The trial was divided into two parts, with AstraZeneca’s challenges relating to the validity of section 8 being argued before the Trial Judge and a second judge seized with many of the same validity challenges in two unrelated matters (summarized above). Further, the experts on the evidentiary issues were examined in a “hot tubbing” format after being questioned in the usual manner, with the Trial Judge asking questions and each expert responding to comments made by the other. Counsel was then permitted to pose follow-up questions.
The trial related to entitlement and other issues relating to section 8, and a Reference is to be held relating to quantification of damages.
The Court rejected AstraZeneca’s challenges to the validity of section 8. The Court also rejected AstraZeneca’s arguments that Apotex did not meet the definition of “second person” so as to trigger section 8. With respect to AstraZeneca’s argument that the alleged infringement of the patent is relevant, the Court held that the judge hearing the pending infringement action could craft a remedy so as to take into consideration the findings and awards made pursuant to section 8 as it would be unconscionable to delay these proceedings in any way until the infringement matter was heard and decided.
The remaining issues related to the date of approvability for Apotex’ product and whether circumstances existed to change the date. In particular, the Court held that Apotex had the capacity to manufacture its omeprazole product at two sites, even though only one had been approved by Health Canada. Apotex could have simply advised Health Canada that it was moving its manufacturing operation to the second site and Health Canada would have worked with Apotex to issue a “no objection” letter.
In conclusion, the Court ordered that Apotex is entitled to be compensated for its loss suffered by virtue of the NOC proceedings and that there is no basis to reduce or refuse such compensation