Smart & Biggar

Toronto ON

Smart & Biggar is widely recognized as Canada’s leading firm for intellectual property. With offices in Ottawa, Toronto, Montreal, Vancouver and Calgary, and over 100 lawyers, patent agents and trademark agents, we are also the largest firm focused purely on IP and related specialty areas. We have a history and tradition of providing the highest quality of IP advisory services and have filed more patent and trademark applications than any firm in Canada. 

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Updates

Healthcare & Life Sciences

Market access: biosimilars no longer reviewed by CADTH
Canada | 18 September 2019

The Canadian Agency for Drugs and Technologies in Health (CADTH) recently released Issue 8 of its Pharmaceutical Reviews Update announcing revisions to its Procedure and Submission Guidelines for the CADTH Common Drug Review, among other things. The update also announced that the CADTH will no longer review biosimilars through the Common Drug Review or the pan-Canadian Oncology Drug Review.

Countdown begins: getting ready for new patented medicines pricing regime
Canada | 18 September 2019

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.

Canada releases final amendments to patented medicines pricing regulations
Canada | 11 September 2019

Health Canada recently announced the final amendments to the Patented Medicines Regulations. The amendments – which represent the first substantive revision to the regulations since their introduction in 1987 – are a significant departure from the existing framework and include new price regulatory factors, updated reference countries and changes in reporting requirements.

Updates to guidance documents: what you need to know
Canada | 11 September 2019

Health Canada recently released a revised Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs, which is effective immediately. The revisions include clarifying additions on the requirements for cross-licensed products for an administrative certification form and letter of authorisation, a drug notification form and labelling. Health Canada also recently released an updated Good Label and Package Practices Guide for Prescription Drugs.

Drug and medical device highlights
Canada | 04 September 2019

Health Canada recently published an annual highlights report for 2018. The report provides information regarding Health Canada drug (for human or veterinary use) and medical device approvals, as well as published safety issues in 2018. Moreover, the Therapeutic Products Directorate and the Biologics and Genetic Therapies Directorate released their Drug Submission Performance Annual Reports for the 2018-2019 fiscal year.

Health Canada consults on promotional and non-promotional activities for health products
Canada | 04 September 2019

Health Canada has announced a consultation on its new draft guidance: The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products. The guidance is intended to clarify and outline the factors and circumstances that contribute to rendering a message or activity non-promotional.

Bill C-97 receives royal assent and Health Canada opens consultation on advanced therapeutic products
Canada | 28 August 2019

Advanced therapeutic products have been the topic of much debate recently. First, Bill C-97 – which includes amendments to the Food and Drugs Act, including a new framework for advanced therapeutic products – received royal assent. Second, Health Canada opened a consultation to seek feedback on what it should consider when developing new clinical trial regulations as well as implementing the pathway for advanced therapeutic products.

PMPRB Steering Committee on Modernisation of Price Review Process Guidelines releases final report
Canada | 28 August 2019

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 proposed new framework for the regulation of the prices of patented medicines. The PMPRB will publish draft guidelines for public consultation once it has had an opportunity to review the report and the amended Patented Medicines Regulations have been published.

Federal Court of Appeal dismisses first PMNOC interlocutory appeal granted leave
Canada | 21 August 2019

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.

Regulations will require hospitals to report adverse drug reactions and medical device incidents
Canada | 21 August 2019

The Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting – Hospitals) and Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting — Hospitals) were recently published. The amendments were enacted further to Vanessa's Law and will require all hospitals to provide specific information relating to serious adverse drug reactions and medical device incidents within 30 days of first documenting the reaction or incident in the hospital.

Federal Court of Appeal requires PMPRB to redetermine whether patent pertains to Galderma's Differin
Canada | 14 August 2019

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.

Court strikes Novo Nordisk's judicial review application
Canada | 14 August 2019

The Federal Court recently struck Novo Nordisk's judicial review application challenging the minster of health's decision to accept for review an abbreviated new drug submission filed by Teva Canada. In striking the application, the court concluded that Novo Nordisk had neither direct nor public interest standing in the matter.

Life sciences intellectual property: 2019 mid-year highlights
Canada | 31 July 2019

The first half of 2019 has seen a number of changes to life sciences IP and regulatory law, including the proposed amendments to the Food and Drugs Act. In addition, the Advisory Council on the Implementation of National Pharmacare released its final report, which recommends that Canada implement a universal, single-payer, public pharmacare programme by enacting new legislation and proceeding in a stepwise approach to implementation.

CADTH reports on integration of CDIAC functions into pCODR process
Canada | 31 July 2019

The Canadian Agency for Drugs and Technologies in Health recently reported changes to transition Cancer Drug Implementation Advisory Committee functions to the CADTH pan-Canadian Oncology Drug Review process. Among other things, the changes aim to enhance the transparency of the pan-Canadian cancer drug review process and allow for greater stakeholder input into the development of a provisional algorithm for each new cancer drug or indication.

Medical devices update
Canada | 24 July 2019

The Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Post-market Surveillance of Medical Devices) were recently pre-published. These proposed changes were made in accordance with Vanessa's Law. The proposed regulations would implement changes to the Food and Drug Regulations and Medical Devices Regulations and (among other things) establish a regulatory framework to require assessments, tests and studies of medical devices.

New PMPRB report examines most promising medicines currently in clinical trials worldwide
Canada | 24 July 2019

The Patented Medicine Prices Review Board (PMPRB) recently published the 2018 edition of the Meds Pipeline Monitor – a horizon-scanning report which provides a snapshot of the new drug landscape. The PMPRB report considered the 733 medicines that are currently in Phase III clinical trials or pre-registration and identified 30 that have the potential to address an unmet need, offer an improvement over existing therapies and treat serious conditions.

Federal Court upholds PMPRB's pricing decision regarding Alexion's Soliris
Canada | 17 July 2019

The Federal Court recently dismissed Alexion's application for judicial review of a Patented Medicines Price Review Board (PMPRB) panel's decision that Soliris (eculizumab) had been sold at an excessive price and its order fixing the amount of the payment to offset excess revenues (C$4.2 million). The application was dismissed on the grounds that, among other things, the PMPRB had not been unreasonable in ordering payment of excess revenues based on the highest international price comparison.

National pharmacare update: publication of advisory council's final report
Canada | 17 July 2019

The minister of health recently published the final report from the Advisory Council on the Implementation of National Pharmacare. The council has recommended that Canada implement universal, single-payer, public pharmacare by enacting new legislation and proceeding in a stepwise approach to implementation.

Supreme Court of Canada denies Apotex leave to appeal in two cases
Canada | 10 July 2019

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.

Guidance document on reporting adverse reactions to marketed health products
Canada | 10 July 2019

Health Canada has published its Overview of the Reporting Adverse Reactions to Marketed Health Products – Guidance Document for Industry. The guidance document provides market authorisation holders with assistance on how to report adverse reactions to pharmaceutical drugs, biologics, radiopharmaceutical drugs and natural health products.

Proposed regulations set to amend process for sale of drugs for medical emergencies
Canada | 03 July 2019

Two sets of proposed amendments to the Food and Drug Regulations were recently published and contain provisions which would streamline the process for providing access to unauthorised drugs for medical emergencies. Access to the drugs will continue to be facilitated through the Special Access Programme for human drugs and the Emergency Drug Release Programme for veterinary products.

Health Canada releases new guidance document regarding drug identification numbers
Canada | 03 July 2019

Health Canada recently released the new Guidance Document: Regulatory Requirements for Drug Identification Numbers. The document assists in interpreting the regulatory requirements associated with drug identification numbers and offers guidance to manufacturers on their obligation to accurately report notifications for a change of drug status to Health Canada.

Update on PMPRB guidelines modernisation
Canada | 26 June 2019

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.

Infringement based on making and selling under existing NOC struck from action
Canada | 26 June 2019

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).

Federal Court dismisses Servier's application for order of prohibition regarding salt patent
Canada | 19 June 2019

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.

Court upholds issuance of NON-W letter and cancellation of reconsideration process for Apotex
Canada | 19 June 2019

The Federal Court of Appeal recently affirmed the Federal Court's dismissal of Apotex's application for judicial review of a minister of health decision relating to its Apo-Omeprazole (omeprazole magnesium) delayed-release tablets. The minister had issued a Notice of Non-Compliance – Withdrawal letter in respect of Apotex's abbreviated new drug submission on the basis that the tablets were not bioequivalent to the relevant Canadian reference product.

Procedural decisions under PMNOC Regulations: common validity issues and naming of defendants
Canada | 12 June 2019

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.

Ontario Court of Appeal overturns ban on online sales of prescription eyewear to Ontario residents
Canada | 12 June 2019

The Ontario Court of Appeal has overturned the Ontario Superior Court of Justice's finding that online sales of prescription eyewear by Essilor Group Canada Inc to Ontario residents violated the Regulated Health Professions Act. The court found that the mere act of delivery did not, in itself, establish a sufficient connection to Ontario so as to bring Essilor's online transactions within the ambit of the act.

