On December 20, 2022, Ontario announced it is implementing a biosimilars transition policy. Starting March 31, 2023, patients receiving coverage from the Ontario Drug Benefit plan for the following innovator biologics can...more
The Patented Medicine Prices Review Board (PMPRB) has advised that the new Guidelines will not be implemented on January 1, 2023, and that the Interim Guidance issued by the Board on August 18, 2022 will remain in place until...more
On December 5, 2022, the Federal Court of Appeal (FCA) dismissed Innovative Medicines Canada (IMC) and sixteen innovative pharmaceutical companies’ appeal regarding the validity of the amended basket of comparator countries...more
On November 21, 2022, the Minister of Health tabled the 2021 Annual Report of the Patented Medicine Prices Review Board (PMPRB). The Report includes information on the PMBRB’s regulatory activities, pharmaceutical sales and...more
On September 1, 2022, a Panel of the Patented Medicine Prices Review Board (PMPRB) issued a decision that the price of Horizon Pharma’s PROCYSBI (cysteamine delayed release capsules) was and is excessive under sections 83 and...more
On October 20, 2022, Saskatchewan announced it is introducing a biosimilars initiative.
For any new patients starting a biologic drug, the Saskatchewan Drug Plan will only offer coverage for the listed biosimilar version....more
September 21, 2022, marked the fifth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fifth year...more
On August 17, 2022, the Federal Court, per Justice Fothergill, dismissed AbbVie’s applications for judicial review of the Minister of Health’s decisions that (1) JAMP was not a “second person” and therefore it was not...more
Health Canada released a number of reports over the summer:
- Annual Health Product Highlights for 2021, which provides an overview of new health products, including drugs and medical devices, that Health Canada approved...more
On May 20, 2022, the Competition Bureau announced that it closed two investigations into pharmaceutical patent litigation settlement agreements as evidence gathered during the two investigations suggested the agreements did...more
As previously reported, on January 11, the Canadian Agency for Drugs and Technologies in Health (CADTH) posted a discussion paper regarding the proposed framework for a potential pan-Canadian formulary. The pan-Canadian...more
We provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, market access and competition) since our last update in October 2021....more
6/30/2022
/ Biosimilars ,
Canada ,
Drug Approvals ,
Health Canada ,
Health Care Providers ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Update: Health Canada’s “ Forward Regulatory Plan: 2023-2025” no longer lists some of the below initiatives, including the 2019 proposed amendments to the Food and Drug Regulations, “Regulations amending the Food and Drug...more
6/29/2022
/ Artificial Intelligence ,
Canada ,
Exports ,
Fees ,
Food & Drug Regulations ,
Generic Drugs ,
Health Canada ,
Machine Learning ,
Medical Devices ,
Natural Products ,
Pharmaceutical Industry ,
Prescription Drugs
As we have previously reported, in response to the COVID-19 pandemic, the Minister of Health had made interim orders pursuant to the Food and Drugs Act to address the significant risk to health posed by shortages in 2020 and...more
3/30/2022
/ Amended Regulation ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
Coronavirus/COVID-19 ,
Health Canada ,
Medical Devices ,
Minister of Health ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Reporting Requirements ,
Supply Shortages
The Federal Court released a pair of decisions in patent litigation relating to paliperidone palmitate (Janssen’s INVEGA SUSTENNA): Janssen Inc v Pharmascience, 2022 FC 62 and Janssen Inc v Apotex, 2022 FC 107. Pharmascience...more
As previously reported, the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Pan-Canadian Formulary Advisory Panel (Panel) held an information session on January 18 about a potential pan-Canadian...more
In H. Lundbeck v Canada (Commissioner of Patents), 2021 FC 1394, the Court granted an application to amend a patent record to remove inventors and a co-owner. A Notice of Allegation (NOA) in respect of the patent was served...more
The Patented Medicine Prices Review Board (PMPRB) has released its 7th edition CompassRX report, Annual Public Drug Plan Expenditure Report for 2019/20. The report was prepared as part of the National Prescription Drug...more
Since our last update in April 2021, there have been many developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory and market access).
Biosimilars approved in Canada -
Health...more
10/27/2021
/ Biologics ,
Biosimilars ,
Canada ,
Drug Approvals ,
Drug Pricing ,
Health Canada ,
Intellectual Property Protection ,
Life Sciences ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
As previously reported, a proposed class action proceeding against over 50 generic drug manufacturers was commenced in 2020. The proposed class action alleges that the defendants conspired to “allocate the market, fix prices...more
9/30/2021
/ Antitrust Division ,
Bid Rigging ,
Class Action ,
Collusion ,
Competition Act ,
Criminal Penalties ,
Department of Justice (DOJ) ,
Generic Drugs ,
Guilty Pleas ,
Litigation Funding ,
Market Allocation Scheme ,
Pharmaceutical Industry ,
Price-Fixing
September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fourth year...more
9/28/2021
/ Amended Regulation ,
Apotex ,
Appeals ,
Canada ,
Dismissals ,
Judgment on the Merits ,
Patent Infringement ,
Patent Litigation ,
Patent Validity ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Sandoz ,
Teva Pharmaceuticals
In today’s competitive innovation economy, companies across industries face a wide range of potential legal issues and risks related to intellectual property (IP). Whether it is infringement of a valuable patented technology,...more
As previously reported, British Columbia, Alberta, and New Brunswick have all launched biosimilar initiatives which require that patients switch from certain reference biologics to biosimilars for certain indications. On May...more
The Federal Government has published the following proposed amending regulations in Part 1 of the Canada Gazette:
- Regulations Amending the Food and Drug Regulations (Exports and Transhipments of Drugs): The amendments...more
7/2/2021
/ Canada ,
Dietary Supplements ,
Exports ,
Food and Drug Act ,
Health Canada ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Labels ,
Proposed Amendments ,
Proposed Regulation
Update: On September 15, 2021, ViiV applied to the Supreme Court of Canada for leave to appeal (Docket No. 39823).
The Federal Court of Appeal dismissed an appeal by ViiV from a decision of the Federal Court granting...more
7/1/2021
/ Appeals ,
Canada ,
Claim Construction ,
Dismissals ,
Interlocutory Orders ,
Motion for Summary Judgment ,
Motions to Quash ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents