As a part of a Patented Medicines (Notice of Compliance) Regulations proceeding, the applicants had filed a motion for the production of certain further documents by the respondent, namely documents that would go to what crystalline forms were used in the making of the generic product, including under s. 6(7) of the Regulations. The motion was denied. On appeal, the applicants argued: (i) that the Prothonotary had imposed an unduly high and improper burden of proof upon them, and (ii) that the Prothonotary further erred in misapprehending the evidence of the applicant’s expert.
However, the Federal Court rejected the appeal. The Court held that “discretionary orders of Prothonotaries ought not to be disturbed on appeal unless the questions raised in the motion are vital to the final issue of the case, or the orders are clearly wrong in the sense that the exercise of discretion was based upon a wrong principle or a misapprehension of the facts.”
The Court stated that the production of the documents was not vital to the final issue of the case. Furthermore, the Court held that “a condition precedent to the exercise of discretion pursuant to subsection 6(7) of the Regulations is that the information sought must be relevant. In exercising the discretion conferred by subsection 6(7), it must also be determined on a balance of probabilities that the requested information is “important” or “required”.”
The Court held that the Prothonotary had also not erred in relation to the burden of proof, and had correctly identified the burden of proof as being that of the balance of probabilities. In addition, the Court held that the Prothonotary had not misapprehended the evidence of the applicant’s expert.
The full text of the decision can be accessed at: http://decisions.fct-cf.gc.ca/en/2011/2011fc919/2011fc919.html