New oncology initiative and Health Canada study on biosimilar drugs
Canada | 05 June 2019

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 invites submissions containing high-quality, real-world evidence
Canada | 05 June 2019

Health Canada recently released a notice inviting drug submissions containing high-quality, real-world evidence along with a document providing principles for the collection and evaluation of real-world evidence. A further joint document regarding the use of real-world evidence is expected to be published later in 2019.

Bill C-97: amendments to Food and Drugs Act establish framework for advanced therapeutic products
Canada | 29 May 2019

Bill C-97, which was recently introduced in the House of Commons, includes proposed amendments to the Food and Drugs Act to introduce a new framework for advanced therapeutic products, including a new licensing framework. It is expected that advanced therapeutic products may include the regulation of newer technologies, such as cell and gene therapies, 3D printing and novel drug delivery methods.

Proposed amendments to Food and Drug Regulations
Canada | 29 May 2019

Health Canada recently released its proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics). The proposed regulations clarify and codify Health Canada's expectations and policies regarding differences in the form of medicinal ingredients in generic drug products that are eligible for submission under the abbreviated new drug submission pathway by introducing a regulatory definition for 'therapeutically active component'.

Amendments to Patented Medicines Regulations expected to come into force no earlier than Spring 2020
Canada | 22 May 2019

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.

On the (Quebec health) record: Quebec government liable for patent infringement
Canada | 22 May 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.

PMPRB publishes 2017 Meds Entry Watch
Canada | 15 May 2019

The Patented Medicine Prices Review Board recently announced the publication of the 2017 edition of Meds Entry Watch. According to the notice, this publication provides information on new medicines entering Canadian and international markets and examines the availability, sales, uptake, pricing and treatment costs of new medicines that were approved by the US Food and Drug Administration, the European Medicines Agency and Health Canada in 2016 and 2017.

Supreme Court denies Apotex leave to appeal decision regarding India facilities
Canada | 15 May 2019

In 2018 the Federal Court of Appeal dismissed Apotex's appeal of a judicial review decision of the Therapeutic Products Directorate (TPD), finding that the Federal Court made no reviewable error in its conclusion that the TPD's decision was not improperly motivated. The Supreme Court recently dismissed Apotex's application for leave to appeal.

Quebec Court of Appeal overturns decision to delist Remicade from Quebec's List of Medications
Canada | 08 May 2019

The Quebec Court of Appeal recently found the minister of health and social services's decision to delist Janssen's Remicade from Quebec's List of Medications to be invalid and ordered the minister to reinstate the drug on the list. The court concluded that the minister had violated procedural fairness and should have given Janssen formal notice and an opportunity to respond before making the change.

Health Canada launches e-learning tool for understanding pre-market regulatory requirements
Canada | 08 May 2019

Health Canada recently launched its e-learning tool for understanding pre-market regulatory requirements for medical devices. Among other things, the tool will provide targeted guidance to enable greater consistency in the understanding, interpretation and application of the Food and Drugs Act, the Medical Devices Regulations and their related policies and guidelines.

Health Canada and CADTH launch new initiative to provide early parallel scientific advice
Canada | 01 May 2019

Health Canada and the Canadian Agency for Drugs and Technologies in Health (CADTH) recently launch a new initiative to provide early parallel scientific advice. The initiative will enable Health Canada and the CADTH to collaborate and share perspectives while each formulating independent advice regarding a sponsor's specific drug development plan. It will also give sponsors the opportunity to hold joint meetings with Health Canada and the CADTH to discuss their advice.

Pharmacare advisory council delivers initial recommendations
Canada | 01 May 2019

In March 2019 the Advisory Council on the Implementation of National Pharmacare delivered its interim report with three initial recommendations: create a national drug agency to oversee national pharmacare, develop a comprehensive, evidence-based list of prescribed drugs to harmonise coverage across Canada; and invest in data on prescription drugs and IT systems. The federal government subsequently delivered the 2019 Federal Budget, which reflects these recommendations.

Final regulations addressing public release of clinical information now in force
Canada | 24 April 2019

The final Regulations Amending the Food and Drug Regulations and Regulations Amending the Medical Devices Regulations recently came into force. Their objective is to provide public access to clinical information submitted to Health Canada for drugs for human use and medical device applications. As a result of the regulations, Health Canada published (among other things) a guidance document to help explain aspects of the new regulations, such as the procedures to prepare information for release.

Apotex seeks leave from Supreme Court of Canada in cefaclor damages action
Canada | 17 April 2019

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.

Court of Appeal dismisses appeal of judgment awarding Apotex damages
Canada | 17 April 2019

In December 2017 Apotex was awarded more than C$11 million in damages and pre-judgment interest for losses resulting from delays in the US Food and Drug Administration's approval of its amoxicillin-clavulanic acid and levodopa-carbidopa products, which had been caused by contractual breaches and negligence on the part of MDS Pharma Services (MDS). However, the Ontario Court of Appeal recently dismissed MDS's appeal and Apotex's cross-appeal of that judgment.

Costco Pharmacies receives C$7.25 million penalty for accepting drug rebates
Canada | 10 April 2019

The Ontario Ministry of Health and Long-Term Care recently announced that CWC Pharmacies (Ontario) Ltd (Costco Pharmacies), a subsidiary of Costco, has been ordered to pay an administrative monetary penalty of C$7.25 million for accepting payments from certain generic manufacturers which had violated the prohibition on drug rebates.

Proposed changes to OHIP+ programme
Canada | 03 April 2019

The OHIP+ programme was implemented by the Province of Ontario to provide free prescription drug coverage for all children and youths (ie, individuals aged 24 and under), regardless of family income or whether they have private insurance. However, under proposed amendments to Ontario Regulation 201/96 made under the Ontario Drug Benefit Act, only children and youths without private insurance will continue to receive coverage through the OHIP+ programme.

Health Canada publishes guidance document on post-market drug benefit-risk assessments
Canada | 27 March 2019

Health Canada recently published its "Overview of the format and content for post-market drug benefit-risk assessment in Canada – guidance document". The objective of the guidance document is to assist market authorisation holders in developing a post-market benefit-risk assessment for a marketed drug when requested.

Health Canada releases further information alongside Action Plan on Medical Devices
Canada | 27 March 2019

Further to its Action Plan on Medical Devices, Health Canada has released, among other documents, a notice announcing an upcoming meeting of its Scientific Advisory Committee on Medical Devices used in the Cardiovascular System and draft guidance to better define regulatory compliance requirements for emerging technologies.

Orders of prohibition relating to polymorphic form patent for Pristiq upheld on appeal
Canada | 20 March 2019

In a pair of decisions, the Federal Court granted orders prohibiting Apotex and Teva from marketing their generic o-desmethyl-venlafaxine succinate products. The Federal Court of Appeal recently dismissed both Apotex's and Teva's appeals. Among other things, Apotex and Teva argued that the application judge had misapplied the test for obviousness and that the application judge had erred in considering several aspects of the inventors' course of conduct.

Health Canada announces decision on naming of biologic drugs
Canada | 20 March 2019

Following its stakeholder consultations and analysis of issues relating to the name of biologic drugs, including biosimilars, Health Canada recently announced its Policy Statement on the Naming of Biologic Drugs. To implement the naming convention, Health Canada will, among other things, communicate with stakeholders on the importance of recording both brand and non-proprietary names throughout the medication use process.

Apotex seeks leave to appeal ramipril pleadings amendment decision
Canada | 27 February 2019

The Ontario Court of Appeal granted Sanofi and Schering leave to amend their defences to plead the Supreme Court of Canada's decision in AstraZeneca Canada Inc v Apotex Inc. In the underlying action, Apotex relied on the invalidity decision in Sanofi-Aventis Canada v Apotex Inc as a central element of its novel claims under the Ontario Statute of Monopolies, the UK Statute of Monopolies and the Trademarks Act. Apotex recently applied for leave to appeal to the Supreme Court of Canada.

Abbott and Takeda plead third party's patent would be infringed by non-infringing alternative
Canada | 20 February 2019

On the eve of a Section 8 trial, the Ontario Superior Court granted Abbott and Takeda leave to amend their pleadings to assert that Apotex's alleged non-infringing alternative was unlawful as it would have infringed a third party's patent. The court found that Apotex had not established that it would be prejudiced by the amendment, as any delay to the trial could be compensated by costs and an adjournment if appropriate.

Health Canada requests feedback on company names added to Generic Submissions Under Review List
Canada | 20 February 2019

Health Canada recently requested feedback on the possible impact on and use to stakeholders if the Generic Submissions Under Review List is updated to include sponsor names (ie, the company that filed the generic submission). Sponsors are included in the Submissions Under Review List for new drug submissions (which includes biosimilars) accepted into review on or after 1 October 2018.

