The Supreme Court of Canada has unanimously overturned decisions
of the Federal Court and Federal Court of Appeal, and held, in the
context of proceedings under the Patented Medicines (Notice of
Compliance) Regulations [PM(NOC) Regulations], that
Pfizer's Canadian Patent No. 2,163,446 for the use of VIAGRA
(sildenafil) was void.
The judgment turned on whether the patent sufficiently disclosed
the invention. The Supreme Court did not regard this to be a case
of sound prediction and thus did not directly address the issue. In
particular, the Court declined to address whether there is an
"enhanced" disclosure requirement for sound prediction,
which has sometimes been applied by lower courts.
Teva Canada Ltd., the appellant, had alleged that the patent did
not meet the disclosure requirements under section 27(3) of the
Patent Act. The Federal Court disagreed, stating that
Pfizer had complied with that section and the patent disclosed a
meritorious invention. In coming to this decision, the validity of
each claim was determined separately pursuant to section 58 of the
Patent Act. It was found that the patent sufficiently
disclosed both the invention and how it worked; principally when
one considered claim 7, a claim for the use of sildenafil alone.
The patent described one of the compounds as "especially
preferred," and sildenafil was specifically claimed. Indeed,
the claim to sildenafil was one of only two claims to the use of a
single compound. Accordingly, the Federal Court prohibited the
Minister of Health from issuing a notice of compliance (NOC) to
The Court of Appeal agreed with this reasoning and also upheld
the finding that the allegation of invalidity was not
In overturning the lower courts, Justice LeBel, writing for the
Supreme Court, began by restating the role of patents and the
quid pro quo of the patent bargain: disclosure of the
invention in exchange for exclusive rights. In his view, the
disclosure requirement is a part of this bargain and should not be
reviewed on a claim-by-claim basis.
Justice LeBel construed the patent to describe a class of
compounds useful in the treatment of erectile dysfunction (ED).
Although sildenafil was an especially preferred compound, nothing
in the patent disclosure distinguished it from the other especially
preferred compounds. To the Court, the use of sildenafil as well as
the other compounds for the treatment of ED comprised a single
inventive concept. However, the Court held that since the patent
did not specifically disclose sildenafil as the compound Pfizer had
tested and shown to work, the patent was void for insufficiency
under section 27 of the Patent Act (although, given that
this was a proceeding under the PM(NOC) Regulations, the
patent could not be "voided" but rather the Court could
find that Teva's allegations of invalidity were justified and
the order prohibiting the Minister from issuing an NOC be set
Of particular interest were the Court's comments regarding
the role of the patent claims. The Court did not regard each claim
as relating to a separate invention but that the invention must be
construed on the basis of the whole specification. In this case,
given that there were two claims to the use of a single compound
but neither was indicated to be the especially preferred compound
sildenafil, the Court held that a skilled reader could not make the
same use of the invention as the inventor could at the time of his
application. Thus, Pfizer's disclosure obligation under the
Patent Act was not fulfilled.
As a result of this judgment, Teva may now proceed with
marketing and selling a generic version of Viagra.
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