Prohibition Order Upheld on Appeal – Allegation as to Inutility Not Justified
Drug: ARIMIDEX® anastrozole
The Court of Appeal (FCA) upheld the Prohibition Order granted by the Federal Court. A copy of the Federal Court decision can be found here. Our summary of the decision can be found here. The FCA's decision dealt mainly with construction of the promise of the patent and the allegation of inutility.
At issue in construction was a sentence that read: "It is a particular object of the present invention to provide aromatase inhibitory compounds with fewer undesirable side effects than [AG]." The FCA upheld the Trial Judge's finding that this was not a promise of the patent but rather was a "forward-looking aim of the invention". Since the FCA upheld the Trial Judge's construction of the patent, it dismissed the appeal as the allegation of a lack of utility was not justified.
Amendments to Pleadings Allowed – Alleging that there Should be No Damages as an Alternative, Non-Infringing Process Existed
The Defendants appealed an order of the Court denying leave to amend their Statements of Defence. The trial as to infringement and validity has concluded, and the trial to determine damages is scheduled for April 2013. The amendments concerned the issues for the damages trial. The appeal was granted.
The proposed amendments allege that as a non-infringing process was available, no damages were suffered by the Plaintiffs. The Court held that there was little Canadian case law specifically rejecting this sort of pleading. The Court held that the Defendants were advancing an arguable and important point of law, and thus, its merits should be determined by the trial judge, despite formidable obstacles to success.
Other Cases of Interest
Official Mark Declared Void as Not Belonging to a "Public Authority"
The Federal Court set aside the decision of the Registrar of Trade-marks (the Registrar) and directed the Registrar to allow Maple Leaf's trade-mark application. The Registrar had refused the application due to the finding that it so nearly resembled an official mark. On appeal, the Applicant challenged whether the owner of the alleged official mark was a "pubic authority". The Applicant argued that if an official mark is advertised in favour of an applicant who is not a public authority then the Federal Court can declare that mark invalid and ineffective at law.
The Court held that a public authority does not broadly refer to a public authority controlled by any country worldwide but rather is limited to public authorities controlled by a Canadian government. There was no evidence that the respondent is subject to control by the Canadian government. Thus, the Court held that the Registrar erred in granting public notice of the adoption and use of the official mark by the Respondent. As a result, the disputed official mark was declared invalid and void ab initio and the Registrar was directed to allow the Applicant's trade-mark application.
Summary Judgment Granted in Copyright Case
The Court granted summary judgment in two parallel copyright actions. The Court held that whether there was a genuine issue turned on whether the plaintiff had standing to sue for infringement under the Copyright Act. In order to have standing to bring a claim for copyright infringement, the plaintiff needed to have an exclusive licence. The Court held that the agreement between the parties did not qualify as an exclusive licence, thus the plaintiff did not have the grant of interest necessary to bring an action for copyright infringement. Thus, there was no genuine issue for trial and the motions for summary judgment were granted.
Summary Judgment Granted in Trade-mark Case
The Court considered the uncontested evidence of the Plaintiffs and found seven separate acts of trade-mark infringement. The Court then applied the minimum compensatory damages award from the case law and awarded damages for each act of infringement to each of the Plaintiffs.
Other Industry News
The Patented Medicines Prices Review Board is seeking comments on proposed changes to the Compendium of Policies, Guidelines and Procedures. Comments are due by May 14, 2012.
The Natural Health Products Directorate (NHPD) has opened a consultation on proposed revisions to the Probiotics Monograph and Abbreviated Labelling Standard (AbLS) for Live Microorganisms, primarily regarding specifications for polychlorinated biphenyls (PCBs), dioxins and dioxin-like polychlorinated biphenyls (DL-PCBs). Comments are due by May 15, 2012.
The Natural Health Products Directorate (NHPD) has opened a consultation on proposed revisions to the marine oil monographs. Comments are due by May 15, 2012.
The Natural Health Products Directorate (NHPD) has opened a consultation on proposed revisions to the enzyme abbreviated labeling standards (AbLS) for a number of enzymes. Comments are due by May 15, 2012.
Health Canada has published an SOP regarding Using the Pharmaceutical Submission Executive Summary Template (PSEST) to Prepare Executive Summaries on Submissions for Marketing Authorization.
Health Canada has published a Guidance Document: Pre-market Evaluation of Hepatotoxicity in Health Products.About BLG
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