Teva awarded section 8 damages regarding pregabalin and olanzapine
by Shirley Liang Komosa »
On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of Compliance) Regulations (“PMNOC Regulations”) regarding pregabalin (Pfizer’s LYRICA) in Teva Canada Limited v Pfizer Canada Inc, 2017 FC 332 (the “pregabalin decision”) and olanzapine (Eli Lilly’s ZYPREXA) in Eli Lilly Canada Inc v Teva Canada Limited, 2017 FC 88 (the “olanzapine decision”). In both decisions, the Court made factual findings that provided direction for a final calculation of Teva’s damages. Notably, an adjustment for “pipefill” was permitted in pregabalin, but not in olanzapine. Generally, pipefill is the difference in a company’s ex-factory sales and IMS retail sales.
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PMNOC proceedings
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Medicine:
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aripiprazole tablets (ABILIFY)
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Applicants:
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Bristol-Myers Squibb Canada Co.
Otsuka Pharmaceutical Co., Ltd.
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Respondents:
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Teva Canada Limited, Actavis Pharma Company and the Minister of Health
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Date Commenced:
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April 12, 2017
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Court File No.:
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T-530-17
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Comment:
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Application for Order of prohibition until expiry of Patents Nos. 2,426,921; 2,713,466; 2,689,052; 2,688,934; 2,688,915; 2,689,051;
2,429,496; 2,700,314; 2,526,562; and 2,511,619.
Teva alleges non-infringement and invalidity.
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Medicine:
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atazanavir sulphate capsules (REYATAZ)
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Applicants:
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Bristol-Myers Squibb Canada Co. and Bristol-Myers Squibb Holdings Ireland
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Respondents:
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Mylan Pharmaceuticals ULC and the Minister of Health
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Date Commenced:
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April 6, 2017
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Court File No.:
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T-507-17
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Comment:
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Application for Order of prohibition until expiry of Patent No. 2,317,736. Mylan alleges invalidity.
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Other Proceedings
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Medicine:
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filgrastim (NEUPOGEN and NEULASTA)
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Plaintiff:
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Amgen Inc.
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Defendant:
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BGP Pharma ULC dba Mylan EPD
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Date Commenced:
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April 5, 2017
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Court File No.:
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T-501-17
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Comment:
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Action for a declaration that claims 43-47 of Patent No. 1,341,537 are valid.
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Medicine:
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Unidentified
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Applicant:
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Unidentified Innovator Company
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Respondent:
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The Attorney General of Canada and the Minister of Health
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Date Commenced:
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March 31, 2017
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Court File No.:
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T-485-17
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Comment:
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Application for a Declaration that a new drug submission filed by the applicant does not trigger the application of section 5 of the PMNOC Regulations and that the applicant is not a second person.
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