Ms Abigail Smith

Abigail Smith

Updates

Healthcare & Life Sciences

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

The long-awaited amendments to the Patented Medicines Regulations were recently published in Part II of the Canada Gazette. Major changes include the introduction of three new price regulatory factors and a revised schedule of reference countries. Although the new law will not be in force until 1 July 2020, there are immediate implications.

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

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

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

Health Canada has announced a consultation on its new draft guidance: The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products.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

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

The Patented Medicines Prices Review Board (PMPRB) Steering Committee on the Modernisation of Price Review Process Guidelines recently released its final report summarising its deliberations in providing stakeholder feedback on the proposed new framework for the regulation of the prices of patented medicines. The PMPRB will publish draft guidelines for public consultation once it has had an opportunity to review the report and the amended Patented Medicines Regulations have been published.

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

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

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

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

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

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

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

Health Canada recently released its Forward Regulatory Plan 2019-2021: Regulations Amending the Patented Medicines Regulations. This brief document provides a high-level overview of the anticipated amendments released in draft form on 2 December 2017, the expected impact of these amendments and the consultation process.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Janssen's application to appeal decision regarding administrative drug submissions dismissed
Canada | 09 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.

Federal Court reaffirms and reissues venlafaxine judgments overturned for hearsay
Canada | 12 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.

Federal Court of Appeal dismisses Teva's appeal relating to utility and sufficiency
Canada | 03 May 2017

The Federal Court of Appeal recently dismissed Teva's appeal of Justice Locke's order prohibiting the minister of health from issuing a notice of compliance to Teva in respect of its calcipotriol and betamethasone dipropionate ointment (Leo Pharma's Dovobet) until the expiry of Patent 2,370,565. Locke rejected Teva's allegations relating to sound prediction and sufficiency.

News from Health Canada
Canada | 18 January 2017

Health Canada recently adopted a new guidance document regarding biosimilar biologic drugs and a revised biosimilars fact sheet which provides general information on biologic drugs, biosimilars, the applicable regulatory framework and access to biosimilars. Further, Health Canada has revised its product monograph guidance, with the intention of making health professional information easier to read and critical safety information easier to find in the Canadian product monograph.

Federal Court of Appeal overturns Teva's award for improper reliance on hearsay evidence
Canada | 17 August 2016

The Federal Court of Appeal recently set aside a Federal Court decision awarding Teva damages under Section 8 of the Patented Medicines (Notice of Compliance) Regulations in relation to its venlafaxine hydrochloride product on the basis that the judge had improperly relied on hearsay evidence. It also provided guidance on other issues, including how to determine lost sales in the 'but for' world.

Intellectual Property

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

The long-awaited amendments to the Patented Medicines Regulations were recently published in Part II of the Canada Gazette. Major changes include the introduction of three new price regulatory factors and a revised schedule of reference countries. Although the new law will not be in force until 1 July 2020, there are immediate implications.

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

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

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

The Patented Medicines Prices Review Board (PMPRB) Steering Committee on the Modernisation of Price Review Process Guidelines recently released its final report summarising its deliberations in providing stakeholder feedback on the PMPRB's proposed new framework for the regulation of the prices of patented medicines.

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

Health Canada recently released its Forward Regulatory Plan 2019-2021: Regulations Amending the Patented Medicines Regulations. This brief document provides a high-level overview of the anticipated amendments released in draft form on 2 December 2017, the expected impact of these amendments and the consultation process.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Federal Court of Appeal dismisses Teva's appeal relating to utility and sufficiency
Canada | 01 May 2017

The Federal Court of Appeal recently dismissed Teva's appeal of Justice Locke's order prohibiting the minister of health from issuing a notice of compliance to Teva in respect of its calcipotriol and betamethasone dipropionate ointment (Leo Pharma's Dovobet) until the expiry of Patent 2,370,565. Locke rejected Teva's allegations relating to sound prediction and sufficiency.

Federal Court of Appeal overturns Teva's award for improper reliance on hearsay evidence
Canada | 15 August 2016

The Federal Court of Appeal recently set aside a Federal Court decision awarding Teva damages under Section 8 of the Patented Medicines (Notice of Compliance) Regulations in relation to its venlafaxine hydrochloride product on the basis that the judge had improperly relied on hearsay evidence. The appeal court also provided guidance on a number of other issues, including how to determine lost sales in the 'but for' world.