Astrazeneca Canada Inc v. Apotex Inc, 2016 FC 865 Drug: omeprazole

In this recently reported decision, the Court granted Apotex leave to deliver Fresh as Amended Responding Statement of Issues for the reference into AstraZeneca's damages or Apotex's profits, following the Court's decision that the ‘693 Patent is valid and infringed by Apotex (see 2015 FC 322, our summary here ).

The impugned amendments relate to one of the defences plead by Apotex, namely that Apotex had available to it non-infringing alternatives (NIA) which would reduce or eliminate the damages or profits available to AstraZeneca. The Court concluded that the proposed amendments did not add new defence. Rather, the amendments expanded the evidence on which Apotex hopes to prove the defence of NIA, which was previously pled by Apotex.

In the Court's view, the threshold question for allowing amendments that go to an existing plea expanding the scope of the evidence available to prove the plea is whether they would survive a motion to strike. The Court agreed with Apotex that AstraZeneca would not have been successful in striking the proposed amendments if they had been in the original Responding Statement. The Court also found that Apotex established that the proposed amendment was necessary to determine the real question in controversy between it and AstraZeneca.

On the issue of whether the amendment will create an injustice or prejudice that is not compensable in costs, the Court noted that Apotex had given assurances that it will fully cooperate regarding any further discovery. The Court also noted an absence of evidence that such discovery would impact the current schedule, except possibly the date of AstraZeneca's election between damages or profits, which can be moved without consequence if required. The Court also found that Apotex had met its burden to establish that the proposed amendments are in the interests of justice.