Mayo v. Prometheus, 566 U.S. 66 (2012)
2012年に米国最高裁判所により下された特許対象（patentable subject matter; 35 U.S.C. §101）に関する判決。最高裁は、チオプリン薬（消化器系の自己免疫疾患治療に用いられる薬）を患者に投与し、チオプリン代謝物の血中濃度を測定し、測定した血中濃度を既知の基準値と照らし合わせてチオプリン薬の投与量を調整することついて特許適格性がない（patent ineligible）と判じた。
代表的なクレーム（US6,355,623のクレーム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 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 about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
https://supreme.justia.com/cases/federal/us/566/66/