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
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
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
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
By judgment dated May 12, 2021, the Federal Court dismissed patent infringement actions related to Sandoz’s pirfenidone capsules and tablets for the treatment of idiopathic pulmonary fibrosis (IPF) (Roche’s ESBRIET):...more
The following provides an overview of the many developments regarding biosimilars in Canada (approvals, pending submissions, regulatory, litigation and market access) that have taken place since our last update in August...more
5/3/2021
/ Biologics ,
Biosimilars ,
Canada ,
Health Canada ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
The Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) require that any section 6(1) action be brought within 45 days after the day on which the first person is served with a notice of allegation (NOA)....more
Update: The Federal Court updated the Guidelines on May 18, 2021, which can be found here.
The Federal Court has released a new consolidated practice direction, Case and Trial Management Guidelines for Complex...more
11/30/2020
/ Amended Regulation ,
Canada ,
Case Management ,
Complex Litigation ,
Discovery ,
Document Productions ,
Evidence ,
Expert Witness ,
Health Canada ,
Patented Medicines ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Trials
UPDATE: On July 9, 2021, the Supreme Court of Canada denied Amgen’s leave to appeal (see article here).
On November 3, 2020, the Federal Court of Appeal heard and dismissed the appeal of the first trial decision under the...more
11/25/2020
/ Amended Regulation ,
Amgen ,
Appeals ,
Biosimilars ,
Canada ,
Dismissals ,
Health Canada ,
Obviousness ,
Patent Litigation ,
Patents ,
Pfizer ,
Pharmaceutical Patents ,
PMNOC Regulations
September 21, 2020 marked the third anniversary of the coming into force of the amended Patented Medicines (Notice of Compliance) Regulations (Regulations), which heralded significant changes to the litigation landscape for...more
The following provides an overview of the many developments regarding biosimilars in Canada (approvals, pending submissions, regulatory, litigation and market access) that have taken place since our last update in October...more
8/27/2020
/ Biosimilars ,
CADTH ,
Canada ,
Drug Approvals ,
Drug Pricing ,
Health Canada ,
Patent Infringement ,
Patented Medicine Prices Review Board (PMPRB) ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Popular ,
Prescription Drugs ,
United States-Mexico-Canada Agreement (USMCA)
On May 7, 2020, the Patented Medicines Prices Review Board (PMPRB or Board) ordered Galderma to file prescribed sales and financial information for DIFFERIN (0.1% adapalene) until the expiry of the 237 patent (2,478,237),...more
As part of the National Prescription Drug Utilization Information System (NPDUIS) initiative, the Patented Medicine Prices Review Board (PMPRB) has released three reports:
1) Market Intelligence Report: Combination...more
An interesting procedural question under the amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) is the extent to which separate actions against multiple generic manufacturers can proceed...more
6/2/2020
/ Appeals ,
Canada ,
Generic Drugs ,
Health Canada ,
Intellectual Property Protection ,
Patent Litigation ,
Patent Validity ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Rule 105
UPDATE: On November 3, 2020, the Federal Court of Appeal dismissed Amgen’s appeal. See our article here.
On April 16, 2020, Justice Southcott of the Federal Court issued the first decision under the amended Patented...more
5/4/2020
/ Abuse of Process ,
Amgen ,
Apotex ,
Appeals ,
Canada ,
Motion to Dismiss ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Popular ,
Prior Use ,
Prior User Rights
On March 11, 2020, the Federal Court of Appeal dismissed Apotex’s appeal of the Federal Court’s decision ordering Apotex to pay over $61M from an accounting of profits from Apotex’s infringement of ADIR’s perindopril patent...more