In a cautionary tale to be heeded by patent drafters, the
Supreme Court of Canada held that Pfizer's patent directed to
sildenafil, better known as Viagra, is invalid for failing to meet
the disclosure requirement of section 27(3) of the Patent
Act. An attack on the validity of the patent by the generic
company, Teva, in the context of a section 55.2 proceeding under
the Patented Medicines (Notice of Compliance) Regulations
was unsuccessful before both the Federal Court and the Federal
Court of Appeal.
The decision of the Federal Court garnered attention by reason
of the Court expressing in obiter, its discomfort with the
fact the patent played "hide and seek with the reader."
The Court questioned why the disclosure did not simply identify the
only compound tested as sildenafil (as claimed in claim 7).
In the patent at issue, claim 1 encompassed 260 quintillion
compounds while the dependent claims were progressively narrower.
Claims 6 and 7 were each directed to one compound. In the
disclosure, it was noted that "one of the special preferred
compounds" had been shown to be effective in treating erectile
dysfunction (ED). The evidence before the Court was that only
sildenafil, the subject of claim 7, was the effective compound. The
disclosure, however, did not specifically identify sildenafil as
the compound that was effective in treating ED. The Supreme Court
of Canada recognized that a person of ordinary skill in the art
could look to the claims and note that two claims were directed to
the use of individual compounds, which might suggest to the skilled
person that the invention was directed to those compounds. However,
the Court also found it would have taken a "minor research
project" to identify the true invention. On this basis, the
Court found the disclosure failed to meet the requirement of
section 27(3) of the Patent Act in that the specification
did not correctly and fully describe the invention and its use as
contemplated by the inventors because the patent would not have
enabled the skilled person to produce the invention using only the
instructions contained in the description.
The Court also considered the issue of utility. While in the
last few years, the Courts had appeared to raise the bar on the
issue of utility, this decision appears to swing the pendulum back
by holding that since, at the time of the filing of the
application, sildenafil could assist in treating ED, this was
sufficient to meet the utility criterion.
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