The Federal Circuit Flexes Its Muscle in Cleveland Clinic (But Not the One it Should Have)
In our January Blog Post related to the January 2019 USPTO Subject Matter Eligibility Guidance (“the Guidance”), and our subsequent Blog Post in February , we noted that it was unclear how the courts will view issued personalized medicine claims examined under the Guidance, as it appeared that the USPTO may want to push the courts to reexamine the boundaries of Mayo1. Well, it now seems that we have an idea – the Federal Circuit does not appear to want to be pushed.
In Cleveland Clinic Foundation v. True Health Diagnostics, LLC2, the Federal Circuit again examined patent claims that were directed to methods associated with a personalized medicine invention. The patents at issue centered around the discovery that patients with coronary artery disease (CAD) have significantly greater levels of leukocyte and blood myeloperoxidase (MPO) levels.3
Claim 1 of U.S. Patent No. 9,575,065 involved in the suit, recited the following:
1. A method of detecting elevated MPO mass in a patient sample comprising:
a) obtaining a plasma sample from a human patient having atherosclerotic cardiovascular disease (CVD); and
b) detecting elevated MPO mass in said plasma sample, as compared to a control MPO mass level from the general population or apparently healthy subjects, by contacting said plasma sample with anti-MPO antibodies and detecting binding between MPO in said plasma sample and said anti- MPO antibodies.
Cleveland Clinic argued that the claims at issue were eligible for patenting as they were not directed to “’assessing a test subject’s risk of having atherosclerotic [CVD]’ by comparing MPO levels to a control group . . . but rather to ‘techniques for detecting elevated levels of MPO in the blood of patients having CVD.’” The Federal Circuit indicated this distinction was “overly superficial” and concluded that the claims were directed to the patent-ineligible natural law that blood MPO levels correlate with risk of atherosclerotic CVD.4 Thus, the Federal Circuit affirmed the district court’s conclusion that claim 1 of the ‘065 patent was ineligible for patenting under 35 U.S.C. § 101. 5
Cleveland Clinic also argued that the district court failed to give the appropriate deference to the subject matter eligibility guidance published by the USPTO in May 2016.6 Specifically, Cleveland Clinic pointed to Example 29 of the May 2016 guidance which included the following exemplary claim:
1. A method of detecting JUL-1 in a patient, said method comprising:
a. obtaining a plasma sample from a human patient; and
b. detecting whether JUL-1 is present in the plasma sample by contacting the plasma sample with an anti-JUL-1 antibody and detecting binding between JUL-1 and the antibody.7
In its discussion of this claim, the USPTO’s May 2016 guidance stated that the claim was eligible because “although nature-based product limitations are recited in the claim (e.g., the plasma sample and JUL-1), analysis of the claim as a whole indicates that the claim is focused on a process of detecting whether JUL-1 is present in a plasma sample, and is not focused on the products per se.8
While the Federal Circuit acknowledged that this exemplary claim from the May 2016 guidance was nearly analogous to claim 1 of the ‘065 patent, it was also “strikingly similar to claim 1 . . . at issue in Ariosa9” and thus not eligible for the same reasons in Ariosa – because “the only remaining non-conventional element of each claim is the discovery that the protein is present in the bodily sample, and the discovery of a natural law cannot by itself prove the requisite inventive concept.10” The Federal Circuit thus declined to give deference to the USPTO’s guidance, and instead cited “the need for consistent application of our case law.”
In view of the Federal Circuit's statements that it is not bound by the USPTO's guidance, and its desire for “consistent application of our case law,” it appears very unlikely that issued personalized medicine claims examined under the Guidance from January 2019 will in fact cause the Federal Circuit to push the boundaries of Athena11, Ariosa and Mayo. Instead it appears likely that the Federal Circuit will wait until the Supreme Court or Congress revisits the issue of subject matter eligibility in the personalized medicine space. Until that time, it is still advisable to file and prosecute patent applications with claims directed to methods of detection and diagnosis for protection of personalized medicine inventions – with the hope that some combination of the courts, the agencies, and the law makers can come to a decision that makes sense for the industry.
2 Case 2018-1218, (Fed. Cir. April 1, 2019); It should be noted that this case is nonprecedential.
3 Id. at page 3.
4 Id. at pages 9-10.
6 Subject Matter Eligibility Examples: Life Sciences, issued May 4, 2016.
7 Id. at page 10.
9 Ariosa Diagnostics, Inc. v. Sequenom, Inc. 788 F.3d 1371 (Fed. Cir. 2015)
10 Cleveland Clinic, Case 2018-1218 at page 14.
11 Athena Diagnostics, Inc., v. Mayo Collaborative Servs., LLC, 915 F.3d 743 (Fed. Cir. 2019).
See the Opinion here.