The 14 year perindopril litigation in Canada is over, with Adir and Servier Canada Inc. (collectively “Servier”) emerging victorious against Apotex Inc. and Apotex Pharmachem Inc. (collectively “Apotex”). The end was marked by the Supreme Court of Canada's dismissal of Apotex's application for leave to appeal a decision requiring it to disgorge its profits associated with infringement of Servier's patent.

Judith Robinson and Joanne Chriqui of Norton Rose Fulbright Canada are proud to have successfully represented Servier at all levels of this hotly contested litigation.

The first chapter was a 2008 trial judgment upholding the validity of Servier's patent for perindopril and finding that Apotex infringed the patent. Next was a 2015 trial judgment awarding an account of Apotex's profits to Servier. These trial judgments were each subject to appeals and applications for leave to the Supreme Court of Canada, and a re-determination decision before the Federal Court at the quantification stage.

The litigation involved complex questions of patent validity, patent infringement in Canada and exportation of infringing goods abroad, standing, unfair competition and alleged violations of the Competition Act, R.S.C. 1985, c C-34 (Competition Act), remedies, accounting of profits, non-infringing alternatives, and apportionment.

Trial Judgment # 1: patent validity, infringement and unfair competition claims

The action began in the Fall of 2006 when Servier sued Apotex and obtained an interim injunction to block exportation to the U.K. and Australia. The action was a test case for expedited proceedings with novel case management techniques.  The trial moved between Montreal, Toronto and a rogatory commission to New Jersey.

The Federal Court found Servier's patent for perindopril valid and infringed by Apotex. The Court dismissed Apotex's counterclaim that asserted unfair competition and a violation of the Competition Act.

Servier elected, and the Court granted, the exceptional remedy of an accounting of Apotex's profits. This trial judgment was confirmed on appeal to the Federal Court of Appeal and Apotex's application for leave to the Supreme Court of Canada was dismissed.

Trial Judgment #2: accounting of Apotex's profits….and a re-determination

One of the issues in quantifying Apotex's profits was Servier's entitlement to profits on the perindopril that Apotex had exported from Canada. Apotex argued that the amount of profits from export sales payable should be reduced because:

  • a portion of Apotex's profits resulted from the provision of non-infringing services, namely an indemnity and legal services provided by Apotex to foreign affiliates; and
  • Apotex had available alleged non-infringing foreign suppliers (non-infringing alternatives).

The Federal Court rejected both arguments and ordered Apotex to disgorge a total of $61 million plus interest to Servier.

A first appeal by Apotex to the Federal Court of Appeal in 2017 was allowed in part on the issue of non-infringing alternatives and remitted to the Federal Court for re-determination. On re-determination, the Federal Court confirmed the original award of profits. A second appeal to the Federal Court of Appeal in 2020 was dismissed.

Finally, Apotex sought leave to appeal to the Supreme Court of Canada from the 2020 Federal Court of Appeal decision. Leave was denied on September 24, 2020.

Links

  Decisions on validity, infringement and unfair competition

  • Laboratoires Servier, Adir, Oril Industries, Servier Canada Inc v Apotex Inc,  2008 FC 825
  • Apotex Inc v ADIR,  2009 FCA 222

Decisions on quantification of accounting of profits

Redetermination on non-infringing alternative

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