Gunars A. Gaikis

The defendants sought directions for motions to strike portions of the plaintiff's Reply, which argued that the original patent invalidity decision could be supported on grounds other than the "promise doctrine" overturned by the Supreme Court.

The court, acting as case management judge, emphasized the need to move the complex, long-standing litigation towards trial and avoid further "silver bullet" motions on narrow legal points.

The judge ruled against scheduling Rule 21 or Rule 20 type motions, stating that the trial judge should determine the factors for exercising equitable discretion regarding the "special circumstances" doctrine.

However, motions within a Master's jurisdiction were directed to Master Sugunasiri.

The defendants sought to schedule a further motion for summary judgment on the Monopolies Act issue, having previously failed on a Rule 21 motion concerning the same claim.

The court denied the request, emphasizing that partial summary judgment is rarely appropriate in complex litigation, especially when recent amendments to pleadings have re-opened other significant issues, such as patent validity.

The judge concluded that the case should proceed to a single trial on all issues to avoid fragmented litigation and multiple appeals, which would prolong the proceedings and consume vast judicial resources.

The appellants (Sanofi-Aventis and Schering Corporation) appealed a motion judge's decision dismissing their motion to amend their statement of defence.

The appellants sought to plead that a 2009 Federal Court decision invalidating their patent for the drug Ramipril was based on wrong legal principles, specifically the "promise doctrine" which was subsequently struck down by the Supreme Court of Canada in 2017.

The motion judge had dismissed the motion on the basis of issue estoppel, finding no change in law justified departing from the doctrine.

The Court of Appeal allowed the appeal, holding that the Supreme Court's decision striking down the promise doctrine constituted a change in law that warranted exercising discretion not to apply issue estoppel, particularly given the centrality of the patent validity issue to the respondent's claim for damages.

The Court allowed AstraZeneca’s appeal and held the patent ‘promise doctrine’ is not the correct approach to utility under s. 2 of the Patent Act.

It found the doctrine improperly imports disclosure obligations into the utility requirement and wrongly invalidates patents when one of multiple promised uses is unproven.

The correct test asks whether the claimed subject-matter has at least one practical use related to that subject-matter, demonstrated or soundly predicted at filing.

Applying that test, the ‘653 patent had sufficient utility and was not invalid.

The defendants moved to strike various claims by the plaintiff, Apotex Inc., including claims under the Trade-marks Act and the Monopolies Acts, as well as claims for unjust enrichment and a "basket clause" for other relief.

The motion was brought under Rules 21.01(1)(b) and 25.11(b) and (c) of the Rules of Civil Procedure, arguing no reasonable cause of action, frivolousness, vexatiousness, or abuse of process, and also raising arguments of "complete code" and res judicata.

The court dismissed the defendants' motions, except for the unjust enrichment and "basket clause" claims which Apotex did not oppose, finding that the legal issues were insufficiently settled to be decided at the pleadings stage.

The court emphasized the need to avoid piecemeal appeals and directed a case conference to expedite the matter to trial.

The defendants moved to strike the plaintiff’s statement of claim or alternatively to stay the action pending the outcome of related Federal Court litigation concerning damages arising from delayed market entry of a generic pharmaceutical product.

Although the defendants ultimately focused their submissions on striking the claim, the court considered whether a temporary stay should be imposed under s. 106 of the Courts of Justice Act.

The court found substantial overlap between the Ontario action and the Federal Court proceedings, including factual background and issues related to calculation of damages arising from the delayed entry of the generic drug.

A stay would prevent duplication of judicial resources and reduce the risk of inconsistent findings, while causing no significant prejudice to the plaintiff beyond delay.

The court therefore exercised its discretion to stay the action pending the outcome of the appeal in the Federal Court proceedings and any further appeals.

Apotex sought a Notice of Compliance (NOC) to market a generic version of AstraZeneca's drug Losec 20, comparing its product to the 1989 version of the drug.

AstraZeneca had withdrawn Losec 20 from the market in 1996 but subsequently listed two new patents against it.

The Minister of Health issued the NOC to Apotex without requiring it to address the new patents, as Apotex's product did not use the new technology.

AstraZeneca applied for judicial review.

The Supreme Court of Canada held that under the Patented Medicines (Notice of Compliance) Regulations, a generic manufacturer is only required to address patents relevant to the innovator product actually copied.

Since Apotex did not claim bioequivalence to the technology in the after-issued patents, it was not subject to the 24-month statutory freeze for those patents.