Recent Developments in Australian & US Patent Law & their Impact ...

Personalized Medicine –
Prometheus Labs US Patent No. 6,355,623
Ausbiotech 2012 – Australian and US Patent Law
1 November 2012
11
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 10 8 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 10 8 red blood cells indicates a need to decrease the amount of said drug
subsequently administered to said subject]]
(c) comparing the level of 6-thioguanine in said subject with a reference standard of a subject not having an
immune-mediated gastrointestinal disorder; and
(d) determining whether the subject with the disorder has a level of 6-thioguanine less than about 230 pmol per 8
x 10 8 red blood cells or greater than about 400 pmol per 8 x 10 8 red blood cells,
wherein when the subject has less than about 230 pmol per 8 x 10 8 red blood cells,
(e) administering a subsequent increased dose of 6-thio to the subject, wherein steps (b)-(d) are optionally
repeated.
or wherein when the subject has greater than about 400 pmol per 8 x 10 8 red blood cells,
(f) administering a subsequent decreased dose of 6-thio to the subject, wherein steps (b)-(d) are optionally
repeated.