Harry B. Radomski

The Court of Appeal for Ontario dismissed Apotex Inc.'s appeal regarding its claim for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations.

Apotex sought damages for delayed market entry of its generic drug due to Eli Lilly's prohibition application.

The trial judge found that Apotex was not entitled to damages, as the prohibition application was dismissed as moot, not on the merits, and that Apotex would not have entered the market earlier in a hypothetical world without the prohibition application due to risk aversion and potential patent infringement liability.

The Court of Appeal upheld these findings, concluding that Apotex failed to demonstrate any actual entitlement to damages.

The plaintiff, Dr. Darryl Gebien, sought court approval for a Third-Party Funding Agreement with Omni Bridgeway Ltd. for a proposed class action against numerous pharmaceutical companies regarding the opioid crisis.

Several defendants objected to specific provisions of the agreement, including those related to amendments, assignments, attornment, costs enforcement, termination procedures, accrued costs, and confidentiality.

The court found that while the agreement generally met the requirements for approval, several of the defendants' objections, particularly concerning comprehensive attornment by Omni Bridgeway Ltd. and the broad confidentiality provisions, were "genuinely meaningful" and required resolution.

The motion for approval was adjourned to allow the parties to address these issues, with the court emphasizing that it is not its role to draft the agreement.

Following complex patent infringement litigation where the defendant, Apotex, was successful on counterclaims of obviousness and anticipation, Apotex brought a motion for elevated costs calculated as a lump sum based on 30% of its actual legal fees.

The Federal Court granted the motion, finding the proceeding complex and the requested lump sum justified in lieu of an assessment under Tariff B, though it applied an initial 20% reduction to the submitted fees to account for certain unreasonable charges.

The Court also ordered post-judgment interest at 2% and reduced the claimed disbursements to exclude costs associated with experts who were unnecessary or unhelpful, ultimately fixing total costs at $2,169,045.

This is a costs endorsement following the dismissal of an appeal.

The respondents, who won the appeal, claimed over $157,000 in costs.

The appellants, who lost the appeal, proposed $25,000.

The court found the respondents' costs submissions inadequate, lacking sufficient explanation for the hours claimed and indicating potential over-preparation.

The court ultimately awarded $25,000 in costs, finding the appellants' offer to settle on costs to be the best evidence of a reasonable, fair, and proportionate amount in the circumstances.

The defendants in a proposed opioid class action moved to dismiss the proceeding for delay under s. 29.1 of the Class Proceedings Act, 1992.

In response, the plaintiff brought a cross-motion for a nunc pro tunc timetable order and commenced parallel proceedings in Manitoba.

The parties reached a settlement wherein the competing motions were dismissed without costs, the Manitoba proceedings would be discontinued, and the Ontario action would be deemed commenced on October 2, 2020, making it subject to the amended certification test under the Smarter and Stronger Justice Act, 2020.

The court approved the settlement and issued the consent orders.

Following the dismissal of the plaintiff's action on a motion for summary judgment, the defendants sought costs on a substantial indemnity basis.

The court found that the plaintiff's unfounded allegations of intentional misconduct, fraud, and conspiracy warranted an elevated scale of costs.

The court distinguished a previous decision involving the same plaintiff and awarded the defendants substantial indemnity costs fixed at $900,000.

The defendants brought a motion for summary judgment to dismiss the plaintiff's action for treble damages and double costs under the Statute of Monopolies and common law torts, following the invalidation of the defendants' patent for Viagra.

Relying on a recent coordinate decision, the court found that the Patent Act and the Patented Medicines (Notice of Compliance) Regulations operate as a complete code, precluding the plaintiff's claims.

The court also dismissed the plaintiff's additional claims for unjust enrichment and nuisance on their merits.

The motion for summary judgment was granted, and both the claim and counterclaim were dismissed.

The court issued trial management directions and an endorsement, adjourning a bifurcated liability trial scheduled to commence on May 21, 2019.

The adjournment was necessitated by the parties' lack of trial readiness, specifically concerning the plaintiff's uncertainty regarding witness identities (over 20 potential witnesses, some unnamed) and the failure to finalize an agreed statement of facts.

Additionally, the plaintiff's last-minute motion to add another foreign defendant, Eli Lilly S.A., introduced unresolved jurisdictional issues that would further complicate and extend the trial.

The court emphasized the importance of efficient trial management and the fair allocation of judicial resources, concluding that proceeding with the trial under these circumstances would risk exceeding the allotted time and prejudice other litigants.

The defendants moved to amend a Protective and Confidentiality Order to add a second law firm, Norton Rose Fulbright LLP, as "outside counsel" alongside their existing counsel.

The plaintiff opposed, citing a potential conflict of interest as Norton Rose Fulbright also represents another drug manufacturer with similar claims against the plaintiff in a separate action.

