Pharma in brief - Federal Court of Appeal refuses to reweigh evidence from a prohibition application under the PM(NOC) Regulations

Cases: Actavis Pharma Company v. Alcon Canada Inc., 2015 FCA 192, Alcon Canada Inc. v. Actavis Pharma Company, 2015 FCA 191

Drug: VIGAMOX® (moxifloxacin hydrochloride)

Nature of cases: Appeal from section 6 prohibition application under the PM(NOC) Regulations

Successful parties: Actavis and Alcon appeals both dismissed

Date of decisions: September 16, 2015

Summary

In two decisions relating to VIGAMOX® (moxifloxacin hydrochloride), the Federal Court of Appeal held that it is not the role of an appellate court to re-weigh evidence that was properly admitted in a prohibition application under the PM(NOC) Regulations. The FCA will only interfere with evidentiary rulings if there has been a clear and fundamental error going to “the very core of the outcome of the case”.

Alcon Canada Inc., Alcon Pharmaceuticals Ltd. and Bayer Intellectual Property GmbH GP (Alcon) brought an application pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations, SOR 93/133 for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Actavis Pharma Company (Actavis) – formally Cobalt Pharmaceuticals Company – in respect of the proposed moxifloxacin hydrochloride solution until the expiry of Canadian Patent Nos. 1,340,114 (‘114 Patent), 2,342,211 (‘211 Patent) and 2,192,418 (‘418 Patent). Phelan J. granted Alcon’s application in respect of the ‘114 Patent but dismissed the application in respect of the ‘211 Patent and ‘418 Patent. We previously reported the Federal Court’s decision here.

Actavis commenced an appeal of the decision in respect of the ‘114 Patent. Alcon commenced an appeal in respect of the ‘211 Patent. No appeal was brought in respect of the ‘418 Patent.

Actavis appeal (2015 FCA 192) – ‘114 Patent

The ‘114 Patent pertains to a class of quinolones including moxifloxacin hydrochloride. Claims 8 and 13 pertain specifically to moxifloxacin, its stereoisomers and mixtures thereof.

Actavis challenged the Federal Court’s findings concerning Actavis’ allegations of promise of the patent, utility and obviousness.

Promise of the patent

Actavis argued that Phelan J. erred in construing the promise of the ‘114 Patent, in part by preferring Alcon’s expert evidence.  Actavis claimed Phelan J. incorrectly preferred Alcon’s expert because he had more experience with patents compared to their own expert. The FCA dismissed this argument, stating that “a judge is entitled to prefer one expert’s evidence over another on a number of grounds” and that a “[j]udge’s preference for one expert over another accordingly does not amount to a reviewable error.”  

Utility/sound prediction

Actavis argued that Phelan J. committed a palpable and overriding error in holding that utility had been soundly predicted. Again, Actavis claimed that Phelan J. made this error by failing to give more weight to their own expert evidence. The FCA rejected this argument, stating that Actavis “ha[d] essentially attempted to re-argue its case by pleading evidence that it would have liked the Judge to prefer” and that this was asking the FCA to “re-weigh evidence”, which is not the role of an appellate court.

Obviousness

The FCA noted that obviousness is a conclusion of mixed fact and law, but that, oddly, Actavis did not disagree with Phelan J.’s reading of the law or his factual finding of the inventive concept.  Instead, Actavis argued that Phelan J. made inconsistent holdings on the inventive concept of the claims. The FCA dismissed these arguments, stating that Phelan J. simply preferred Alcon’s expert evidence, which was entirely in his prerogative.   The appeal was dismissed.

Alcon appeal (2014 FC 462) – ‘211 patent

The ‘211 Patent claims the use of moxifloxacin and compositions thereof in topically treating or preventing opthalmic infections.

Alcon challenged the Federal Court’s findings in respect of Actavis’ allegation of obviousness.

Obviousness

Alcon argued that Phelan J. misapplied the test for obviousness by relying on a flawed evidentiary basis. The FCA held that Phelan J. did not commit a palpable and overriding error by relying on expert opinion without adopting every single aspect of it. Rather, the FCA found that Phelan J. carefully considered the expert testimony, placed himself in the position of a skilled person in the art, and made his own factual conclusions from the evidence on the prior art and the inventive step.

Alcon also argued that Phelan J. erred in failing to evaluate the Sanofi factors in his obvious to try analysis. The FCA rejected this argument, stating that Phelan J. explicitly set out the Sanofi factors and made reference to the obvious to try test on a number of occasions.

Finally, as in the Actavis appeal, the FCA stated that it is improper for appellants to re-argue their case on appeal by pointing to evidence that reaches opposite conclusions from those reached by the trial judge. The FCA reiterated that it is not the role of an appellate court to re-weigh evidence. The appeal was dismissed.

Link to decisions:

Actavis Pharma Company v. Alcon Canada Inc., 2015 FCA 192

Alcon Canada Inc. v. Actavis Pharma Company., 2015 FCA 191

Alcon Canada Inc. v. Cobalt Pharmaceuticals Company, 2014 FC 462