On 20 March 2012, the Supreme Court released its opinion on Mayo Collaborative Services v. Prometheus Laboratories, Inc., a case relating to patentability of a method of treating autoimmune diseases using thiopurine drugs. The Supreme Court had the task of deciding whether a claim such as shown below is valid under 35 USC 101.
1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine in said 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 8x108 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 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
For a claim to be valid under 35 USC 101, the invention recited in the claim must fall under one of the following categories: process, machine, manufacture, and composition. In addition, the claimed invention cannot be law(s) of nature, natural phenomena, or abstract ideas. However, the claimed invention could be an application of law(s) of nature. The question the Supreme Court answered is whether the claimed invention is law(s) of nature or application of law(s) of nature.
This case has a long history. In 2009, the Federal Circuit found that a claim such as shown above is eligible for a patent under 35 USC 101 (Prometheus Laboratories, Inc. v. Mayo Collaborative Services (Fed. Cir. 2008-1403, decided September 16, 2009)). The Federal Circuit justified its decision using the machine-or-transformation test developed in In re Bilski (In re Bilski, Fed. Cir., No. 2007-1130, October 30, 2008). On the other hand, the Supreme Court found that a claim such as shown above is invalid under 35 USC 101 because it effectively claims the underlying laws of nature.