On January 7, 2015, Justice de Montigny of the Federal Court
released his judgment and reasons in Eli Lilly Canada Inc. v.
Mylan Pharmaceuticals ULC, 2015 FC 17, allowing Lilly's application
for an order prohibiting the Minister of Health from issuing a
Notice of Compliance to Mylan until the expiry of Canadian Patent
No. 2,226,784 (the "'784 Patent"). The patent relates
to Lilly's successful erectile dysfunction ("ED")
drug CIALIS® (tadalafil).
The Court found that Mylan's allegations of invalidity on
the basis of lack of utility and obviousness-type double patenting
were unjustified. Justice de Montigny's reasons signal the
Court's continuing hesitation to impute potentially
invalidating promises of utility if they are not clearly and
explicitly stated in the patent. Further, the case establishes that
the relevant date for conducting the double patenting analysis is
the earlier patent's claim date.
Utility: Promise of the Patent
Lilly argued that the promise of the '784 Patent is the use
of certain claimed compounds to treat ED. Mylan disagreed,
asserting that the patent also promises that the compounds will be
effective on oral administration and will not have severe side
The Court preferred Lilly's construction, holding that the
promise of the '784 Patent does not relate to the specific
route of administration, but rather to the effectiveness of the
compounds to treat ED. Justice de Montigny explained that although
oral administration is a preferred feature of the invention, it is
not the promise of the entire patent. Additionally, he disagreed
with Mylan's assertion that the claim term
"treatment" imports a consideration of side effects,
holding that there is no reference to toxicity in the '784
Utility: Sound Prediction
Since the utility of the claimed compounds to treat ED was not
demonstrated prior to the filing date, the Court undertook an
analysis of whether such utility could be soundly predicted.
Justice de Montigny found that in light of the common general
knowledge, the '784 Patent taught a skilled person that the
claimed compounds potently and selectively caused penile erection.
He further held that even if the promise of the patent was
construed to included oral administration, such utility was also
soundly predicted by the filing date.
Mylan argued that if the promise of the '784 Patent does not
include oral administration, it must be invalid for
double-patenting over an earlier Canadian patent which claims the
same compounds. The Court disagreed, holding that while both
patents claim the same chemical compounds, the earlier patent does
not contemplate use of the compounds to treat ED.
On the issue of the relevant date for an obviousness-type double
patenting analysis, the Court explained that the key consideration
is whether the claims in the later patent disclose novelty or
ingenuity over the earlier patent. As such, "[o]ne cannot read
into the claims of the first patent more than what would have been
understood by the person skilled in the art at the claim date when
comparing the claims of the second patent to those of the first
patent" (at para. 134). On this basis, Justice de Montigny
held that the correct date for determining the issue of double
patenting is the priority date of the earlier patent.
The Federal Court dismissed a motion by Apotex seeking particulars from Allergan's pleading relating to the prior art, inventive concept, promised utility and sound prediction of utility of the patents at issue.
Last year we saw the Canadian Courts release trademark decisions that granted a rare interlocutory injunction, issued jailed sentences for failure to comply with injunctive relief, grappled with trademark and internet issues...
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