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Data protection granted for THALOMID »

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Apotex's impeachment action concerning quinapril patents partially dismissed as moot »

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Data protection granted for THALOMID

On February 6, 2012, the Federal Court granted Celgene's application for judicial review and declared that THALOMID is entitled to data protection: Celgene Inc. v. The Minister of Health, 2012 FC 154. The Minister of Health previously and erroneously had decided that THALOMID (Celgene's brand of thalidomide) was not entitled to data protection in view of prior approvals of thalidomide products in 1960 (KEVADON) and 1961 (TALIMOL).

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Supreme Court of Canada news

Merck seeks leave to appeal decision finding Merck liable under 1998 version of section 8 regarding lovastatin. As reported in the January 2012 issue of Rx IP Update, the Federal Court of Appeal reversed the Trial Judge's finding and held that the 1998 version of section 8 of the Patented Medicines (Notice of Compliance) Regulations ("Regulations") applied to Apotex's claim against Merck relating to a prohibition proceeding regarding lovastatin (Merck's MEVACOR). The Court of Appeal found that Apotex is entitled to claim loss it suffered as a result of the Minister's delay in issuing the notice of compliance. It further held that Merck's patent infringement defence can be raised under section 8(5) so as to reduce or eliminate the amount of loss otherwise recoverable taking into account all relevant facts, and remitted the matter back to the Trial Judge to quantify Merck's liability. Merck has sought leave to appeal.

Merck & Co. Inc. v. Apotex Inc., February 17, 2012 (SCC Case No. 34681).
Federal Court of Appeal decision — 2011 FCA 364.
Federal Court decision — 2010 FC 1264.

Apotex seeks leave to appeal decision affirming patent infringement by Apotex regarding lovastatin. The Court of Appeal affirmed the Trial Judge's finding of infringement of certain batches of lovastatin by Apotex and Apotex Fermentation. Apotex has sought leave to appeal.

Apotex Inc. v. Merck & Co. Inc., February 17, 2012 (SCC Case No. 34676).
Federal Court of Appeal decision — 2011 FCA 363.
Federal Court decision — 2010 FC 1265.

Apotex seeks leave to appeal decision affirming unavailability of unjust enrichment claim in section 8 actions. Apotex is seeking leave to appeal the decision of the Federal Court of Appeal that Apotex could not pursue unjust enrichment claims in two separate actions relating to raloxifene (Eli Lilly's EVISTA) and pantoprazole (Nycomed's PANTALOC) as no cause of action independent of the operation of section 8 was alleged.

Apotex Inc. and Eli Lilly Canada Inc., February 14, 2012 (SCC Case No. 34669 and 34670).
Federal Court of Appeal decision — 2011 FCA 358.

Shoppers Drug Mart seeks leave to appeal decision upholding Ontario Regulations prohibiting private label generic drugs. As reported in the January 2012 issue of Rx IP Update, the Ontario Court of Appeal overturned the Divisional Court decision holding that certain provisions of the Regulations made under the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act, which effectively prohibits the sale of private label generic drugs in the public and private markets in Ontario, are invalid. The Court of Appeal held that the impugned Regulations are intra vires the parent statutes and remain in full force and effect. Shoppers Drug Mart has sought leave to appeal.

Shoppers Drug Mart Inc. v. Ontario (Health and Long-Term Care), February 6, 2012 (SCC Case No. 34649).
Ontario Court of Appeal decision — 2011 ONCA 830.
Divisional Court decision — 2011 ONSC 615.

 

Patented Medicine Prices Review Board news

New NEWSletter released. The PMPRB has released its January 2012 NEWSletter.

Newsletter.

Voluntary Compliance Undertakings. The Board recently accepted Voluntary Compliance Undertakings for Celgene's THALOMID (thalidomide) and Leo Pharma's DOVOBET (calcipotriol and betamethasone dipropionate).

Notice pertaining to THALOMID.
Notice pertaining to DOVOBET.

 

Recent Court decisions

Patented Medicines (Notice of Compliance) Regulations

Apotex's impeachment action concerning quinapril patents partially dismissed as moot. Apotex commenced an impeachment action seeking a declaration that two patents relating to quinapril (ACCUPRIL) are invalid and Apotex's Apo-Quinapril tablets will not infringe either patent. Apotex had previously lost a prohibition proceeding under the Regulations concerning the same two patents (2007 FCA 209; rev'g 2005 FC 1205). Following expiry of one of the patents, the defendants brought a motion seeking partial dismissal of the action for mootness. Justice Lemieux held that the action is moot with regards to the expired patent. He declined to exercise the Court's discretion to hear that part of the action, finding the jurisprudence established by the Court of Appeal is clear that a finding of invalidity cannot reach back to a claim under section 8 of the Regulations.

Apotex Inc. v. Warner-Lambert Company LLC, February 10, 2012.
Federal Court decision — 2012 FC 202.

 

New Court proceedings

Patented Medicines (Notice of Compliance) Regulations

 

 

 

 

 

 

 

 

 

 
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