By Robert Lower
The Supreme Court handed down its decision in Mayo v. Prometheus Laboratories March 20, 2012, holding U.S. Patent Nos. 6,355,623 and 6,680,302 invalid for failure to satisfy 35 U.S.C. § 101. Prometheus is the exclusive licensee to these patents, which boil down to a process for calculating a dosing regimen for a drug that threads the needle between an inefficacy and overdose, based on the level of metabolites in patients’ blood. The court referenced the first claim of the ‘623 patent in reaching its opinion:
1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8 x 108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8 x 108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
The U.S. Patent and Trademark Office argued the process satisfies the § 101 threshold requirement for patentability, and urged the court to turn to other sections of the patent act to screen the patents in issue. Nonetheless, the court struck the patents for failure to satisfy § 101, which reads:
“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” 35 U.S.C. § 101
If stripping Prometheus of these patents is good, it must follow that preventing issuance of others like it in the first place would be better. § 101 is not the best way to accomplish this goal.
So why did the court rule on § 101? Mayo pushed it. Why did Mayo push it? Along with seeking invalidation of these patents, Mayo probably argued § 101 hoping for a blanket ruling that medical treatments cannot be patented, perhaps to protect Mayo’s business interests (Mayo sought to sell a competing test). While this ruling does not establish a blanket bar against patentability of medical treatments, it certainly does not provide clarity as to what is patentable in the medical arena. It’s not clear why the court ran with Mayo’s § 101 argument instead of looking to other reasons for invalidly.
Had the court invalidated these patents as obvious and/or non-novel under 102 and 103, they could have prevented more patents of this type in the future, without leaving inventors scratching their heads wondering if they should simply direct their talent away from medicine, and towards inventive categories for which the law is predictable.
Under this ruling, claims like the Prometheus process claims could seemingly be reframed as an apparatus, such as a test kit to fall outside the scope of the court’s ruling.