The court found that the defendants failed to provide a sufficient explanation for seeking to add Norton Rose Fulbright as co-counsel under paragraph 10(b) of the order, rather than simply seeking leave under paragraph 10(g) to allow them to view confidential information.

The court identified a foreseeable risk of conflict of interest due to Norton Rose Fulbright's dual representation and the lack of evidence regarding screening mechanisms or waivers.

The motion was dismissed.

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.

Following the dismissal of the defendants' motion for leave to appeal, the plaintiff sought costs of $40,000 on a substantial indemnity basis, relying on an offer to settle.

The court rejected the request for substantial indemnity costs, finding the offer was not a true compromise and did not trigger Rule 49.10.

Considering the complexity and significance of the litigation, the court fixed costs at $10,000 inclusive of disbursements and HST.

The defendants sought leave to appeal an order dismissing their motion to strike the plaintiff's claims for damages arising from delayed market entry of a generic drug.

The defendants argued the Patent Act provided a complete code, precluding common law claims.

The Divisional Court dismissed the motion for leave to appeal, finding no conflicting Ontario decisions and no good reason to doubt the correctness of the motion judge's order, emphasizing that pleadings motions should rarely warrant appellate review.

In this patent damages appeal under s. 8 of the Patented Medicines (Notice of Compliance) Regulations, the Court upheld the Federal Court of Appeal decision and dismissed the patentees' appeal.

The Court agreed with the majority's reasoning on liability period, market-entry assumptions, and compensation for lost sales tied to unapproved indications.

Apotex Inc. sought judicial review of decisions by the Executive Officer of the Ontario Public Drug Programs refusing to increase the reimbursable pricing of three generic antibiotic drugs.

The applicant argued that the historic pricing exemption should apply to allow price increases and challenged the Executive Officer's reliance on the single source pricing exemption to negotiate a price increase with a competitor.

The Divisional Court dismissed the application, finding that the Executive Officer's interpretation of the legislation and regulations was reasonable and that her actions to ensure a continued supply of the drugs were lawful and in the public interest.

Apotex appealed a prohibition order preventing the Minister of Health from issuing a notice of compliance for its generic version of Plavix.

Apotex alleged that Sanofi's selection patent for clopidogrel bisulfate was invalid on the grounds of anticipation, obviousness, and double patenting.

The Supreme Court of Canada dismissed the appeal, clarifying the tests for anticipation and obviousness in Canadian patent law.

The Court adopted a two-step approach for anticipation (prior disclosure and enablement) and a four-step approach for obviousness, including a flexible 'obvious to try' consideration.

The Court found the selection patent was not anticipated, not obvious, and did not constitute double patenting.

Apotex Inc. sought judicial review of regulations enacted by the Ontario government that reduced the reimbursement price of generic prescription drugs to 50% of brand-name drugs.

Apotex argued the government failed to meet its statutory obligations for public consultation and consideration under Bill 102, and breached procedural fairness based on legitimate expectations.

The Canadian Generic Pharmaceutical Association intervened.

The Divisional Court dismissed the application, finding that the government met the notice and consultation requirements, the Lieutenant Governor in Council did not exceed its jurisdiction in altering the proposed regulations, and the doctrine of legitimate expectations does not apply to purely legislative functions.

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.

Apotex Inc. sought judicial review of the Respondents' decision to remove the designation of its generic drug, Apo-Flavoxate, as an interchangeable drug product under the Drug Interchangeability and Dispensing Fee Act (DIDFA) and to delist it from the Comparative Drug Index.

The Divisional Court found that the decision to delist the drug under DIDFA was not rationally connected to the decision to delist it as an eligible benefit under the Ontario Drug Benefit Act.

The majority held that the circumstances surrounding the decision constituted a denial of natural justice and quashed the regulation, restoring the drug's interchangeable status.

A dissenting opinion would have upheld the decision as a valid exercise of public interest discretion.

The appellant, a generic drug manufacturer, appealed a Divisional Court decision dismissing its application challenging the vires of the Ontario government's drug pricing policy.

The policy imposed a price freeze on generic drugs and regulated their prices as a percentage of the equivalent brand name drug (the 70/90 rule).

The appellant argued the regulations were ultra vires the Drug Interchangeability and Dispensing Fee Act and the Ontario Drug Benefit Act, and were arbitrary and discriminatory.

The Court of Appeal dismissed the appeal, finding that the amended legislation explicitly authorized the Minister to consider the prices of other drug products when setting the drug benefit price.

The court also held that the policy was not arbitrary or discriminatory, as its purpose was to achieve the lowest prices for drug products in the public interest.

The applicants brought applications for judicial review.

During the hearing, counsel for a third party requested an adjournment to review the filings and potentially seek intervenor status, as the third party had not been served.

The court granted the adjournment to allow the third party to decide whether to intervene.

The court also issued an interim order delaying the effective date of the third party's generic drug listings pending the resumption of the hearing.