Smart & Biggar/Fetherstonhaugh updates

Alexion denied leave to appeal in case challenging constitutionality of PMPRB's remedial powers
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

No store, no problem: broad interpretation of 'use' advantageous for foreign retail trademark owners
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • 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.

Patented Medicine Prices Review Board releases annual report on drug market entry
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

Patented Medicine Prices Review Board's multi-stakeholder steering committee holds first meeting
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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".

Alexion denied leave to appeal in case challenging constitutionality of PMPRB's remedial powers
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • 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.

First judicial consideration of Vanessa's Law: Health Canada must disclose requested clinical trial data
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 05 September 2018

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

Shire's VYVANSE patent valid, prohibition order issued
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

Shire's VYVANSE patent valid, prohibition order issued
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • 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.

Mid-year life sciences highlights
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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 publishes guidance documents that address reporting of adverse reactions
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

Proposed new regulations for hospital reporting of serious adverse drug reactions
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

Health Canada issues updated guidance on PMNOC Regulations
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

Date set for implementation of Hague Agreement and modernised industrial design regime
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • 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
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • 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.

Quebec court declines to dismiss claim under Ontario Statute of Monopolies
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

Eli Lilly seeks leave in olanzapine Section 8 damages action
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 25 July 2018

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

Supreme Court denies Idenix leave to appeal in SOVALDI dispute
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

PMPRB forming working group on guideline reform
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

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