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ARTICLE · 15 MAY 2023

Apotex's Section 8 Claim For Apo-Atomoxetine Dismissed

On March 30, 2023, the Ontario Superior Court of Justice dismissed Apotex's claim under section 8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations)...

CanadaIntellectual Property

On March 30, 2023, the Ontario Superior Court of Justice dismissed Apotex's claim under section 8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) relating to Apo-Atomoxetine (Lilly's STRATTERA) and Canadian Patent No. 2,209,735 (735 patent): Apotex v Eli Lilly, 2023 ONSC 1968.

Background

In 2008, Teva commenced an action to impeach the 735 patent (Teva impeachment action). Apotex subsequently served Lilly with a Notice of Allegation addressing the 735 patent and Lilly brought an application against Apotex under section 6(1) of thePMNOC Regulations (Apotex prohibition application).

Justice Barnes of the Federal Court presided over the trial of the Teva impeachment action and found the 735 patent invalid. The Minister of Health quickly granted Apotex a Notice of Compliance (NOC) for Apo-Atomoxetine. Justice Barnes also heard the Apotex prohibition application, but dismissed it for mootness. However, he found that none of

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