not err in focusing on certain representative claims in its analysis, the appellate court also said. The asserted dependent claims not addressed by the district court did not contain additional inventive concepts. In addition, it was not error to reject the claims under Section 101 prior to claim construction or discovery.

Infringement of ’260 patent. The ’260 patent was a method-of-treatment patent whose claims required "administering a lipid lowering agent to the selected human patient." CCF did not allege that True Health directly infringed the ’260 patent, but instead alleged that True Health indirectly infringed via contributory and induced infringement. The Federal Circuit held that the district court properly dismissed CCF’s indirect infringement claims.

Contributory infringement. CCF failed to state a claim for contributory infringement because it did not identify any "material or apparatus" sold by True Health. Contributory infringement occurs if a party sells or offers to sell, a material or apparatus for use in practicing a patented process, and that material or apparatus is material to practicing the invention, has no substantial non-infringing uses, and is known by the party to be especially made or especially adapted for use in an infringement of such patent. Lab reports attached to the complaint merely reflected the manner in which True Health reported the results of the service it provides, but did not constitute a "material or apparatus" for purposes of a contributory infringement claim.

Induced infringement. As for the induced infringement claim, CCF alleged that True Health knew of the ’260 patent. Even if the CCF adequately pleaded knowledge, mere knowledge of possible infringement by others did not amount to inducement, the court noted. CCF failed to present evidence that True Health had specific intent to induce doctors to administer a lipid lowering agent based on elevated levels of MPO.

The case is No. 2016-1766.

Attorneys: Lawrence D. Rosenberg (Jones Day) for The Cleveland Clinic Foundation and Cleveland HeartLab, Inc. Adam Louis Marchuk (Perkins Coie LLP) for True Health Diagnostics LLC.

Companies: The Cleveland Clinic Foundation; Cleveland HeartLab, Inc.; True Health Diagnostics LLC

MainStory: TopStory Patent FedCirNews

Back to Top

Interested in submitting an article?

Submit your information to us today!

Learn More
Reading IP Law Daily on tablet

IP Law Daily: Breaking legal news at your fingertips

Sign up today for your free trial to this daily reporting service created by attorneys, for attorneys. Stay up to date on intellectual property legal matters with same-day coverage of breaking news, court decisions, legislation, and regulatory activity with easy access through email or mobile app.

Free Trial Learn More