Life sciences intellectual property: 2018 highlights
Canada | 06 February 2019

There have been a number of key developments in Canadian life sciences IP and regulatory law over the past 12 months, including a consultation on the different approaches to the naming of biological drugs. Among other developments, four biosimilars were approved, the Canadian Agency for Drugs and Technologies in Health announced revisions to its biosimilar and administrative review process and significant proposed amendments to the Patent Rules were released.

Health Canada publishes revisions to guidance document on notifying Health Canada of foreign actions
Canada | 23 January 2019

Health Canada recently updated its Notifying Health Canada of Foreign Actions – Guidance Document for Industry, including by providing a link to an online reporting form. This update comes after the foreign risk reporting requirement provisions of the Food and Drug Regulations came into force in October 2018.

List of generic submissions under review now available
Canada | 16 January 2019

Health Canada recently advised that it would implement certain proposals for its prescription drug product transparency initiatives. In particular, Health Canada will start providing regulatory decision summaries for the approval of drugs which are approved on the basis of abbreviated new drug submissions. Among others things, Health Canada now provides a new, separate Generic Submissions Under Review List, which includes a list of the generic submissions under review by medicinal ingredient.

Federal Court of Appeal overturns cefaclor damages decision on pre-judgment interest issue
Canada | 16 January 2019

The Federal Court of Appeal recently allowed in part Apotex's appeal of a decision awarding Eli Lilly over C$100 million for Apotex's infringement of eight process patents relating to the antibiotic cefaclor. The court remitted the decision to the Federal Court for reconsideration solely on the issue of interest.

Divided success in Sandoz's motion to strike monetary remedies and other novel claims
Canada | 19 December 2018

A Federal Court order has issued on a motion to strike that was brought by Sandoz in four actions relating to the infringement of rituximab patents. The court declined to strike out the claims for damages and an accounting of profits on the basis that, at law, such remedies are unavailable in such an action. The court's treatment of the novel claims by Roche may be of interest to litigants under the current scheme of the Patented Medicines (Notice of Compliance) Regulations.

Court allows Sanofi and Schering to plead that Federal Court ramipril patent invalidity decision was flawed
Canada | 19 December 2018

The Ontario Court of Appeal recently overturned a motion judge's decision denying Sanofi and Schering leave to amend their defences to plead the Supreme Court of Canada's decision in AstraZeneca Canada Inc v Apotex Inc. The present action is one of several novel claims by Apotex seeking damages pursuant to the Ontario Statute of Monopolies and the UK Statute of Monopolies.

Amgen not precluded from asserting patent under current PMNOC Regulations
Canada | 21 November 2018

The Federal Court of Canada has refused Pfizer's motion to dismiss an action under the Patented Medicines (Notice of Compliance) (PMNOC) Regulations between Amgen and Pfizer. Pfizer sought to dismiss the action, asserting that it was redundant, scandalous, frivolous, vexatious or otherwise an abuse of process. Pfizer based its argument on a decision under the old PMNOC Regulations in which the court had found that Apotex's allegation of invalidity was justified.

Apotex not permitted to plead promise-based invalidity grounds in Section 8 lansoprazole action
Canada | 21 November 2018

The Ontario Superior Court of Justice recently dismissed Apotex's motion to plead promise-based invalidity grounds in a Section 8 lansoprazole action. The motion had arisen in the context of a Section 8 action in which Apotex claimed damages for delay in the issuance of its notice of compliance for its generic lansoprazole product (Takeda's Prevacid) due to prohibition applications commenced by Abbott and Takeda.

Interim order permits import of FDA-approved drug to address Canadian shortage of EpiPens
Canada | 14 November 2018

The minister of health recently made an order permitting the immediate import and sale of epinephrine auto-injectors for use in emergency treatment of life-threatening allergic reactions to address the shortage of EpiPen products. This is the first time that an interim order under Section 30.1(2)(a) of the Food and Drugs Act has been used to address the shortage of an approved product.

Prohibition denied for Ranbaxy's bupropion extended-release tablets
Canada | 14 November 2018

The Federal Court recently dismissed Valeant's application under the Patented Medicines (Notice of Compliance) Regulations regarding Ranbaxy's bupropion extended-release tablets. The court found that the amount of permeation enhancer in the Ranbaxy formulation was outside the scope of the range claimed. As such, Ranbaxy's allegation of non-infringement was found to be justified.

Recent PMPRB reports
Canada | 07 November 2018

The Patented Medicine Prices Review Board (PMPRB) recently released its fourth edition CompassRX report, which was prepared as part of the National Prescription Drug Utilisation Information System and examines public drug plan expenditures in Canada. The PMPRB also released the 2017 Supplement to the Market Intelligence Report, Biologic Response Modifier Agents 2015 and its 2017 Annual Report.

Supreme Court of Canada denies Sobeys leave to appeal in loyalty rewards programme dispute
Canada | 07 November 2018

The Supreme Court of Canada recently denied Sobeys' application for leave to appeal the Alberta Court of Appeal's decision in a dispute regarding the Alberta College of Pharmacists' policy prohibiting pharmacists and pharmacies from offering loyalty rewards programmes or inducements to patients. This decision follows the court's 2016 refusal to grant Sobeys leave to appeal a decision allowing the College of Pharmacists of British Columbia to prohibit "customer incentive programmes".

Certificate of supplementary protection regime: first anniversary update
Canada | 31 October 2018

The certificate of supplementary protection (CSP) regime, which recently celebrated its first anniversary, was a long-awaited complement to the existing forms of protection for pharmaceutical products in Canada. As the regime is still new, companies are reminded to consider applying for a potential CSP for any planned new product in Canada early in the lifecycle planning.

Amended PMNOC Regulations: first anniversary update
Canada | 31 October 2018

The amended Patented Medicines (Notice of Compliance) Regulations came into force on 21 September 2017, heralding significant changes to the regulatory landscape for pharmaceutical companies in Canada. Following the first anniversary of the amendments, it is timely to examine the status of actions under the amended regulations, as well as the new procedural rules and guidelines which were introduced in conjunction therewith.

National pharmacare advisory council seeks feedback
Canada | 24 October 2018

The Advisory Council on the Implementation of National Pharmacare was launched in July 2018. The council recently invited all Canadians to provide their feedback on national pharmacare in order to "help shape the Council's independent report to the Federal Government, to be presented in spring 2019… which will provide the Government with recommendations and a plan on how to move forward on national pharmacare".

CADTH Pharmaceutical Reviews Update published
Canada | 24 October 2018

​The Canadian Agency for Drugs and Technologies in Health (CADTH) has published the CADTH Pharmaceutical Reviews Update. This is a new consolidated publication that will communicate updates to the CADTH's drug review process. Among other things, the first issue of the update invites stakeholder comments on a number of proposals and announces changes to the Pan-Canadian Oncology Drug Review.

Health Canada releases statistical report on PMNOC Regulations and data protection
Canada | 17 October 2018

Health Canada recently released the Therapeutic Products Directorate Statistical Report 2017/2018, which provided an overview of its administration of the Patented Medicines (Notice of Compliance) Regulations and data protection regime. The report includes information regarding trends in listing on the Patent Register and the Register of Innovative Drugs, as well as related court activity.

Health Canada to implement further pre-market transparency initiatives for prescription drugs
Canada | 17 October 2018

Health Canada recently announced that it will move forward with Phase III of its prescription drug product transparency initiatives. As of 1 October 2018, the Health Products and Food Branch will implement five proposals discussed in its April 2018 What We Heard report concerning regulatory decision summaries and information in the Submissions Under Review List.

Apotex's appeal in judicial review of decision seeking further information from India facilities dismissed
Canada | 10 October 2018

In 2017 the Federal Court dismissed Apotex's application for judicial review of the Therapeutic Products Directorate decision which continued to require Apotex to submit additional information with respect to products manufactured or tested in its facilities in India. The Federal Court of Appeal recently dismissed Apotex's appeal of the Federal Court's decision.

Teva succeeds in Section 8 bortezomib action
Canada | 10 October 2018

The Federal Court recently granted Teva's claim for compensation under Section 8 of the Patented Medicines (Notice of Compliance) (PMNOC) Regulations for losses suffered while market entry of Teva's bortezomib product was delayed by Janssen's applications under the PMNOC Regulations relating to Patents 2,203,936 and 2,435,146. Teva had succeeded on allegations of obviousness in both proceedings.

Federal Court dismisses first motion for early dismissal under amended PMNOC Regulations
Canada | 03 October 2018

The Federal Court recently dismissed the first motion for summary dismissal brought under Section 6.08 of the amended Patented Medicines (Notice of Compliance) Regulations. The underlying action for infringement concerned Amgen Canada's regulatory submission for approval of its biosimilar of Hoffmann-La Roche's Herceptin. Amgen sought to dismiss the action regarding two of the four asserted patents, both of which contained use claims.

