Canada Inc. v. Apotex Inc., 2013 FCA
appeals the trial court’s decision in a proceeding commenced by Apotex under s.
8 of the PM(NOC) Regulations. The particular trial court determinations
under appeal are 1) it was not relevant to the s. 8 claim that AstraZeneca has
sued Apotex for infringement of the patent in issue and the infringement trial
has not yet been completed; and 2) it was not relevant to the s. 8 claim that
during the period in respect of which s. 8 damages are claimed, Apotex intended
to manufacture its product at a manufacturing site other than the one mentioned
in its then pending regulatory submission.
first issue: there is jurisprudence to the effect that in assessing s. 8
damages, the judge has the discretion under s. 8(5) to reduce the damages based
on an argument of ex turpi causa which could include an infringement
claim. In this case, however, there has been no judicial determination that
Apotex has infringed the patent, or would have done so but for the mandatory
statutory stay during the prohibition proceedings. The trial judge had the
discretion to refuse the request of AstraZeneca to delay the proceedings, and
he did so. It will be for the judge trying the infringement action to ensure
that overall, taking both proceedings together, a party is compensated for its
second issue: the trial judge found that during the period relevant to the
claim for s. 8 damages, Apotex could have manufactured its product at either of
its two manufacturing facilities, and that nothing in the applicable regulatory
regime would have precluded it from doing so. Those findings of fact were
reasonably open to the trial judge on the evidence before him. The record
discloses no basis for interfering with those findings.