The Federal Court has reaffirmed and clarified how a pharmaceutical brand company should respond to a generic company’s motion to strike an application for abuse of process under s. 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations.
In Valeant Canada LP / Valeant Canada S.E.C. v Apotex Inc. (2016 CarswellNat 6573, 2016 FC 1359), the court reaffirmed that a generic company – in this case, Apotex Inc. (“Apotex”) – may bring a 6(5)(b) motion at almost any time, and that, in order to succeed, a brand company – Valeant Canada LP / Valeant Canada S.E.C. (“Valeant”), in this case – must respond in some manner to show the application is not bereft of any chance of success. In other words, a brand company that deliberately chooses not to file evidence either in support of its application or in response to a 6(5)(b) motion must live with the consequences of, in many cases, having its application struck.
The motion related to Valeant’s patent for a pharmaceutical composition (the “496 Patent”). Apotex delivered a Notice of Allegation to Valeant, alleging that its 1000 mg metformin tablets (the “Apotex Tablets”) would not infringe Valeant’s 496 Patent.
Valeant thereafter filed a Notice of Application, stating that Apotex’s product infringed the 496 Patent, and that Apotex’s allegations of non-infringement were not justified. Apotex brought a 6(5)(b) motion, arguing that Valeant’s application was an abuse of process and was bereft of any chance of success. Apotex filed supporting affidavits demonstrating that the Apotex Tablets did not contain the essential claims of the 496 Patent. In response, Valeant claimed that it had the right for its application to be heard and had no obligation to respond to Apotex’s case on the motion. Valeant neither sought to schedule an exchange of evidence nor filed evidence for the motion. It also did not cross-examine any of Apotex’s witnesses.
The court granted the order, striking Valeant’s application in its entirety. According to the court, Valeant’s argument that Apotex would infringe the 496 Patent was bereft of any chance of success. The court reasoned that a generic company can bring a 6(5)(b) motion at any time, even before the steps for the main application are scheduled, and that a brand company should respond with evidence that it has some chance of success (through a clerk, for example) or include more detailed grounds than boilerplate language in the Notice of Application in order to secure its qualified right to a hearing. This lower threshold than under a summary judgment motion, which imposes a beyond reasonable doubt standard, means that a brand company may succeed without putting its best foot forward, giving its whole case away or exposing experts to two rounds of cross-examination. A 6(5)(b) motion is not, consequently, a means to give a generic “two kicks at the can”. Rather, a 6(5)(b) motion is a means to strike cases that have no arguable case on the merits of the application.
We will continue to monitor the development of this proceeding should it be appealed and update our blog accordingly.