September 2017

Federal Court of Appeal Applies Supreme Court’s Utility Test
to SPRYCEL Patent

In its first decision to consider the Supreme Court of Canada’s landmark decision in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 [Esomeprazole](see our article here) on the utility requirement, the Federal Court of Appeal has overturned a finding of inutility made under the promise doctrine, with practical guidance for the requirement of a scintilla of utility: Bristol-Myers Squibb v Apotex, 2017 FCA 190.

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Publication of Final Regulations on Patent Linkage and
Term Restoration

As previously reported, on September 7, 2017, the Government of Canada published final pharmaceutical regulations flowing from CETA:

1. the Regulations Amending the Patented Medicines (Notice of Compliance) Regulations, 2017 [“PMNOC Regulations amendments”], and
2. the Certificate of Supplementary Protection Regulations [“CSP Regulations”]
   
   

Health Canada has since published a guidance document outlining the application process under the CSP Regulations, and a notice regarding the application of the PMNOC Regulations amendments. The Federal Court has published a practice notice regarding actions brought under the PMNOC Regulations amendments. Both sets of regulations came into force on September 21, 2017.

In case you missed it

Watch the replay of our Pharma Patents Webinar to learn more about the new regulations.

AstraZeneca succeeds in omeprazole patent infringement
profits case

As reported previously, AstraZeneca was successful on issues left for the Court to decide in a trial of an accounting of Apotex’s profits from infringement of AstraZeneca's omeprazole (LOSEC) formulation patent. Apotex has appealed.

SCC leave sought of decision refusing natural health product licence

As previously reported, the Federal Court of Appeal (FCA) set aside the order of mandamus compelling the Minister of Health to grant a licence to The Winning Combination for its natural health product, RESOLVE. The FCA held that the Federal Court erred in extrapolating a reasonable apprehension of bias from the evidence, and that new evidence undermined the basis of the Federal Court’s decision. The FCA remitted the matter back to the Minister for redetermination: 2017 FCA 101. On August 14, 2017, The Winning Combination Inc. applied to the Supreme Court for leave (docket no. 37697).

New Court Proceedings

For complete details about these pharmaceutical proceedings, click here.

trastuzumab (HERCEPTIN): Pfizer v Genentech

adalimumab (HUMIRA): Samsung Bioepis v AbbVie

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