On October 20, 2005, the Supreme Court of Canada granted Apotex Inc. leave to appeal from a decision of the Federal Court of Appeal, which denied Apotex marketing approval for a drug containing the medicine omeprazole, used in the treatment of gastric problems.
In January 2004, Apotex was granted regulatory approval by the Minister of Health to market its omeprazole drug, Apo-Omeprazole. Shortly thereafter, AstraZeneca Canada Inc. instituted three judicial review proceedings seeking to quash the grant of regulatory approval on the grounds that the requirements of the Patented Medicines (Notice of Compliance) Regulations had not been satisfied.
On September 20, 2004, Justice Michael Kelen of the Federal Court dismissed each of AstraZeneca's judicial review applications. AstraZeneca appealed all three decisions. On February 9, 2005, Justice Marc Noël, writing for the Federal Court of Appeal, upheld the order of Justice Kelen in one of AstraZeneca's proceedings.
However, on May 18, 2005, the Federal Court of Appeal (Justice Karen Sharlow dissenting) reversed the other orders of Justice Kelen, quashing Apotex's marketing approval for Apo-Omeprazole.
AstraZeneca and Apotex each sought leave to appeal to the Supreme Court of Canada from their respective unsuccessful appeals. On September 15, 2005, the Supreme Court dismissed AstraZeneca's leave application with costs. The following month, Apotex was granted leave to appeal, with costs in any event of the cause.
The decision of the Federal Court of Appeal, from which Apotex will appeal, concerns important questions of interpretation of the scheme of the Patented Medicines (Notice of Compliance) Regulations, which scheme generic drug manufacturers must confront before introducing a generic version of an innovator drug product. In particular, the Supreme Court will be asked to clarify the scope of its decision in Bristol-Myers Squibb Co. v. Canada (Attorney General), 2005 SCC 26, released the day before the judgment that Apotex will appeal.
Apotex will also ask the court to consider in what circumstances brand name drug manufacturers can seek recurring prohibitions orders to postpone generic drug competition.
AstraZeneca was represented by Smart & Biggar on all appeal proceedings, with a team that included Gunars Gaikis, J. Sheldon Hamilton, Yoon Kang and Nancy Pei. Apotex was represented by Harry Radomski, Andrew Brodkin, Julie Rosenthal, Miles Hastie and Sorelle Simmons of Goodmans LLP.
In January 2004, Apotex was granted regulatory approval by the Minister of Health to market its omeprazole drug, Apo-Omeprazole. Shortly thereafter, AstraZeneca Canada Inc. instituted three judicial review proceedings seeking to quash the grant of regulatory approval on the grounds that the requirements of the Patented Medicines (Notice of Compliance) Regulations had not been satisfied.
On September 20, 2004, Justice Michael Kelen of the Federal Court dismissed each of AstraZeneca's judicial review applications. AstraZeneca appealed all three decisions. On February 9, 2005, Justice Marc Noël, writing for the Federal Court of Appeal, upheld the order of Justice Kelen in one of AstraZeneca's proceedings.
However, on May 18, 2005, the Federal Court of Appeal (Justice Karen Sharlow dissenting) reversed the other orders of Justice Kelen, quashing Apotex's marketing approval for Apo-Omeprazole.
AstraZeneca and Apotex each sought leave to appeal to the Supreme Court of Canada from their respective unsuccessful appeals. On September 15, 2005, the Supreme Court dismissed AstraZeneca's leave application with costs. The following month, Apotex was granted leave to appeal, with costs in any event of the cause.
The decision of the Federal Court of Appeal, from which Apotex will appeal, concerns important questions of interpretation of the scheme of the Patented Medicines (Notice of Compliance) Regulations, which scheme generic drug manufacturers must confront before introducing a generic version of an innovator drug product. In particular, the Supreme Court will be asked to clarify the scope of its decision in Bristol-Myers Squibb Co. v. Canada (Attorney General), 2005 SCC 26, released the day before the judgment that Apotex will appeal.
Apotex will also ask the court to consider in what circumstances brand name drug manufacturers can seek recurring prohibitions orders to postpone generic drug competition.
AstraZeneca was represented by Smart & Biggar on all appeal proceedings, with a team that included Gunars Gaikis, J. Sheldon Hamilton, Yoon Kang and Nancy Pei. Apotex was represented by Harry Radomski, Andrew Brodkin, Julie Rosenthal, Miles Hastie and Sorelle Simmons of Goodmans LLP.
