Pharma In Brief - Federal Court Of Appeal Overturns Federal Court Decision And Dismisses Application For Prohibition Order

Case: Pharmascience Inc. v AstraZeneca Canada Inc. et al 2014 FCA 133 Nature of case: Appeal of a s.6 prohibition order pursuant to the PM(NOC) Regulations Date of decision: May 22, 2014 (public reasons available as of June 10, 2014)

Summary

Pharmascience Inc. (Pharmascience) appealed from the decision of Justice O'Keefe of the Federal Court (reported as AstraZeneca Canada Inc. v. Pharmascience Inc., 2012 FC 1189) prohibiting the Minister of Health from issuing a Notice of Compliance to Pharmascience for its version of the drug omeprazole formulated using low viscosity hydroxypropylmethylcellulose (HPMC).

The appeal was allowed and the application for a prohibition order was dismissed. This decision is notable in that it specifies that evidence going beyond the mere fact of detailing an allegation of invalidity in a notice of allegation has to be adduced by a respondent to properly put this allegation "into play". The decision further defines that the legal standard that has to be met by an applicant in response to an allegation of lack of utility is "proof on the balance of probabilities" that the invention is useful.

By way of background, AstraZeneca Canada Inc. (AstraZeneca) brought an application for prohibition in response to Pharmascience's notice of allegation which claimed that Canadian Patent No. 2,290,531 ('531 Patent) was invalid on a number of grounds including lack of utility and obviousness. The Federal Court of Appeal held that the application judge erred in law with respect to both the legal standard to be met by Pharmascience in order to "put its allegations into play", and the legal standard AstraZeneca was required to meet to prove that its invention was useful. Upon review of the evidence, the Court of Appeal concluded that the evidence adduced by Pharmascience was sufficient to put its allegation of lack of utility into play and that in response, AstraZeneca had not satisfied its onus of showing on a balance of probabilities that the allegation of invalidity of the '531 Patent was not justified.

Analysis

Trial decision

At trial, Pharmascience submitted that the '531 Patent did not indicate that any tests were performed to demonstrate that low viscosity HPMC actually possessed the claimed utility, and no substantive data was provided to demonstrate the promised utility. In this regard, the application judge found that since the allegation of lack of utility was raised in its Notice of Allegation, Pharmascience has met...