PROMETHEUS
IS THERE LIFE FOR MEDICAL DIAGNOSTIC PATENTS AFTER PROMETHEUS?
The Supreme Court’s much-anticipated Prometheus decision has prompted strong reactions among IP practitioners, as MaryAnne Armstrong, PhD, explains.
On March 20, 2012, the US Supreme Court handed down the long-awaited decision in Mayo Collaborative Services v Prometheus Laboratories Inc. T e Prometheus decision rocked the IP world and leſt people wondering whether there is any room leſt for patents in the medical diagnostic industry, particularly as it applies to personalised medicine.
T e claims in the Prometheus patent were directed to a method of optimising therapeutic effi cacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine; and
(b) determining the level of 6-thioguanine, 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 … and … 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.
T e Supreme Court, in analysing the patentabilty of the Prometheus claims, emphasised that it was well-known to treat gastrointestinal disorders with thiopurine drugs, and that
these drugs
metabolised into 6-thioguanine. It was further well-known that patients metabolised the drugs inconsistently and that the level of 6-thioguanine could be used as a measure of whether the drug level was too high or too low. T e Prometheus claims took the well-known step of administering the drug to particular patients and the associated well-known phenomena (metabolism to 6-thioguanine and correlation of 6-thioguanine with appropriate drug levels) and recited defi ned parameters for concluding whether the drug level was too high or too low.
T e Supreme Court noted that the claims of Prometheus set forth laws of nature (the relationship
the claims do signifi cantly more than simply describe these natural relations. To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent- eligible processes that apply natural laws?”.
In reaching its decision, the Supreme Court discussed the earlier decisions of Diamond v Diehr and Parker v Flook. T e Supreme Court considered Diehr and Flook to be two representative endpoints at opposing ends of the spectrum for determining the patentability of an invention which applies a law of nature.
between the concentration of
metabolites in the blood and likelihood that the drug will be ineff ective or cause harmful side- eff ects) which, by themselves, are unpatentable. T e Supreme Court then considered “whether
T e Supreme Court seemed to suggest, in comparing Diehr and Flook, that because in Diehr the steps of measuring the specifi c recited parameters and applying those parameters to open a rubber curing mould were novel and unobvious, the invention was patentable. T e Supreme Court contrasted the Diehr invention to that of Flook, wherein it was noted that all of the parameters being measured and steps taken were conventional
www.worldipreview.com
Life Sciences Intellectual Property Review 2012
31
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64