CaseBayer Inc. and Bayer Pharma Aktiengesellschaft v. Apotex Inc. et al. (“Bayer”)

Drug: drospirenone + ethinylestradiol (YAZ®)

Nature of case: Prohibition proceeding under Patented Medicines (Notice of Compliance) Regulations (“Regulations”)

Date of decision: May 1, 2014


On May 1, 2014, the Federal Court dismissed Bayer’s application for an Order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. (“Apotex”) for its generic YAZ® birth control product until the expiry of Canadian Patent No. 2,179,728 (“Apotex Proceeding”). This decision reaffirms the Court’s approach to avoid repeat s. 6 litigation on the same patent by brand manufacturers against multiple generics under the Regulations.  

Bayer had previously filed suit against Cobalt Pharmaceuticals (“Cobalt”) in respect of the same product and patent (“Cobalt Proceeding”).  The Court (per Hughes J.) dismissed Bayer’s application for a prohibition order in the Cobalt Proceeding on October 22, 2013.  Hughes J. held that the relevant patent claims were not infringed and not patentable for being directed to a method of medical treatment.  Bayer filed an appeal.

Bayer commenced the Apotex Proceeding while the Cobalt Proceeding was still underway. After dismissing Bayer’s application in the Cobalt Proceeding, the same presiding judge (Hughes J.) advised the parties at a pre-trial conference in the Apotex Proceeding that he had reviewed the record and was unlikely to come to a different conclusion than he had reached in the prior Cobalt case.  He invited the parties to consider their position prior to the hearing of the application.  The parties subsequently advised the Court that they would not be making any submissions, “it being understood that the application will be dismissed by the court on the basis of Reasons for Judgment in [the Cobalt Proceeding]”.

In issuing his decision, Mr. Justice Hughes noted that: “The Court has been critical of situations where multiple proceedings have been taken in respect of the same patent under the NOC Regulations where a previous determination has been made as to the justification of allegations as to infringement and/or validity”.  In addition, the Court stated that: “[T]here is little need to relitigate a patent under the NOC Regulations except where significantly different issues are raised or significantly different new evidence is placed on the record”.

The Court held that Bayer should bear cost consequences for continuing the Apotex Proceeding after the release of the decision in the Cobalt Proceeding.  He awarded “regular” costs and disbursements to Apotex at the middle of Column IV up to October 25, 2013 (the date Apotex requested that Bayer terminate the Apotex Proceeding), recognizing that Bayer commenced the Apotex Proceeding before the Cobalt Proceeding was decided.  Hughes J. then awarded “elevated” costs and at the middle of Column IV plus 25% thereafter on fees only.  No 25% premium was ordered on disbursements.  

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