Cleveland Clinic Foundation v. True Health Diagnostics LLC
859 F.3d 1352
Fed. Cir.2017Background
- Cleveland Clinic and Cleveland Heartlab sued True Health for infringing three patents claiming methods to detect myeloperoxidase (MPO) in bodily samples and a fourth patent claiming treatment (administering a lipid‑lowering agent based on elevated MPO).
- The testing patents disclose using routine detection methods (e.g., ELISA, flow cytometry, colorimetric assays) and comparing patient MPO levels to statistically derived control/predetermined values to assess cardiovascular risk.
- True Health, a diagnostic lab, performed MPO testing and delivered lab reports; Cleveland Clinic alleged True Health continued the testing formerly performed under contract and infringed the testing patents and indirectly infringed the treatment patent (the ’260 patent).
- The district court dismissed: (1) all claims of the testing patents as patent‑ineligible under 35 U.S.C. § 101 (Mayo/Alice framework), and (2) contributory and induced infringement claims as to the ’260 patent for failure to plead required elements; leave to amend was denied.
- The Federal Circuit affirmed: the testing claims were directed to a natural law (correlation between MPO and cardiovascular risk) and added only conventional detection and statistical comparison steps; indirect‑infringement allegations as to the ’260 patent were insufficient.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether testing patents claim patent‑eligible subject matter under § 101 | Testing claims recite specific detection steps and statistical comparisons and thus are patentable applications of the MPO–disease correlation | Claims are directed to a natural law (MPO–cardiovascular correlation) and use only conventional detection/statistical techniques | Claims are directed to a natural law and lack an inventive concept; patent‑ineligible (affirmed) |
| Whether the district court erred by addressing representative claims and ruling at motion to dismiss without claim construction | District court should construe terms and consider more dependent claims before § 101 ruling | § 101 can be resolved on Rule 12(b)(6) when claims and specification show eligibility issues; representative claims suffice when others are substantially similar | No error; court properly resolved § 101 at motion to dismiss and used representative claims |
| Whether True Health can be liable for contributory infringement of the ’260 method‑of‑treatment patent | Lab reports and testing services function as material/apparatus for practicing the claimed treatment method | True Health provides a service (testing/reports), not a material or apparatus; § 271(c) requires selling a material/apparatus | Contributory infringement dismissed: lab reports/services are not a “material or apparatus” under § 271(c) |
| Whether True Health can be liable for induced infringement of the ’260 patent | Delivering test results reasonably leads physicians to administer lipid‑lowering drugs, supporting inducement liability | Inducement requires specific intent and overt action to encourage infringement; mere knowledge and reports are insufficient | Induced‑infringement claim dismissed for failure to allege specific intent and action to induce; dismissal affirmed |
Key Cases Cited
- Alice Corp. v. CLS Bank Int'l, 573 U.S. 208 (Sup. Ct. 2014) (two‑step framework for § 101 patent eligibility)
- Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (Sup. Ct. 2012) (claims applying a law of nature must add an inventive concept beyond well‑known, routine activity)
- Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015) (methods that start and end with naturally occurring phenomena and use routine techniques are patent‑ineligible)
- Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016) (distinguishing claims directed to new laboratory techniques from claims directed to natural laws)
- In re Bill of Lading Transmission & Processing Sys. Patent Litig., 681 F.3d 1323 (Fed. Cir. 2012) (requirements for contributory infringement under § 271(c))
- DSU Med. Corp. v. JMS Co., 471 F.3d 1293 (Fed. Cir. 2006) (inducement requires specific intent and action to encourage infringement)