The Cleveland Clinic Foundation et al. v. True Health Diagnostics LLC

Docket No. 2016-1766

June 16, 2017

Brief Summary: Patent directed at detecting myeloperoxidase release as a sign of cardiovascular disease ineligible under § 101. DC decision of no contributory or induced infringement affirmed since CCF fell “short of showing specific intent and action’ on behalf of True Health”.

Summary: Cleveland Clinic Foundation (CCF) appealed DC finding that three of its patents (US 7,223,552; 7,459,286; 8,349,581) claiming methods for testing for myeloperoxidase (MPO) in a bodily sample released as an early symptom of heart disease are ineligible subject matter under § 101, and that CCF failed to state a claim of contributory or induced infringement of a fourth patent (US 9,170,260) including administering “a lipid lowering agent” following an MPO assay. The opinion explains that “[t]he inventors purportedly discovered how to ‘see’ MPO in blood and correlate that to the risk of cardiovascular disease” by comparing data to “a ‘predetermined’ or ‘control value’” derived from “apparently healthy” people. The FC panel opinion explained that it reviews procedural questions not unique to patent law under the law of the regional circuit (de novo under the 6th Cir. (Univ. Utah, FC 2013) but under the “lesser standard” of abuse of discretion due to events at the DC) and questions under § 101 de novo. CCF argued the DC only analyzed certain claims and “should have undertaken claim construction and developed the factual and expert record before analyzing whether the claims were” patent eligible. The FC panel disagreed since “[w]here, as here, the claims ‘are substantially similar and linked to the same’ law of nature, analyzing representative claims is proper” (Content Extraction, FC 2014). The FC panel also found CCF “provided no proposed construction of any terms or proposed expert testimony that could change the § 101 analysis.” The two-step Alice § 101 test was applied (step one: are the claims “directed to ineligible subject matter, such as a law of nature” (Mayo, US 2012; McRO, FC 2015; Thales Visionix, FC 2017); step two: determine whether “the elements of the claims…individually [or] as an ordered combination transform the nature of the claims into a patent eligible concept” (Ariosa, FC 2015)). The claims were found to be directed to natural phenomena (“the testing patents purport to detect MPO and other MPO-related products, which are naturally occurring in bodily samples…the method starts and ends with naturally occurring phenomena with no meaningful non-routine steps in between” (as in Ariosa, “[t]he inventors…did not create or alter any of the genetic information”, and unlike CellzDirect (FC 2016) in which “the claims…were…directed to a new and useful laboratory technique”). In the second Alice step, “[t]he claims, whether considered limitation by limitation or as a whole” were found not to “sufficiently transform the natural existence of MPO in a bodily sample into a patentable invention” (“merely tell[ing] those ‘interested in the subject about the correlations that the researchers discovered” (Mayo)). Regarding contributory or induced infringement of the ‘260 patent, it found CCF fell “short of showing specific intent and action’ on behalf of True Health” with respect to doctors that may prescribe the lipid-lowering drugs, and therefore affirmed the DC decision.

This entry was posted in Contributory Infringement, Inducement to Infringe, Infringement, Patentability, Uncategorized. Bookmark the permalink.

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