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Supreme Court to consider validity of Ontario Regulations prohibiting private-label drugs »

Supreme Court of Canada news »

Patented Medicine Prices Review Board news »

Health Canada news »

Recent Court decisions »

Federal Court dismisses appeal of Trademarks Opposition Board's decision refusing to register NATURE'S SOURCE trademark »

New Court proceedings »

Supreme Court to consider validity of Ontario Regulations prohibiting private-label drugs

On August 30, 2012, the Supreme Court of Canada issued its decision that it would hear appeals from Shoppers Drug Mart and the Katz Group, who seek a reversal of the Ontario Court of Appeal's decision that certain 2010 provisions of the Regulations under the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act are intra vires the parent statutes. These provisions effectively prohibit the sale of private-label generic drugs in the public and private markets in Ontario.

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Supreme Court of Canada news

Wyeth seeks leave to appeal decision determining that Teva is not precluded from pursuing ratiopharm's section 8 claim regarding venlafaxine. On August 7, 2012, Wyeth sought leave to appeal a Federal Court of Appeal decision reversing Justice Hughes's finding that the equitable doctrine of election barred Teva from pursuing a section 8 claim initiated by ratiopharm against Wyeth regarding venlafaxine (Wyeth's EFFEXOR XR) and his subsequent dismissal of Teva's action. The Court of Appeal determined that the equitable doctrine of election does not apply and allowed Teva's appeals. In particular, the Court determined that both (i) Teva's rights under its licence agreement with Wyeth and (ii) Teva's conduct under the agreement could not possibly have affected the potential future right of ratiopharm (and consequently the post-amalgamation Teva) to claim section 8 damages. The Court also concluded that no off-set would be required to account for gains realized by Teva under the licence agreement with Wyeth. In particular, the Court determined that (i) Teva and ratiopharm's pre-amalgamation profits are a historical fact rather than the profits of the amalgamated Teva and (ii) the terms of the licence agreement that would have permitted Teva to enter the market earlier than it actually did are not proof that Teva actually could have done so.

Teva Canada v Wyeth LLC and Pfizer Canada, August 7, 2012 (SCC Case No. 34918).
Federal Court of Appeal decision — 2012 FCA 141.
Federal Court decisions — 2011 FC 1169 and 2011 FC 1442.

 

Patented Medicine Prices Review Board news

Voluntary Compliance Undertakings. The Board recently approved a Voluntary Compliance Undertaking for Biogen Idec Canada Inc.'s AVONEX PS.

VCU.

 

Health Canada news

Annual Drug Submission Performance reports released. The Therapeutic Products Directorate ("TPD") and the Biologics and Genetic Therapies Directorate ("BGTD") have released their annual Drug Submission Performance reports. The reports contain information regarding pharmaceutical, biologic and radiopharmaceutical drug submission review activity from 2007 to 2012.

The TPD reports that the time for approval of new drug submissions ("NDSs") was a median of 453 days with a range of 216-1563 days for the fiscal period April 1, 2010 – March 31, 2011, and a median of 350 days with a range of 204-1119 days for the fiscal period April 1, 2011 – March 31, 2012. For abbreviated new drug submissions ("ANDSs") based on comparative studies (e.g. clinical or non-clinical data, bioavailability, pharmacokinetic and pharmacodynamic data, with or without chemistry and manufacturing data for a drug that does not include a new active substance), the time for approval was a median of 553 days, with a range of 308-1411 days for the fiscal period April 1, 2010 – March 31, 2011, and a median of 627 days, with a range of 266-1156 days for the fiscal period April 1, 2011 – March 31, 2012. For ANDSs based only on chemistry and manufacturing data for a drug (not including a new active substance), the time for approval was a median of 549 days, with a range of 398-931 days for the fiscal period April 1, 2010 – March 31, 2011, and a median of 690 days, with a range of 18-990 days for the fiscal period April 1, 2011 – March 31, 2012.

The BGTD reports that the time for approval of NDSs was a median of 431 days with a range of 225-1444 days for the fiscal period April 1, 2010 – March 31, 2011, and a median of 386 days with a range of 350-819 days for the fiscal period April 1, 2011 – March 31, 2012.

Therapeutic Products Directorate Report.
Biologics and Genetic Therapies Directorate Report.

 

Recent Court decisions

Trademark decisions

Federal Court dismisses appeal of Trademarks Opposition Board's decision refusing to register NATURE'S SOURCE trademark. The Federal Court upheld the Board's decision refusing to register the applicant's trademark, NATURE'S SOURCE, on the basis that there was a likelihood of confusion with the respondent's trademark, NATURSOURCE. The applicant sought to register NATURE'S SOURCE in association with services, inter alia, retail store services specializing in the sale of nutritional supplements, vitamins and mineral supplements, etc. but excluding food items, while the respondent's registered mark NATURSOURCE is registered for use in association with healthy and natural foods. The Court recognized that the applicant's services and the respondent's wares are not of the same class. Nevertheless, it considered the Board's finding of confusion to be reasonable.

Nature's Source Inc v Natursource Inc
Federal Court decision — 2012 FC 917.

 

New Court proceedings

Patented Medicines (Notice of Compliance) Regulations

 

 

 

 

 

Other proceedings

 

 

 
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