Error in Registering Trade-mark Must be Corrected via Section 57 of the Trade-marks Act
The Registrar of Trade-marks (Registrar) allowed the trade-mark application by Fresh Hemp Foods. 299614 Alberta (the Applicant) appealed the decision pursuant to section 56(1) of the Trade-marks Act.
The Court held that it was clear that the registration was allowed because the Registrar erroneously thought the opposition to the registration had been withdrawn. Although the Court found that Fresh Hemp Foods was granted rights that it would not otherwise have had because of this error, the Court held that the correct way to proceed is to commence expungement proceedings pursuant to section 57, and not an appeal pursuant to section 56. Accordingly, the application was dismissed.
Palpable and Overriding Error Found by Court of Appeal in Considering New Evidence to be Material
The Court found that additional evidence provided by the Respondents would have materially affected the outcome at the Trade-marks Opposition Board (Board). The Court of Appeal held that the Court committed a palpable and overriding error in making this finding. In particular, the Court of Appeal found that the evidence of two witnesses about the interpretation of the Engineering and Geoscience Professions Act was irrelevant, the additional affidavits added no new material facts compared to what was before the Board, and the Board's decision was not unreasonable. The appeal was allowed.
Court of Appeal Confirms that Subsequent Declaration of Invalidity does not Vary Order of Prohibition
The issue to be determined by the Court of Appeal in this appeal was whether an Order of prohibition in a proceeding pursuant to the Patented Medicines (Notice of Compliance) Regulations can be varied pursuant to Rule 399 of the Federal Courts Rules, as a result of a declaration of invalidity in a subsequent proceeding. The Court dismissed the motion, and Apotex appealed the finding.
The Court of Appeal noted that, in an unrelated proceeding, the Court of Appeal previously has held that an order of prohibition does not get set aside when a patent is declared invalid, and that Apotex must convince the Court of Appeal that this decision is manifestly wrong in order to succeed.
The Court of Appeal held that they were not persuaded that the Court committed a reviewable error but noted that arguments to the effect that prior decisions are bad law are better addressed through an application for leave to appeal to the Supreme Court of Canada.
Fact-specific Issues Relevant to Calculating Section 8 Damages are Decided
This decision provides answers to certain issues that would allow the parties to calculate the loss under section 8 of the PM(NOC) Regulations that arose from an earlier decision of the Federal Court. In that earlier decision, Apotex's allegations of non-infringement for the product pantoprazole were found to be justified.
The issues left to be resolved in this proceeding included: 1) the burden of proof; 2) the number and identity of generic market entrants; 3) market share; 4) price; 5) inventory adjustment; 6) double ramp-up; 7) rebates; 8) interest; and 9) discretion to reduce the award based on Apotex's misconduct.
This was a highly fact-based exercise, but the Court did decide to not deduct the "ramp up" period at the start of the relevant period because a "ramp up" was experienced by Apotex in the real world. In distinguishing precedent, the Court considered that adding it in a second time was seen as doubling the ramp up to the detriment of the generic company.
Prejudgment interest was calculated from the quarter proceeding the date the Apotex sent their statement of claim, calculated from the patent hold date.
Takeda had argued that the award should be reduced by Apotex's alleged breach of undertaking. In the NOA, Apotex had stated that "[e]ach of the claims of the '748 Patent includes as an essential element a Helicobacter-inhibiting anti-microbial agent. Our sodium pantoprazole tablets shall not contain said agent, as that term is construed in accordance with the claims of the '748 Patent, nor shall our tablets be marketed or promoted to doctors, pharmacists or others to be used in combination with a Helicobacter-inhibiting anti-microbial agent or as part of a medicament package comprising said agent. As such, our tablets shall not infringe any of the claims of the '748 patent."
The Court declined to find that the allegation within Apotex's NOA rose to the level of an undertaking to be relied upon by the Court. Therefore, the fact that Apotex took no steps to prevent the marketing and promoting of their product for the treatment of Helicobacter pylori was of no consequence.
Health Canada has published a number of new and updated forms: Notice – Post- Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form; Drug Master File (DMF) Application Form; Health Canada 3011: Drug Submission Application Form for Human, Veterinary, Disinfectant Drugs and Clinical Trial Application/Attestation; and Clinical Trials Site Information Form.
Health Canada has started a Consultation – Data requirements for switching medicinal ingredients from prescription to non-prescription status.
The PMPRB has released two new analytical reports under the National Prescription Drug Utilization Information System (NPDUIS) Initiative: The Drivers of Prescription Drug Expenditures – A Methodological Report and The New Drug Pipeline Monitor (5th Ed).
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