Mayo v. Prometheus – The Emperor’s New Law of Nature?

September 21, 2012

Published in the Boston Business Journal – TechFlash Section

The March 20, 2012 Supreme Court decision in Mayo v. Prometheus has had time to sink in. Most patent practitioners reacted with initial shock, followed by reluctant acceptance and readiness to work-around the decision for their clients. But now, patents are dying on the vine, portfolios are being reevaluated, and investment decisions made that will reduce entrepreneurship, limit job creation, and eliminate opportunities for patients to be diagnosed and treated. What else can be done? The high court has spoken: Correlations of analyte levels with disease are unpatentable laws of nature. But a closer look reveals that the emperor has no clothes–that is–no law of nature.

In Mayo v. Prometheus, the Supreme Court conspicuously failed to explain how the Prometheus claims amount to a law of nature, the decisive and unexpected issue in the case. The decision is founded on established and noncontroversial precedent that patent rights cannot preclude a law of nature, but that applications of such laws are suitable for patent protection. Thus, the Court was obliged to show how the Prometheus claims preclude a law of nature and why they are not an application of such a law. But, providing no analysis other than an irrelevant comparison to basic laws of physics, the Court appears to have assumed that everything that happens within the human body is just a “black box” of natural law. Not only was this far from the truth, and dangerously naïve, but it also set a terrible precedent to guide the medical diagnostics industry.

The claims in question amount to a method of determining a safe and effective dose for a narrow class of manmade drugs (6-mercaptopurines). The inventors considered many variables, including age, gender, and genetic polymorphism of the enzyme thiopurine methyltransferase in the patient, as well as multiple “toxic” side effects including allergic reactions, neoplasia, infections, hepatitis, bone marrow suppression, and pancreatitis. Out of this mix, and using costly clinical data, they applied inventive skill to determine that certain amounts of a blood-born metabolite (6-thioguanine) can predict successful treatment. While the method is simple to carry out (measure a blood-born metabolite and compare to two numbers), it represents a subjective medical opinion derived by the inventors after weighing and selecting multiple factors and evaluating unpredictable clinical data. The relationship embodied in the Prometheus claims is not a law of nature because it does not describe a broad natural phenomenon. It describes the reaction of individual human bodies when exposed to a narrow class of artificial chemicals. Importantly, the upper and lower limits for 6-thioguanine recited in the Prometheus claims have no meaning or effect in the natural world, but only in the context of medical treatment using 6-mercaptopurines. The Prometheus limits are not like Planck’s constant. They are technology.

By failing to distinguish a law of nature from its application, the Supreme Court has opened the floodgates for attacks on patents in all technologies. For nature can be found in every patent claim.

Lin Hymel, Ph.D., J.D., is Of Counsel with the McLane Law Firm and specializes in patent prosecution, client counseling, and patent reexamination pertaining to biotechnology, pharmaceuticals, chemistry, materials science, and medical devices.