Patents for Testing Enzymes to Assess Cardiovascular Disease Invalid Under § 101
In a patent infringement case before the United States District Court for the Northern District of Ohio, the court granted (February 23, 2016) the defendant’s motion to dismiss because the court held that the asserted claims of plaintiff’s patents for testing enzymes to assess cardiovascular disease encompassed unpatentable subject matter (e.g., was directed to an abstract idea).
This case involved multiple patents assigned to The Cleveland Clinic Foundation and/or the Cleveland HeartLab for assessing a patient’s risk for cardiovascular disease (CVD). More specifically, researchers identified that Myeloperoxidase (MPO) (an enzyme) is released by white blood cells when inflammation occurs in the body. Thus, when an artery wall is damaged or becomes inflamed, MPO is released in an effort to kill bacteria. As such, MPO is an early symptom of many types of cardiovascular disease.
In total, the Cleveland Clinic Foundation was the owner of four patents relating to utilizing MPO to detect potential cardiovascular disease in a patient (U.S. Patent Nos. 7,223,552; 7,459,286; 8,349,581; and 9,170,260). The ‘552 patent was the subject of validity challenges in two reexamination proceedings, and the ‘552 was confirmed valid in both proceedings.
In summary, the patents were directed to a method of analyzing MPO biomarkers in a patient’s blood sample to predict a patient’s potential for CVD by comparing the level of MPO in the patient’s blood with levels of MPO in a control subject to identify whether the patient has elevated levels of MPO.
Claim 1 of the ‘552 recites:
A method for characterizing a test subject’s risk of having atherosclerotic cardiovascular disease, comprising:
determining levels of myeloperoxidase (MPO) activity, myeloperoxidase (MPO) mass, or both in a bodily sample from the test subject, said bodily sample being blood, serum, plasma, blood leukocytes selected from the group consisting of neutrophils and monocytes, or any combination thereof,
wherein elevated levels of MPO activity or MPO mass or both in the bodily sample of the test subject as compared to at least one predetermined value based on levels of MPO activity, MPO mass or both, respectively, in comparable bodily samples obtained from control subjects diagnosed as not having the disease indicates that the test subject is at risk of having atherosclerotic cardiovascular disease.
In addressing the validity of the patents, the court began with describing the two-part test set forth in Alice v. CLS Bank and Mayo v. Prometheus. More specifically, step 1 is identifying whether the claims at issue are directed to a law of nature; and step 2, if so, whether the patents contain an “inventive concept.”
In its step 1 analysis, the court found that the claims at issue are directed to a law of nature (or natural law) because the claims recite a correlation between MPO in the blood and the risk of CVD.
In its step 2 analysis, the court held that the claims at issue do not contain an “inventive concept.” More particularly, the court identified that the patents contained “determining” and “comparing” steps that were insufficient to satisfy the Alice test. For instance, with regards to the “determining” step, the court found that the step “simply calls for determining the MPO mass or activity level from the blood sample by whatever method the user chooses,” and went to identify sections in the patents where the patents acknowledge that these methods were well-known in the art at the time of the invention.
With regards to the “comparing” step, the court found that the step “simply requires comparing the MPO mass or activity level in the test subject to the level in a control population” and that “the control samples are in turn derived from basic statistical techniques and can vary in form.” Again, the court determined that this step was insufficient to be an “inventive concept” because the statistical information was well-understood, conventional information.
In summary, the court stated that “the steps in combination simply instruct a user to apply a natural law, i.e., that an increase in MPO mass or MPO activity in a blood sample correlates to an increase in CVD risk.”
The court also cited the decisions in Molecular Pathology v. Myriad Genetics and Ariosa Diagnostics, Inc. v. Sequenom, Inc. for support that the claims at issue were directed to a law of nature.
I will note that in these cases (such as this case and the Sequenom case), courts have utilized the detailed description against the patent owner in supporting the court’s decision. For example, the courts relied upon statements that certain steps were well-known or previously known to support that the conclusion that the claims are directed to a law of nature. Applicants should take care in describing certain steps as well-known or previously known since these types of admissions are being utilized to reject the claims as being merely directed to an abstract idea.