Eli Lilly's Effient combination use patent found obvious
Canada | 03 October 2018

The Federal Court recently dismissed Eli Lilly's application for a prohibition order, finding that Apotex's allegation of obviousness of Patent 2,432,644 (the '644 Patent) was justified. The '644 Patent covered the use of prasugrel (Eli Lilly's Effient) in combination with aspirin for diseases caused by thrombus or embolus. Apotex made a number of attacks on the patent's validity, specifically with regard to patentable subject matter, obviousness and sufficiency and overbreadth.

Health Canada news: September 2018
Canada | 26 September 2018

There have been a number of recent Health Canada developments. For example, in June 2018 the Advisory Council on the Implementation of National Pharmacare was launched, together with the release of a discussion paper and the opening of a public consultation. In addition, Health Canada recently published notice of revised guidance documents on post-notice of compliance changes and its Drug and Medical Device Highlights 2017 report.

Tobacco companies cannot compel production of health records
Canada | 26 September 2018

The province of British Columbia recently brought an action against Philip Morris International and other tobacco manufacturers to recover healthcare costs relating to the treatment of diseases caused or contributed to by exposure to a tobacco product pursuant to the Tobacco Damages and Healthcare Costs Recovery Act. The Supreme Court of Canada held that British Columbia could not be compelled to produce a collection of anonymised healthcare databases that it intended to use to prove causation and damage.

Alexion denied leave to appeal in case challenging constitutionality of PMPRB's remedial powers
Canada | 19 September 2018

The Supreme Court of Canada recently dismissed Alexion Pharmaceuticals' application for leave to appeal the Federal Court of Appeal decision in Alexion Pharmaceuticals Inc v Canada (Attorney General). The Federal Court of Appeal had dismissed Alexion's challenge of the constitutionality of certain Patent Act provisions relating to the Patented Medicine Prices Review Board's remedial powers.

CADTH releases new guidelines
Canada | 19 September 2018

The Canadian Agency for Drugs and Technologies in Health (CADTH) recently published the Procedure and Submission Guidelines for the CADTH Common Drug Review, which consolidate two previously separate guidelines and include a number of revisions to the submission requirements. These changes will be enforced for all submissions and resubmissions received on or after 27 July 2018.

Patented Medicine Prices Review Board's multi-stakeholder steering committee holds first meeting
Canada | 12 September 2018

The Patented Medicine Prices Review Board (PMPRB) has been consulting on its proposed reform of the federal price review process and associated guidelines. As part of this reform, the steering committee held its first meeting on 25 June 2018 to "discuss aspects of the new regime and assist the PMPRB in synthesizing stakeholder views on key technical and operational modalities of new draft Guidelines that would give effect to these changes".

Patented Medicine Prices Review Board releases annual report on drug market entry
Canada | 12 September 2018

The Patented Medicine Prices Review Board recently announced the publication of the second annual edition of Meds Entry Watch 2016. The report provides a review of long-term trends in new active substances approved by Health Canada, among others, between 2009 and 2015. It also describes the availability, pricing and sales of such new active substances in 2015 and 2016 and provides a preliminary analysis of their effect on the market as of the fourth quarter of 2016.

First judicial consideration of Vanessa's Law: Health Canada must disclose requested clinical trial data
Canada | 05 September 2018

In the first case calling upon a court to interpret and apply the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), the Federal Court ordered Health Canada to release requested complete copies of all sections of all clinical study reports and all electronic datasets from the clinical trials, including participant level datasets, for Gardasil, Gardasil 9, Cervaris, Tamiflu and Relenza.

Shire's VYVANSE patent valid, prohibition order issued
Canada | 05 September 2018

The Federal Court has granted Shire's application under the pre-amended Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the minister of health from issuing a notice of compliance to Apotex for its lisdexamfetamine product (Shire's Vyvanse) until the expiry of Canadian Patent 2,527,646. The application had been consolidated with Apotex's action seeking a declaration of invalidity and non-infringement and was decided on the basis of the evidence adduced in that action.

Health Canada publishes guidance documents that address reporting of adverse reactions
Canada | 15 August 2018

Health Canada recently published the Reporting Adverse Reactions to Marketed Health Products guidance document, which provides assistance on reporting adverse reactions to marketed health products. Further, it published Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products, which addresses the format and content of annual summary reports and issue-related summary reports, as well as procedures for their submission to Health Canada.

Mid-year life sciences highlights
Canada | 15 August 2018

There have been a number of major highlights in Canadian life sciences law over the past six months, including the consultation on the proposed Regulations Amending the Patented Medicines Regulations. Among other developments, eight certificates of supplementary protection were issued and a number of new biosimilars were approved. Further, the creation of an Advisory Council on the Implementation of National Pharmacare was announced in February 2018.

Health Canada issues updated guidance on PMNOC Regulations
Canada | 08 August 2018

Health Canada recently issued updated guidance on the Patented Medicines (Notice of Compliance) (PMNOC) Regulations. Revisions include the introduction of directions on how to provide litigation information to Health Canada so that it is aware of barriers to the issuance of a second person's notice of compliance and the provision of example scenarios outlining when certificates of supplementary protection will be eligible for inclusion on the Patent Register.

Proposed new regulations for hospital reporting of serious adverse drug reactions
Canada | 08 August 2018

Health Canada recently announced the publication of proposed Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting – Hospitals) and Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting – Hospitals). Pursuant to the proposed amendments, all hospitals must provide the specified information relating to serious adverse drug reactions and medical device incidents within 30 days of first documenting the reaction or incident.

Mid-year biosimilars update
Canada | 01 August 2018

There were a number of biosimilars developments in the first half of 2018, including with regard to approvals and patent litigation. In addition, the Canadian Agency for Drugs and Technologies in Health published its environmental scan on biosimilars and Health Canada issued its Notice to industry: Aligned reviews between Health Canada and health technology assessment organisations.

Quebec court declines to dismiss claim under Ontario Statute of Monopolies
Canada | 01 August 2018

In an action relating to amlodipine besylate (Pfizer's Norvasc), Apotex is seeking relief in the Quebec Superior Court pursuant to the Ontario Statute of Monopolies, the UK Statute of Monopolies, the Trademarks Act and unjust enrichment. Pfizer has brought a motion to dismiss Apotex's claim. The Quebec Superior Court recently dismissed an application by Pfizer (part of the motion to dismiss) to dismiss the action, finding that the court has jurisdiction under the Ontario Statute of Monopolies.

Eli Lilly seeks leave in olanzapine Section 8 damages action
Canada | 25 July 2018

In early 2018 the Federal Court of Appeal dismissed Eli Lilly Canada's appeal of a trial decision awarding more than C$70 million to Teva Canada under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. The Federal Court of Appeal recently granted Teva's cross-appeal seeking to add to its recovery lost pipe fill sales and an adjustment to account for underreporting of sales in the data relied on by both parties' experts. Eli Lilly has since applied to the Supreme Court for leave to appeal.

Supreme Court denies Idenix leave to appeal in SOVALDI dispute
Canada | 25 July 2018

The Supreme Court recently dismissed Idenix's application for leave to appeal the decision of the Federal Court of Appeal affirming the trial decision relating to two competing patents over Gilead's SOVALDI (sofosbuvir). The Federal Court of Appeal upheld the validity of Gilead's patent and declared Idenix's patent invalid on the basis of insufficiency of disclosure and inutility.

New regulations governing post-market oversight of opioids
Canada | 18 July 2018

As part of a federal initiative to address the opioid crisis, the Regulations Amending the Food and Drug Regulations (Opioids) recently came into force, adding post-market oversight of prescription opioids. The minister of health can now impose terms and conditions on the market authorisation for listed opioids. The amendments also introduce a mandatory warning sticker and patient information handout for 'Class A' opioids (as set out in Part A of the List of Opioids).

PMPRB forming working group on guideline reform
Canada | 18 July 2018

The Patented Medicine Prices Review Board (PMPRB) recently announced that the next step in its guideline reform will be the inception of a multi-stakeholder working group intended to gather stakeholder input on key technical aspects of the new regime. The PMPRB anticipates concurrently releasing more specific guidance on how it foresees putting the anticipated regulatory changes into operation.

Update on Vanessa's Law
Canada | 11 July 2018

The Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), approved in 2014, amended the Food and Drugs Act and granted new powers to the minister of health directed at post-marketing oversight of therapeutic products (ie, drugs, medical devices and drug-device combinations). There have been many developments since 2014, including the passage of certain associated regulations and the release of Health Canada guidance.

