Smart & Biggar/Fetherstonhaugh

Toronto ON

Smart & Biggar is Canada's largest firm practising exclusively in intellectual property and technology law. Within industry and our profession, we have earned a national and international reputation for excellence. Related through common partners and personnel to Fetherstonhaugh, the firms have been dedicated to efficiently providing clients with service of the highest quality for over a century.

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Updates

Healthcare & Life Sciences

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 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.

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 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.

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.

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.

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".

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Supreme Court denies leave regarding natural health product licence
Canada | 13 June 2018

The Supreme Court recently dismissed The Winning Combination's leave to appeal. The Federal Court of Appeal had previously set aside the order of mandamus compelling the minister of health to grant a licence to The Winning Combination for its natural health product, Resolve.

Teva seeks leave in levofloxacin damages assessment
Canada | 13 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.

Health Canada reports on consultation on proposed approach to cannabis regulation
Canada | 06 June 2018

Bill C-45 – An Act respecting Cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and Other Acts – is currently before the Senate. Rather than pre-publishing draft regulations, the government released regulatory proposals by way of a consultation paper. Health Canada recently announced the release of a report which provides a summary of the comments received on the consultation paper.

Apotex fails to establish that it would have obtained non-infringing product from foreign suppliers
Canada | 06 June 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.

CADTH releases 2018-2021 strategic plan
Canada | 30 May 2018

The Canadian Agency for Drugs and Technologies in Health (CADTH) recently announced the release and published a brief overview of its strategic plan for 2018 to 2021. According to the plan, the CADTH – a health technology assessment agency – plans to transition to a health technology management agency.

Proposed national pharmacare programme and prescription and generic drug pricing modifications
Canada | 30 May 2018

Unlike many Organisation for Economic Cooperation and Development member countries, Canada has no national pharmacare programme (ie, a single system of public insurance coverage for prescription drugs). However, the Standing Committee on Health recently released a report advocating the establishment of such a programme as an insured service under the Health Act. The report also made a number of recommendations, including with respect to drug pricing.

Costco pharmacy directors fined for professional misconduct
Canada | 23 May 2018

The discipline committee of the Ontario College of Pharmacists recently found that two directors of Costco pharmacies had committed acts of professional misconduct by soliciting C$1,266,000 in payments relating to advertising which would reasonably be regarded as rebates for the purchase of interchangeable drug products.

Federal Court grants motion to strike plaintiff's quia timet pleading in oxycodone infringement action
Canada | 23 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.

CADTH Common Drug Review accepting submissions up to six months before market approval
Canada | 16 May 2018

The Canadian Agency for Drugs and Technologies in Health has announced that the Common Drug Review Programme will now accept drug submissions up to six months before a drug manufacturer's anticipated receipt of a notice of compliance (NOC) or NOC with conditions from Health Canada.

Consultation on proposed regulations under Health Sector Payment Transparency Act 2017
Canada | 16 May 2018

The Ontario legislature recently passed the Strengthening Quality and Accountability for Patients Act 2017, which enacts or amends 10 statutes, including the Health Sector Payment Transparency Act 2017. When in force, the transparency act will require the disclosure of financial relationships between pharmaceutical or medical device manufacturers (among other payors) and healthcare professionals (among other recipients).

Alexion files for leave to appeal to Supreme Court in challenge of PMPRB's remedial powers
Canada | 09 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.

Patented Medicine Prices Review Board releases March 2018 newsletter
Canada | 09 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 Budget 2018 announces advisory council for national pharmacare programme
Canada | 02 May 2018

The federal budget was recently tabled in the House of Commons. It announced the creation of the Advisory Council on the Implementation of National Pharmacare, which will be led by former Minister of Health of Ontario Eric Hoskins and make recommendations on potential approaches to national pharmacare.

New use patent valid and infringed by biosimilar
Canada | 02 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 | 18 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. 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 | 18 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.

Federal Court of Appeal confirms patent infringer not entitled to dictate appropriate remedy
Canada | 11 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.

Court denies pleading amendments regarding Supreme Court decision that struck down promise doctrine
Canada | 04 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.

