Bayer’s Moxifloxacin PM(NOC) Application Dismissed Via Section 6(5)(b) Motion

Prothonotary Lafrenière of the Federal Court of Canada has grantedPharmaceutical Partners of Canada Inc’s (PPC) motion under Section 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations (Regulations)to dismiss Bayer’s application under the Regulations with respect to Canadian Patent No. 2,378,424 (424 Patent). PPC was seeking a notice of compliance to market a generic version of Bayer’s AVELOX® IV, a moxifloxacin hydrochloride intravenous (iv) product. The 424 Patent claims the combination of moxifloxacin with a sodium chloride solution within specified concentrations.

Section 6(5)(b) motions are designed to quickly dismiss applications by brand applicants that have no chance of succeeding at hearing. In this case, PPC argued that Bayer’s evidence, which was composed of two expert affidavits, could not establish infringement (either direct or induced) of PPC’s product. Bayer conceded that there was no evidence of direct infringement but argued that the content in PPC’s Product Monograph would induce health practitioners to infringe the 424 Patent.

While PPC’s Product Monograph states that PPC’s product is safe to use with sodium chloride, it also states that dilution of the product with another solution, including sodium chloride solutions, is not required. Thus, despite the opinion of Bayer’s experts who concluded that the Product Monograph would induce infringement, the Court held that, by itself, a statement that PPC’s product can be used with solutions containing sodium chloride is not sufficient to conclude that PPC induces healthcare practitioners to co-administer its product with sodium chloride. The Court went on to state that Bayer’s evidence did not contain any facts to support its allegation that PPC was inducing infringement. The Court clarified that the opinion of an expert does not amount to a fact.

Bayer has three patents listed against moxifloxacin hydrochloride iv. With the success of this motion, PPC must still address Canadian Patents numbered 1,340,114 and 2,192,418 in order to receive its notice of compliance.

For the entire decision see: http://tinyurl.com/kla6939