Case: Bayer Inc. and Bayer Pharma
Aktiengesellschaft v. Apotex Inc. et al.
Drug: drospirenone + ethinylestradiol
Nature of case: Prohibition proceeding under
Patented Medicines (Notice of Compliance) 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
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
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
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
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