CADTH outlines revisions to biosimilar and pharmaceutical review programmes
Canada | 04 April 2018

In its Common Drug Review Update – Issue 133, the Canadian Agency for Drugs and Technologies in Health announced revisions to its biosimilar and administrative review process. Among other things, the update created a streamlined approach for biosimilar reviews, made application fees applicable to all Common Drug Review submissions and resubmissions and introduced new fee guidance for pharmaceutical review programmes.

Health Canada publishes updated guidance on classification of products at device-drug interface
Canada | 28 March 2018

Health Canada recently published an update to the guidance document Classification of Products at the (Medical) Device-Drug Interface. The update is intended to reflect the changes to the definition of a 'medical device' made to the Food and Drugs Act following the enactment of the Protecting Canadians from Unsafe Drugs Act and bring greater clarity to the description of how Health Canada classifies health products at the device-drug interface.

PMPRB releases report analysing generic drug pricing
Canada | 28 March 2018

The Patented Medicine Prices Review Board (PMPRB) recently announced the publication of the most recent edition of its series of reports on generic drug pricing. Generics360 compares generic drug prices in Canada with those in other countries, with a particular focus on the PMPRB comparator countries. Although not factored into the published results, the report also describes a joint initiative to introduce price discounts of 25% to 40% on some of the most commonly prescribed drugs.

Federal Court of Appeal dismisses Teva's levofloxacin damages appeal
Canada | 21 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.

Health Canada implements mandatory use of eCTD format
Canada | 14 March 2018

Health Canada previously announced January 1 2018 as the proposed date for mandatory filing of specified regulatory activity. As such, all new drug submission, supplementary new drug submission, abbreviated new drug submission and supplemental abbreviated new drug submission regulatory activities for human drugs – as well as additional information and subsequent regulatory activities and transactions – must be filed in Electronic Common Technical Document format as of this date.

Stakeholder consultation on naming of biologic drugs, including biosimilars
Canada | 14 March 2018

Health Canada and the Institute for Safe Medication Practices Canada recently opened their consultation on different approaches to the naming of biologic drugs, including biosimilars. The consultation aims to gain insight into stakeholder views on the practical impacts of different approaches to the naming of biologic drugs and biosimilars throughout the medication use process, including prescribing, dispensing and adverse drug reaction reporting.

Consultation on use of foreign-sourced reference product as Canadian reference product
Canada | 07 March 2018

Health Canada recently published a notice soliciting comments and recommendations from stakeholders regarding potential changes to its guidance document on the use of a foreign-sourced reference product as a Canadian reference product. Stakeholder feedback should be submitted to Health Canada by March 18 2018, preferably in electronic form.

New guidance document on administrative processing of drug submissions and applications
Canada | 07 March 2018

Health Canada recently announced a guidance document clarifying the requirements for drug submissions and applications to be processed under the administrative pathway. The administrative pathway will be available, with some restrictions, for manufacturer and product name change applications, additional product name applications and licensing agreements between two manufacturers. The guidance will be effective from March 1 2018.

Appeal of summary dismissal under PMNOC Regulations: dismissal order stayed
Canada | 28 February 2018

The Federal Court recently dismissed a Patented Medicines (Notice of Compliance) Regulations application concerning Apotex's generic aripiprazole product on a summary basis under Section 6(5)(b) of the regulations. An appeal was subsequently filed. On December 15 2017 the Federal Court of Appeal granted a motion by the appellants to stay the dismissal order until the appeal could be heard. The appeal was recently allowed on the parties' consent.

Apotex granted damages for delayed FDA approval of two products
Canada | 28 February 2018

The Ontario Superior Court of Justice recently held that Apotex was entitled to damages for losses resulting from delays in the US Food and Drug Administration's approval of two of its products, which had been caused by contractual breaches and negligence on the part of MDS Pharma Services. Due to MDS's failure to comply with the US regulatory framework for conducting bioequivalence studies, Apotex had been unable to rely on the MDS studies and was forced to repeat them, thus delaying US market entry.

Federal Court grants summary dismissal motion under PMNOC Regulations
Canada | 14 February 2018

The Federal Court recently issued its judgment in Bristol-Myers Squibb v Apotex Inc, in which it granted Apotex's motion under Section 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations. As a result, the court granted an order dismissing the underlying application in respect of Apotex's proposed generic aripiprazole product.

