Drug Testing In Canadian Patent Suit Not Permitted To Be Used In Foreign Litigation

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