Astrazeneca Canada Inc. v. Apotex Inc., 2015 FCA 158 (Dawson, J.A.)
July 6, 2015
Gunars Gaikis, Yoon Kang, Lynn Ing and Urszula Wojtyra of Smart and Biggar for the Appellants Astrazeneca Canada Inc. Astrazenca Aktiebolag and Astrazenca UK Limited
Harry Radomski, Richard Naiberg and Sandon Shogilev of Goodmans LLP for the Respondents Apotex Inc. and Apotex Pharmachem Inc.
This was an appeal from the judgment of the Federal Court Judge (the Judge) wherein the Appellants’ patent was held to be invalid because of inutility. The patent in question claims the enantiomer, (-)-omeprazole, with a specified level of optical purity – (-)-omeprazole being the active ingredient in a formulation prescribed to treat ulcers, gastroesophageal reflux disease, and related diseases. The Judge held (i) that the patent promised improved pharmacokinetic and metabolic properties for the claimed compound which will give an improved therapeutic profile, such as a lower degree of inter-individual variation; and (ii) that this promise was neither demonstrated nor soundly predicted at the time of patent filing.
The Federal Court of Appeal (FCA) upheld the Judge’s ruling, finding no legal error in the Judge’s construction of promised utility nor any palpable and overriding error in the Judge’s appreciation of the evidence. The FCA provided the following reasons: (i) the Judge construed the promised utility of the relevant claims in a manner that was open to him and did not reject the notion that utility should be construed on a claim by claim basis; (ii) the Judge was not required by law to construe the promised utility of a claim(s) in a manner that is virtually coterminous with the inventive concept of that claim(s); (iii) the Judge did not err by giving the disclosure elevated emphasis but, instead, construed the promise within the context of the patent as a whole; and (iv) the Judge did not err by adopting overly narrow definitions of words in the description (particularly the word “will”) – instead, the construction of the promise was reached reading the patent as a whole through the eyes of the skilled reader. Thus, the appeal was dismissed with costs.
By: Phil Goldbach, AbCelex Technologies Inc.