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."
The 916 patent describes a need for a once-a-day PPI dosage form that can provide a full day of effect, without "nocturnal breakthrough events" experienced by some patients. The 916 patent teaches "that alleviation of nocturnal breakthrough is a function of the concentration of the PPI in the patient" and "there is a threshold concentration that must be surpassed in a second dose" for therapeutic effect.
Construction and Infringement
The Asserted Claims of the 916 patent all depend on claim 1 (the sole independent claim), which contains the following elements:
- A dosage form that includes a PPI;
- the PPI is released as a first and a second dose;
- the first and second dose are released as discrete pulses;
- each pulse of the PPI is sufficient to raise plasma concentrations above a threshold concentration of at least 100 ng/mL;
- the second dose contains at least 10% more of the PPI than the first dose; and
- the first and the second dose independently comprise between 5 mg and 300 mg of the PPI.
The PPI of claim 16 is dexlansoprazole.
The Apotex...
