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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).
The guidance document Fees for the Right to Sell Drugs was updated to reflect amendments that mandate the reporting of drug shortages and discontinuations by authorization holders to a third-party website for certain categories of drugs that have the potential, in a shortage or discontinuation situation, to adversely affect the health of Canadians.
Notice: Guidance Document – Fees for the Right to Sell Drugs A new guidance document entitled Cancellation of a Drug Identification Number (DIN) and Notification of the Discontinuation of Sales was released. The amendments introduce a new definition of the term “discontinue” and require manufacturers to notify Health Canada within 30 days of the discontinuation of the sale of a drug. This new guidance is intended to facilitate proper compliance with these provisions.
Notice: Guidance Document: Cancellation of a Drug Identification Number (DIN) and Notification of the Discontinuation of Sales Lastly, Health Canada outlined significant changes to the information to be included in the Annual Drug Notification Form (ADNF) resulting from the amendments. These include separate lists for products that have been assigned a DIN but have not been marketed (Approved Products) and products which are marketed but have not had sales for 12 consecutive months (Dormant Products). Additionally, manufacturers will be required to provide further information regarding products listed as discontinued on the ADNF. These changes will be incorporated into the ADNF that will be sent to manufacturers in June of 2017.
Notice: Upcoming Changes to the Annual Drug Notification Form
PMNOC proceedings
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Medicine:
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perindopril arginine (ARCOSYL)
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Applicants:
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Les Laboratoires Servier and Servier Canada Inc
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Respondents:
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Apotex Inc and the Minister of Health
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Date Commenced:
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March 3, 2017
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Court File No.:
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T-306-17
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Comment:
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Application for Order of prohibition until expiry of Patent No.
2,423,825. Apotex alleges invalidity (double patenting, improper selection, insufficiency, obviousness, inutility, overbreadth, and anticipation).
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Other Proceedings
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Medicine:
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aripiprazole (ABILIFY)
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Plaintiffs:
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Otsuka Pharmaceutical Co, Ltd, Bristol-Myers Squibb Canada Co, Otsuka Canada Pharmaceutical Inc
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Defendants:
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Apotex Inc and Apotex Pharmachem Inc
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Date Commenced:
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February 14, 2017
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Court File No.:
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T-200-17
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Comment:
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Action for infringement of Patents Nos. 2,426,921; 2,689,052; 2,688,934; 2,688,915; 2,689,051; and 2,429,496.
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Medicine:
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unidentified
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Applicants:
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Canada RNA Biochemical Inc and Martin Kwok
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Respondent:
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Minister of Health
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Date Commenced:
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February 27, 2017
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Court File No.:
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T-278-17
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Comment:
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Application for Order requiring the Minister of Health to produce documents requested pursuant to the Access to Information Act.
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Medicine:
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unidentified
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Applicants:
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BIE Health Products O/B 2037839 Ontario Ltd and Richard Beemer
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Respondent:
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Minister of Health
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Date Commenced:
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February 27, 2017
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Court File No.:
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T-277-17
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Comment:
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Application for Order requiring the Minister of Health to produce documents requested pursuant to the Access to Information Act.
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