Bristol-Myers Squibb Canada Co. et al v. Mylan Pharmaceuticals ULC et al,

Drug: efavirenz

This is an appeal of a decision of a Prothonotary, refusing to order Mylan to produce requested information about its manufacturing process and the crystal structure of efavirenz in its product. On appeal, the Applicants alleged that the Prothonotary imposed an unduly high and improper burden to justify production; that the Prothonotary erred in failing to follow a previous decision; and that the Prothonotary erred in considering the amount of documentary production already undertaken by Mylan. The Court dismissed the appeal.

The Court determined that that the standard of review was whether the Order was based upon a wrong principle or a misapprehension of the facts, given that the questions raised in the motion are not vital to the final issues. The Court found that the Prothonotary correctly identified the burden of proof as being on a balance of probabilities that the information requested was important, required and relevant. The Court further found that the Prothonotary did not misapprehend the expert evidence and that the Prothonotary properly distinguished the within case from that of the previous decision relied upon by the Applicants. Finally, the Court held that the reference by the Prothonotary to the amount of documentary production by Mylan was an observation made by the Prothonotary and not the basis for the decision.