Canada Case Law

Bayer Inc. v. Amgen Canada Inc.

Court

Federal Court of Appeal

OSIP reasonably interpreted the Regulations to mean a patent is added to the Patent Register as of the date the patent is found eligible and not the date of initial submission; subsection 5(4) therefore properly excluded the 315 Patent from Amgen's obligations because it was added after Amgen's NDS filing date; the Federal Court correctly applied the reasonableness standard and the appeal is dismissed.

Source excerpt

• Patented medicines (notice of compliance) regulations
• Patent register eligibility and timing
• Frozen register (s.5(4))
• Standard of review (reasonableness)
• Judicial review procedure

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Alexion Pharmaceuticals, Inc. v. Amgen Canada Inc.

Court

Federal Court

Federal Court upheld Alexion’s 810 Patent, finding Amgen failed to prove anticipation or obviousness and granting infringement relief for BEKEMV eculizumab.

• Anticipation
• Obviousness
• Claims construction
• Injunction
• Delivery up/destroy
• Patent medicines (notice of compliance) regulations

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Apotex Inc. v. Eli Lilly and Company

Court

Court of Appeal for Ontario

The appeal is dismissed because the trial judge did not err in holding that, even if s.8 applied, Apotex failed to prove it would have entered the market earlier in the hypothetical world given the continuing patent rights, its demonstrated risk‑averse real‑world behaviour, and the realistic risk of substantial liability in a patent infringement action; appellate deference to the trial judge's multi‑factor factual assessment was appropriate, rendering the statutory interpretation issue academic.

Source excerpt

• Patented medicines (notice of compliance) regulations
• Section 8 damages
• Hypothetical profits analysis
• Prohibition applications
• Early work exception (s.55.2)

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JAMP Pharma - Reasons for Order and Order granting an application for leave to file affidavit evidence under Rule 119(3)

Court

Competition Tribunal

The Tribunal granted Janssen leave under Rule 119(3) to file focused factual affidavit evidence responsive to defined topics (whether Finlius is a fighting brand, limited factual pricing evidence tailored to negate predatory pricing allegations and show comparable pricing, marketing and communications materials and training as implemented, patient support program scope, terms of any agreements with prescribers on advisory boards, product indication and formulary/delisting facts, and an agreement bearing on JAMP's ability to bring claims), subject to strict limits against wide-ranging or merit…

Source excerpt

• Section 103.1 leave to commence
• Section 79 abuse of dominance
• Rule 119(3) affidavit evidence
• Fighting brand
• Predatory pricing
• Biosimilars

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Eli Lilly Canada Inc. v. Apotex Inc.

Court

Federal Court of Appeal

The Court upheld the Federal Court's construction that in the context of the 784 Patent a "physiologically acceptable" salt requires non-toxicity and also sufficient stability and purity (not degraded); the Federal Court did not err in relying on expert evidence and its factual findings supported conclusions of overbreadth and insufficiency; the appeal was dismissed with costs.

Source excerpt

• Claim construction
• Insufficiency
• Overbreadth
• Inutility
• Expert evidence
• Standard of review

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I.F. v. Gilead Sciences, Inc.

Court

Supreme Court of British Columbia

The court certified a proposed class action alleging Gilead negligently designed and marketed TDF drugs despite knowing of TAF as a safer alternative.

• Negligent design
• Duty of care
• Certification
• Punitive damages
• Regulatory approval
• Negligent-design

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Pharmascience Inc. v. Janssen Inc.

Court

Federal Court of Appeal

The appeal is dismissed: the Federal Court correctly held that most claims are vendible product claims and that the asserted use claims (17–32) define fixed dosages and schedules that do not require the exercise of professional skill and judgment; therefore the claims are patentable subject matter and the injunction should stand; costs awarded to respondents CAD 10,000.

Source excerpt

• Methods of medical treatment exclusion
• Patentable subject matter
• Dosage regimens
• Injunctions
• Costs

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Apotex Inc. v. Janssen Inc.

Court

Federal Court of Appeal

The Federal Court of Appeal dismissed the appeal, holding that the Federal Court did not err in finding on the evidence that Apotex would induce infringement because its product monograph would so influence prescribers and patients that the infringing acts would not have occurred without that influence; the Federal Court's factual inferences were open on the record and not palpably or overridingly erroneous.

Source excerpt

• Inducement of patent infringement
• Product monograph influence
• Causation / but-for test
• Standard of review (palpable and overriding error)
• Summary trial

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Pharmascience Inc. v. Janssen Inc.

Court

Federal Court of Appeal

The Federal Court of Appeal upheld the Federal Court: the 75 mg-eq. dose is a component, not the patented article, and its sale by Janssen would not, absent clear evidence or express conditions, carry an implied licence to combine that component with unlicensed components to practise the patented dosing regimen; therefore use of Janssen 75 mg-eq. with Pharmascience doses would constitute direct infringement and Pharmascience would induce infringement; appeal dismissed.

Source excerpt

• Inducement of patent infringement
• Implied licence
• Sale of patented article
• Notice of compliance regulations
• Summary trial

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Allergan Inc. v. Juno Pharmaceuticals Corp.

Court

Federal Court

Federal Court patent action over LUMIGAN RC. The Court held claims 16 and 19 of the 691 Patent valid, rejecting obviousness and insufficient disclosure challenges.

• Obviousness
• Sufficiency of disclosure
• Claim construction
• Notice of compliance (noc) proceedings
• Ophthalmic preservatives and formulation
• Patent-obviousness

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