Case information

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Case summaries are prepared by the Office of the Registrar of the Supreme Court of Canada (Law Branch). Please note that summaries are not provided to the Judges of the Court. They are placed on the Court file and website for information purposes only.

Intellectual Property – Patents – Medicines – Patented Medicines (Notice of Compliance) Regulations SOR/93-133 – Section 8 damages – Whether domestic jurisprudence should be reconsidered in the face of instructive foreign law in the Virgin Atlantic decision – Whether tensions within domestic jurisprudence regarding supposed non-finality of decisions under the Regulations should be reconciled – Whether case law should be interpreted in a manner that supports the Parliamentary interest in ensuring that patent protection is balanced with the public interest of ensuring the timely entry of low cost medicines.

In 2007, Eli Lilly Inc. was granted an order prohibiting the Minister of Health from issuing a Notice of Compliance (“NOC”) to Apotex for its generic olanzapine products until after the expiry of Eli Lilly’s ‘113 patent. This order was affirmed on appeal. Subsequently, in the context of an infringement and invalidity action between Eli Lilly and a different generic manufacturer, the ‘113 patent was declared invalid. On appeal, the Court of Appeal remitted the issue of invalidity back to the trial judge for redetermination of the utility and sufficiency of disclosure grounds of alleged invalidity. The trial judge found that the promised utility was not soundly predicted and that the ‘113 patent was therefore invalid. This decision was upheld on appeal and leave to appeal to this Court was refused. Apotex received its NOC to market its generic version of olanzapine in 2009. Apotex then moved under Rule 399 of the Federal Courts Rules, SOR/98-106 to set aside the 2007 prohibition order and to dismiss the underlying applications.