Applying for an NOC Does Not Sustain an Action

Purdue Pharma v Collegium Pharmaceutical, Inc 2018 FC 199 O'Reilly J
            Oxycodone

Purdue Pharma began an infringement action against Collegium for infringement of Purdue’s patent related to oxycodone, on the basis that Collegium had taken various steps to obtain marketing approval in Canada in respect of its oxycodone product. The steps alleged included importing the drug for purposes of its NDS, filing an NDS, obtaining approval in the US, publicly expressing its intention to market the drug in Canada, and invoking the NOC Regulations by serving Purdue with an NOA [21].

Reversing Aalto J, O'Reilly J granted Collegium’s motion to strike. He held that these facts did not allege anything going beyond the regulatory use exemption in s 55.2. There is no requirement that the party seeking to strike on that basis tender evidence that the activity in question did not go beyond attempting to meet regulartory requirement: “Rather, a statement of claim will be deficient on its face if it merely alleges activity that falls within the statutory exemption in s 55.2" [20].

Nor will these facts support a quia timet action. The prospect of Collegium launching at risk after succeeding in the NOC proceeding is not in itself sufficient to satisfy the requirement of imminence, given that it might never actually obtain the NOC prior to expiry of the patent [26]-[28].

More generally, this decision implies that allegations which amount to saying that the defendant was attempting to meet Canadian regulatory requirements will not survive a motion to strike [28]. Note that Purdue has also instituted NOC proceedings, which are not affected [1]. Of course, this will all be moot with the new NOC Regs.