Patent Found Valid and Infringed - Accounting of Profits
Awarded Appeal Granted with respect to Summary Judgment re
Standing to Sue for Infringement Liability for Section 8 Damages Upheld The Supreme Court is releasing their judgment for two leave
decisions this Thursday. The first, Gilead Science Canada Inc. v.
Minister of Health Limited, relates to when a patentee may list a
patent claiming the medicinal ingredient of a commercial product on
the Patent Register. Our summary of the Court of Appeal decision was reported October 15, 2012. Health Canada has published a notice that it has updated its
fees for the Administration of Drug Master Files. It has
also published a two new forms: Drug Master File (DMF) Fee Form and Drug Submission/Application Fee Form. In
addition, it has published a number of Guidance Documents: Fees for the Review of Drug Submissions and
Applications, Fees for the Review of Medical Device Licence
Applications, Medical Device Licence Renewal and Fees for the
Right to Sell Licensed Medical Devices, and Fees for the Right to Sell Drugs. The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
Patent Actions
Apotex v. H. Lundbeck.
Drug: escitalopram
Apotex sued for impeachment of Lundbeck's patent. Lundbeck
counterclaimed for infringement. The Court held that the patent was
valid and infringed. The patent claimed, inter alia, the
escitalopram enantiomer.
The Court held that the previous disclosure of citalopram was not
anticipatory. In considering obviousness, the Court held that the
issue is not which techniques would have been used, but rather,
"whether those techniques would have been successful, given
the wide range of chemicals and other variables which might be used
in the reactions." According to the Court, it boiled down to
whether it was obvious to try certain techniques, or whether one
would give up in frustration. (para 93). The Court recognized, in
this analysis, that a different skill set is required to create a
recipe, than to follow it. Regarding motivation, the Court
recognized that "wishing does not make something come
true" or make it easier. Motivation may make one try harder to
make something work, but at some point, the experiments are no
longer routine.
Regarding inutility, Apotex tried to rely on a statement about the
toxicity of a particular salt made in another patent application as
a binding admission. The Court held that what was said was not
important, but rather, whether the salt was actually toxic. As
Apotex filed no evidence on the issue, the Court accepted
Lundbeck's evidence and dismissed the allegation of
inutility.
Apotex argued that a misstatement in the patent should lead to the
patent being declared void for insufficiency. The Court held that
the sentence in question was not essential, and thus, the patent
should survive. The Court also held that testing done with the
patent in hand for the purposes of determining which compound is
escitalopram is different than testing done in order to find the
invention. Thus, the patent does not fall for insufficiency.
Regarding sound prediction, the Court held that the patent did not
promise that escitalopram would be more potent than racemic
citalopram. Most of the inhibition was found in escitalopram as
compared to racemic citalopram, but the comparison in the data
could not be taken as a promise. In this case, the inventive
concept was the two enantiomers and methods to obtain them. The
patent was not invalid for a lack of sound prediction.
The Court then considered infringement and remedies. Infringement
was admitted if validity was found. Apotex had stockpiled
escitalopram in advance of both the NOC decision and the Appeal. It
then sold some of that stockpile. The Court held that both of these
activities were infringing, but did not warrant an award of
punitive damages. However, Apotex did make a profit on those sales
and the Court held they must account for it. "It would be
completely unreasonable to hold that the only consequence of
infringement over several years would be to declare the patent
valid and to enjoin them from continuing to do what they should not
have done in the first place." (para 272). In considering the
approach to accounting for profits, the Court distinguished other
jurisprudence and held that because the only active ingredient in
Apotex' product was escitalopram, it must turn over all profits
less legitimate expenses incurred. The Court also granted a
permanent injunction.Copyright Cases
Nautical Data International v. C-Map
USA
The Court granted a motion for summary judgment relating to
standing to sue for copyright infringement in two actions,
resulting in dismissal of the two actions. The Court of Appeal
found that the defendants did not meet their burden of proving that
there is no genuine issue for trial, and that the motion for
summary judgment should have been dismissed.Other Cases of Interest
Astrazeneca Canada v. Apotex
Drug: ompeprazole
AstraZeneca appealed the decision of the Trial Judge with respect
to liability for damages pursuant to s. 8 of the NOC Regulations
(decision here, our summary here). Two factual questions were at issue on
appeal: whether it was relevant that Astrazeneca had sued Apotex
for infringement and that trial had not yet been completed; and
whether it was relevant that Apotex intended to manufacture its
product at a site other than the one mentioned in its pending
regulatory submission.
The Trial Judge held that at the time the infringement case was
heard, the Court could then craft an appropriate remedy taking into
account any compensation award in these proceedings. Furthermore,
Apotex could have manufactured its product at either of the two
facilities, so the change in location was not relevant. The Court
of Appeal upheld these findings.
The Trial Judge held that at the time the infringement case was
heard, the Court could then craft an appropriate remedy taking into
account any compensation award in these proceedings. Furthermore,
Apotex could have manufactured its product at either of the two
facilities, so the change in location was not relevant. The Court
of Appeal upheld these findings.Decisions in Leave to Appeal to the Supreme Court
The second leave application, Phillips Morris Products S.A.,
Rothmans, Benson & Hedges Inc. v. Marlboro Canada Limited,
Imperial Tobacco Canada Limited, relates to trade-marks used in
association with cigarettes. Our summary of the Court of Appeal decision was reported July 9, 2012.Other Industry News