Tribunal dismisses Eli Lilly’s NAFTA challenge on promise utility doctrine

by Shirley Liang Komosa

As previously reported, Eli Lilly submitted claims to international arbitration under the North American Free Trade Agreement (NAFTA) seeking damages from the Government of Canada, asserting that the Canadian courts' application of the promise doctrine to Eli Lilly's STRATTERA (atomoxetine) and ZYPREXA (olanzapine) patents (“Patents”) contravenes Canada's obligations under NAFTA.

On March 16, 2017, the Tribunal issued its Final Award dismissing Eli Lilly’s claims. On the merits of the claims, the Tribunal found that Eli Lilly had failed to demonstrate (1) that the promise doctrine constitutes a fundamental or dramatic change in the utility requirement under Canadian patent law or (2) that the promise doctrine is arbitrary and/or discriminatory.

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Federal Court of Appeal dismisses Teva’s appeal relating to utility and sufficiency

by Abigail E. Smith

On March 14, 2017, the Federal Court of Appeal (FCA) dismissed Teva’s appeal of Locke J.’s Order prohibiting the Minister of Health from issuing a notice of compliance (NOC) to Teva in respect of its calcipotriol and betamethasone dipropionate ointment (Leo Pharma’s DOVOBET) until the expiry of Patent No. 2,370,565: Teva Canada Limited v Leo Pharma Inc, 2017 FCA 50. The patent covers a three-component, non-aqueous ointment used in the treatment of psoriasis. The ointment is comprised of vitamin D or a vitamin D analogue (Component A), a corticosteroid (Component B), and a solvent (Component C). Teva’s appeal related to sound prediction and sufficiency.

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Ontario Superior Court dismisses summary judgment motion in Lansoprazole Section 8 Claim

by Kevin Siu

On February 27, 2017, the Ontario Superior Court of Justice (2017 ONSC 1348) dismissed a motion for summary judgment brought by Abbott Laboratories and Takeda Pharmaceuticals, the defendants in an action for damages brought by Apotex under section 8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations).

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Apotex seeks leave on omeprazole formulation patent

As previously reported, on January 12, 2017, the Federal Court of Appeal affirmed the validity of AstraZeneca’s Patent No. 1,292,693: Apotex Inc v AstraZeneca Canada Inc, 2017 FCA 9. On March 13, 2017, Apotex applied to the Supreme Court for leave to appeal (docket no. 37478).

Bill C-30 passes second reading in the Senate

On March 7, 2017, Bill C-30 passed second reading in the Senate and was referred to the Standing Senate Committee on Foreign Affairs and International Trade. Bill C-30 implements the Comprehensive Economic and Trade Agreement between Canada and the European Union (CETA). As previously reported, it was introduced in the Senate on February 14, 2017. The European Parliament voted to approve CETA on February 15, 2017. CETA's implications for pharmaceuticals were reported here.

Health Canada updates guidance to reflect recent amendments to the Food and Drug Regulations

On March 14, 2017, Health Canada issued guidance and provided instruction relating to amendments to the Food and Drug Regulations flowing from the Regulations Amending the Food and Drug Regulations (Shortages of Drugs and Discontinuation of Sale of Drugs).