Ontario Bill 160 receives royal assent
Canada | 14 February 2018

Ontario Bill 160, the Strengthening Quality and Accountability for Patients Act 2017, enacts or amends 10 statutes, including the Health Sector Payment Transparency Act 2017. The act will require payors – including manufacturers of pharmaceutical or medical devices – to report financial relationships with healthcare professionals and organisations, as well as other prescribed recipients.

Life sciences intellectual property: 2017 highlights
Canada | 07 February 2018

With major developments regarding patent linkage, patent term and other substantive patent issues, 2017 was one of the most significant years in history for Canadian life sciences IP and regulatory law. Highlights included the Supreme Court's striking down of the promise doctrine, the Canada-EU Comprehensive Economic and Trade Agreement amendments and the laying of the foundations to overhaul the Patented Medicine Prices Review Board regulations and guidance.

Proposed amendments to Food and Drug Regulations and Medical Devices Regulations
Canada | 07 February 2018

Among other changes, Health Canada recently released proposed amendments to the Food and Drug Regulations. Under the amendments, "clinical summaries, reports and supporting data of clinical trials submitted in support of a drug submission" would cease to be treated as confidential and would be released to the public following a final regulatory decision, with no requirement to notify the affected party of the release.

Senate reviews Cannabis Act
Canada | 31 January 2018

The so-called 'Cannabis Act', which provides a framework for restricted access to cannabis and is intended to come into force no later than July 2018, recently passed its first reading in the Senate. Concurrently, Health Canada issued a notice of intent to develop regulations under the proposed act and launched a public consultation, which was open for comments until January 20 2018.

Supreme Court dismisses Apotex's leave application
Canada | 31 January 2018

​In April 2017 the Federal Court of Appeal overturned the Federal Court's conclusion that Apotex had failed to mitigate the loss that it incurred as a result of Health Canada's tortious conduct in considering Apotex's Apo-Trazodone drug submission. The Federal Court of Appeal otherwise dismissed the parties' appeals relating to Apotex's claims in negligence, misfeasance in a public office and contract. The Supreme Court recently dismissed Apotex's leave application.

Health Canada issues guidance on use of foreign-sourced reference products as CRPs
Canada | 24 January 2018

Health Canada recently issued a guidance document on the use of foreign-sourced reference products as Canadian reference products. The guidance is directed at sponsors of all abbreviated new drug submissions and abbreviated extraordinary use new drug submissions that seek to obtain approval based on a demonstration of pharmaceutical equivalence and bioequivalence to a reference drug product marketed outside Canada.

Biosimilars update
Canada | 24 January 2018

There were a number of developments concerning biosimilars in 2017. For example, 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. In addition, the Comprehensive Economic and Trade Agreement amendments have had an effect on biologics and numerous patent litigations involved biosimilars.

PMPRB releases scoping paper concerning proposed amended regulations
Canada | 17 January 2018

The Patented Medicine Prices Review Board recently released a high-level overview of the potential new framework proposed by the Regulations Amending the Patented Medicines Regulations. The overview aims to provide a non-binding outline of preliminary thoughts on how best to implement the proposed changes and should be read in conjunction with the proposed amendments and the regulatory impact analysis statement.

Decision striking out challenge to constitutionality of PMPRB regime upheld
Canada | 17 January 2018

The Federal Court of Appeal recently upheld the decision striking out Alexion's pleadings challenging the constitutionality of the Patented Medicine Prices Review Board (PMPRB) regime. The Federal Court of Appeal upheld the decision on the basis of, among other things, the fact that Alexion had not been entitled to bring the constitutional issue before the Federal Court, as it had not raised the issue before the PMPRB.

Canada releases proposed amendments to patented medicines pricing regulations
Canada | 10 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.

Health Canada publishes final guidance documents on quality requirements for regulatory filings
Canada | 03 January 2018

Health Canada recently published the final version of a number of guidance documents and templates which implement new requirements for new drug submissions and abbreviated new drug submissions. The changes will be implemented by way of a phased-in approach, with the general quality guidance requirements being implemented in January 2018 and the new stability requirements and requirements for commercial and pilot scale batches being implemented in October 2019.

