Canada’s Intellectual Property Firm

Ontario Superior Court dismisses Apotex’s Statutes of Monopolies claims regarding sildenafil

On September 27, 2021, the Ontario Superior Court of Justice granted Pfizer’s motion for summary judgment and dismissed Apotex’s claims for treble damages and double costs under the Ontario and English Statutes of Monopolies, Trademarks Act, and common law torts of conspiracy, unjust enrichment and nuisance: Apotex Inc v Pfizer Ireland Pharmaceuticals, 2021 ONSC 6345.

The action related to Canadian Patent No. 2,163,446 (446 Patent) for the use of sildenafil (VIAGRA) in the treatment of erectile dysfunction. In 2012, the Supreme Court of Canada found the 446 patent void for insufficient disclosure (Teva Canada Ltd v Pfizer Canada Inc, 2012 SCC 60, as previously reported). Apotex claimed it was entitled to various statutory and common law damages arising from Pfizer benefitting from a patent later found invalid.

This is the second decision to dismiss a claim by Apotex seeking remedies beyond s. 8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations).  As previously reported, the Court in Apotex Inc v Eli Lilly Canada Inc, 2021 ONSC 1588 (ZYPREXA decision) dismissed Apotex’s claims against Eli Lilly under substantially the same causes of action (Apotex’s appeal is pending and currently scheduled to be heard in February 2022).  

The Court held that judicial comity required it to follow the ZYPREXA decision unless it is clearly wrong. The Court agreed with the ZYPREXA decision, including that “the Patent Regime [i.e., the Patent Act and PMNOC Regulations] operates as a complete code.” Further, to permit claims of damages outside of the Patent Regime “would effectively disrupt the regime itself.” The Court also reinforced the principle that a subsequent finding of invalidity does not, in and of itself, render the patent holder’s actions unlawful or improper where the actions are authorized under the Patent Regime. Applying the ZYPREXA decision to the facts, the Court held that Apotex’s claims cannot succeed.

While the Court dismissed all of Apotex’s claims under the “complete code” analysis, it further rejected Apotex’s arguments for unjust enrichment and nuisance (which were not raised in the ZYPREXA decision) on the grounds that:

  1. there is no causal connection between Pfizer’s alleged enrichment and Apotex’s alleged deprivation, and more importantly, the Patent Regime is a juristic reason justifying any potential enrichment; and
  2. Apotex made no allegation that Pfizer substantially interfered with Apotex’s use and enjoyment of its manufacturing facilities.

Apotex may appeal as of right.

Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.

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