Motion for Particulars in Action underSection 8 Deniedas Not Necessary
Inc.,2014 FC 1186
Drug: eletriptan hydrobromide
Pfizer brought a motion in an action brought pursuant to section 8 of the Patented Medicines (Notice of Compliance) Regulations seeking to strike particular paragraphs of Apotex's Statement of Claim or in the alternative, particulars of those paragraphs. The impugned paragraphs related to the nature of the damages claimed, the type of loss allegedly suffered by Apotex and whether the amount claimed exceeded $50,000 as required by the Federal Courts Rules.
The Court began by noting that statements by Pfizer that it cannot understand the case against it are "surprising" because it is a Defendant in at least one other proceeding with a similar Statement of Claim and in which no similar motion was brought by Pfizer.
The Court held that particulars of the damages claimed need not be provided because damages pursuant to section 8 are evolving. Further, these damages are a statutory remedy and the Courts have described the scope of these damages, and therefore Pfizer does not require particulars. The Court agreed with Pfizer that it is necessary to plead that damages greater than $50,000 are being claimed but the Court granted Apotex relief from this requirement and held that the action shall proceed on the basis that damages will exceed $50,000. Costs were awarded to Apotex in a fixed amount to be paid forthwith.
Motion for Reply Evidence Granted in Part
Leo Pharma Inc.
v. Teva Canada Limited, 2014 FC
Drug: calcipotriol and betamethasone dipropionate
This is an appeal from the decision of a Prothonotary, denying leave to file reply evidence in a proceeding pursuant to the Patented Medicines (Notice of Compliance) Regulations. The Court noted that the Prothonotary was satisfied that Leo Pharma could not have anticipated
the evidence filed by Teva, that filing the proposed reply evidence would not cause substantial or serious prejudice to Teva, and that Leo Pharma was not splitting its case. However, the Prothonotary was not persuaded that the reply evidence would assist the Court or serve the interests of justice. The Prothonotary held that sur-reply by Teva would then be permitted, which would result in the potential for further motions.
The Court noted that the standard on a discretionary decision of the Prothonotary is whether the decision was clearly wrong, as being based on a wrong principle or a misapprehension of the facts.
Two paragraphs in an affidavit were the subject of the motion. The Court found no reason to interfere with the decision of the Prothonotary with respect to one paragraph because Leo Pharma should have anticipated the issue. However, the Court found that the Prothonotary erred with respect to the second paragraph. The Court held that because Leo Pharma was taken by surprise, reply was fair. The Court indicated that the Prothonotary should address the schedule and whether sur-reply was necessary.
Breach before the Registrar of Trademarks can be Cured by a Proceeding in Court
This is an appeal of a decision found here.
The Court of Appeal noted that the first issue to be considered was whether a breach of natural justice that may have occurred before the Registrar of Trademarks would have been cured by a proceeding in the Federal Court. The Court of Appeal found no error in the Court's determination that a breach of notice and the right to be heard by the Registrar can be addressed in an appeal with new evidence under section 56 of the Trade-marksAct. The issue therefore became whether the breach was in fact cured by the appeal. The Court of Appeal held that the argument made in support of the submissions that the breach was not cured was based on a mistaken belief that the burden of proof is lower before the Registrar as compared to the Court. The Court of Appeal also agreed with the Court regarding the evidence of use and the reliance on foreign correspondence. The appeal was dismissed.
OTHER INDUSTRY NEWS
Health Canada is seeking feedback from stakeholders regarding their information needs about therapeutic products as part of Health Canada's Regulatory Transparency and Openness Framework. The consultation is open until May 25, 2015.
Health Canada is holding a Consultation on the Amendments to the Food and Drugs Act: Guide to New Authorities (power to require & disclose information, power to order a label change and ). The consultation is open for comment until June 8, 2015.
Health Canada is holding a consultation on the Release of Draft (Step 2) International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals on Human Use (ICH) Guidance: M8 - Electronic Common Technical Document: Implementation Guide. The consultation is open for comment until May 15, 2015.
The Competition Bureau is seeking input on its first three-year Strategic Plan. Comments must be received no later than April 10. 2015.
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