New regulations governing powers to require assessments, tests and studies
Canada | 11 July 2018

The sections of the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) that grant the minister of health powers to require assessments, tests and studies and create appropriate regulations recently came into force. Among other things, the amendments support post-market safety by imposing notification requirements for foreign incidents and eliminate the requirement for filing clinical case reports in a filed submission or supplement.

Ontario Court of Appeal dismisses summary judgment appeal in Section 8 case
Canada | 04 July 2018

The Ontario Court of Appeal recently dismissed Abbott and Takeda's appeal of the Ontario Superior Court of Justice's decision to dismiss their motion for summary judgment in an action brought by Apotex under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. The action concerned lansoprazole, the active ingredient in Apo-Lansoprazole. The Ontario Court of Appeal concluded that the motions judge had not erred in finding that Apo-Lansoprazole would have received approval in 2007.

Apotex not entitled to reopen trial on esomeprazole (Nexium) patent validity
Canada | 04 July 2018

The validity of AstraZeneca's NEXIUM patent has finally been decided by the Supreme Court of Canada, with any doubt about the court's intent resolved by its dismissal of Apotex's motion to raise new grounds of patent invalidity. The court also held that AstraZeneca was entitled to a declaration of infringement and ordered the quantification of AstraZeneca's damages or Apotex's profits.

Procedural decisions relating to Herceptin under amended PMNOC Regulations
Canada | 27 June 2018

Two recent decisions addressed procedure under the 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations. In the first case, Prothonotary Aylen ruled that the court lacked jurisdiction to consider a motion under Section 5(3.7) of the regulations to vary confidentiality rules imposed by a party that has served a notice of allegation under Section 5(3.5). In the second case, Aylen dismissed Pfizer's motion to dismiss, adjourn or delay a motion filed by Amgen under Section 6.08.

Health Canada to propose post-market amendments to Medical Devices Regulations
Canada | 27 June 2018

Health Canada recently issued a notice of intent to "propose regulatory changes to strengthen the post-market surveillance and risk management of medical devices in Canada". Among other things, the amendments will provide the minister of health with the authority to request analytical issue reports from a manufacturer when there is a suspicion of a safety concern and require manufacturers to notify Health Canada of any significant change in the safety of a medical device.

Release of information contained in drug submissions and medical device applications
Canada | 20 June 2018

In December 2017 Heath Canada released proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations, providing for the public release of clinical information contained in drug submissions and medical device applications. Health Canada recently published a draft guidance document addressing the implementation of the proposed amended regulations.

First CSPs issued and application fee increased
Canada | 20 June 2018

Health Canada recently issued the first certificates of supplementary protection (CSPs) against three approvals. In addition, on 1 April 2018 the CSP application fee was increased to C$9,192.

Intellectual Property

Countdown begins: getting ready for new patented medicines pricing regime
Canada | 16 September 2019

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.

Canada releases final amendments to patented medicines pricing regulations
Canada | 09 September 2019

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 nears end of project to modernise patent, trademark and industrial design laws
Canada | 02 September 2019

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.

Where is my CIPO mail? What to know about correspondence for Madrid applications
Canada | 02 September 2019

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.

Federal Court of Appeal dismisses first PMNOC interlocutory appeal granted leave
Canada | 19 August 2019

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.

PMPRB Steering Committee on the Modernisation of Price Review Process Guidelines releases final report
Canada | 19 August 2019

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.

Federal Court of Appeal requires PMPRB to redetermine whether patent pertains to Galderma's Differin
Canada | 12 August 2019

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.

Competition Bureau updates IP Enforcement Guidelines
Canada | 12 August 2019

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 succeeds in trademark infringement battle
Canada | 05 August 2019

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.

Detailed overview of deadlines and requirements under new Patent Rules
Canada | 29 July 2019

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.

Life sciences intellectual property: 2019 mid-year highlights
Canada | 29 July 2019

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.

Supreme Court of Canada denies Apotex leave to appeal in two cases
Canada | 08 July 2019

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.

Experimental use exception under recently amended Patent Act
Canada | 08 July 2019

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.

Infringement based on making and selling under existing NOC struck from action
Canada | 01 July 2019

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).

Update on PMPRB guidelines modernisation
Canada | 01 July 2019

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.

Federal Court dismisses Servier's application for order of prohibition regarding salt patent
Canada | 24 June 2019

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.

Canada introduces Bill C-100: step towards ratification of NAFTA 2.0
Canada | 24 June 2019

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.

Prior user rights under recently amended Patent Act
Canada | 17 June 2019

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.

Top 10 changes to Canada's trademark law
Canada | 17 June 2019

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.

Procedural decisions under PMNOC Regulations: common validity issues and naming of defendants
Canada | 10 June 2019

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.

Nice Classification with a trap – Canada introduces class top-up fees with no back door
Canada | 10 June 2019

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.

New oncology initiative and Health Canada study on biosimilar drugs
Canada | 27 May 2019

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.

Filing fee for certificates of supplementary protection now increased
Canada | 27 May 2019

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.

Amendments to Patented Medicines Regulations expected to come into force no earlier than Spring 2020
Canada | 20 May 2019

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.

Act now: follow this to-do list to save money on Canadian trademarks before 17 June 2019
Canada | 20 May 2019

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.

On the (Quebec health) record: Quebec government liable for patent infringement
Canada | 13 May 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.

Competition Bureau publishes final updated IP Enforcement Guidelines
Canada | 13 May 2019

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.

Supreme Court denies Apotex leave to appeal decision regarding India facilities
Canada | 06 May 2019

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.

Federal Court finds invalidity allegations relating to patent for metformin formulations unjustified
Canada | 22 April 2019

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.

Save money: renew all trademark registrations now
Canada | 15 April 2019

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.

Apotex seeks leave from Supreme Court of Canada in cefaclor damages action
Canada | 15 April 2019

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.

Save money: file your multi-class applications now
Canada | 25 March 2019

Canadian trademark law will be overhauled on 17 June 2019, with many significant changes – both procedural and substantive – coming into effect. This article discusses the important strategies to consider before these changes take effect, including tips that could save time and money now and in future.

Orders of prohibition relating to polymorphic form patent for Pristiq upheld on appeal
Canada | 18 March 2019

In a pair of decisions, the Federal Court granted orders prohibiting Apotex and Teva from marketing their generic o-desmethyl-venlafaxine succinate products until the expiration of Patent 2,436,668. Both Apotex and Teva appealed the decisions, claiming – among other things – that the application judge had misapplied the test for obviousness and erred in considering several aspects of the inventors' course of conduct. However, the Federal Court of Appeal recently dismissed both parties' appeals.

2018 round-up: notable trademark case law
Canada | 04 March 2019

A number of trademark cases were heard by the Canadian courts in 2018, including a decision on a motion for summary judgment brought by Duracell, a decision on whether Imperial Tobacco Canada Limited's trademarks were confusing in light of new survey evidence filed on appeal and a decision on whether retail store services require a brick-and-mortar establishment or direct delivery of products to Canada to constitute use of a trademark in Canada.

Trademarks in Canada: a year of change and global harmony
Canada | 04 March 2019

Canada's trademarks profession had an exciting 2018. The long-awaited changes to the Trademarks Act were announced, many of which will bring Canada into line with the rest of the world. In addition, further unexpected legislative developments were announced, which will significantly affect trademark protection.

Abbott and Takeda plead that third party's patent would be infringed by non-infringing alternative
Canada | 25 February 2019

On the eve of a Section 8 trial, the Ontario Superior Court granted Abbott and Takeda leave to amend their pleadings to assert that Apotex's alleged non-infringing alternative was unlawful as it would have infringed a third party's patent. The court found that Apotex had not established that it would be prejudiced by the amendment, as any delay to the trial could be compensated by costs and an adjournment if appropriate.

Apotex seeks leave to appeal ramipril pleadings amendment decision
Canada | 25 February 2019

The Ontario Court of Appeal granted Sanofi and Schering leave to amend their defences to plead the Supreme Court of Canada's decision in AstraZeneca Canada Inc v Apotex Inc. In the underlying action, Apotex relied on the invalidity decision in Sanofi-Aventis Canada v Apotex Inc as a central element of its novel claims under the Ontario Statute of Monopolies, the UK Statute of Monopolies and the Trademarks Act. Apotex recently applied for leave to appeal to the Supreme Court of Canada.

2018 round-up: notable patent cases
Canada | 11 February 2019

A number of patent decisions were taken by the Canadian courts in 2018, including one concerning a relatively rare interlocutory injunction and several others decided on the merits. Damages totalling C$7,915,000 were awarded in one case based on lost profits and reasonable royalties, as well as compound interest, but the justice refused to award punitive damages. Several of the decisions remain under appeal.

