On January 27, 2014, the Federal Court of Appeal in Novartis
Pharmaceuticals Canada Inc. v. Cobalt Pharmaceuticals Co.,
2014 FCA 17 (Novartis), upheld the Federal Court's
denial of an application for a prohibition order under the Canadian
Patented Medicines (Notice of Compliance) Regulations on
the basis that the impugned patent was directed to a method of
medical treatment. With this third
decision1 on alleged methods of medical
treatment in the past year alone, Canadian courts continue to hold
methods of medical treatment to be unpatentable, while providing
only limited guidance about the limits of permissible
In Novartis, the claims at issue were directed to a
particular frequency of dosing zoledronic acid to treat
osteoporosis, namely intermittent administration about once a year.
For example, claim 16 was directed to "use of zoledronic acid
for the treatment of postmenopausal osteoporosis wherein the
zoledronic acid ... is in a unit dosage form of about 5 mg which is
administered intermittently, with a period of about one year
between the first and each subsequent administration, wherein each
administration is intravenous." Of note, the Federal
Court had found that the dosing frequency was the sole aspect of
the invention that made it not obvious. The issue, therefore,
was whether a dosing frequency falls within the scope of patentable
subject matter set out in the definition of "invention"
in section 2 of the Patent Act.
Consistent with European practice, Canadian courts have long
found methods of medical treatment to be unpatentable, even after
the Patent Act's former prohibition against patenting
drug substances was repealed. Relying on the 1972 decision of the
Supreme Court of Canada in Tennessee Eastman Company v.
Commissioner of Patents,  S.C.R. 111, which involved a
surgical method for joining incisions by applying certain
compounds, Canadian courts have found the following subject matter,
for example, to be unpatentable: dosage ranges dependent on a
patient's weight,2 a titration
regime,3 and use claims where
components and dosages need to be
selected.4 The courts' rationale
appears to be that Canadian patents ought not interfere with the
ability of physicians to exercise their skill and judgment.
In Novartis, the Federal Court of Appeal had the
opportunity to clarify what exactly amounts to an unpatentable
method of medical treatment. Unfortunately, the four
paragraph decision does little more than affirm the decision
below. Under Canadian case law, therefore, it is settled that
vendible products, such as pharmaceutical dosage forms, are
patentable subject matter. Claims as to the use of a drug to
treat a medical condition are also allowed, whether worded as such
or as Swiss-type claims ("the use of drug X in the manufacture
of a medicament to treat condition
Y"5). By contrast, claims
directed to subject matter falling within the skill of a medical
professional have been found improper. In practice, however,
this distinction may be difficult to draw in respect of claims that
include both a vendible product (e.g., a dosage form)
and subject matter related to the exercise of professional
judgment (e.g., a dosing regimen). In these circumstances, Canadian
courts scrutinize the patent specification's language to
determine if a claim to a commercial product requires skill to
administer it. If so, the claim will likely be invalid.
In the result, a claim to "the substance X in the form of a 5
mg tablet for the treatment of Y" is proper, but a claim to
"the use of substance X in a dosage range between A and B for
the treatment of X" probably is not.
The Novartis case confirms that Canadian patent
applicants should use caution in relying on therapeutic dosing
limitations to distinguish the prior art. Such limitations
could be argued to fall within the skill and judgment of a medical
practitioner, and invalidate the claims at issue.
A recent Saskatchewan Court of Queen's Bench decision allowed a court-appointed receiver to sell and transfer intellectual property rights free and clear of encumbrances, finding that a license to use improvements of an invention was a contractual interest and not a property interest.
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