Latest updates

Health Canada publishes guidance documents that address reporting of adverse reactions
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • August 15 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
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • August 15 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.

Proposed new regulations for hospital reporting of serious adverse drug reactions
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • August 08 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
  • August 08 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
  • August 06 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
  • August 06 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.

Mid-year biosimilars update
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • August 01 2018

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

Quebec court declines to dismiss claim under Ontario Statute of Monopolies
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • August 01 2018

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

Eli Lilly seeks leave in olanzapine Section 8 damages action
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • July 25 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
  • July 25 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
  • July 18 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.

New regulations governing post-market oversight of opioids
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • July 18 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).

New regulations governing powers to require assessments, tests and studies
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • July 11 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.

Update on Vanessa's Law
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • July 11 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.

Eli Lilly seeks leave in olanzapine Section 8 damages action
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • July 09 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.

Ontario Court of Appeal dismisses summary judgment appeal in Section 8 case
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • July 04 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
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • July 04 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.

PMPRB forming working group on guideline reform
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • July 02 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
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • July 02 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.

Health Canada to propose post-market amendments to Medical Devices Regulations
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • June 27 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.

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