Contrasts and distinctions: 2018 Canadian patent law developments
Canada | 11 February 2019

Canada saw a range of disparate patent law developments in 2018, including the renegotiation of the North American Free Trade Agreement. Separate from this, the second federal budget bill for 2018 introduced a series of amendments to the Patent Act, which concern diverse matters such as licensing commitments on standard-essential patents and the role of the prosecution history in claim construction.

Life sciences intellectual property: 2018 highlights
Canada | 04 February 2019

There have been a number of key developments in Canadian life sciences IP and regulatory law over the past 12 months, including a consultation on the different approaches to the naming of biological drugs. Among other developments, four biosimilars were approved, the Canadian Agency for Drugs and Technologies in Health announced revisions to its biosimilar and administrative review process and significant proposed amendments to the Patent Rules were released.

What's in a name? Has Canada made it more difficult to register name and surname marks?
Canada | 28 January 2019

The Canadian Intellectual Property Office recently revised its practice notice regarding name and surname objections. Previously, examiners had to locate a minimum of 25 listings in Canadian phone directories before a name and surname objection could be raised. The revised practice notice indicates that "to better reflect the purpose of paragraph 12(1)(a)", effective immediately, examiners are no longer required to find a minimum number of listings before an objection under this section can be raised.

Federal Court of Appeal overturns cefaclor damages decision on prejudgment interest issue
Canada | 21 January 2019

The Federal Court of Appeal recently allowed in part Apotex's appeal of a decision awarding Eli Lilly over C$100 million for Apotex's infringement of eight process patents relating to the antibiotic cefaclor. The court remitted the decision to the Federal Court for reconsideration solely on the issue of interest.

Five important changes to Patent Act now in effect
Canada | 07 January 2019

The Budget Implementation Act 2018, which recently received royal assent, introduced important changes to the Patent Act that will affect the scope of protection available under Canadian patents. Effective immediately, the amendments concern licensing commitments in respect of standard-essential patents, prosecution histories in claim construction, the experimental use of patented inventions, the scope of prior user rights and written demand requirements.

New Patent Rules: 12 notable changes and tips
Canada | 24 December 2018

The government recently released its proposed new Patent Rules in the Canada Gazette. This is one of the last steps necessary for implementing the significant changes to Canada's patent law which are expected to come into force in 2019. Many of the changes intend to implement the Patent Law Treaty and help to minimise the risk of loss of rights, while others will reduce the rights of patent applicants and patentees.

Divided success in Sandoz's motion to strike monetary remedies and other novel claims
Canada | 17 December 2018

A Federal Court order has issued on a motion to strike that was brought by Sandoz in four actions relating to the infringement of rituximab patents. The court declined to strike out the claims for damages and an accounting of profits on the basis that, at law, such remedies are unavailable in such an action. The court's treatment of the novel claims by Roche may be of interest to litigants under the current scheme of the Patented Medicines (Notice of Compliance) Regulations.

Court allows Sanofi and Schering to plead that Federal Court ramipril patent invalidity decision was flawed
Canada | 17 December 2018

The Ontario Court of Appeal recently overturned a motion judge's decision denying Sanofi and Schering leave to amend their defences to plead the Supreme Court of Canada's decision in AstraZeneca Canada Inc v Apotex Inc. The present action is one of several novel claims by Apotex seeking damages pursuant to the Ontario Statute of Monopolies and the UK Statute of Monopolies.

The date is set – new trademark law will be in force June 2019
Canada | 03 December 2018

After years of uncertainty, a date has been set for the implementation of Canada's new trademark law, which will come into force on 17 June 2019. The law will bring about significant changes, including the simplification of trademark applications, the elimination of the government registration fee for new applications and the introduction of fees per class.

Anti-dilution remedy not limited to registered trademarks
Canada | 03 December 2018

Section 22 of the Trademarks Act, depreciation of a registered trademark's goodwill, is a potentially powerful yet generally underused weapon for dealing with damaging comparative advertising campaigns. Dilution-type claims to prevent comparative ads displaying a registered trademark are particularly complex as they require that the advertising actually 'use' the registered mark within the meaning of the Trademarks Act.

We have lift off: Canada's new industrial design regime launched
Canada | 26 November 2018

Numerous and substantial amendments were recently made to the Industrial Design Act and the Industrial Design Rules. The amendments will modernise Canada's industrial design law and harmonise it with other jurisdictions. Among other changes, applicants may now file a divisional application for any design that is originally disclosed – not merely claimed – in a parent application as filed and choose whether to provide a description of the design or statement of limitation.

Apotex not permitted to plead promise-based invalidity grounds in Section 8 lansoprazole action
Canada | 19 November 2018

The Ontario Superior Court of Justice recently dismissed Apotex's motion to plead promise-based invalidity grounds in a Section 8 lansoprazole action. Apotex claimed damages for delay in the issuance of its notice of compliance for its generic lansoprazole product due to prohibition applications commenced by Abbott and Takeda. Abbott and Takeda had pleaded patent infringement as a defence and brought a counterclaim for patent infringement. Apotex in turn challenged the validity of Takeda's patents.

New Bill C-86 introduces many more changes to IP laws
Canada | 19 November 2018

The government recently introduced Bill C-86. The changes introduced by the bill are in addition to the many amendments to the Trademarks Act and Patent Act yet to be brought into force. These changes represent continuing efforts by the government to update and modernise Canada's IP legislation and ensure that it is compliant with Canada's international obligations.

Amgen not precluded from asserting patent under current PMNOC Regulations
Canada | 12 November 2018

The Federal Court of Canada has refused Pfizer's motion to dismiss an action under the Patented Medicines (Notice of Compliance) (PMNOC) Regulations between Amgen and Pfizer. Pfizer sought to dismiss the action, asserting that it was redundant, scandalous, frivolous, vexatious or otherwise an abuse of process. Pfizer based its argument on a decision under the old PMNOC Regulations in which the court had found that Apotex's allegation of invalidity was justified.

Prohibition denied for Ranbaxy's bupropion extended-release tablets
Canada | 12 November 2018

The Federal Court recently dismissed Valeant's application under the Patented Medicines (Notice of Compliance) Regulations regarding Ranbaxy's bupropion extended-release tablets. The court found that the amount of permeation enhancer in the Ranbaxy formulation was outside the scope of the range claimed. As such, Ranbaxy's allegation of non-infringement was found to be justified.

Federal Court affirms that trademark use for services does not require bricks-and-mortar business in Canada
Canada | 05 November 2018

A recent Federal Court of Canada decision signals that it is maintaining consistency in its broad interpretation of use of a trademark in connection with services and provides comfort for non-Canadian businesses that have no physical presence in Canada. The decisions reverse a longstanding trend by the Trademarks Opposition Board of ignoring ancillary services as being sufficient to constitute use in Canada.

Certificate of supplementary protection regime: first anniversary update
Canada | 29 October 2018

The first anniversary of the certificate of supplementary protection (CSP) regime was 21 September 2018. CSPs, which provide an additional patent-like protection term, are intended to partly compensate innovators for the time invested in researching and obtaining regulatory approval in Canada. This article looks back on the previous year, recaps how the regime works and provides an update on the CSPs granted and rejected to date.

USMCA versus NAFTA: what's changed and what it means for intellectual property in Canada
Canada | 22 October 2018

After more than one year of negotiations, Canada recently reached a new free trade agreement with Mexico and the United States. Among other things, the US-Mexico-Canada Agreement has updated the North American Free Trade Agreement's IP chapter in order to modify the landscape for pharmaceuticals and for patent, copyright and trademark owners. While Canada is already compliant with many of the new agreement's provisions, a number of the changes may have an impact on its IP laws.

Health Canada releases statistical report on PMNOC Regulations and data protection
Canada | 15 October 2018

Health Canada recently released the Therapeutic Products Directorate Statistical Report 2017/2018, which provided an overview of its administration of the Patented Medicines (Notice of Compliance) Regulations and data protection regime. Among other things, the report includes information regarding trends in listing on the Patent Register and related court activity.

Teva succeeds in Section 8 bortezomib action
Canada | 01 October 2018

The Federal Court recently granted Teva's claim for compensation under Section 8 of the Patented Medicines (Notice of Compliance) (PMNOC) Regulations for losses suffered while market entry of Teva's bortezomib product was delayed by Janssen's applications under the PMNOC Regulations relating to Patents 2,203,936 and 2,435,146. Teva had succeeded on allegations of obviousness in both proceedings.

Eli Lilly's Effient combination use patent found obvious
Canada | 24 September 2018

The Federal Court recently dismissed Eli Lilly's application for a prohibition order, finding that Apotex's allegation of obviousness of Patent 2,432,644 (the '644 Patent) was justified. The '644 Patent covered the use of prasugrel (Eli Lilly's Effient) in combination with aspirin for diseases caused by thrombus or embolus. Apotex made a number of attacks on the patent's validity, specifically with regard to patentable subject matter, obviousness and sufficiency and overbreadth.

