Action for patent infringement under PMNOC Regulations dismissed due to non-infringement and invalidity.
Takeda Canada Inc. brought a patent infringement action under the PMNOC Regulations regarding Canadian Patent No. 2,570,916, which relates to the drug DEXILANT® (dexlansoprazole).
Takeda alleged that Apotex Inc.'s proposed generic product would infringe the patent.
The Court found that Apotex's product did not infringe the patent, as it functioned as a single, continuous delayed-release formulation rather than the pulsatile release dosage form claimed.
The Court also held that the patent was invalid for failing to meet disclosure requirements and failing to soundly predict utility.