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A Sheep In Wolf’s Clothing – Alleged Errors of Fact Should Not Be Dressed Up As Errors Of Law

The Federal Court of Appeal recently considered two competing appeals regarding patents listed on the Patent Register against Alcon’s moxifloxacin product, VIGAMOX. In the Application below, Justice Phelan dealt with three patents and held that Actavis’ allegation of obviousness in respect of Canadian Patent No. 2,342,211 was justified, whereas its allegations in respect of Canadian Patent No. 1,340,114 and 2,192,418 were not justified. Alcon appealed in respect of the 211 Patent and Actavis appealed in respect of the 114 Patent (see our post here). The prohibition Order in respect of the 418 was not appealed.

211 Patent

The 211 Patent is generally directed to the use of moxifloxacin or its pharmaceutically useful salts or hydrates at a concentration of 0.1 to 1.0 wt% for topically treating or preventing ophthalmic infection.  The Federal Court of Appeal dismissed Alcon’s appeal and upheld the applications judge’s findings on obviousness: it would have been obvious to try a known compound (moxifloxacin) in a known use (treating and preventing ophthalmic infection) at a concentration known to be effective (0.1 to 1.0 wt%) for the treatment of eye infections.

The Federal Court of Appeal noted  that parties should not attempt to re-argue their first instance cases at the appellate level:

[26] At the hearing before this Court, the appellants referred to a flurry of evidence before the panel which allegedly pointed to the opposite conclusions from those reached by the Judge. Throughout their submissions, the appellants argued that several errors allegedly committed by the Judge constituted errors of law. In reality, the grounds raised by the appellants in this appeal, although dressed as errors of law, directly challenged the Judge’s factual findings. In so doing, the appellants actually attempted to re-argue their case on appeal, asking this Court to reweigh the evidence. This is not the role of a Court of Appeal.

Moxifloxacin’s  “three knowns” were collectively known in light of the state of the art as of the relevant date. In making this determination, the applications judge “carefully set out the prior art evidencing what a skilled person would have knowledge of, i.e. what would make moxifloxacin obvious to try given its activity against bacteria, the known concentration range for efficacy of ophthalmic formulations and the efficacy of similar quinolone compounds like ciprofloxacin.” The applications judge relied on evidence that there were other drugs from the same class (quinolones) that were being used to treat eye infections.

Alcon raised other arguments that the applications judge misapprehended or ignored evidence that the prior art taught away from moxifloxacin on issues relating to safety and efficacy. However, the Court rejected these arguments as the 211 Patent claimed only the treatment of ophthalmic infections, and made no claim to features such as safety or efficacy.

Lastly, Alcon argued the applications judge erred by not evaluating the Sanofi factors in the obvious-to-try analysis for the 211 Patent in the reasons below. The Federal Court of Appeal noted that multiple patents were considered in the reasons below, and the Sanofi factors were set out earlier in the decision in respect of another patent.

A copy of this decision can be found here.