The recent Prometheus decision rendered by the U.S.
Supreme Court (U.S., No. 10-1150) is perceived by many as a blow,
if not a death knell, for the protection of advances in
In a unanimous ruling, the U.S. Supreme Court held that 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 nature.
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 discoveries."
Unfortunately, the situation in Canada is not very different. In
recent years, claims directed to dosage regimens (expressed, for
example, as plasma concentrations in a patient) have been rejected
as falling outside the definition of "invention" because
they are directed to a method of medical treatment that requires
professional skill. It is to be noted that method of medical
treatment claims are not patentable subject matter in Canada
because they are essentially non-economic and unrelated to trade,
industry or commerce; in other words, not directed to a vendable
product (unlike use claims, which are patentable).
The situation in Canada is somewhat anomalous because claims
directed to a dosage regimen have been upheld by the Supreme Court
of Canada, while in more recent decisions, the same type of claims
have been struck down.
In Apotex v. Wellcome Trust et al. 2002 S.C.C. 77, 21
CPR (4th) 499 (pertaining to the AZT Patent), the validity of the
following claim was upheld:
Claim 27: A formulation according to claim 21 or 26, wherein
said 3'-azido-3'- deoxythymidine is present in an amount
effective to achieve a peak plasma concentration on administration
of from about 1 to about 75 μm.
The Trial Division of the Federal Court of Canada upheld the
validity of the claim on the ground "the patent deals with an
economic area related to trade, commerce or industry. Indeed, the
patent claims protection for drug formulations which are of
considerable economic as well as medical value." The decision
of the Federal Court, in respect of the question of methods of
medical treatment, was upheld by the Federal Court of Appeal (10
CPR (4th) 65). That decision, in turn, was appealed to the Supreme
Court of Canada. On appeal, the Supreme Court specifically
addressed the question of whether any of the claims of the AZT
Patent were directed to a method of medical treatment. The Supreme
Court stated, "The AZT patent does not seek to 'fence
in' an area of medical treatment. It seeks the exclusive right
to provide AZT as a commercial offering. How and when, if at all,
AZT is employed is left to the professional skill and judgment of
the medical profession."
Yet in subsequent decisions, commencing with the Axcan
decision (2006 FC 527), the Courts rejected claims directed a
dosage regimen. In Axcan, the claim at issue read:
Pharmaceutical composition for the treatment of primary biliary
cirrhosis, characterized in that it includes ursodeoxycholic acid
as a vehicle and if necessary pharmaceutical excipients, the said
composition being processed in a form allowing for the said
treatment of primary biliary cirrhosis based on a dosage of 13 to
In distinguishing the AZT decision, the Court held,
"The invention here is quite different. It is up to the
physician based on his or her knowledge of the patient's rate
of metabolism and other factors to determine the appropriate daily
dosage. I cannot, for a moment, contemplate that Axcan can claim
exclusive property in the dosage and sue a physician for
prescribing . . . at a dosage less than 13 mg/kg/day or greater
than 15mg/kg/day." The Court goes on to conclude, "There
is a distinction between the dosage in a capsule and a dosage range
based on the patient's weight. As I read the claim, the
emphasis is on the dosage range and a dosage range is not a
The Canadian Intellectual Property Offi ce has also been
rejecting claims directed to a dosage regimen on the basis of the
In conclusion, a comparison of the U.S. and the Canadian
jurisprudence can be summed up as follows: Different grounds of
rejection but the same result.
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guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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