ottawa sign with aitken lee llc team

Decision To Not File Evidence On Motion To Dismiss Sinks Prohibition Application

 On December 8, 2016 Prothonotary Aalto dismissed Valeant’s prohibition application against Apotex regarding metformin as an abuse of process. Apotex’s Notice of Allegation alleged, among other things, non-infringement and Apotex brought a motion under paragraph 6(5)(b) of the PM(NOC) Regulations to have the application dismissed for being an abuse of process.

In support of its motion, Apotex filed affidavit evidence of an expert who opined that that Apotex’ metformin tablets would not infringe Valeant’s 496 Patent. Prothonotary Aalto noted that Valeant chose not to file any evidence on the motion, did not seek an opportunity to file its evidence on the main application nor did it cross-examine Apotex’s expert:

[10] In a calculated strategic decision, Valeant chose not to file any evidence on this motion. Rather, it chose to engage with Apotex on this motion and did not seek an opportunity to file its evidence on the main application. It also did not cross-examine any of the Apotex witnesses. In sum, there is no evidence on this motion from Valeant save and except for the allegations contained in its notice of application.

Prothonotary Aalto also noted that Valeant’s notice of application did not provide anything other than bald allegations regarding infringement:

[8] The notice of application is of no assistance in understanding the position of Valeant or the grounds upon which it claims a prohibition order. The notice of application simply states “the Apotex Product infringes the 496 Patent” and “Apotex’s allegations of non-infringement are not justified”. No details other than these bald allegations are provided.

Valeant argued that they had no burden or onus in a 6(5)(b) motion to prove anything and, as the applicant, they have a right to a full hearing on the merits and therefore Apotex’ motion must be dismissed.Prothonotary Aalto disagreed, holding that the application is an abuse of process because Valeant deliberately chose not to adduce any evidence justifying why the application should be allowed to proceed. In doing so, Prothonotary Aalto dismissed various arguments advanced by Valeant, holding:

  • There is nothing in section 6(5) that prevents a generic manufacturer from bringing a motion prior to the filing of the applicant’s evidence and there is no onus on a generic manufacturer to seek a schedule for the delivery of evidence as the applicant has the onus of moving the proceeding forward;
  • A generic manufacturer’s burden on a 6(5)(b) motion is to demonstrate that the application is bereft of any chance of success; and
  • An applicant is only entitled to a hearing provided there is evidence showing the application is not bereft of any chance of success. An applicant cannot receive the benefit of a 24-month stay without some reasonable basis for the application being brought.

Finally, in response to Valeant’s argument that section 6(5) motions give generic manufacturers two opportunities to make their case and challenge the Applicant’s evidence, Prothonotary Aalto held that an applicant is not required to put all its evidence forward on a 6(5) motion; it must simply show there is a reasonable basis for bringing the application.

A copy of Prothonotary Aalto’s Order and Reasons granting Apotex’ motion and dismissing the application can be found here.