Harry B. Radomski

The applicant generic drug manufacturers brought an urgent motion under s. 6(2) of the Judicial Review Procedure Act to proceed with an application for judicial review before a single judge of the Divisional Court.

The applicants alleged that a competitor had obtained an unfair advantage regarding the upcoming release of a new schedule for the drug formulary.

The court found that the applicants would suffer irreparable harm due to the permanent loss of market share associated with the first-to-market advantage, and that the prerequisites of s. 6(2) were met.

The application for judicial review was permitted to continue.

The appellants challenged the validity of the respondents' patent for the use of AZT in the treatment and prophylaxis of HIV/AIDS.

The appellants argued that the patent lacked utility at the time of application, claimed more than was invented, and failed to name NIH scientists as co-inventors.

The Supreme Court of Canada dismissed the appeal, holding that the utility of AZT was established through the doctrine of sound prediction at the time of the patent application.

The Court also found that the prophylactic claims were soundly predicted and that the NIH scientists were not co-inventors because they merely verified the respondents' inventive concept.

In a postscript endorsement regarding costs, the Court of Appeal assessed the successful respondent's costs at $13,661, agreeing with the appellant's submissions.

The Minister of Health failed to submit their bill of costs in a timely manner despite requests, prompting the court to arbitrarily assess their costs at $4,000 inclusive of GST, noting that the court cannot function based on the time convenience of counsel.

The Minister of Health appealed a Divisional Court decision that allowed Apotex Inc.'s application for judicial review.

Apotex sought to increase the listed prices of three of its drug products in the Formulary after a generic competitor failed to bring its lower-priced products to market.

The Minister refused to recommend the price increase, citing a cost neutrality policy.

The Court of Appeal held that the appropriate standard of review for the Minister's highly discretionary decision was patent unreasonableness.

The Court found that the Minister's refusal was rational and not patently unreasonable, as the Formulary was already in effect and the cost neutrality policy was applicable.

The appeal was allowed and the application for judicial review was dismissed.

Apotex appealed a Divisional Court decision upholding the provincial government's decision to list its generic drug, Apo-Sertraline, on the provincial Formulary with a limited use designation.

The limitation restricted its interchangeability with Pfizer's Zoloft to the treatment of depression, reflecting federal patent protections on other uses.

Apotex argued the province exceeded its jurisdiction under the Drug Interchangeability and Dispensing Fee Act by considering patent restrictions rather than just therapeutic equivalence.

The Court of Appeal dismissed the appeal, finding the province had clear jurisdiction to ensure the Formulary only lists drugs that are legal to sell under federal law.

Apotex appealed a trial judge's decision allowing Bayer to elect an accounting for profits as a remedy for patent infringement and directing a referee to count all infringing capsules sold by Apotex.

Apotex argued that the trial judge reversed the burden of proof, misconstrued the patent, and erred in finding a causal link between the infringement and all profits.

The Court of Appeal dismissed the appeal, finding no error in the trial judge's exercise of discretion to award an accounting for profits or in the direction to the referee, as Apotex's product infringed the patent in its entirety.

The appellant appealed the trial judge's dismissal of its motion to amend its damage claim and the award of only nominal damages for expenditures incurred prior to the respondent's breach of contract.

The respondent cross-appealed the finding that it breached the contract and the trial judge's costs order.

The Court of Appeal dismissed both the appeal and cross-appeal, finding that the trial judge correctly concluded the amendment would cause prejudice, that the appellant's expenses would have exceeded its benefits had the contract been performed, and that the respondent's reasons for terminating the contract were manufactured.

The applicant brought a motion for interim relief pending the determination of its application for a declaration that the Minister of Health acted unlawfully in refusing to recommend its generic drug for inclusion in the Drug Benefit Formulary.

The Minister had reconsidered its recommendation after a Federal Court decision quashed the applicant's Notice of Compliance, despite a subsequent stay of that decision.

The court dismissed the motion, finding that the Minister's refusal was motivated by a desire to protect the public interest, and therefore the applicant failed to meet the balance of convenience requirement for interim relief.

Apotex applied for a Notice of Compliance (NOC) to market the patented drug Norfloxacin, alleging non-infringement because it would obtain the drug from Novopharm under a supply agreement.

Novopharm held a compulsory licence that prohibited sublicensing.

The patentee and its licensees sought an order prohibiting the Minister from issuing the NOC, arguing the supply agreement was an invalid sublicence and the application was premature.

The Supreme Court of Canada held that the supply agreement was not a sublicence.

Furthermore, the Court determined that the proper date for assessing the justification of a Notice of Allegation is the date of the hearing, not the date it was issued.

Since Novopharm was legally entitled to produce the drug for the Canadian market by the hearing date, the allegation was justified.

The appeal was allowed and the prohibition order was dismissed.

Novopharm held a compulsory licence for the patented medicine nizatidine, owned by Eli Lilly.

Novopharm and Apotex entered into a supply agreement whereby Novopharm would obtain the medicine and supply it to Apotex.

Eli Lilly sought to terminate Novopharm's licence, arguing the agreement constituted an impermissible sublicence, and sought prohibition orders against the issuance of Notices of Compliance to both Novopharm and Apotex.

The Supreme Court of Canada held that the supply agreement did not constitute a sublicence, as it did not grant Apotex the independent right to exercise Novopharm's licensed rights.

The Court also held that Apotex's proposed reformulation of the bulk medicine into final-dosage form would not infringe Eli Lilly's patents.

The appeals by Novopharm and Apotex were allowed.

The appellants appealed a judgment of the Federal Court of Appeal that affirmed an order granting mandamus to compel the Minister of National Health and Welfare to issue a notice of compliance respecting a generic version of a drug.

The Supreme Court of Canada dismissed the appeal substantially for the reasons of the Federal Court of Appeal.