Drug: nefazodone hydrochloride
BMS brought a motion to strike out certain amendments made to its pleadings by Apotex. In that motion, the Prothonotary found that, while Apotex was entitled to make minor amendments without leave in response to certain amendments by BMS, Apotex’ amendments were more significant. As a result, Apotex was invited to bring a motion to amend its pleadings. A judge in the Federal Court upheld this decision. Apotex brought the motion seeking leave to amend its pleadings, which the Prothonotary refused and a Federal Court judge overturned. The proposed amendments related to sound prediction and lack of utility of the compound nefazodone. Both appeals were heard together.
The Court of Appeal noted that the trial is scheduled to begin in approximately one month. The Court of Appeal considered the standard of review, and ultimately found that, as the Prothonotary’s decision raises a question vital to the final issue of the case, the Court of Appeal must review de novo. The Court of Appeal found that Apotex’ motion to amend its pleadings should be denied, essentially in accordance with the decision of the Prothonotary. In particular, the Court took into consideration circumstances relevant to the interests of justice, particularly that all issues to be determined at trial should be raised in the pre-trial memorandum and in discussions at the pre-trial conference. The Court found that the issues Apotex was now seeking to include in its pleadings had not been raised at that stage.