The Federal Court of Canada has dismissed a patent infringement action by Takeda Canada Inc. against Apotex Inc. relating to the drug DEXILANT®, finding that the claims of Takeda's Canadian Patent No. 2,570,916 (the "916 Patent") are not infringed and are invalid.
In reaching this decision, the Court held that Takeda failed to either demonstrate or soundly predict the results claimed in the specification at the filing date. While the claims of the 916 patent were directed to an oral dosage of a compound, the study disclosed in the specification related only to an IV dosage of that compound. Although Takeda did conduct a study validating the results, the study was not included in the patent application (or otherwise put into the public domain at the time of publishing). The Court held that this second study would have been required for a person skilled in the art to soundly predict the utility claimed, and therefore found the claims of the 916 Patent to be invalid for lacking adequate disclosure of a prediction of utility.
For related reasons, the Court further held that the disclosure provided in the 916 Patent was insufficient to enable a person skilled in the art to implement the claimed invention as a person skilled in the art would need to undertake further research to achieve the claimed invention based on the disclosure and general common knowledge at the time of filing.
The full decision may be found here.
Federal Court Case Emphasizes Importance Of Sufficient Disclosure
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