Eli Lilly Canada Inc. v. Teva Canada Limited, 2017 FC 88 Drug: olanzapine
In this case, Teva is seeking compensation pursuant to s. 8 of the NOC Regulations for having been prevented from coming to market with its generic olanzapine product. The Court was not asked to make any calculations, but rather, to set the parameters necessary for those calculations to be made. The Court confirmed that Teva bears the legal burden of establishing all of the elements of its claim for damages. Teva must show that its alleged losses were a product of the operation of the NOC Regulations and there must be a causal connection between the damages sought and the NOC Proceedings initiated by Lilly.
The Court first ruled on preliminary evidentiary issues relating to whether fact witnesses could give an opinion as to what they thought would have happened in the ‘but-for' world and to hearsay issues. The Court held that opinions of fact witnesses are not admissible. It was suggested that counsel should explore what was done in the real world, and then ask the witness whether they knew of any reason why they would have acted differently in the ‘but-for' world. "The fact that the burden falls on Teva to prove that it could have and would have launched … does not mean that it is entitled to ask a fact witness to answer that question." Furthermore, the Court followed the recent FCA decision, holding that "hearsay evidence cannot be admitted unless it falls within a recognized exception… or it meets the criteria of necessity and reliability."
The Court then considered the evidence and determined the period of liability, the size of the olanzapine market, the generic share of the olanzapine market, Teva's share of the generic olanzapine market and the real amount of Teva's losses (pipe fill, trade spend, and other costs).