Sandoz's Comparison to Bayer's Ciprofloxacin Minibags does not Trigger Requirement to Address Listed Patent

The Federal Court of Appeal, in Bayer Healthcare AG v. Sandoz Canada Incorporated [2008 FCA 25], dismissed Bayer's appeal regarding the issuing of a notice of compliance (NOC) to Sandoz for ciprofloxacin. Bayer's ciprofloxacin product is a ready-to-use mini bag for use as an intravenous drip. It contains a 2mg/ml concentration of ciprofloxacin. Sandoz's ciprofloxacin product is contained in a glass vial, which needs to be diluted before use. Its concentration is 10mg/ml. Bayer argued that Sandoz should be obliged to address Canadian Patent No. 1, 282, 006 (the "˜006 patent) because it is listed against Bayer's ciprofloxacin minibags. Sandoz's ANDS included a reference to Bayer's minibag to support its position that an impurity contained in its product was tolerable because that the same impurity existed in Bayer's minibags. The Court, however, concluded that that reference was only to establish a safe level of the impurity and was not a comparison or reference for the purposes of demonstrating bioequivalence under s. 5(1) of the Patented Medicines (NOC) Regulations, prior to October 2006. Bayer further argued that Sandoz should be required to address the "˜006 patent under s. 5(1.1) of the Regulations following the post October 2006 amendments. The Court disagreed and held that s. 5(1.1) did not apply either because Bayer's patented minibags contain a different strength of ciprofloxacin. Summary by: Abigail Browne