PMPRB releases Annual Report 2016
Canada | 20 December 2017

The federal minister of health recently submitted the Patented Medicine Prices Review Board Annual Report 2016 to the House of Commons and the Senate. The report indicates that in 2016 Canadian patented drug prices were the fourth-highest among the seven comparator countries against which the board reviewed prices and that sales of patented drug products totalled C$15.5 billion. Research and development spending remained unchanged from 2015.

Intellectual Property

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

Streamlined trademark litigation – Federal Court of Appeal opens door to full compensation
Canada | 15 January 2018

A recent Federal Court of Appeal decision has shed light on a streamlined litigation procedure that brand owners may find attractive. In its decision, the court suggested that trademark owners which commence infringement proceedings in the Federal Court, by way of the summary procedure known as 'application', may still be able to recover damage awards – even by way of a reference.

PMPRB releases Annual Report 2016
Canada | 08 January 2018

The federal minister of health recently submitted the Patented Medicine Prices Review Board Annual Report 2016 to the House of Commons and the Senate. The report indicates that in 2016 Canadian patented drug prices were the fourth-highest among the seven comparator countries against which the board reviewed prices and that sales of patented drug products totalled C$15.5 billion. Research and development spending remained unchanged from 2015.

Federal Court declines to assess litigation funding arrangement in patent infringement case
Canada | 08 January 2018

The plaintiff in a patent infringement action against Pfizer recently brought a motion seeking approval of a litigation funding agreement (LFA) with a third party, as required by the terms of the agreement. The prothonotary dismissed the motion on the basis that such approval is not required beyond class proceedings. Further, the Federal Court had no jurisdiction to determine the validity of the LFA.

Recent developments in Alexion cases
Canada | 18 December 2017

The Federal Court of Appeal recently heard Alexion's appeal of a decision striking out its constitutional challenge to the price regulation scheme and confiscatory powers found in the Patent Act. A decision is under reserve. Alexion also has a pending judicial review of the Patented Medicine Prices Review Board's decision that it sold Soliris (eculizumab) at excessive prices.

Federal Court finds PMPRB unreasonable in determining that patent pertains to medicine
Canada | 18 December 2017

The Federal Court recently found that the Patented Medicine Prices Review Board's assessment that a patent pertained to Galderma Canada's Differin was unreasonable, as it had failed to consider the entire patent. As a result, the court quashed the board's decision requiring Galderma to file pricing information for Differin.

Patented Medicine Prices Review Board update
Canada | 27 November 2017

The Patented Medicine Prices Review Board recently announced the release of a hearing panel's decision regarding the pricing of a breakthrough drug and the publication of a report which compares lists of drugs covered by the public drug plans to determine the extent of overlap in drug coverage. Further, in response to an unopposed request filed by the board to do so, a hearing panel discontinued an excessive pricing proceeding relating to Apotex's Apo-Salvent CFC Free.

Court declares that administrative errors during application cannot void issued patent
Canada | 27 November 2017

The Federal Court of Appeal recently ruled that Pfizer's failure to pay the correct issue fee did not render its patent void. In the context of a Section 8 case, Apotex had brought a partial summary judgment motion to have Pfizer's patent declared void for failure to comply with the Patent Act. The court cited the general principle that "pre-patent issuance defects in the administrative process for applying for a patent cannot be relied upon by an alleged infringer to render a patent void".

Idenix seeks leave to appeal from Supreme Court in SOVALDI dispute
Canada | 13 November 2017

The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents concerning Gilead's SOVALDI (sofosbuvir). The Court of Appeal upheld the validity of Gilead's Patent 2,527,657 and declared Idenix's Patent 2,490,191 invalid on the basis of insufficiency of disclosure and inutility. Idenix has applied to the Supreme Court for leave to appeal.

