The long-awaited amendments to the Patented Medicines Regulations were recently published in Part II of the Canada Gazette. Major changes include the introduction of three new price regulatory factors and a revised schedule of reference countries. Although the new law will not be in force until 1 July 2020, there are immediate implications.
Health Canada recently announced the final amendments to the Patented Medicines Regulations. These amendments represent the first substantive revision to the regulations since their introduction in 1987 and are a significant departure from the existing framework. The amendments include new price regulatory factors, updated reference countries and changes in reporting requirements.
Canada's recent accession to the Patent Law Treaty marks the near completion of its long and ambitious journey to modernise its patent, trademark and industrial design laws and harmonise its IP laws with its most important trading partners worldwide. As a result of the recent and upcoming changes, Canadian businesses and right holders alike can expect a more consistent and level playing field for securing IP rights.
The Canadian Intellectual Property Office (CIPO) was the first office to allow trademark applicants to use the Madrid e-filing system from day one. Under Canada's new Trademarks Regulations, CIPO is authorised to send correspondence only to the applicant or an appointed Canadian trademark agent and not to foreign representatives. Some but not all communications will also be sent to the International Bureau of the World Intellectual Property Organisation.
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.
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.
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.
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.
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.