NOC Decisions

Order of Prohibition Granted in respect of One of Two Asserted Patents
Bayer Inc. v. Cobalt Pharmaceuticals Company, 2013 FC 1061
Drug: drospirenone and ethinylestradiol

Two patents were under consideration by the Court in this application brought pursuant to the Patented Medicines (Notice of Compliance) Regulations. With respect to the first patent, the Court noted that the issue to be considered was whether the claims were directed to a product in which one of the compounds was micronized, or whether there was no restriction on the form if it achieved certain rapid dissolution characteristics. The Court agreed with Bayer that the claims are not limited to a micronized form and therefore Cobalt’s allegation as to non-infringement was not justified. The Court also found that the allegation of obviousness was not justified. The Court noted that the Court of Appeal has held that “a distinction must be made between the potential use to which an invention may be put, and an explicit promise to achieve a specific result identified in the patent.” The Court accordingly found that the allegation of lack of sound prediction and inutility, as well as overbreadth, insufficiency and ambiguity were not justified. The Order of prohibition was granted in respect of this patent.

With respect to the second patent, the Court was required to construe the claims and found that there was no certainty as to the dosage covered by the claims and it would most likely be 2 mg. As Cobalt’s product will contain 3 mg, the allegation of non-infringement was justified. The Court found the allegation of obviousness was not justified. In terms of double patenting, the Court wrote “[g]iven the expiry dates of each of the ‘426 patent (August 31, 2020) and the ‘728 patent (December 22, 2019), it is obvious that the ‘426 patent may be challenged for Double Patenting in light of the ‘728 patent, but not the other way around.”

The Court ultimately found that the allegations of double patenting were not justified, nor those of inutility or lack of sound prediction. However, the Court found that the claims do not claim a vendible product but instead provide for a choice to be made from a variety of compounds and dosage ranges, and therefore the allegation of unpatentable subject matter for claiming a method of medical treatment are justified in respect of all but one claim, which covered a single dosage of each of two compounds. The Court dismissed this application for prohibition in respect of this patent.


Motion for Default Judgment Denied without Affidavit Evidence
Monsanto Canada Inc. v. Verdegem, 2013 FC 50

The Plaintiffs brought a motion for default judgment after no Statement of Defence was filed and no response to the Request to Admit was provided. The Plaintiffs did not provide any affidavit evidence relating to the substance of the claim for patent infringement, but instead argued that in light of the fact that no answer was provided to the Request to Admit, the Defendants were deemed to have admitted the facts set out therein.

The Court dismissed the motion, without prejudice to a further motion, on the basis that affidavit evidence is required on a motion for default judgment, and a Request to Admit cannot be substituted for this evidence. The Court also refused to exercise its discretion to accept the Request to Admit instead of affidavit evidence.

Other Decisions of Interest

Teva’s Allegation for Section 8 Damages not Struck on Appeal
Teva Canada Limited v. Pfizer Canada Inc., 2013 FC 1066
Drug: amlodipine

Pfizer appealed a decision refusing to strike Teva’s Statement of Claim to the Federal Court, but the appeal was dismissed because a de novo review was not warranted. The issue was neither vital to the final issue of the case, and the order was not clearly wrong.

Teva seeks damages against Pfizer for keeping RATIO-AMLODIPINE off the market pursuant to section 8 of the PM(NOC) Regulations. The court found that the original decision applied the correct “but for” approach in asking whether Teva could have received its Notice of Compliance and begin selling, but for Pfizer’s application.

Other Industry News

Health Canada has released of the Therapeutic Products Directorate Statistical Report 2012/2013 for the Patented Medicines (Notice of Compliance) Regulations and Data Protection.


Chantal Saunders

Beverley Moore

Adrian J. Howard


Intellectual Property
Intellectual Property Litigation