Smart & Biggar/Fetherstonhaugh updates

Medical devices update
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 24 July 2019

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

New PMPRB report examines most promising medicines currently in clinical trials worldwide
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

National pharmacare update: publication of advisory council's final report
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 17 July 2019

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

Federal Court upholds PMPRB's pricing decision regarding Alexion's Soliris
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 17 July 2019

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

Guidance document on reporting adverse reactions to marketed health products
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 10 July 2019

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

Supreme Court of Canada denies Apotex leave to appeal in two cases
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 10 July 2019

The Supreme Court of Canada has denied Apotex leave to appeal in two recent cases. In the first case, Apotex sought leave to appeal a decision of the Ontario Court of Appeal permitting Sanofi and Schering to amend their defences to claims relating to ramipril. In the second case, Apotex sought leave to appeal a decision of the Federal Court of Appeal relating to damages awarded to Eli Lilly in respect of Apotex's infringement of process patents relating to cefaclor.

Supreme Court of Canada denies Apotex leave to appeal in two cases
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 08 July 2019

The Supreme Court of Canada has denied Apotex leave to appeal in two recent cases. In the first case, Apotex sought leave to appeal a decision of the Ontario Court of Appeal permitting Sanofi and Schering to amend their defences to claims relating to ramipril. In the second case, Apotex sought leave to appeal a decision of the Federal Court of Appeal relating to damages awarded to Eli Lilly in respect of Apotex's infringement of process patents relating to cefaclor.

Experimental use exception under recently amended Patent Act
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 08 July 2019

Canada recently introduced the Budget Implementation Act 2, which brought about several changes to the Patent Act affecting the scope of protection available under Canadian patents. Included in the changes was the addition of a new provision providing an exception from infringement for experimental use of patented technologies. The new provision applies to any action or proceeding that was not finally disposed of as of 13 December 2018.

Proposed regulations set to amend process for sale of drugs for medical emergencies
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 03 July 2019

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

Health Canada releases new guidance document regarding drug identification numbers
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 03 July 2019

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

Update on PMPRB guidelines modernisation
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 01 July 2019

The Patented Medicine Prices Review Board (PMPRB) previously announced that the steering committee on guidelines modernisation would hold its final meeting on 13 May 2019 to discuss both a draft report of its deliberations and the working group's final report. Once the steering committee's report has been finalised and the regulatory amendments have been published in Part II of the Canada Gazette, the PMPRB will release its draft guidelines for public consultation.

Infringement based on making and selling under existing NOC struck from action
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 01 July 2019

The Federal Court has granted in part Pharmascience's motion to strike out portions of Teva's statement of claim under Subsection 6(1) of the Patented Medicines (Notice of Compliance) (PMNOC) Regulations relating to glatiramer acetate (Teva's Copaxone and Pharmascience's Glatect). The court found that it is plain and obvious that Section 6.02 of the PMNOC Regulations prohibits the joinder of a regular infringement action under the Patent Act with an action pursuant to Subsection 6(1).

Infringement based on making and selling under existing NOC struck from action
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 26 June 2019

The Federal Court has granted in part Pharmascience's motion to strike out portions of Teva's statement of claim under Subsection 6(1) of the Patented Medicines (Notice of Compliance) (PMNOC) Regulations relating to glatiramer acetate (Teva's Copaxone and Pharmascience's Glatect). The court found that it is plain and obvious that Section 6.02 of the PMNOC Regulations prohibits the joinder of a regular infringement action under the Patent Act with an action pursuant to Subsection 6(1).

Update on PMPRB guidelines modernisation
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 26 June 2019

The Patented Medicine Prices Review Board (PMPRB) previously announced that the steering committee on guidelines modernisation would hold its final meeting on 13 May 2019 to discuss both a draft report of its deliberations and the working group's final report. Once the steering committee's report has been finalised and the regulatory amendments have been published in Part II of the Canada Gazette, the PMPRB will release its draft guidelines for public consultation.

Canada introduces Bill C-100: step towards ratification of NAFTA 2.0
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 24 June 2019

In a step towards ratifying the United States-Mexico-Canada Agreement (USMCA), the government recently introduced Bill C-100, entitled "An Act to implement the Agreement between Canada, the United States of America and the United Mexican States", in Parliament. If ratified, the USMCA will replace the North American Free Trade Agreement and will require several changes to Canada's IP laws.

Federal Court dismisses Servier's application for order of prohibition regarding salt patent
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 24 June 2019

The Federal Court recently dismissed Servier's application for a prohibition order under the pre-amended Patented Medicines (Notice of Compliance) Regulations for Canadian Patent 2,423,825 regarding a perindopril arginine/amlodipine product (Servier's Viacoram). Apotex had alleged that the patent was invalid for obviousness, overbreadth, inutility and insufficiency.

Federal Court dismisses Servier's application for order of prohibition regarding salt patent
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • 19 June 2019

The Federal Court recently dismissed Servier's application for a prohibition order under the pre-amended Patented Medicines (Notice of Compliance) Regulations for Canadian Patent 2,423,825 regarding a perindopril arginine/amlodipine product (Servier's Viacoram). Apotex had alleged that the patent was invalid for obviousness, overbreadth, inutility and insufficiency.

Court upholds issuance of NON-W letter and cancellation of reconsideration process for Apotex
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • 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.

Top 10 changes to Canada's trademark law
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 17 June 2019

After five years of anticipation, sweeping changes to Canada's trademark law have finally come into force. Among other things, Canadian applicants can now file applications in more than 80 countries around the world through a single international application and declarations of use are no longer required to secure registrations.

Prior user rights under recently amended Patent Act
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • 17 June 2019

The Budget Implementation Act 2 has brought about several changes to the Patent Act that affect the scope of protection available under Canadian patents, including a revision of Section 56, which concerns the rights of prior users of patented technologies. However, as many of the Section 56 amendments will require judicial interpretation, the true scope of prior user rights under the revised provision may be unknown for some time.

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