On July 5, 2016, the Federal Court granted an order prohibiting the Minister of Health from issuing a notice of compliance (NOC) to Fresenius for its moxifloxacin hydrochloride product (Bayer's AVELOX I.V) until expiry of Patent No. 2,192,418: Bayer Inc v Fresenius Kabi Canada Ltd, 2016 FC 581. The patent claims the monohydrate form of moxifloxacin hydrochloride having specified NMR and X-ray diffractogram characteristics. Fresenius alleged non-infringement in its notice of allegation (NOA), alleging its product is in solution form, which cannot contain the crystalline form required by Claim 1. Moreover, Fresenius alleged it would not use the monohydrate moxifloxacin specified by the patent in its manufacturing of Fresenius-moxifloxacin or in the manufacture of the active pharmaceutical ingredient (API) used in the manufacture of Fresenius-moxifloxacin.
Justice Brown held that Fresenius’ NOA failed to include a detailed statement of the legal and factual basis for the allegation of non-infringement, as required by the PMNOC Regulations. In particular, Fresenius’ NOA did not disclose that its product was to be manufactured offshore and imported to Canada, nor did it raise the legal principles relevant to infringement by importation. The NOA merely alluded to importation with “code words”; the relevant facts were disclosed only once the proceedings were commenced and a confidentiality agreement had been reached. The Court found that this was not “sufficient to make the patentee fully aware of the grounds on which the generic claimed that the relevant patent would not be infringed”. Though previous decisions have allowed (i) some later elaboration on allegations contained in the NOA, and (ii) certain confidential information (i.e. formulation details) to be produced subsequent to the delivery of an NOA, the Court rejected the argument that this matter fell within the scope of those decisions. The Court therefore granted an order of prohibition.
Justice Brown considered the allegation of non-infringement on the merits in the alternative and held that had he found the NOA to be sufficient, he would have concluded that the allegation of non-infringement was justified. The Court held that Bayer’s experts’ testing evidence on samples made by reproducing the API manufacturing process did not establish that the monohydrate appears in the manufacturing process. However, even if the Court had found presence of the monohydrate, the Court held that Bayer had not satisfied the Court that the Saccharin factors (see Pfizer Canada Inc v Canada (Health), 2007 FC 898) relevant to infringement by importation had been met.
Fresenius sought reconsideration of the decision on the basis that the prohibition order granted was inconsistent with the reasons. In particular, it argued that the Court concluded that the NOA was insufficient only in relation to the allegation of infringement by importation, but that the essence of its allegation – simple infringement – was justified. The Court found no inconsistency between the reasons and the prohibition order, reiterated that the NOA’s failure to include a detailed statement was a fatal defect, and thus dismissed the motion, 2016 FC 970. Fresenius’ appeal is pending (Court of Appeal File No. A-236-16).