FCA Will not Reweigh Expert Evidence to Appeal Patent Invalidity

FCA Will not Reweigh Expert Evidence to Appeal Patent Invalidity

Alcon Canada Inc v Actavis Pharma Company, 2015 FCA 191

The Federal Court of Appeal (“FCA”) dismissed an appeal wherein a party sought to reverse a finding of invalidity against its patent by surreptitiously asking the FCA to reweigh the expert evidence as a challenge against the Federal Court (“FC”) Judge’s findings of fact. Appeals should not be used as attempts to re-litigate cases by pointing to evidence that supports conclusions contrary to those reached by a judge of a lower court. A patent that is invalidated by a lower court cannot be saved by reweighing evidence on appeal. Parties seeking to challenge a decision of a lower court must ensure that they have proper grounds for appeal, as the FCA will only interfere with evidentiary findings where there has been a clear and fundamental error going to the very core of the outcome of the case.

Background: Invalidity of ‘211 Patent

Vigamox is an antibacterial eye drop containing the antibacterial agent moxifloxacin hydrochloride (“moxifloxacin”). [4] Vigamox was covered by three of Alcon Canada Inc.’s (“Alcon”) patents – Canadian Patents No. 1,340,114 (the “‘114 Patent”), 2,342,211 (the “‘211 Patent”) and 2,192,418 (the “‘418 Patent”) (collectively, the “patents”). The ‘211 Patent claimed and disclosed Vigamox and covered its use in the treatment and prevention of ophthalmic infections. [4]

Alcon applied for an order prohibiting the Minister of Health from issuing a notice of compliance to Actavis Pharma Company (“Actavis”), formally known as Cobalt Pharmaceuticals Company, for a generic version of Vigamox, until the expiry of the patents. Actavis argued that the ‘211 Patent was invalid on the basis of obviousness and anticipation, the ‘114 Patent was invalid on the basis of a lack of sound prediction and utility, and that its product would not infringe the ‘418 Patent.

The Federal Court (“FC”) rendered a decision on May 14, 2014, which found that the ‘211 Patent was invalid for reasons of obviousness. The FC held that the ‘211 Patent related to moxifloxacin (a known compound) being used for treating and preventing ophthalmic infection (a known use) at a concentration known to be effective. The FC concluded that the ‘211 Patent would therefore have been obvious or obvious to try and that there was no difference between the state of the art and the inventive concept of the ‘211 Patent. Alcon appealed this decision. The issue on appeal was whether the Judge erred in concluding that the ‘211 Patent was obvious or obvious to try.

Obviousness: FCA Refuses to Reweigh the Expert Evidence

Alcon disagreed with the evidence relied upon by the Judge in assessing obviousness and argued that the Judge misapplied the test for obviousness [13]. Palpable and overriding error is the standard of review for factual determinations made by judges regarding obviousness. It is a deferential standard and has a high threshold, which requires a party alleging it to demonstrate a clear (palpable) and fundamental (overriding) error going to “the very core of the outcome of the case.” [12] A judge is assumed to have considered all evidence before the court and does not make a palpable and overriding error by failing to refer to a particular piece of evidence.

Alcon alleged that the Judge erred in preferring and relying on one of Actavis’ expert’s evidence. Alcon alleged that the Judge’s reliance on Actavis’ expert’s evidence, coupled with the failure to consider certain admissions the expert made on cross-examination, led the Judge to adopt an inappropriate “hindsight approach” in assessing obviousness. [15]

The FCA did not agree with Alcon. The FCA noted that the Judge could use Actavis’ expert’s opinion without adopting “every single aspect of it”. [19] The FCA found that in considering the expert’s testimony and situating himself as the skilled person in the art, the Judge was “equipped with the ‘goggles’ of the person skilled in the art”, which allowed him to draw his own factual conclusions from the evidence on the prior art and the inventiveness steps. [20] The FCA was satisfied that the Judge drew his own conclusions on the evidence regarding whether the inventive step of trying moxifloxacin for the treatment of ophthalmic infections would have been obvious to the skilled person in the art.

Alcon alleged that the Judge erred in failing to evaluate the Sanofi factors in his obvious to try analysis. The FCA rejected this allegation, noting that the Judge explicitly set out the Sanofi factors and made reference to the obvious to try test on numerous occasions (Judge’s reasons, paras 139, 144, 160-170, 174, 175, 181, and 183).


The FCA dismissed the appeal as they found that Alcon lacked proper grounds and was attempting to reweigh evidence that was properly previously admitted in the prohibition application.