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 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 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).
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.
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.
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.
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.
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.
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.
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.
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.
Canada's trademark regime is changing, bringing about dramatic amendments to the law, regulations and practice. These long-awaited changes will have a significant impact on brand owners in terms of both strategy and costs. In order to prepare for the changes, brand owners should consider renewing and classifying registrations, filing multi-class applications, pushing allowed applications to registration and ensuring that all portfolios are troll-proof before the new law enters into force on 17 June 2019.
In a digital-age David versus Goliath case, the Federal Court recently held that the Quebec government had infringed two patents owned by Dr Luc Bessette relating to a shared medical records system that he had invented 20 years ago. This is the first time that the Quebec government has been held liable for patent infringement and the decision provides important guidance to institutions, enterprises and inventors alike.
The Competition Bureau recently published the final version of its updated IP Enforcement Guidelines (IPEGs). As noted by the bureau, the "updates are modest". Most of the changes to the IPEGs reflect the 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations and, in particular, the termination of dual litigation.
In 2017 the Federal Court of Appeal dismissed Apotex's appeal of a judicial review decision of the Therapeutic Products Directorate, which required Apotex to submit additional information concerning products manufactured or tested in its facilities in India. The Supreme Court recently dismissed Apotex's application for leave to appeal.
Valeant Canada's application for an order prohibiting the minister of health from issuing a notice of compliance to Generic Partners for its generic version of Valeant's Glumetza, a metformin formulation, was recently granted. With respect to anticipation and double patenting, the court found that the prior art document on which Generic Partners had relied for both allegations did not disclose all three of the size, shape and time elements of the claimed formulations.
The new trademark law will take effect on 17 June 2019. Among the changes is a new fee-per-class structure, under which the government renewal fee will be C$400 for the first class and C$125 for each additional class. Brand owners can potentially realise huge savings if they take steps to renew all of their existing Canadian trademark registrations before the new law takes effect.
The Federal Court of Appeal recently allowed in part Apotex's appeal of a decision awarding Eli Lilly more than C$100 million for Apotex's infringement of eight process patents relating to the antibiotic cefaclor. The court rejected Apotex's argument that a non-infringing alternative would have been available to Apotex during the relevant period. The case was remitted to the Federal Court for reconsideration on the issue of prejudgment interest; Apotex has applied to the Supreme Court of Canada for leave to appeal.