On February 1, 2019, the Ontario Ministry of Health and Long-Term Care (“Ministry”) announced that CWC Pharmacies (Ontario) Ltd. (“Costco Pharmacies”), a subsidiary of Costco, was ordered to pay an Administrative Monetary Penalty (“AMP”) of $7.25M for accepting payments from certain generic manufacturers which violated the prohibition on drug rebates.
Apotex seeks leave from Supreme Court of Canada in cefaclor damages action
By Andrew Mandlsohn
As previously reported, the Federal Court of Appeal (FCA) allowed in part Apotex’s appeal of a decision awarding Eli Lilly over $100 million for Apotex’s infringement of eight process patents related to the antibiotic cefaclor. The FCA rejected Apotex’s argument that a non-infringing alternative would have been available to Apotex during the relevant period. The FCA remitted the decision to the Federal Court for reconsideration solely on the issue of prejudgment interest: Apotex v Eli Lilly, 2018 FCA 217. On January 22, 2019, Apotex applied to the Supreme Court of Canada for leave to appeal (Docket No. 38485).
Court upholds Minister’s refusal to list ELANCO patent due to filing date
By Lynn Ing
The Federal Court has dismissed Elanco’s application for judicial review of the Minister of Health’s refusal to list Canadian Patent No. 2,812,704 on the Patent Register in respect of IMPRESTOR (pegbovigrastim): Elanco v Canada (Attorney General), 2019 FC 5. The Minister assigned a filing date for Elanco’s New Drug Submission (NDS) as the date the Veterinary Drugs Directorate determined the submission to be administratively complete, rather than the date on which all substantive components of the submission were provided for evaluation. All substantive components had not initially been submitted as Health Canada had agreed that Elanco could participate in a phased submission process, aligned with the timeline for submission of data to the United States Food and Drug Administration to enable simultaneous reviews. The Judge found that the Minister’s determination of the filing date was reasonable. Since Elanco filed its patent application after the NDS filing date, the patent did not meet the timing requirements for listing eligibility under subsection 4(6) of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations). Elanco did not appeal.
Ontario Court of Appeal dismisses appeal of judgment awarding Apotex damages from contract research organization for delayed FDA approval of two products
By Abigail Smith
As previously reported, in December 2017, Apotex was awarded over $11M in damages and pre-judgment interest for losses flowing from delays in the US Food and Drug Administration’s (FDA) approval of Apotex’s amoxicillin-clavulanic acid and levodopa-carbidopa products caused by the contractual breaches and negligence of MDS Pharma Services (MDS), a contract research organization hired to carry out bioequivalence studies for those products. On January 16, 2019, the Court of Appeal for Ontario dismissed MDS’ appeal and Apotex’s cross-appeal of that judgment: Apotex Inc v Nordion (Canada) Inc, 2019 ONCA 23. The Court rejected MDS’ argument that the trial judge had erred in finding that Apotex’s claim was not time-barred. Rather, the Court found that the limitations period did not begin to run until 6 months after the date on which the trial judge concluded that it began. The Court found no palpable and overriding error in the trial judge’s interpretation of the contract or his finding that Apotex had adequately mitigated its damages. With respect to Apotex’s cross-appeal, the Court found no palpable and overriding error in the trial judge’s assessment of damages, and rejected Apotex’s argument that damages ought to have been fixed at $12.6M.
New Court Proceedings
For complete details about these proceedings, click here.
PMNOC Actions
abiraterone acetate (ZYTIGA): Janssen and BTG v Sandoz
abiraterone acetate (ZYTIGA): Janssen and BTG v Pharmascience
fingolimod (GILENYA): Novartis v Natco
fampridine (FAMPYRA): Biogen and Acorda v Pharmascience
Other Actions
naproxen/esomeprazole magnesium (VIMOVO): Mylan v AstraZeneca
fingolimod (GILENYA): Novartis v Accord, Apotex, Marcan, Mylan, Pharmascience, Taro and Teva
Selected Rankings
Canadian IP Impact Case of the Year
AstraZeneca v Apotex (NEXIUM)
LMG Life Sciences
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Canada’s Intellectual Property Litigation Firm of the Year
Benchmark Canada
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