Federal Court Of Canada Finds Non-Infringement And Invalidity Of Takeda’s Patent

On February 7, 2024, the Federal Court of Canada (the Court) issued its decision in Takeda Canada Inc. v Apotex Inc., 2024 FC 106, dismissing Takeda Canada Inc.’s (Takeda) claims for infringement of its Canadian Patent No. 2,570,916 (the 916 Patent) by Apotex Inc. (Apotex).

The 916 Patent relates to Takeda’s drug DEXILANT®, dexlansoprazole oral dose capsules which treat heartburn associated with gastroesophageal reflux disease and heal damage to the esophagus from stomach acid.  Takeda claimed that the making, constructing, using, or selling by Apotex of its dexlansoprazole oral dose capsules in strengths of 30 mg and 60 mg (the Apotex Products) would infringe at least one of claims 1, 5-8, 10-11, or 26 of the 916 Patent (the Asserted Claims).  Apotex denied infringement and argued that the Asserted Claims were invalid for anticipation, obviousness, lack of utility, insufficiency, overbreadth, ambiguity and/or as unpatentable subject matter.

Upon performing claim construction and analyzing the claims of the 916 Patent, the Court found that the Apotex Products did not infringe any of Takeda’s Asserted Claims.  The Court found that the essential elements of the Asserted Claims included a first and second dose of dexlansoprazole in the dosage form which is released from the dosage form in two discreet pulses.  The evidence showed that the Apotex Products contained only one dose of dexlansoprazole in the dosage form, which is released in a continuous, delayed fashion.  Because the Apotex Products did not contain all the essential elements of the Asserted Claims, the Court found they did not infringe the Asserted Claims. 

Though this finding of non-infringement would have been sufficient to dispose of Takeda’s action, the Court went on to consider the invalidity arguments which were raised by the parties at trial.  The Court ultimately found that the Asserted Claims were invalid for failure to meet the disclosure requirements under subsection 27(3) of the Patent Act and to provide proper disclosure of the factual basis and line of reasoning to support a sound prediction of utility.

Therefore, as the Asserted Claims of the 916 Patent were both not infringed and invalid, the Court dismissed Takeda’s action.

Summary By: Claire Bettio