The Patented Medicines Prices Review Board (PMPRB) Steering Committee on the Modernisation of Price Review Process Guidelines recently released its final report summarising its deliberations in providing stakeholder feedback on the PMPRB's proposed new framework for the regulation of the prices of patented medicines.
Most interlocutory decisions under the Patented Medicines (Notice of Compliance) (PMNOC) Regulations are made by prothonotaries of the Federal Court. The first Federal Court of Appeal decision in an appeal of an interlocutory order under the amended PMNOC Regulations was recently issued. The court found that the prothonotary had been entitled to arrive at a view of what was best for the particular proceeding and saw no reviewable error that would justify its intervention.
The Federal Court of Appeal recently granted the Patented Medicine Prices Review Board's (PMPRB's) appeal and returned to the board the matter of whether the invention of the patent at hand pertained to Galderma's Differin. The court addressed several issues, including whether the PMPRB had acted unreasonably in limiting its review of the patent to selected portions.
The Competition Bureau recently released its updated IP Enforcement Guidelines. While the guidelines are technical and directed at IP and competition law practitioners, there are key aspects of the bureau's approach and various scenarios involving competition and intellectual property that could arise for consideration. As such, when issues relating to IP and competition law arise, including when deciding whether to pursue the licensing or enforcement of IP rights, legal advice should be sought.
Pampered Chef, a world leader in the sale of premium kitchenware products, recently succeeded at trial in defending trademark infringement, passing off and dilution and depreciation of goodwill claims brought by Canada's largest retailer, Loblaws, in relation to its use of a trademark that includes the letters 'P' and 'C'. After considering all of the factors, the court dismissed all of the claims against Pampered Chef, notwithstanding the fame of Loblaws' marks and the similarities between the parties' goods.
The government recently published the final version of the new Patent Rules in Part II of the Canada Gazette. The new rules and associated amendments to the Patent Act will come into force on 30 October 2019. In order to safely and effectively prosecute Canadian patent applications under the new Patent Rules, there are a number of recommendations of which practitioners should be aware.
Although the amendments to the Patented Medicines Regulations did not come into force as expected, a number of life sciences IP and regulatory law developments took place in the first half of 2019. For example, there were two Patented Medicines (Notice of Compliance) Regulations decisions on the merits, as well as a pair of appeal decisions. In addition, the Competition Bureau released its IP Enforcement Guidelines and Bill C-100 was published to implement the United States-Mexico-Canada Agreement.
The Supreme Court of Canada has denied Apotex leave to appeal in two recent cases. In the first case, Apotex sought leave to appeal a decision of the Ontario Court of Appeal permitting Sanofi and Schering to amend their defences to claims relating to ramipril. In the second case, Apotex sought leave to appeal a decision of the Federal Court of Appeal relating to damages awarded to Eli Lilly in respect of Apotex's infringement of process patents relating to cefaclor.
Canada recently introduced the Budget Implementation Act 2, which brought about several changes to the Patent Act affecting the scope of protection available under Canadian patents. Included in the changes was the addition of a new provision providing an exception from infringement for experimental use of patented technologies. The new provision applies to any action or proceeding that was not finally disposed of as of 13 December 2018.
The Federal Court has granted in part Pharmascience's motion to strike out portions of Teva's statement of claim under Subsection 6(1) of the Patented Medicines (Notice of Compliance) (PMNOC) Regulations relating to glatiramer acetate (Teva's Copaxone and Pharmascience's Glatect). The court found that it is plain and obvious that Section 6.02 of the PMNOC Regulations prohibits the joinder of a regular infringement action under the Patent Act with an action pursuant to Subsection 6(1).
The Patented Medicine Prices Review Board (PMPRB) previously announced that the steering committee on guidelines modernisation would hold its final meeting on 13 May 2019 to discuss both a draft report of its deliberations and the working group's final report. Once the steering committee's report has been finalised and the regulatory amendments have been published in Part II of the Canada Gazette, the PMPRB will release its draft guidelines for public consultation.
The Federal Court recently dismissed Servier's application for a prohibition order under the pre-amended Patented Medicines (Notice of Compliance) Regulations for Canadian Patent 2,423,825 regarding a perindopril arginine/amlodipine product (Servier's Viacoram). Apotex had alleged that the patent was invalid for obviousness, overbreadth, inutility and insufficiency.
In a step towards ratifying the United States-Mexico-Canada Agreement (USMCA), the government recently introduced Bill C-100, entitled "An Act to implement the Agreement between Canada, the United States of America and the United Mexican States", in Parliament. If ratified, the USMCA will replace the North American Free Trade Agreement and will require several changes to Canada's IP laws.
After five years of anticipation, sweeping changes to Canada's trademark law have finally come into force. Among other things, Canadian applicants can now file applications in more than 80 countries around the world through a single international application and declarations of use are no longer required to secure registrations.
The Budget Implementation Act 2 has brought about several changes to the Patent Act that affect the scope of protection available under Canadian patents, including a revision of Section 56, which concerns the rights of prior users of patented technologies. However, as many of the Section 56 amendments will require judicial interpretation, the true scope of prior user rights under the revised provision may be unknown for some time.
With the long-awaited changes to the Trademarks Act and Regulations imminent, brand owners should be excited about Canada's alignment with international trademark standards and the new opportunities that these changes will bring. However, brand owners should be aware that Canada has adopted a unique policy concerning the required filing fees which differs significantly from the general practice of other member countries.
In two recent cases, the Federal Court considered procedural decisions in actions under the Patented Medicines (Notice of Compliance) Regulations. In one case, the court ordered that common validity issues in actions relating to Bayer's Xarelto against Apotex and Teva will be heard concurrently. In another case, the court refused to allow the plaintiffs to name additional Teva parties as further defendants in three actions relating to Celltrion's Herzuma, a trastuzumab biosimilar of Roche's Herceptin.
In accordance with Section 9(1) of the Certificate of Supplementary Protection (CSP) Regulations, the fee for filing a CSP recently increased. This article sets out a number of important reminders relating to CSPs and annual maintenance fees.
The new pan-Canadian Oncology Biosimilars Initiative aims to ensure appropriate implementation and cost-effective use of therapeutic oncology biosimilars. Separately, Health Canada recently announced that it is collaborating with the Drug Safety and Effectiveness Network on a project to study patients with certain diseases who are taking biologic drugs. The study aims to compare the safety and effectiveness of biosimilar drugs to the reference biologic drug.
Health Canada recently released its Forward Regulatory Plan 2019-2021: Regulations Amending the Patented Medicines Regulations. This brief document provides a high-level overview of the anticipated amendments released in draft form on 2 December 2017, the expected impact of these amendments and the consultation process.