Allyson Whyte Nowak

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Ontario Superior Court denies pleading amendments based on Supreme Court of Canada’s rejection of promise doctrine in ramipril damages action

As we reported, Federal Court jurisprudence is being continually reshaped by the Supreme Court’s decision in AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36 (NEXIUM Decision). In Apotex v. Schering Corporation, 2018 ONSC 903, the Ontario Superior Court has now considered the impact of the NEXIUM Decision in the context of Apotex’s action for … Continue reading

FCA upholds damage award based on Teva’s infringing sales of levofloxacin

The Federal Court of Appeal has upheld the Federal Court’s order that Teva Canada Limited pay Janssen Inc. (Janssen Canada) and Janssen Pharmaceuticals, Inc. (Janssen US) over $18 million for infringing sales of levofloxacin (reported here). The Court of Appeal’s decision addresses standing, mitigation, market reconstruction, and how freely a trial judge can swing the … Continue reading

Federal Court releases new guidelines for prohibition actions under the amended Patented Medicines (Notice of Compliance) Regulations

As we reported, amendments to the Patented Medicines (Notice of Compliance) Regulations (the Regulations) took effect on September 21, 2017, as part of the broader roll-out of measures implementing the Comprehensive Economic and Trade Agreement (CETA) with the European Union. The amendments introduce significant changes to proceedings under the Regulations, which will now proceed by … Continue reading

CETA tracker: CETA implemented September 21

Final CETA regulations impacting pharmaceuticals come into force Canadian and European Union leaders signed the Comprehensive Economic and Trade Agreement (CETA) on October 30, 2016. As we reported, the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act (CETA Act) and accompanying regulations provide key reforms to the Patent Act affecting the pharmaceutical industry, including … Continue reading

Apotex disentitled to section 8 recovery on the basis of patent infringement in omeprazole case

For the first time, the Federal Court has disentitled compensation pursuant to section 8 of the Regulations on the basis of infringement of a patent. This holding was also based on the court’s finding that Apotex would not have had an available non-infringing alternative (NIA) at any point during the period of infringement (September 5, … Continue reading

CETA tracker: Final Regulations released

Final CETA regulations impacting pharmaceuticals published but not yet in force As we reported, in July the Canadian government released draft versions of the proposed patent term restoration / Certificate of Supplementary Protection (CSP) and Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) under Bill C-30. On September 7, the government released the final versions … Continue reading

CETA tracker: CETA Upends the Once-Delicate Balance

New CETA regulations impacting pharmaceuticals published but not yet in force The Canadian government has published the proposed patent term restoration / Certificate of Supplementary Protection (CSP) and Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) under Bill C-30.  A 15-day consultation is open for interested parties to make submissions. Since their first enactment, the … Continue reading

Supreme Court dismisses leave to appeal regarding patent validity and infringement in omeprazole case

On June 2, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal the decision finding that AstraZeneca’s Canadian Patent No. 1,292,693 was valid and infringed by Apotex’s manufacture, sale, and promotion of Apo-Omeprazole capsules. Case:  Apotex Inc v AstraZeneca Canada Inc, et al (SCC Docket: 37478) Drug:  LOSEC® (omeprazole) Nature of case:  Appeal … Continue reading

Federal Court comments on the admissibility of ‘but for’ world s. 8 evidence and rejects generic pipefill claim

Case:  Eli Lilly Canada Inc et al v Teva Canada Limited, 2017 FC 88 Drug:  ZYPREXA® (olanzapine) Nature of case: Action pursuant to section 8 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the Regulations) Successful party: Teva Canada Limited Date: April 4, 2017 (public reasons) Summary The Federal Court established the parameters to … Continue reading
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