Drug: omeprazole

Pharmascience Inc. v. Canada (Minister of Health), 2014 FCA 133

This was an apeal of an Order granting an Order of prohibition. The trial decision is found here.

The issue to be determined by the Court of Appeal related to whether the allegation of lack of utility was justified. The Court of Appeal began by considering the burdens on the respective parties. The Court of Appeal held “the onus on Pharmascience to put its allegations “into play” cannot be satisfied by the mere fact of detailing its allegation in its notice of allegation.” The Court of Appeal concluded that the application judge erred in law by failing to apply the correct legal standard in this regard. The Court of Appeal also found that the application judge erred in law in considering the legal standard that AstraZeneca was required to meet to prove that its invention was useful. This legal standard is proof on the balance of probabilities.

The Court of Appeal held that the patent did not provide information about how many samples were tested and what the individual results were in the experiments set out in the patent, and as a result,  “it is impossible to say that the experiments actually prove that which the inventors claim they prove.” The Court of Appeal noted that the patent did not provide information to allow a third party to confirm the validity of the experimental results, and AstraZeneca’s expert did not provide this information, and therefore AstraZeneca did not put sufficient evidence before the Court to establish allegation of lack of utility was not justified. The appeal was granted.