Federal Court dismisses first motion for early dismissal under amended PMNOC Regulations
Canada | 24 September 2018

The Federal Court recently dismissed the first motion for summary dismissal brought under Section 6.08 of the amended Patented Medicines (Notice of Compliance) Regulations. The underlying action for infringement concerned Amgen Canada's regulatory submission for approval of its biosimilar of Hoffmann-La Roche's Herceptin. Amgen sought to dismiss the action regarding two of the four asserted patents, both of which contained use claims.

No store, no problem: broad interpretation of 'use' advantageous for foreign retail trademark owners
Canada | 17 September 2018

Non-Canadian retailers can breathe a sigh of relief thanks to a recent Federal Court decision which reaffirms its position that providing retail store services does not require a bricks-and-mortar establishment or direct delivery of products to Canada to constitute 'use' of a trademark in Canada. The decision also reverses the Trademarks Opposition Board's longstanding trend of ignoring ancillary services as being sufficient to constitute 'use' in Canada.

Alexion denied leave to appeal in case challenging constitutionality of PMPRB's remedial powers
Canada | 10 September 2018

The Supreme Court of Canada recently dismissed Alexion Pharmaceuticals' application for leave to appeal the Federal Court of Appeal decision in Alexion Pharmaceuticals Inc v Canada (Attorney General). The Federal Court of Appeal had dismissed Alexion's challenge of the constitutionality of certain Patent Act provisions relating to the Patented Medicine Prices Review Board's remedial powers.

Shire's VYVANSE patent valid, prohibition order issued
Canada | 03 September 2018

The Federal Court has granted Shire's application under the pre-amended Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the minister of health from issuing a notice of compliance to Apotex for its lisdexamfetamine product (Shire's Vyvanse) until the expiry of Canadian Patent 2,527,646. The application had been consolidated with Apotex's action seeking a declaration of invalidity and non-infringement and was decided on the basis of the evidence adduced in that action.

Date set for implementation of Hague Agreement and modernised industrial design regime
Canada | 06 August 2018

The government recently published the new Industrial Design Regulations in the Canada Gazette and set 5 November 2018 as the date on which the amendments to the Industrial Design Act and the regulations will come into force. The amendments will allow applicants to file international design applications designating Canada under the Hague Agreement and will be the first of several major changes to Canada's IP regime expected to take effect over the next year.

Media pirates walk the plank: extraordinary remedies against copyright infringers
Canada | 06 August 2018

In most jurisdictions, copyright owners face numerous challenges when seeking to enforce their rights against media pirates, including with regard to ongoing harm pending judgment, proving damages and unscrupulous defendants destroying evidence or failing to comply with court orders. However, in a series of recent decisions, the Federal Court granted various extraordinary remedies against media pirates, making Canada an attractive forum for copyright owners to litigate such cases.

Eli Lilly seeks leave in olanzapine Section 8 damages action
Canada | 09 July 2018

In early 2018 the Federal Court of Appeal dismissed Eli Lilly Canada's appeal of a trial decision awarding more than C$70 million to Teva Canada under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. The Federal Court of Appeal recently granted Teva's cross-appeal seeking to add to its recovery lost pipe fill sales and an adjustment to account for underreporting of sales in the data relied on by both parties' experts. Eli Lilly has since applied to the Supreme Court for leave to appeal.

PMPRB forming working group on guideline reform
Canada | 02 July 2018

The Patented Medicine Prices Review Board (PMPRB) recently announced that the next step in its guideline reform will be the inception of a multi-stakeholder working group intended to gather stakeholder input on key technical aspects of the new regime. The PMPRB anticipates concurrently releasing more specific guidance on how it foresees putting the anticipated regulatory changes into operation.

Supreme Court denies Idenix leave to appeal in SOVALDI dispute
Canada | 02 July 2018

The Supreme Court recently dismissed Idenix's application for leave to appeal the decision of the Federal Court of Appeal affirming the trial decision relating to two competing patents over Gilead's SOVALDI (sofosbuvir). The Federal Court of Appeal upheld the validity of Gilead's patent and declared Idenix's patent invalid on the basis of insufficiency of disclosure and inutility.

Top five reasons to consider patent litigation in Canada
Canada | 25 June 2018

Canada has historically been a much less active jurisdiction for patent litigation compared to the United States, which can be explained in part by the simple fact that the US market is almost 10 times the size of the Canadian market. However, there are a few notable differences in the procedure and substantive law applied in both jurisdictions that have resulted in Canada becoming an increasingly attractive option for high-stakes patent litigation in recent years.

Ontario Court of Appeal dismisses summary judgment appeal in Section 8 case
Canada | 25 June 2018

The Ontario Court of Appeal recently dismissed Abbott and Takeda's appeal of the Ontario Superior Court of Justice's decision to dismiss their motion for summary judgment in an action brought by Apotex under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. The action concerned lansoprazole, the active ingredient in Apo-Lansoprazole. The Ontario Court of Appeal concluded that the motions judge had not erred in finding that Apo-Lansoprazole would have received approval in 2007.

Procedural decisions relating to Herceptin under amended PMNOC Regulations
Canada | 18 June 2018

Two recent decisions addressed procedure under the 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations. In the first case, Prothonotary Aylen ruled that the court lacked jurisdiction to consider a motion under Section 5(3.7) of the regulations to vary confidentiality rules imposed by a party that has served a notice of allegation under Section 5(3.5). In the second case, Aylen dismissed Pfizer's motion to dismiss, adjourn or delay a motion filed by Amgen under Section 6.08.

Apotex not entitled to reopen trial on esomeprazole (Nexium) patent validity
Canada | 18 June 2018

The validity of AstraZeneca's NEXIUM patent has finally been decided by the Supreme Court of Canada, with any doubt about the court's intent resolved by its dismissal of Apotex's motion to raise new grounds of patent invalidity. The court also held that AstraZeneca was entitled to a declaration of infringement and ordered the quantification of AstraZeneca's damages or Apotex's profits.

Teva seeks leave in levofloxacin damages assessment
Canada | 04 June 2018

The Federal Court of Appeal recently dismissed Teva's appeal regarding the quantification of damages for its infringement of Janssen's patent for levofloxacin (Levaquin). The Federal Court of Appeal rejected Teva's arguments, finding that the Federal Court had not erred in constructing the hypothetical world and that its factual findings were supported by evidence. On 26 March 2018 Teva applied to the Supreme Court for leave to appeal.

First CSPs issued and application fee increased
Canada | 04 June 2018

Health Canada recently issued the first certificates of supplementary protection (CSPs) against three approvals. In addition, on 1 April 2018 the CSP application fee was increased to C$9,192.

New patent term extension framework
Canada | 28 May 2018

The amendments to the Patent Act and the enactment of the Certificate of Supplementary Protection (CSP) Regulations flowing from the Canada-EU Comprehensive Economic and Trade Agreement introduced a new framework in Canada for the issuance of CSPs. CSPs provide an additional patent-like protection term and are intended to partly compensate innovators for the time required to research and obtain regulatory approval in Canada.

Apotex fails to establish that it would have obtained non-infringing product from foreign suppliers
Canada | 28 May 2018

Servier and its related company ADIR were recently successful in another chapter of the patent litigation concerning perindopril when the Federal Court again dismissed the non-infringing alternative defence of Apotex Inc and Apotex Pharmachem Inc (collectively, Apotex). The court found that Apotex would not have called on foreign third parties to manufacture perindopril to supply its affiliates in the United Kingdom and Australia and thus reaffirmed the quantum of profits from its original judgment.

Colour it mine: protecting colour trademarks
Canada | 21 May 2018

A number of changes will soon be made to Canadian trademark law, which will make it possible to protect a colour per se as a trademark (as opposed to a colour applied to a product with a particular shape). Rights holders seeking to protect colours as trademarks in Canada may therefore benefit from the new regime. However, overcoming objections based on functionality or establishing distinctiveness may present significant new hurdles to the registration of such marks.

Federal Court grants motion to strike plaintiff's quia timet pleading in oxycodone infringement action
Canada | 21 May 2018

In a recent case, the Federal Court granted the plaintiff's motion to strike a rival pharmaceutical company's statement of claim for infringement of a patent relating to oxycodone salt. The court overturned the prothonotary's dismissal of the motion, finding that the facts alleged nothing beyond the regulatory use exemption and that the imminence branch of the test for a quia timet action had not been met.

Patented Medicine Prices Review Board releases March 2018 newsletter
Canada | 14 May 2018

The Patented Medicine Prices Review Board (PMPRB) recently released its March 2018 newsletter (the first since July 2017). Highlights include an update on the PMPRB guidelines, the release of the PMPRB's 2016 annual report and notice that several publications will be released in 2018.

