In CanMar Foods Ltd. v TA Foods Ltd., 2019 FC 1233, the Federal Court interpreted and applied the new file wrapper estoppel provision, section 53.1 of the Patent Act, RSC 1985, c P-4, for the first time.
Government releases final amendments to the PMPRB’s Patented Medicines Regulations to lower the prices of patented medicines
The Government is moving forward with changes to the PMPRB intended to lower the prices of patented medicines in Canada in order to lay the foundation for National Pharmacare. The changes are set out in final amendments to the Patented
Federal Court of Appeal agrees that the PMPRB incorrectly applied the patent-pertaining analysis
The Federal Court of Appeal has provided new guidance on the proper approach to the “patent pertaining” analysis used by the Patented Medicine Prices Review Board (PMPRB or Board), including on the identification of the medicine and the
Competition Bureau publishes Final IP Enforcement Guidelines
On March 13, the Competition Bureau published a revised version of its IP Enforcement Guidelines (IPEGs). The IPEGs clarify the Bureau’s approach to conducting investigations of alleged anti-competitive activities that involve IP, including settlement of pharmaceutical patent litigation
Federal Court of Appeal upholds Health Canada’s requirement for additional information on testing data integrity
The Federal Court of Appeal (FCA) has dismissed Apotex’s appeal arising from its application to end Health Canada’s requirement for additional information establishing the integrity of data from Indian drug manufacturing facilities. The FCA found that the Federal
Federal Court upholds patent validity and grants prohibition order against generic lisdexamfetamine in pre-CETA PM(NOC) application
The Federal Court dismissed Apotex’s action to invalidate the claims of Canadian Patent No. 2,527,646 (the 646 Patent), which was consolidated with Shire’s application to prohibit the Minister of Health from issuing a Notice of Compliance for Apotex’s generic
Supreme Court dismisses leave to appeal on damages against Health Canada for Apo-Trazodone
On December 14, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal the decision finding that Health Canada does not owe a duty of care to drug manufacturers in reviewing drug submissions.
Case: Apotex Inc v Canada (Minister
Federal Court of Appeal Provides Further Guidance on Inventive Concept
The Federal Court of Appeal has provided additional guidance on the framework for analyzing obviousness. In dismissing an appeal from the Federal Court, the Court of Appeal identified the search for an inventive concept as an “unnecessary satellite debate” and
Federal Court upholds cancellation of reconsideration of Apotex’s ANDS for Apo-omeprazole
The Federal Court dismissed Apotex’s application for judicial review of the Minister of Health’s withdrawal of a notice of compliance (NOC) granted to Apotex Inc. for Apo-omeprazole. Health Canada withdrew the NOC because Apotex had not demonstrated bioequivalence.
Apotex files leave to appeal to SCC on damages against Health Canada for Apo-Trazodone
Apotex filed an application for leave to appeal the decision allowing its claim for damages for misfeasance of public office, negligence and breach of contract against Health Canada based on its review of Apotex’s drug submission for Apo-Trazodone. Apotex has