Apotex's motion to dismiss Valeant's NOC Proceeding pursuant to s. 6(5)(b) of the NOC Regulations was granted with costs.
Apotex's NOA alleged non-infringement. It then advised Valeant it would be bringing the within motion. Valeant did not set a schedule in the main application, however, it engaged on the motion. Apotex filed the evidence of a law clerk, of an Apotex employee describing the contents of Apotex's ANDS for its tablets, and of an expert witness who testified as to non-infringement. Valeant filed no evidence on the motion, and did not cross-examine Apotex's witnesses. It also did not file evidence on the merits before the motion was heard.
The Court held that Apotex has provided to Valeant, each and every document requested. Furthermore, the Court held that the evidence demonstrated that Apotex's tablets do not contain the essential elements of the patent at issue. The Court also held that Valeant's allegation of non-infringement was simply a bald allegation.
The Court held that Valeant made a calculated, strategic decision not to file evidence, and must live with the consequences. In addition, as the bald statement in the application does not set out any grounds to support the infringement allegation, it is on its face, bereft of any chance of success, and should be struck. The Court held that Apotex's burden on the motion is not as high as Valeant argued, and if the application contained any information from which it could be reasonably inferred that there was some substance to the infringement allegation, the application would not be bereft of any chance of success. Valeant's right to a hearing on the merits is a qualified right. There needs to be merit to the application. Thus, the application was struck.
Health Canada has revised Part I: Health Professional Information, and Part II: Scientific Information — Guidance Document: Product Monograph and the five associated templates for prescription products.