Healthcare & Life Sciences updates

Canada

Contributed by Smart & Biggar/Fetherstonhaugh
Court upholds issuance of NON-W letter and cancellation of reconsideration process for Apotex
  • Canada
  • 19 June 2019

The Federal Court of Appeal recently affirmed the Federal Court's dismissal of Apotex's application for judicial review of a minister of health decision relating to its Apo-Omeprazole (omeprazole magnesium) delayed-release tablets. The minister had issued a Notice of Non-Compliance – Withdrawal letter in respect of Apotex's abbreviated new drug submission on the basis that the tablets were not bioequivalent to the relevant Canadian reference product.

Federal Court dismisses Servier's application for order of prohibition regarding salt patent
  • Canada
  • 19 June 2019

The Federal Court recently dismissed Servier's application for a prohibition order under the pre-amended Patented Medicines (Notice of Compliance) Regulations for Canadian Patent 2,423,825 regarding a perindopril arginine/amlodipine product (Servier's Viacoram). Apotex had alleged that the patent was invalid for obviousness, overbreadth, inutility and insufficiency.


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