Takeda Canada Inc. v. Apotex Inc.
APOTEX INC.
TAKEDA PHARMACEUTICAL COMPANY LIMITED
TAKEDA PHARMACEUTICAL USA, INC.

Summary: This judgment arises from a patent infringement action involving Canadian Patent No. 2,570,916, related to DEXILANT®, a drug used to treat gastroesophageal reflux disease (GERD). Takeda Canada Inc. claimed that Apotex Inc.'s product infringed on their patent, but Apotex contested this and argued the patent's invalidity on several grounds including anticipation, obviousness, and insufficient disclosure.

Key Points:

  • Patent and Product Details: The patent focuses on a pulsatile release dosage form of a proton pump inhibitor (PPI), dexlansoprazole. Takeda's DEXILANT® releases the active ingredient in two phases in the small intestine to manage gastric acid production effectively.
  • Allegations of Infringement: Takeda alleged that Apotex's product, which also involved dexlansoprazole in similar two-phase release capsules, infringed their patent. Apotex denied these claims and challenged the validity of the patent.
  • Findings on Validity and Infringement: The court found that the patent claims were not infringed by Apotex’s product and declared them invalid due to failure in meeting the disclosure requirements necessary for a sound prediction of utility under the Patent Act.

Outcome: The action was dismissed, with the court ruling that Apotex's product did not infringe on Takeda's patent and that the patent itself was invalid. The court's decision highlighted the importance of detailed and sufficient patent claim disclosures to support their validity. Costs were awarded to Apotex. No specific amount provided.

Federal Court
T-151-22
Intellectual property
Defendant
27 January 2022