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ARTICLE · 05 MARCH 2024

Dexlansoprazole Formulation Patent Invalid And Not Infringed By Apotex

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On February 7, 2024, the Federal Court dismissed Takeda's action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations in relation to dexlansoprazole.

CanadaIntellectual Property
Brandon Heard
Brandon Heard
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On February 7, 2024, the Federal Court dismissed Takeda's action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations in relation to dexlansoprazole (Takeda's DEXILANT). Justice Furlanetto determined that the Asserted Claims of Canadian Patent No. 2,570,916 (916 patent) were not infringed and were invalid for insufficiency and failure to disclose the factual basis and line of reasoning for sound prediction of utility: Takeda Canada Inc v Apotex Inc, 2024 FC 106.

Background

DEXILANT is a "pulsatile release formulation ... that includes two types of delayed-release beads containing dexlansoprazole", and releases dexlansoprazole, a proton pump inhibitor (PPI) in "two discrete pulses". DEXILANT "is used to treat heartburn associated with gastroesophageal reflux disease (GERD), as well as to heal damage to the esophagus from stomach acid."

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The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.

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