Judge Gaughan of the U.S. District Court for the Northern District of Ohio granted the defendant’s motion to dismiss after finding three Cleveland Clinic Foundation diagnostic patents invalid under 35 USC § 101. While the result is not surprising in view of recent patent eligibility decisions, it serves as reminder of the real-world impact of recent Supreme Court and Federal Circuit cases. 

The Diagnostic Patents At Issue

The diagnostic patents at issue were directed to methods of assessing risk for atherosclerotic cardiovascular disease by measuring levels of myeloperoxidase. As summarized by the district court, the methods indirectly measure blood vessel inflammation by measuring levels of myeloperoxidase, which is an enzyme released by white blood cells into the blood stream when an artery wall becomes damaged or inflamed.

Claim 14 of U.S. Patent 7,223,552 was one of the diagnostic claims considered by the court:

14. A method of assessing a test subject’s risk of developing a complication of atherosclerotic cardiovascular disease comprising:
determining levels of myeloperoxidase (MPO) activity, myeloperoxidase (MPO) mass, or both in a bodily sample of 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 test subject’s bodily sample as compared to 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 developing a complication of atherosclerotic cardiovascular disease.

Claim 21 of U.S. Patent 7,459,286 was another diagnostic claim considered by the court:

21. A method of assessing the risk of requiring medical intervention in a patient who is presenting with chest pain, comprising
characterizing the levels of myeloperoxidase activity, myeloperoxidase mass, or both, respectively in the bodily sample from the human patient, wherein said bodily sample is blood or a blood derivative,
wherein a patient whose levels of myeloperoxidase activity, mycloperoxidase mass, or both is characterized as being elevated in comparison to levels of myeloperoxidase activity, myeloperoxidase mass or both in a comparable bodily samples obtained from individuals in a control population is at risk of requiring medical intervention to prevent the occurrence of an adverse cardiac event within the next six months.

Claim 5 of U.S. Patent 8,349,581 was another diagnostic claim considered by the court:

5. A method of determining whether a patient who presents with chest pain is at risk of requiring medical intervention to prevent an adverse cardiac event within the next six months comprising:
determining the level of risk predictor in a bodily sample from the subject, wherein said risk predictor is myeloperoxidase activity, myeloperoxidase mass, a myeloperoxidase (MPO)-generated oxidation product or any combination thereof, wherein said bodily sample is blood, serum, plasma or urine, wherein said myeloperoxidase-generated oxidation product is nitrotyrosine or a myeloperoxidase-generated lipid peroxidation product selected from hydroxy-eicosatetraenoic acids (HETEs); hydroxy-octadecadienoic acids (HODEs), F2Isoprostanes; the glutaric and nonanedioic monoesters of 2-lysoPC (G-PC and ND-PC, respectively); the 9-hydroxy-10-dodecenedioic acid and 5-hydroxy-8-oxo-6-octenedioic acid esters of 2-lysoPC (HDdiA-PC and HOdiA-PC, respectively); the 9-hydroxy-12-oxo-10-dodecenoic acid and 5-hydroxy-8-oxo-6-octenoic acid esters of 2-lysoPC (HODA-PC and HOOA-PC, respectively); the 9-keto-12-oxo-10-dodecenoic acid and 5-keto-8-oxo-6-octenoic acid esters of 2-lysoPC (KODA-PC and KOOA-PC, respectively); the 9-keto-10-dodecendioic acid and 5-keto-6-octendioic acid esters of 2-lysoPC (KDdiA-PC and KOdiA-PC, respectively); and the 5-oxovaleric acid and 9-oxononanoic acid esters of 2-lysoPC (OV-PC and ON-PC, respectively), or any combination thereof, and
comparing the level of said risk predictor in the bodily sample of the patient to the level of said risk predictor in comparable samples obtained from a control population,
wherein a subject whose bodily sample contains elevated levels of said risk predictor as compared to the control value is at risk of requiring medical intervention to prevent an adverse cardiac event within 6 months of presenting with chest pain.

Boxed In By Alice, Mayo, Myriad, Intema, Sequenom 

The district court made quick work of the patent eligibility analysis, finding the diagnostic patent claims invalid under the two-part Alice test. As for the first part of the test, the court found that the claims were directed to “a natural law, i.e., the correlation between MPO inthe blood and the risk of [cardiovascular disease].” As for the second part of the test, the court found that none of the “determining” or “comparing” steps added “significantly more” to the claims that amounted to an “inventive concept,” since well-known techniques could be used. Considering the claims as a whole did not save them, because “like the claims at issue in Perkin Elmer [v. Intema], [the claims at issue] do not require that a doctor act on any risk.”

(Intema was a non-precedential decision, but I wrote about it in this article.)

It is not surprising that the court cited the Federal Circuit decision in Sequenom, but it is annoying that the court also cited the Supreme Court decision in Myriad, since the Supreme Court seemed to be careful in that decision to leave in tact the patent-eligibility of methods related to the discovery of naturally-occurring materials:

[T]his case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. Judge Bryson aptly noted that, “[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications of that knowledge.

Aren’t diagnostic methods new applications of knowledge based on the discovery of a natural law? Shouldn’t the first person with knowledge of the natural law be in a position to claim applications of that knowledge?

What Does The Future Hold?

As long as Sequenom is controlling precedent, it will be difficult to uphold the patent-eligibility of diagnostic patents such as those considered here. But what are diagnostic and personalized medicine companies to do in the meantime? In March, I will be speaking at several events that will discuss these issues.

On March 10, 2016, I am moderating a panel on “Sequenom and Section 101 Challenges in Diagnostics and Personalized Medicine,” with speakers Dr. Hans Sauer of BIO and Prof. Adam Mosoff of George Mason University School of Law at the Advanced Patent Law Institute presented by the University of Texas School of Law, the USPTO, and George Mason University School of Law, held at the USPTO’s Alexandria, Virginia campus. (For more information or to register, visit the UT  Law CLE website here.)

On March 15, 2016, I am moderating a panel on “Subject Matter Eligibility,” with speakers Drew Hirshfeld, Commissioner for Patents, USPTO, Mike Fuller from Knobbe, Martens, Olson & Bear, LLP, Manny Schecter from IBM Corp., and Laura Sheridan from Google, Inc., at the IPO Education Foundation’s Patent Bar & Office Dialog Summit, held at the JW Mariott Hotel in Washington, D.C. (For more information or to register, visit the IPO Education Foundation website here.)