In a decision last month, the U.S. Supreme Court in a 9-0 ruling
has held that the method claims of two patents directed to
optimizing the dose of a specific drug for treating an autoimmune
disease are not patentable because they merely recite laws of
The outcome of this decision brings Canada and the U.S. to the
same end result for these types of patents (no enforceable patent),
but how we get there differs.
The U.S. Supreme Court decision reverses the Federal
Circuit's earlier rulings, which had upheld the validity of the
claims. Claim 1 of U.S. Patent 6,355,623 reads as
"A method of optimizing therapeutic efficacy for treatment
of an immune-mediated gastrointestinal disorder, comprising:
administering a drug providing 6-thioguanine to a subject
having said immune-mediated gastrointestinal disorder, and
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
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
The Court held that the claims did not do "significantly
more" than describe the laws of nature and accordingly were
not patentable. The steps in the claimed methods (apart from
the natural laws themselves) were found to involve
"well-understood, routine, conventional activity previously
engaged in by researchers in the field". The Court
expressed the view that upholding the patents at issue would
"risk disproportionately tying up the use of the underlying
natural laws, inhibiting their use in the making of further
This decision, which is perceived as a blow to the protection of
advances in personalized medicine in the U.S., is in line with more
recent Canadian jurisprudence.
In Canada, claims directed to dosage regimens have been rejected
as being directed to a method of medical treatment requiring the
application of professional skill, thus falling outside an economic
area related to trade, commerce or industry and outside of the
definition of "invention". On the basis of a different
legal reasoning, the U.S. and Canadian Courts have ultimately
reached the same conclusion.
Also, watch for a more in depth article in the upcoming Life
Sciences and Law: Current Issues 2012-2013 book available in
June 2012 online and at the BIO International Convention in
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In the recent decision, the British Columbia Court of Appeal addressed the issue of liability on the part of a Canadian government regulator for damages arising out of negligent performance of its duties where the performance of those duties led to a recall of the plaintiff's product.
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