Andrew Ryan Brodkin

The appellant generic manufacturer challenged the validity of a patent claiming dosing regimens for a long-acting injectable antipsychotic on the basis that the claims were impermissible methods of medical treatment.

The majority held that methods of medical treatment remain unpatentable subject matter under s. 2 of the Patent Act because professional medical skill and judgment are not proper subject matter for a patent, notwithstanding the repeal of former s. 41(1).

It further held that the proper inquiry is whether the claimed invention fences in professional medical skill and judgment, assessed purposively and with substance over form.

Applying that test, the dosing regimens were patentable because, once the physician selected the regimen, implementation did not require individualized clinical judgment of the kind the doctrine protects.

The appeal was dismissed without costs, although two judges would have held that methods of medical treatment are not inherently unpatentable.

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 appellants, generic drug manufacturers, sought damages exceeding one billion dollars against the respondents, innovator drug companies, after the respondents' patent for the drug Olanzapine was declared invalid.

The appellants claimed damages under the Statute of Monopolies, the Trademarks Act, and the common law tort of civil conspiracy for the period they were kept out of the market.

The Court of Appeal upheld the motion judge's dismissal of the action, finding that the Patent Act and the PM(NOC) Regulations provided a complete code for remedies, and the respondents were not liable for damages caused by the lawful operation of the statutory regime.

The court also upheld the motion judge's $700,000 partial indemnity costs award against the appellants.

The Court of Appeal for Ontario issued an endorsement regarding a request to vary a trial costs award.

Following a successful appeal and cross-appeal by the Respondents (plaintiffs/defendants by counterclaim), they sought to vary the trial costs award, arguing entitlement to a higher scale due to beating a Rule 49 settlement offer.

The Appellants (defendants/plaintiffs by counterclaim) opposed this request.

The Court declined to vary its decision, noting that the Respondents had not appealed or sought leave to appeal the trial costs, nor had they raised the issue in their notices of cross-appeal or in their submissions on costs.

The respondents were successful in resisting appeals by the Varma/Madra Appellants and the Palihapitiya Appellants, and succeeded on their cross-appeal.

They sought costs on a substantial indemnity basis.

The Court of Appeal found no justification for a higher scale and awarded partial indemnity costs fixed at $300,000, payable equally by the two groups of appellants.

The Court of Appeal dismissed appeals by two groups of appellants (Varma/Madra and Palihapitiya) and allowed a cross-appeal by the respondents.

The case involved corporate malfeasance, breach of fiduciary duty, breach of contract, knowing assistance, and conspiracy related to the establishment of a competing fund (Annex Fund) and the undervalued sale of a technology company (Xtreme Labs), including the concealment of an equity interest in Hatch Labs (Tinder).

The trial judge's findings of liability for damages and disgorgement were largely upheld, and the disgorgement amount was increased on cross-appeal to serve a stronger deterrent purpose.

The court affirmed that directors of a corporate general partner can owe fiduciary duties directly to a limited partnership.

The defendants sought to adjourn a scheduled 20-day trial to bring a summary judgment motion, or alternatively, to await a decision in a similar case.

The plaintiff opposed, arguing procedural requirements for such an adjournment.

Following a relevant summary judgment decision by another judge in a related action, the court vacated the trial date and ordered a schedule for the defendants' summary judgment motion.

The court found that a summary judgment could resolve the case more quickly and cheaply, emphasizing judicial economy and the principle of stare decisis, and that prior decisions refusing summary judgment in similar cases did not preclude reconsideration given new circumstances.

The defendants brought two motions to amend their pleadings in an action for "section 8" damages under the Patented Medicines (Notice of Compliance) Regulations.

The proposed amendments sought to introduce a defence based on the ex turpi causa doctrine, arguing that the plaintiff's alleged non-infringing alternative (NIA) would infringe a third-party patent, thus making hypothetical sales unlawful and precluding damages.

The plaintiff opposed, arguing the amendments were not tenable and would cause non-compensable prejudice.

The court, applying Rule 26.01, found the proposed amendments raised tenable legal arguments, distinguishing and interpreting relevant case law on NIAs and the ex turpi causa doctrine.

The court also found that any prejudice to the plaintiff could be compensated by costs or an adjournment.

The motions to amend the pleadings were granted.

Apotex brought a motion to amend its pleadings in an ongoing patent dispute over the drug Lansoprazole.

Following the Supreme Court's rejection of the 'Promise Doctrine' in AstraZeneca, Apotex sought to recast its previous Promise Doctrine allegations as claims of insufficiency, overbreadth, and fraud under sections 27 and 53 of the Patent Act.

The court dismissed the motion, finding that the proposed amendments were legally untenable and merely repackaged the defunct Promise Doctrine.

Furthermore, the court held that the fraud allegations lacked the strict particularity required by the Rules of Civil Procedure and awarded elevated costs to the respondents.

This is a costs endorsement following an appeal in a pharmaceutical patent dispute.

The Court of Appeal determined that costs in the cause was not appropriate and awarded costs to the respondent on a partial indemnity basis: $15,000 from Takeda and $25,000 from Abbott, inclusive of disbursements and HST.

This appeal concerns damages claimed by Apotex for lost sales of its generic drug Apo-lansoprazole due to proceedings initiated by Abbott and Takeda under section 6 of the Patented Medicines (Notice of Compliance) Regulations.

The motion judge dismissed the defendants' motion for summary judgment, finding that Apotex would have received regulatory approval on April 17, 2007, but for the section 6 proceedings.

The appellants argued that Apotex's submission was deficient because it lacked a high-fat meal bioequivalence study.

The Court of Appeal upheld the motion judge's decision, finding no legal requirement for such a study and ample evidence supporting approval on the original submission.

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 moving parties (innovator drug manufacturers) brought a motion for summary judgment to dismiss the responding party's (generic drug manufacturer) claim for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations.

The moving parties argued that the generic drug could not have been lawfully approved by Health Canada in April 2007 due to non-compliance with bioequivalence study guidelines, rendering the section 8 claim invalid.

The court dismissed the motion, finding that Health Canada's guidelines did not have the force of law and that the evidence established the generic drug would have received a Notice of Compliance in April 2007 but for the moving parties' prohibition proceedings.

The court also distinguished prior case law and held that the moving parties lacked standing to challenge the Minister's drug approval decisions in a section 8 damages action.

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.

The defendants brought a motion to strike portions of the plaintiff's fresh as amended statement of claim and for particulars.

The plaintiff, a generic drug manufacturer, sued the defendants for misfeasance in public office and other torts related to the handling of new drug submissions.

The court struck the claim for unlawful discrimination, finding it had no reasonable prospect of success, and struck certain paragraphs for improperly pleading evidence.

However, the court refused to strike claims based on res judicata, finding the tort claims distinct from prior judicial review proceedings, and refused to strike claims related to the loss of the benefit of section 8 of the Patent Medicines (Notice of Compliance) Regulations.

The motion for particulars was dismissed.

The appellant generic drug manufacturer sought damages against the federal Crown for losses incurred when Health Canada prohibited the sale of its drug.

The Crown successfully moved for summary judgment in the lower courts on the basis that the appellant was required to first invalidate the prohibition decision via judicial review.

The Supreme Court of Canada allowed the appeal, applying its companion decision in TeleZone.

The Court held that section 17 of the Federal Courts Act grants concurrent jurisdiction over claims for damages against the Crown, and nothing in the Act requires a plaintiff to successfully challenge the underlying administrative decision on judicial review before pursuing a tort action.

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 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.