On January 12, 2017, the Canadian Federal Court of Appeal (FCA) upheld the validity and the infringement of AstraZeneca’s omeprazole formulation patent by Apotex (Canadian Patent No. 1,292,693 or 693 Patent) in Apotex Inc v AstraZeneca Canada Inc, 2017 FCA 9. The 693 Patent claims a new omeprazole preparation comprising “an inert subcoating […] disposed on ”an alkaline core, and an outer enteric coating”.

The FCA dismissed Apotex’s appeal from the Federal Court (FC) findings of infringement and invalidity on the grounds of sufficiency, ambiguity, overbreadth and inutility, but allowed its appeal on the application of 6-year limitation period provided by the current Patent Act.  We previously reported the FC decision (2015 FC 322) in E-TIPS® newsletter here

The key construction issue on appeal was whether the wording of the preparation claim covered a subcoating that was applied using a process not known at the relevant time. The FCA held that the objective intention of the inventor “is to be found within the four corners of the patent” without reference to post-art evidence and that it “is trite law that a court will consider the disclosure” for claim construction as a special lexicon for an expression in the claim.  The FCA reviewed the disclosure and found that the phrase “disposed on” described the position of the subcoating in the finished preparation, as opposed to a particular manufacturing process. 

The FCA also held that Apotex arguing one construction over another does not make a claim ambiguous and held that to establish sufficiency, the inventor is required to describe only one method for making the invention. 

Regarding the limitation period, the FCA held that the FC erred in concluding that the 6-year limitation period, which was not present in the old Patent Act, applied to all acts of infringement of the 693 Patent, an old Act patent.  The FCA interpreted section 39 of the Federal Courts Act and noted that each act of infringement constituted a distinct cause of action and that the Court should look into the place where each cause of action arose: if all elements of the cause of action occur in one province, that province’s limitation period applies.  Otherwise, a six-year limitation period applies.

Summary By: Junyi Chen


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