Federal Court declares invalid patent for medical device measuring osmolarity of tear film
Canada | 14 May 2018

The Federal Court recently found certain claims of a patent relating to a chip for measuring the osmolarity of a sample of bodily fluid, including tear film, invalid on the basis of obviousness and anticipation. The court agreed with the claim construction urged by the plaintiffs, finding that the claims encompassed both in vivo and ex vivo applications of the invention. Thus, the defendant's competing medical device – which measured osmolarity in vivo – fell within the scope of the claims.

Alexion files for leave to appeal to Supreme Court in challenge of PMPRB's remedial powers
Canada | 07 May 2018

Alexion Pharmaceuticals recently filed an application for leave to appeal a Federal Court of Appeal decision to the Supreme Court. In its decision, the Federal Court of Appeal had dismissed Alexion's challenge of the constitutionality of certain Patented Medicine Prices Review Board provisions provided for in the Patent Act.

New use patent valid and infringed by biosimilar
Canada | 07 May 2018

The Federal Court recently upheld the validity of Kennedy Trust's patent covering a use of infliximab (Janssen's Remicade) and granted Kennedy's counterclaim that Hospira's biosimilar Inflectra had infringed the patent. This is the third patent infringement action decision relating to a biologic and the second on the merits relating to a biosimilar.

Court dismisses Section 8 damages appeal and grants cross-appeal
Canada | 23 April 2018

The Federal Court of Appeal recently issued public reasons for its dismissal of Eli Lilly Canada Inc's appeal of a Federal Court decision that had awarded Teva Canada Limited more than C$70 million under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. Further, the court granted Teva's cross-appeal – which sought to add to its recovery of lost pipefill sales – and an adjustment to account for an underreporting of sales in the data relied on by both parties' experts.

No Section 8 liability for valid and infringed patent in Nexium proceeding
Canada | 23 April 2018

If a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) Regulations against a generic entrant, but subsequently prevails in an infringement action regarding the same patent, can it be liable for Section 8 damages under the regulations? According to a recent Federal Court decision, the answer appears to be no.

How cannabis brand owners can cover their buds with plant breeders' rights
Canada | 16 April 2018

The federal government is moving quickly towards legalising the possession and consumption of cannabis for recreational purposes. Although Canada's cannabis industry is already 'overgrown' with many licensed and unlicensed producers all vying for consumers' attention with different brands and strains of cannabis, only a few have taken advantage of the exclusive rights afforded producers under the Plant Breeders' Rights Act.

Accounting of profits remedy offers significant benefits to patent owners
Canada | 16 April 2018

The availability of an accounting of profits in Canada as a remedy for patent infringement can offer significant benefits to patentees, including in cases involving infringing goods sourced from Canada that are being sold elsewhere. The availability of such a remedy and a number of other factors, including the ability to expedite proceedings and the lower cost of litigation, make Canada an attractive jurisdiction for patentees from the United States and elsewhere to litigate patent infringement matters.

Federal Court of Appeal confirms patent infringer not entitled to dictate appropriate remedy
Canada | 09 April 2018

In 2016 the Federal Court found that Apotex and Cobalt had infringed Bayer's valid patent for an oral contraceptive composition. The Federal Court subsequently held that Bayer was entitled to elect between damages and an accounting of Apotex's profits. In so holding, the court disagreed with Apotex's argument that it, rather than Bayer, should be entitled to elect whether Bayer should be limited to recovering Apotex's profits. The Federal Court of Appeal recently dismissed Apotex's appeal of the latter decision.

The trolls have arrived: suspicious trademark applications on the rise
Canada | 09 April 2018

In some cases, trolls (or 'squatters') apply for trademarks that are used by brand owners in other countries with the goal of forcing those owners to negotiate with the trolls when they enter the new market. In light of Canada's use-based trademark system, this had not previously been viewed as a serious problem. However, the announcement that amendments to the Canadian Trademarks Act will eliminate use requirements poses the risk of trolls targeting Canada.

Government announces suspension of IP provisions under CPTPP
Canada | 02 April 2018

The government recently published the Comprehensive and Progressive Partnership for Trans-Pacific Partnership (CPTPP) - Backgrounder. According to the backgrounder, Canada and other signatories have agreed to suspend certain IP, patent and pharmaceutical obligations under the Trans-Pacific Partnership, including with respect to patent term adjustments to compensate for unreasonable patent office delays and marketing authorisation delays.

Court denies pleading amendments regarding Supreme Court decision that struck down promise doctrine
Canada | 02 April 2018

After the Federal Court found certain claims of a Canadian patent to be invalid, Apotex sought relief in the Ontario Superior Court of Justice pursuant to the Ontario Statute of Monopolies, the UK Statute of Monopolies and the Trademarks Act. The latter court recently dismissed motions by the defendants for leave to amend their statements of defence following the recent Supreme Court decision in AstraZeneca Canada Inc v Apotex Inc, which struck down the promise doctrine.

Court approves website seizure and Anton Piller order against online copyright piracy platform
Canada | 26 March 2018

The Federal Court of Appeal recently declared that an interim injunction authorising the shutdown and seizure of piracy websites and an Anton Piller order were legal and had been properly executed. The court also granted an interlocutory injunction against the owner and operator of these websites, which had hosted and distributed a number of add-ons. The court noted that these add-ons had been designed to facilitate access to infringing material and could not benefit from the conduit exception to infringement.

Federal Court of Appeal dismisses Teva's levofloxacin damages appeal
Canada | 26 March 2018

The Federal Court of Appeal recently issued public reasons for its decision dismissing Teva's appeal relating to the damages and costs that the Federal Court had awarded against it for its infringement of Janssen's patent for levofloxacin (Levaquin). The Federal Court had awarded close to C$19 million in damages and pre-judgment interest to the plaintiffs and subsequently granted C$1 million in costs.

Signed, sealed and almost delivered: new trademark law in sight
Canada | 19 March 2018

Although the new trademark law was finalised in 2014, it has yet to come into force. Before it can be implemented, the government must finalise new trademarks regulations and the Trademarks Office's IT system must be modified to accommodate the changes to the law. Once implemented, the changes will be the most significant in 50 years – both procedurally and substantively.

Don't let your brand go to pot: what cannabis brand owners need to know
Canada | 19 March 2018

The federal government is moving quickly towards legalising the possession and consumption of cannabis for recreational purposes. However, Canada's cannabis industry is already 'overgrown' with both licensed and unlicensed producers, all vying for consumers' attention. Brand owners, start-ups and so-called 'ganjapreneurs' in Canada's cannabis industry face a number of unique challenges and should strategise accordingly – ideally before launching a cannabis brand in Canada.

Patent Prosecution Highway: getting your patent application into the fast lane
Canada | 12 February 2018

Canada launched its Patent Prosecution Highway programme in 2008 with the goal of fast tracking patent examination and improving patent quality. The programme has been a phenomenal success and offers numerous benefits to applicants. Data published by the Canadian Intellectual Property Office suggests that applicants which use it have their applications examined sooner and encounter fewer office actions.

Top 10 IP law and practice highlights of 2017
Canada | 05 February 2018

Canadian IP law and practice saw significant developments in 2017, including the largest award for patent infringement in Canadian history and the Supreme Court's abolition of the controversial 'promise of the patent' doctrine. Further, in terms of foreshadowing a significant overhaul to Canada's IP legislation across all areas, 2017 was an active year.

Biosimilars update
Canada | 29 January 2018

There were a number of developments concerning biosimilars in 2017. For example, new certificates of supplementary protection now apply to biologics and numerous patent litigations involved biosimilars. In addition, Health Canada held a workshop and issued a report which notes that it intends to consult with stakeholders about the impact of the naming of biosimilars on prescribing, dispensing and pharmacovigilance needs.

Six key trademark filing and protection strategies in 2018
Canada | 22 January 2018

With the start of 2018, the countdown to the implementation of Canada's new trademark law has begun in earnest. While the changes will have benefits, there will also be some new challenges. However, a number of key strategies can be employed now in order to obtain maximum benefit from the existing legal landscape for trademarks in Canada and prepare brand owners for the new law.

Proposed new Industrial Design Regulations mark step towards joining Hague Agreement
Canada | 22 January 2018

The governor in council recently took the formal step of publishing proposed new Industrial Design Regulations in the Canadian Gazette. The regulations are being amended in order to allow Canada to join the Hague Agreement Concerning the International Registration of Industrial Designs, which provides a mechanism for registering an industrial design in several countries by means of a single application.

Canada releases proposed amendments to patented medicines pricing regulations
Canada | 15 January 2018

The governor in council recently published the proposed Regulations Amending the Patented Medicines Regulations. The proposed regulations represent a significant overhaul of the Patented Medicines Regulations and are estimated by Health Canada to result in savings of C$12.6 billion net present value over 10 years. While the regulations have yet to be adopted, companies should be factoring these potential changes into their business planning now.