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Federal Court of Appeal Upholds Fampridine Trial Decision

Biogen appealed a decision of the Federal Court dismissing its patent infringement actions on the basis that all of the asserted claims of Canadian patent number 2,562,277 were invalid for obviousness (discussed here).  

The 277 Patent relates to use of a composition of sustained release fampridine to treat multiple sclerosis. Biogen sells its fampridine product under the brand name FAMPYRAⓇ in Canada. Taro and Pharmascience sought to access to the Canadian market with their own fampridine products and sent notices of allegation to Biogen, prompting the underlying patent infringement actions. 

Expert evidence admissible despite duplication

As a preliminary matter, Biogen argued that the trial judge erred in not declaring the expert report of Dr. Ebers inadmissible because the report duplicated paragraphs taken from Taro’s NOA, a document Dr. Ebers did not review.

Gauthier J.A. rejected this argument, holding that there is a minimum due diligence obligation on the party who wishes to bring an admissibility objection to ensure it is squarely made and properly determined, especially where that party intends to have the objection reviewed on appeal. The Federal Court of Appeal observed that the duplication would have been evident as soon as Biogen received the report. However, by the time Biogen raised the issue, Dr. Ebers had been admitted as an expert on consent and his report had been accepted into the evidentiary record. By acknowledging that the duplication raised an issue as to impartiality and choosing not to strike out the report, the trial judge exercised its gatekeeping role as best it could in the circumstances. Citing Cojocaru, Gauthier J.A. noted that this was not an egregious case of duplication and that courts must carefully consider the exact nature of the information copied before concluding the expert cannot perform their duty.

The claims did not include a subjective element

The trial judge construed the claim terms “use for improving walking” and “use for increasing walking speed” as referring only to quantitative, statistically significant changes given the variability of symptoms and the prevalence of the placebo effect in MS patients. On appeal, Biogen argued that these terms include both quantitative and qualitative/subjective elements.   

The Court of Appeal rejected Biogen’s proposed interpretation of the claims because the 277 Patent did not claim that any responsive MS patient will subjectively perceive sufficient improvement to justify taking the medicament. The Court of Appeal concluded that Biogen’s proposed interpretation of clinically meaningful “improvement” and “increase” would completely change the nature of the monopoly claimed and would not reflect the inventors’ objective intention.

The Federal Court did not err in finding obviousness

Biogen argued that the trial judge made an extricable error of law by failing to don the mantle of the person skilled in the art in assessing obviousness and therefore did not account for general skepticism regarding alternative MS therapies in assessing whether the 277 Patent was obvious.

The trial judge found that the PSA would be skeptical of new alternative MS treatments that were not supported by double blind placebo-controlled trials, but nonetheless did not accept that this meant the PSA would completely disregard the prior art unless absolutely persuaded of its validity. Gauthier J.A. held that the trial judge did not make any reviewable error in its assessment of the evidence or in its finding of obviousness. Gauthier J.A. noted that while most scientists are cautious, this does not mean the standard for obviousness is certainty. This is especially true in the pharmaceutical field, where application of the “obvious to try” test is sanctioned by the Supreme Court of Canada. On this basis, it was reasonable for the trial judge to accept the information expressed in the most recent publications available in respect of sustained release fampridine as of April 2004. This evidence supported the trial judge’s finding of obviousness.  

Gauthier J.A. dismissed Biogen’s appeal and held that the trial judge made no reviewable errors justifying appellate intervention. A copy of the decision is available here.

Taro was successfully represented by Scott Beeser and Jonathan Stainsby of Aitken Klee.

Pharmascience was successfully represented by Marcus Klee and Aleem Abdulla of Aitken Klee.