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Leave to appeal granted to the Minister of Health and Long-Term Care (Ontario) regarding ''private label'' generics

Norton Rose Canada LLP
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Canada
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May 11 2011

On April 29, 2011, the Ontario Court of Appeal granted leave to the Minister of Health and Long-Term Care, the Lieutenant Governor-in-Council, and the Attorney General of Ontario to appeal the decisions in Katz Group Canada Inc. v. Minister of Health and Long Term Care (Court File No. 33410) and Shoppers Drug Mart v. Minister of Health and Long Term Care (Court File No. 33210) in which the Divisional Court held that section 12.02 of Ontario Regulation 20196 made under the Ontario Drug Benefit Act and section 9 of Ontario Regulation 935 made under the Drug Interchangeability and Dispensing Fee Act regarding "private label" generics were ultra vires and of no force and effect

Federal Court of Appeal upholds decision denying listing of dosage form patent on patent register TARGIN (Oxycontin)

Norton Rose Canada LLP
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Canada
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April 28 2011

On April 14, 2011, the Federal Court of Appeal dismissed an appeal by Purdue Pharma ("Purdue") thereby upholding the decision of the lower Court and the Minister of Health which denied the listing of Canadian Patent No. 2,098,738 ("738 Patent") on the Patent Register

Federal Court of Appeal refuses to strike pleading of patent infringement ZYMAR (gatifloxacin)

Norton Rose Canada LLP
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Canada
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April 27 2011

On April 14, 2011, the Federal Court of Appeal dismissed an appeal by Apotex Inc. and Apotex Pharmachem Inc. ("Apotex") from an order dismissing its motion to strike the statement of claim filed by Allergan, Inc., Allergan Sales, LLC, Allergan USA, Inc. and Kyorin Pharmaceutical Co., Ltd ("Allergan") in a patent infringement action

Regulatory reform in Canada: market authorization and protection of ''extraordinary use new drugs''

Norton Rose Canada LLP
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Canada
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April 19 2011

The Government of Canada introduced amendments to the Food and Drug Regulations (the "Regulations") and the Patented Medicines (Notice of Compliance) Regulations which provide an application process for the market authorization and protection of Extraordinary Use New Drugs ("EUNDs"

Working example no longer required to patent monoclonal antibodies

Norton Rose Canada LLP
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Canada
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April 4 2011

On June 4, 2010, the Patent Appeal Board ("Board") determined that claims to a monoclonalantibody are enabled where the antigen is a novel polypeptide which has been fully characterized (for example by complete amino acid sequence

Federal Court of Appeal affirms decision granting prohibition order XALATAN (latanoprost)

Norton Rose Canada LLP
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Canada
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March 23 2011

On March 17, 2011, the Federal Court of Appeal ("FCA") upheld the December 18, 2009 decision of Justice Heneghan which granted Pfizer's application for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Pharmascience in respect of its generic version of latanoprost (XALATAN) until after the expiry of Canadian Patent No. 1,339,132 ("132 Patent"

Federal Court rejects allegations of obviousness, inutility and insufficiency: prohibition order granted AVANDIA (rosiglitazone)

Norton Rose Canada LLP
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Canada
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March 17 2011

On March 1, 2011, the Federal Court granted GlaxoSmithKline's ("GSK") application for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Pharmascience in respect of its generic version of rosiglitazone (AVANDIA) until after the expiry of Canadian Patent No. 1,328,452 ("452 Patent"

Ontario Superior Court strikes down prohibition of "private label" generic drugs

Norton Rose Canada LLP
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Canada
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February 4 2011

On February 3, 2011, the Ontario Superior Court of Justice (Divisional Court) allowed two applications for judicial review brought by the Katz Group Canada Inc. and Shoppers Drug Mart and held that the private label generic prohibitions contained in the regulations under the Ontario Drug Benefit Act ("ODBA") and the Drug Interchangeability and Dispensing Fee Act ("DIDFA") (the "Regulations") were ultra vires and of no force and effect

Canadian Chamber of Commerce recommends measures to improve Canadian IP protection in the pharmaceutical field

Norton Rose Canada LLP
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Canada
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January 20 2011

On January 19, 2011, the Canadian Intellectual Property Council ("CIPC") and the Canadian Chamber of Commerce released a report addressing the need for greater protection of intellectual property in the pharmaceutical field

Supreme Court of Canada holds that PMPRB has jurisdiction over sales made ''into Canada'' pursuant to the special access program (Thalomid)

Norton Rose Canada LLP
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Canada
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January 20 2011

On January 20, 2011, the Supreme Court of Canada dismissed an appeal by Celgene Corporation ("Celgene") and held that the Patented Medicine Prices Review Board ("Board") has jurisdiction to regulate the price of patented medicines that are sold into Canada pursuant to the Health Canada Special Access Program as part of its "consumer protection" mandate

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