CaseAstraZeneca Canada Inc. v. Apotex Inc. 2015 FCA 158

Drug: NEXIUM® (esomeprazole)

Nature of case: Appeal of a judgment on invalidity of Canadian Patent No. 2,139,653 (‘653 Patent)

Successful party: Apotex Inc. (on trial and on appeal)

Date of decision: July 6, 2015

Summary

AstraZeneca Canada Inc. (AstraZeneca) appealed from the decision of Justice Rennie of the Federal Court (reported as AstraZeneca Canada Inc. v. Apotex Inc., 2014 FC 638) holding that AstraZeneca’s ‘653 Patent was invalid for lack of demonstrated or soundly predicted utility. The Federal Court of Appeal dismissed AstraZeneca’s appeal on the basis that the trial judge properly construed the “promise” of the patent.

Analysis

Trial decision

By way of background, the trial decision dealt with an impeachment action brought by Apotex Inc. (Apotex), which alleged invalidity of the ‘653 Patent for lack of utility, anticipation and obviousness. Justice Rennie concluded that the “promise” of the patent (compounds provide improved pharmacokinetic and metabolic properties with an improved therapeutic profile, such as a lower degree of interindividual variation) was not demonstrated or soundly predicated at the time of filing.  Apotex’s allegations of obviousness and anticipation were dismissed.

Federal Court of Appeal Decision

On this appeal, AstraZeneca contended that the Federal Court erred in law by: (a) failing to consider the patent’s promised utility on a claim by claim basis; (b) failing to construe the utility of the claims in a manner consistent with the inventive concept and; (c) failing to apply a purposive construction to the promise of utility.

The Court of Appeal accepted that the law is “well settled” that utility must be assessed on a claim by claim basis, and further agreed with AstraZeneca that while some “promises” may be “overarching” across claims, “promises” may also be limited to a subset of the claims.  While the Court agreed that the trial judge did not explicitly consider any single claim or subset of claims when determining the “promise” of the patent, this was not an error since AstraZeneca did not ask the Court to do so.  The trial judge could rightfully rely upon the “lis” as presented by the parties.

With respect to AstraZeneca’s submission on the “inconsistency” between the trial judge’s construction of utility with the asserted claims’ inventive concept, the Federal Court of Appeal found that the argument that a promise of utility must be construed to be “virtually coterminous” with the inventive concept of the relevant claim has no support in Federal Court jurisprudence.

Finally, the Federal Court of Appeal determined that the trial judge properly construed the “promise” of the patent by considering the patent as a whole through the eyes of the skilled reader, and properly considered the difference between “goals” and “promises”.  Having failed to demonstrate any legal or palpable and overriding error, the appeal was dismissed.

Link to decisions:

The Federal Court of Appeal decision may be found here.

The Federal Court decision may be found here.