Novartis Pharmaceuticals Canada Inc. v. Mylan Pharmaceuticals ULC, 2016 FC 1091

In this motion, Novartis sought to amend a protective order that was issued on consent in the context of an application proceeding. The amendment would allow Novartis to use samples it obtained from Mylan and the expert affidavits setting out the results and analysis of tests performed on those samples for the purposes of litigation taking place in Portugal. The Portuguese proceedings are between Novartis and a company related to Mylan and involve the same rivastigmine transdermal patches. The evidence showed that samples of Mylan's patch were produced in the Portuguese proceeding, but that under the applicable procedural rules, testing was conducted by an independent laboratory, according to a protocol designed by a jointly selected expert. Novartis, dissatisfied with the protocol that was adopted, has tried several times to have the joint expert authorize tests similar to those Novartis conducted in the Canadian PM(NOC) proceedings. Novartis' request has been refused every time. Thus, Novartis seeks an amendment in order to introduce the testing evidence from the Canadian PM(NOC) proceedings directly in the Portuguese proceeding, should the Portuguese panel permit that evidence be adduced in that proceeding.

Given that the production of the samples in the Canadian proceeding was entirely voluntary, the Court found that the appropriate test to apply in this motion was the strict test of Smith, Kline and French Laboratories Ltd v Canada (Attorney General) (1989) 24 CPR (3d) 484. The Court noted that its determination might have been different if the information at issue had been contained in documents that could have been compelled, however, the Court did not need to make that determination in this motion.

While the protective order provided that information could be used in any related proceedings, the Court noted that it was clear that the Portuguese litigation was not a proceeding related to the PM(NOC) application since:

  • It is completely independent from the prohibition application;
  • It proceeds independently;
  • The determination of this application does not affect the Portuguese litigation and the determination of the Portuguese litigation does not affect this application;
  • The two proceedings have no consequences on each other nor do they give rise to rights that may be recognized, enforced or contested through the other proceeding.

The Court also noted that at the time the protective order was negotiated between the parties, Novartis was aware of the existence of the Portuguese proceedings. The Court found that the potential relevance of the samples in the Portuguese proceeding was conceivable, and therefore, there was no change in circumstances that could justify a variation of the protective order. The Court dismissed the motion. The Court would have come to the same conclusion even if the Smith, Kline and French test was not applicable or displaced in favour of the test in Juman v Doucette, 2008 SCC 8, which requires careful weighting of the public interest asserted by the person seeking relief against the public interest in maintaining the confidentiality of the information.