S.C.C. Ends Pfizer Drug Dispute

The Supreme Court of Canada dismissed, on May 22, 2003, an application for leave to appeal to the S.C.C.; ending Pfizer Inc.’s Liptor drug dispute. Apotex Inc. was seeking leave to appeal the decision of the Federal Court of Appeal. The Court of Appeal had overturned a decision of the Federal-Court Trial Division that was adverse to Pfizer Canada Inc.

In August 2001, Justice Eleanor Dawson of the Federal Court-Trial Division held that an allegation served by Apotex under the Patented Medicines (Notice of Compliance) Regulations—to the effect one of Pfizer’s patents protecting the blockbuster drug Liptor was invalid—was justified. Apotex had alleged that the patent was invalid on the basis that it had been dedicated to public use. Had this decision remained, Pfizer Canada would not have been able to rely on that patent as a means to prevent the issuance of marketing approval to Apotex for a generic copy of Liptor. Pfizer appealed the decision and the matter was heard by Justices Allen Linden, Edgar Sexton and Karen Sharlow of the Federal Court of Appeal. And on November 18, 2002, the court reversed the Trial Division’s decision.

The Court of Appeal made a number of significant rulings, including recognizing as legally effective the Canadian patent office practice of allowing patents to be dedicated to the public, and affirming that a generic manufacturer cannot challenge a drug patent under the Regulations without itself applying for regulatory approval to market the patented drug. The court ruled that the proceedings were premature and ordered that Apotex’s notice of allegation should be quashed. The court also found a palpable and overriding error in the Trial Division’s assessment of the facts of the case, which justified the appellate court’s intervention. The S.C.C. dismissed, with costs, Apotex’s application for leave to appeal.

Pfizer was represented by Torys LLP on all appeal proceedings, with a team that included Sheila Block, Andy Shaughnessy and Cynthia Tape, assisted by Conor McCourt (intellectual property). Apotex was represented by Harry Radomski, Richard Naiberg and Julie Perrin of Goodmans LLP.