Pfizer obtains prohibition orders for polymorphic form patent
Canada | 06 November 2017

The Federal Court recently granted prohibition orders preventing Apotex and Teva from marketing their generic o-desmethyl-venlafaxine products (based on Pfizer's Pristiq) until the expiry of Patent 2,436,668. The court held that Apotex's allegations regarding non-infringement and invalidity on the basis of obviousness, inutility, anticipation double patenting and overpromising and Teva's allegations of invalidity on the basis of obviousness and inutility were not justified.

AstraZeneca and overpromising on grounds other than utility
Canada | 06 November 2017

The Supreme Court recently dismissed Apotex's motion to amend its judgment in AstraZeneca Canada Inc v Apotex Inc. Apotex had asked that the case be remanded to the Federal Court to determine whether overpromising has rendered the 653 Patent invalid. Two recent Federal Court decisions also illustrate attempts to raise overpromising as a ground of invalidity outside the promised utility doctrine rejected in AstraZeneca.

New challenges and opportunities for pharmaceutical trademarks
Canada | 23 October 2017

In Canada, trademarks for pharmaceutical preparations and related products have faced numerous challenges, some of which are unique to the industry. In addition, a number of important changes and new opportunities will be introduced by upcoming amendments to the trademark law, which are expected to come into force in 2019.

Federal Court of Appeal applies Supreme Court's utility test to Sprycel patent
Canada | 16 October 2017

The Federal Court of Appeal – in its first decision to consider the Supreme Court's landmark decision in AstraZeneca Canada Inc v Apotex Inc on the utility requirement – recently overturned a finding of inutility made under the promise doctrine, with practical guidance for the requirement of a scintilla of utility. Following the Supreme Court's decision, the Federal Court of Appeal reversed the Federal Court's decision, noting that the Supreme Court had unanimously abolished the promise doctrine.

Protecting your brand at the border: new reporting mechanism for dangerous counterfeit goods
Canada | 09 October 2017

The Canada Border Services Agency, the federal organisation responsible for policing Canada's borders, recently issued a customs notice to advise the public and rights holders that its Border Watch hotline now accepts information and tips on dangerous counterfeit or pirated goods that are destined for Canada. This hotline is yet another tool available to rights holders that wish to protect their brands in Canada.

AstraZeneca succeeds in omeprazole patent infringement profits case
Canada | 02 October 2017

The Federal Court recently issued its public judgment and reasons concerning the financial compensation to be paid to AstraZeneca as a result of Apotex's infringement of the omeprazole formulation patent. AstraZeneca sought an account of Apotex's profits after the court found that the omeprazole formulation patent was valid and had been infringed during the liability phase. The remaining issues were decided in AstraZeneca's favour.

Structural engineers score big as Federal Court enforces copyright on football complex structure
Canada | 02 October 2017

In a recent case, the Federal Court confirmed that the plaintiff's steel structure for an indoor football complex could benefit from copyright protection in Canada as an 'architectural work' under the Copyright Act. This is the first time in nearly 50 years that a building structure has been granted this protection by the Canadian courts.

A new frontier for global IP litigation
Canada | 25 September 2017

A series of recent cases, from big trials to precedent-setting appeals before the Supreme Court, have garnered international attention from IP owners. With these decisions, changes in law and improved court procedures for assisting litigants in getting to trial and obtaining interlocutory remedies more efficiently, Canada is proving to be an attractive jurisdiction for the protection and enforcement of IP rights.

Gilead prevails in SOVALDI appeal
Canada | 11 September 2017

The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents over Gilead's SOVALDI (sofosbuvir). In the trial decision, the court had declared Idenix's patent invalid on the basis of insufficiency of disclosure and inutility, while upholding the validity of Gilead's patent. While the case did not raise new issues of law, some points arose which may have broader applicability to future cases.

Proposed amendments to Patent Rules published for public consultation
Canada | 21 August 2017

The government recently opened a public consultation on proposed amendments to the Patent Rules. The changes relate principally to pending amendments to the Patent Act that are intended to bring it into compliance with the Patent Law Treaty. A number of significant changes to Canadian patent practice will result if the proposed rules come into force in their present form.

