In a rare case where drug samples were given under consent in an NOC proceeding Novartis sought, but was denied, to use these samples in a related litigation in Portugal (2016 FC 1091).
Samples are rarely provided in NOC proceedings. Nevertheless, production may be compelled if samples were provided to the Minister as part of the drug submission (Patented Medicines (Notice of Compliance) Regulations (SOR/93-133), s. 6(7)). This was not the situation in this case where Mylan consented to producing the samples, subject to the existing protective order.The test to be met to be relieved of the implied undertaking rule is the strict test of Smith, Kline and French Laboratories Ltd v Canada (Attorney General) (1989), (24 CPR (3d) 484, aff’d 74 CPR (3d) 165). This test requires that Novartis establish a change in circumstances or a compelling reason not directly considered when the order was given. Novartis failed to meet this test as it was unable to establish a change in circumstance since the production order was signed. At the time the protective order was negotiated, Novartis was aware of the Portuguese litigation and potential relevance of the samples in the Canadian NOC proceeding. The protective order stipulated that the samples and related testing information could not be used other than the application, appeals therefrom or proceedings related thereto. Prothonotary Tabib found it clear that the Portuguese litigation, while the same parties and the same drug, was not a proceeding related to the Canadian application.
Drugs litigated in Canada are often part of a global drug portfolio with corresponding litigation occurring around the world. There is an ongoing concern that information produced in one jurisdiction will harm a related case in other jurisdictions. This decision eases the concerns of global litigation teams that drug samples produced and test in Canada will not interfere with proceedings in other litigation.
The full decision is available here.