Smart & Biggar updates
Market access: biosimilars no longer reviewed by CADTH
Smart & Biggar- Healthcare & Life Sciences
- Canada
- 18 September 2019
The Canadian Agency for Drugs and Technologies in Health (CADTH) recently released Issue 8 of its Pharmaceutical Reviews Update announcing revisions to its Procedure and Submission Guidelines for the CADTH Common Drug Review, among other things. The update also announced that the CADTH will no longer review biosimilars through the Common Drug Review or the pan-Canadian Oncology Drug Review.
Countdown begins: getting ready for new patented medicines pricing regime
Smart & Biggar- Healthcare & Life Sciences
- 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.
Countdown begins: getting ready for new patented medicines pricing regime
Smart & Biggar- Intellectual Property
- 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
Smart & Biggar- Healthcare & Life Sciences
- 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.
Updates to guidance documents: what you need to know
Smart & Biggar- Healthcare & Life Sciences
- Canada
- 11 September 2019
Health Canada recently released a revised Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs, which is effective immediately. The revisions include clarifying additions on the requirements for cross-licensed products for an administrative certification form and letter of authorisation, a drug notification form and labelling. Health Canada also recently released an updated Good Label and Package Practices Guide for Prescription Drugs.
Canada releases final amendments to patented medicines pricing regulations
Smart & Biggar- Intellectual Property
- 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.
Drug and medical device highlights
Smart & Biggar- Healthcare & Life Sciences
- Canada
- 04 September 2019
Health Canada recently published an annual highlights report for 2018. The report provides information regarding Health Canada drug (for human or veterinary use) and medical device approvals, as well as published safety issues in 2018. Moreover, the Therapeutic Products Directorate and the Biologics and Genetic Therapies Directorate released their Drug Submission Performance Annual Reports for the 2018-2019 fiscal year.
Health Canada consults on promotional and non-promotional activities for health products
Smart & Biggar- Healthcare & Life Sciences
- 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.
Canada nears end of project to modernise patent, trademark and industrial design laws
Smart & Biggar- Intellectual Property
- Canada
- 02 September 2019
Canada's recent accession to the Patent Law Treaty marks the near completion of its long and ambitious journey to modernise its patent, trademark and industrial design laws and harmonise its IP laws with its most important trading partners worldwide. As a result of the recent and upcoming changes, Canadian businesses and right holders alike can expect a more consistent and level playing field for securing IP rights.
Where is my CIPO mail? What to know about correspondence for Madrid applications
Smart & Biggar- Intellectual Property
- Canada
- 02 September 2019
The Canadian Intellectual Property Office (CIPO) was the first office to allow trademark applicants to use the Madrid e-filing system from day one. Under Canada's new Trademarks Regulations, CIPO is authorised to send correspondence only to the applicant or an appointed Canadian trademark agent and not to foreign representatives. Some but not all communications will also be sent to the International Bureau of the World Intellectual Property Organisation.
Bill C-97 receives royal assent and Health Canada opens consultation on advanced therapeutic products
Smart & Biggar- Healthcare & Life Sciences
- Canada
- 28 August 2019
Advanced therapeutic products have been the topic of much debate recently. First, Bill C-97 – which includes amendments to the Food and Drugs Act, including a new framework for advanced therapeutic products – received royal assent. Second, Health Canada opened a consultation to seek feedback on what it should consider when developing new clinical trial regulations as well as implementing the pathway for advanced therapeutic products.
PMPRB Steering Committee on Modernisation of Price Review Process Guidelines releases final report
Smart & Biggar- Healthcare & Life Sciences
- 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.
Federal Court of Appeal dismisses first PMNOC interlocutory appeal granted leave
Smart & Biggar- Healthcare & Life Sciences
- Canada
- 21 August 2019
Most interlocutory decisions under the Patented Medicines (Notice of Compliance) (PMNOC) Regulations are made by prothonotaries of the Federal Court. The first Federal Court of Appeal decision in an appeal of an interlocutory order under the amended PMNOC Regulations was recently issued. The court found that the prothonotary had been entitled to arrive at a view of what was best for the particular proceeding and saw no reviewable error that would justify its intervention.
Regulations will require hospitals to report adverse drug reactions and medical device incidents
Smart & Biggar- Healthcare & Life Sciences
- Canada
- 21 August 2019
The 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) were recently published. The amendments were enacted further to Vanessa's Law and will require all hospitals to provide specific information relating to serious adverse drug reactions and medical device incidents within 30 days of first documenting the reaction or incident in the hospital.
Federal Court of Appeal dismisses first PMNOC interlocutory appeal granted leave
Smart & Biggar- Intellectual Property
- Canada
- 19 August 2019
Most interlocutory decisions under the Patented Medicines (Notice of Compliance) (PMNOC) Regulations are made by prothonotaries of the Federal Court. The first Federal Court of Appeal decision in an appeal of an interlocutory order under the amended PMNOC Regulations was recently issued. The court found that the prothonotary had been entitled to arrive at a view of what was best for the particular proceeding and saw no reviewable error that would justify its intervention.
PMPRB Steering Committee on the Modernisation of Price Review Process Guidelines releases final report
Smart & Biggar- Intellectual Property
- 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.
Federal Court of Appeal requires PMPRB to redetermine whether patent pertains to Galderma's Differin
Smart & Biggar- Healthcare & Life Sciences
- Canada
- 14 August 2019
The Federal Court of Appeal recently granted the Patented Medicine Prices Review Board's (PMPRB's) appeal and returned to the board the matter of whether the invention of the patent at hand pertained to Galderma's Differin. The court addressed several issues, including whether the PMPRB had acted unreasonably in limiting its review of the patent to selected portions.
Court strikes Novo Nordisk's judicial review application
Smart & Biggar- Healthcare & Life Sciences
- Canada
- 14 August 2019
The Federal Court recently struck Novo Nordisk's judicial review application challenging the minster of health's decision to accept for review an abbreviated new drug submission filed by Teva Canada. In striking the application, the court concluded that Novo Nordisk had neither direct nor public interest standing in the matter.
Federal Court of Appeal requires PMPRB to redetermine whether patent pertains to Galderma's Differin
Smart & Biggar- Intellectual Property
- Canada
- 12 August 2019
The Federal Court of Appeal recently granted the Patented Medicine Prices Review Board's (PMPRB's) appeal and returned to the board the matter of whether the invention of the patent at hand pertained to Galderma's Differin. The court addressed several issues, including whether the PMPRB had acted unreasonably in limiting its review of the patent to selected portions.
Competition Bureau updates IP Enforcement Guidelines
Smart & Biggar- Intellectual Property
- Canada
- 12 August 2019
The Competition Bureau recently released its updated IP Enforcement Guidelines. While the guidelines are technical and directed at IP and competition law practitioners, there are key aspects of the bureau's approach and various scenarios involving competition and intellectual property that could arise for consideration. As such, when issues relating to IP and competition law arise, including when deciding whether to pursue the licensing or enforcement of IP rights, legal advice should be sought.