Down, but not out – initial adverse decision not bar to future recovery of '.ca' domain name
Canada | 21 August 2017

A pair of recent decisions under the Canadian Internet Registration Authority Domain Name Dispute Resolution Policy demonstrate that a trademark owner which fails to obtain a domain name transfer at a first panel hearing may nonetheless achieve a favourable outcome upon a second panel hearing. The cases in question also highlight the importance of submitting carefully prepared evidence that establishes the owner's prior rights to the trademark in Canada.

Promise doctrine struck down and AstraZeneca's NEXIUM patent upheld as useful
Canada | 14 August 2017

The Supreme Court recently delivered an important and highly anticipated decision in AstraZeneca Canada by rejecting the so-called 'promise doctrine' and clarifying the requirement for patent utility in Canada. The unanimous decision represents an important victory for innovators seeking protection in Canada and is especially welcome in the highly litigated area of pharmaceutical patents.

Janssen's application to appeal decision regarding administrative drug submissions dismissed
Canada | 14 August 2017

The Federal Court of Appeal recently allowed four appeals concerning decisions by the minister of health to issue a notice of compliance to Teva for exemestane tablets and Hospira for Inflectra. The court found that the minister was reasonable in finding that these cross-referenced drug submissions did not trigger Section 5 of the Patented Medicines Notice of Compliance Regulations.

CETA draft regulations on patent linkage and term restoration published for public comment
Canada | 07 August 2017

The government recently published the long-anticipated draft regulations regarding changes to the Patented Medicines (Notice of Compliance) Regulations and proposed Regulations to Implement Certificates of Supplementary Protection to compensate innovators for lost patent term due to regulatory delays. The proposed changes will herald a new environment for pharmaceutical companies, with long-lasting impact.

"The Internet has no borders": Supreme Court upholds global injunction in search results case
Canada | 31 July 2017

The Supreme Court recently upheld an injunction requiring Google, a non-party to an infringement action, to remove links to infringing websites from its global search results. The decision represents a powerful statement that Canadian courts of equity have broad jurisdiction to issue injunctions against parties and non-parties alike, including with extraterritorial effect, provided that the injunction would be just and equitable in all of the circumstances of the case.

Dow obtains largest ever Canadian patent infringement award
Canada | 31 July 2017

The Federal Court recently issued its further judgment and reasons concerning the amount of financial compensation to be paid to Dow Chemical Company as a result of earlier patent infringement and validity proceedings against NOVA Chemicals Corporation. The final award totals over C$645 million (including pre-judgment interest), which is the largest reported award in a Canadian patent infringement case.

Captain Morgan makes Admiral Nelson's walk the plank
Canada | 24 July 2017

The Federal Court recently found Heaven Hill and its Canadian broker, Diamond Estates, liable for passing off their Admiral Nelson's rum products as those of Diageo and for infringing and depreciating the goodwill attached to Diageo's Captain Morgan character and label trademarks. The decision is a reminder of the clear benefits of registering key character and label elements on product packaging as trademarks.

Patented Medicines Prices Review Board update
Canada | 24 July 2017

The Minister of Health recently announced a consultation regarding proposed amendments to the Patented Medicines Regulations that would significantly affect the Patented Medicines Prices Review Board's (PMPRB's) approach to drug price evaluation. The PMPRB also published a new annual publication providing information on recently launched drugs in Canada and select international markets as well as its annual report on the drivers of drug expenditures in select Canadian public drug plans.

Federal Court reaffirms and reissues venlafaxine judgments overturned for hearsay
Canada | 17 July 2017

In 2016 the Federal Court of Appeal set aside a decision of the Federal Court awarding Teva close to C$125 million in damages under Section 8 of the Patented Medicines (Notice of Compliance) Regulations for its venlafaxine hydrochloride product, based on the Federal Court's reliance on inadmissible hearsay evidence. The Federal Court recently rendered its redetermination decision, reaffirming and reissuing its prior judgments in the matter.

New draft Trademark and Industrial Design Regulations released
Canada | 10 July 2017

While the new Trademarks Act and Industrial Design Act have been finalised, the Trademarks Regulations and the Industrial Design Regulations have not. The Canadian Intellectual Property Office recently released the first draft of the new regulations, which provide considerable detail outlining how Canada will adhere to the Madrid Protocol, the Nice Agreement and the Hague Agreement.