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Beverley Moore
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Claim for Section 8 Damages Allowed
Apotex Inc. v. Pfizer Canada Inc., 2013
FC 493
Drug: azithromycin
In this case, Apotex claimed damages pursuant to s. 8 of the
NOC Regulations, and Pfizer alleged that Apotex should not
be entitled to damages, due to the principles of ex turpi
causa relating to its alleged infringement of the relevant
patent. The period of liability and the quantum of damages will be
determined in a separate proceeding. The Court held that Apotex had
made out its claim for compensation.
The Court held that, under the principles of judicial comity, it
was bound by the construction of the patent performed by the judge
in the NOC Proceeding, as it had not been shown any reason to
depart from that construction.
The Court accepted that there is a close connection between s. 6
and s. 8 of the NOC Regulations, as to hold otherwise
would "create a duplicate regulatory alternative to
infringement and impeachment actions under the Patent Act,
one completely disconnected from the rest of the scheme of the
Regulations." (para 20). Furthermore the allegations addressed
in the s. 8 proceeding must relate to the proceeding brought
pursuant to s. 6. Thus, entirely new allegations of infringement or
invalidity are not relevant in a s. 8 proceeding. Now that the
product is on the market and can be tested, evidence can be
introduced to show actual infringement. However, as the NOA did not
raise issues of invalidity, such issues cannot now be alleged in
the context of the s. 8 proceeding.
The Court held that it is settled law that the principles of
ex turpi causa do not prevent a s. 8 proceeding from being
brought. However, they do apply to the relevant circumstances a
court should consider pursuant to s. 8(5). In this case, the Court
held that Pfizer had not provided evidence to show, on a balance of
probabilities, that Apotex infringed the patent at issue; they had
only shown the possibility that the tablets may have contained a
small amount of infringing material. Thus, the Court did not rule
out the possibility that Pfizer's evidence could be relevant to
the amount of compensation appropriate pursuant to s. 8(5).
In this case, the Court held that Apotex must meet two
requirements: 1) it must show that Pfizer's application
pursuant to s. 6(1) was dismissed; and 2) it must show it suffered
a loss during the period it was kept off the market. Apotex was
held to have met those requirements. Thus, Apotex' claim was
allowed, with quantum to be determined.
Costs Awarded on Substantial Indemnity Basis for
Summary Judgment Motion
Apotex v. Abbott et al., 2013 ONSC
2958
Drug: Lansoprazole
Abbott and Takeda had previously been successful in a motion for
partial summary judgment dismissing Apotex' claims for
disgorgment of profits based on allegations of unjust enrichment
(Decision here; summarized
here). The parties were unable to agree on the costs of the
motion. This decision considers the circumstance and sets the costs
award on a substantial indemnity basis.
The Court held that this was a complex summary judgment motion. In
this case, Abbott and Takeda were held to have separate interests
in this proceeding, and did not produce duplicative work. Thus,
each should be entitled to their costs.
The Court held that Apotex had made claims of wrongful allegations
by alleging that Abbott and Takeda engaged in abusive conduct by
merely invoking the regime that Parliament created. The Court could
not condone a strategy where these types of allegations could be
pled, and a party would be shielded from costs consequences by not
vigorously pursuing them. While the allegations at issue were held
not to be akin to fraud or actual deceit, they were held to cross
the line into counter-productive conduct that warrants a costs
sanction.
The Court also held that although a finding of forum shopping was
not explicitly made, the similarities between this proceeding and
those in Federal Court are "plain and striking".
"Out of the same facts, Apotex tried its argument in two
different forums and, unsurprisingly, received the same answer
twice." (para 27).
Thus, the Court awarded substantial indemnity costs, although, it
did reduce the amount claimed by Abbott and Takeda to $65,000 and
$39,000 respectively.
Other Industry News
The PMPRB has published the schedule and filing requirements for the Human Drug
Advisory Panel (HDAP) in 2014.