AstraZeneca Canada Inc v Apotex Inc, 2015 FCA 158
The Federal Court of Appeal (FCA) upheld a declaration for invalidity of AstraZeneca’s Canadian Patent No. 2,139,653. The Federal Court (FC) had found that the patent promised that particular compounds would give an improved therapeutic profile based on the phrase “…with improved pharmacokinetic and metabolic properties which will give an improved therapeutic profile”. [13, emphasis added] The FC determined that this promise could not be demonstrated or soundly predicted at the time of filing.  On appeal, the FCA upheld the decision and in doing so reaffirmed a number of points of law that were challenged by AstraZeneca.
First, AstraZeneca criticized the FC for not following claim-by-claim construction when it determined the promise of the patent.  AstraZeneca pointed to a portion of the judgment where the judge resolved a disagreement among the experts about exactly what the patent promised. Apotex’s expert had submitted that the skilled reader would understand that the patent promised an improved therapeutic profile in addition to the other (less relevant) promises that AztraZeneca’s expert was willing to concede.  The FC preferred the evidence of Apotex’s expert over that of AstraZeneca’s. On AstraZeneca’s reading of the FC decision, the judge’s reasoning amounted to rejecting the notion that utility should be construed on a claim by claim basis,  contrary to settled law.  The FCA disagreed with this reading, and found that the discussion was merely directed towards weighing the competing experts’ evidence, not rejecting claim by claim construction. 
A second argument AstraZeneca raised was that, as a matter of law, there should be a “unitary, harmonious understanding of the essential elements of the claim, inventive concept, and utility”.  The FCA rejected the assertion, stating simply that AstraZeneca was unable to provide jurisprudence to support its position. 
Third, the FCA also rejected AstraZeneca’s argument that the FC gave the disclosure elevated emphasis. The FC did not err by construing the promise within the context of the patent as a whole. 
Fourth, AstraZeneca argued that the FC took an overly narrow definition of the word “will” when it read following phrase in the disclosure: “improved pharmacokinetic and metabolic properties which will give an improved therapeutic profile”. [13, emphasis added] In doing so, AstraZeneca argued that the FC failed to apply purposive construction. The FCA acknowledged that the word “will” often refers to an expectation or goal rather than a promise, but still held that the FC did not err in finding that a promise was made when reading the patent as a whole from the eyes of a skilled reader. 
The important takeaway for patent drafters is that the FCA upheld a promise that hinged on the word “will” in the phrase “…with improved pharmacokinetic and metabolic properties which will give an improved therapeutic profile”. The FC found “will” to indicate a promise rather than a goal or expectation.
An interesting consideration for academics is AstraZeneca’s proposal that the essential elements of a claim, the inventive concept, and utility should be coterminous. The proposal was rejected on precedential grounds, but the argument may still serve as an interesting tool for understanding these related concepts.
Update: A hearing has been scheduled at the Supreme Court of Canada for November 8, 2016, with interveners including the Intellectual Property Institute of Canada and the Intellectual Property Owners Association.