Two requirements under the new Patent Rules warrant particular attention for new Canadian patent applications and national phase entries: the Patent Cooperation Treaty national phase entry deadline and the requirement for certified copies of priority documents. Applicants should plan now to ensure that applications under the new rules enter the Canadian national phase within 30 months of the earliest priority date.
The Federal Court recently released the first decision in which the scope of Section 53.1 of the Patent Act – the so-called 'file wrapper estoppel' provision – was considered. The court's decision suggests that, notwithstanding the clear language of the provision, foreign prosecution histories may be admissible for the purposes of claim construction in certain extraordinary circumstances.
The recent amendments to the Patented Medicines Regulations have been the subject of two court challenges launched by groups of innovative pharmaceutical companies – one in the Quebec Superior Court and the other in the Federal Court. The applicants before the Quebec court brought a constitutional challenge to the Patented Medicine Prices Review Board provisions of the Patent Act and the regulations, while the applicants before the Federal Court challenged the validity of the amending regulations.
The amended Patented Medicines (Notice of Compliance) Regulations, which came into force two years ago, heralded significant changes to the IP landscape for pharmaceutical companies in Canada. Among other changes, the amendments ended dual litigation and provided innovators with a right of appeal. This article provides an update as of the second anniversary of the amendments.
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.
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 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.
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.
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.
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 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).
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.