On October 25, 2023, the Patented Medicine Prices Review Board (PMPRB) announced that it will launch the first phase of consultations on new guidelines. The first phase will include a policy roundtable with stakeholders on...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
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
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
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
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
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
In an action commenced by Allergan against Apotex in respect of ulipristal (Allergan’s FIBRISTAL) under the Patent Medicines (Notice of Compliance) Regulations (PMNOC Regulations), an issue arose as to the appropriate...more
2/10/2020
/ Affirmative Defenses ,
Allergan Inc ,
Apotex ,
Canada ,
International Litigation ,
Notice of Compliance ,
Patent Litigation ,
Patented Medicines ,
Pharmaceutical Patents ,
Pleadings ,
PMNOC Regulations
As more biosimilars continue to be approved across the world, it is helpful to compare the applicable regimes across major jurisdictions. We have collaborated with Brian Coggio of Fish & Richardson, and Mary Foord-Weston and...more
12/2/2019
/ Biologics ,
Biosimilars ,
BPCIA ,
Canada ,
Data Protection ,
Drug Approvals ,
EU ,
European Medicines Agency (EMA) ,
Food and Drug Administration (FDA) ,
Health Canada ,
Orphan Drugs ,
Patent Term Adjustment ,
Patent Term Extensions ,
Patented Medicines ,
Patents ,
PMNOC Regulations ,
Supplemental Protection Certificates ,
United States
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 June 2018....more
11/1/2019
/ Biosimilars ,
CADTH ,
Canada ,
Competition Authorities ,
Drug Approvals ,
Generic Drugs ,
Health Canada ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Pharmaceutical Industry ,
Pharmaceutical Patents
September 21, 2019 was the second anniversary of the coming into force of the amended Patented Medicines (Notice of Compliance) Regulations (Regulations) heralding significant changes to the landscape for pharmaceutical...more
10/3/2019
/ Allergan Inc ,
Amended Regulation ,
Amgen ,
Apotex ,
Bristol-Myers Squibb ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
Hatch-Waxman ,
Health Canada ,
Janssen Pharmaceuticals ,
Joinder ,
Leave to Appeal ,
Notice of Compliance ,
Patent Infringement ,
Patented Medicines ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Sandoz ,
Teva Pharmaceuticals ,
Trial Plan
Federal Court of Appeal requires PMPRB to re-determine whether patent ‘pertains to’ Galderma’s DIFFERIN -
On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB...more
8/1/2019
/ Adverse Action Report ,
Annual Reports ,
Appeals ,
Biosimilars ,
CADTH ,
Canada ,
Dismissals ,
Draft Guidance ,
Drug Pricing ,
Guidance Update ,
Health Canada ,
Hospitals ,
Interlocutory Appeals ,
Judicial Review ,
Patent Act ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Public Consultations ,
Teva Pharmaceuticals
By: Urszula Wojtyra On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB or Board) and returned to the Board the matter of whether the invention of the 237...more
7/11/2019
/ Agency Deference ,
Appeals ,
Canada ,
Claim Construction ,
Judicial Review ,
Patent Expiration ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Patents ,
Reasonableness Factors ,
Remand ,
Standard of Review
National Pharmacare Update: Publication of the final report of the Advisory Council -
On June 12, 2019, the Minister of Health tabled the final report, A Prescription for Canada: Achieving Pharmacare for All, from the...more
7/3/2019
/ CADTH ,
Canada ,
Cancer ,
Clinical Trials ,
Drug Pricing ,
European Medicines Agency (EMA) ,
Food and Drug Administration (FDA) ,
Health Canada ,
Life Sciences ,
Medical Devices ,
National Pharmacare ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
PMNOC Regulations
As previously reported, the amended Patented Medicines (Notice of Compliance) Regulations (“Regulations”) came into force on September 21, 2017, heralding significant changes to the landscape for pharmaceutical companies in...more
10/1/2018
/ Amended Regulation ,
Canada ,
CETA ,
Discovery ,
Draft Guidance ,
Filing Deadlines ,
Health Canada ,
Jurisdiction ,
Leave to Appeal ,
Motion for Summary Judgment ,
Motion to Dismiss ,
Patent Infringement ,
Patent Validity ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Right To Appeal ,
Statute of Limitations
In public reasons released on July 30, 2018, the Federal Court dismissed the first motion for summary dismissal brought under section 6.08 of the amended Patented Medicines (Notice of Compliance) Regulations (PMNOC...more
Health Canada News -
Health Canada issues updated guidance on PMNOC Regulations -
Health Canada has issued updated guidance reflecting the September 21, 2017 amendments: Guidance Document: Patented Medicines (Notice of...more
7/3/2018
/ Adverse Action Report ,
Biosimilars ,
Canada ,
Cannabis Act ,
Health Canada ,
Hospitals ,
Intellectual Property Protection ,
Medical Devices ,
Patent Litigation ,
Patented Medicines ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Proposed Regulation
No Section 8 Liability for Valid and Infringed Patent in NEXIUM Proceeding -
What happens when a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) (PMNOC)...more
4/4/2018
/ Calculation of Damages ,
Canada ,
Corporate Misconduct ,
Costco ,
Dismissals ,
Eli Lilly ,
Janssen Pharmaceuticals ,
Medical Devices ,
Motion To Strike ,
Patent Infringement ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Patents ,
Pharmacies ,
PMNOC Regulations ,
Prescription Drugs ,
Rebates ,
Section 8 ,
Teva Pharmaceuticals
Apotex granted damages from contract research organization for delayed FDA approval of two products -
Appeal of summary dismissal under PMNOC Regulations: dismissal order stayed...more
2/2/2018
/ Administrative Proceedings ,
Apotex ,
Appeals ,
Biologics ,
Biosimilars ,
Canada ,
Damages ,
Dismissals ,
Drug Approvals ,
Electronic Filing ,
FDA Approval ,
Foreign Patent Applications ,
Health Canada ,
Patent Applications ,
Patented Medicines ,
PMNOC Regulations ,
Prescription Drugs ,
Stays
The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues.
As we...more
1/11/2018
/ Apotex ,
Appeals ,
AstraZeneca ,
Biosimilars ,
Bristol-Myers Squibb ,
Calculation of Damages ,
Canada ,
CETA ,
Confidential Business Information (CBI) ,
Constitutional Challenges ,
Damages ,
Data Protection ,
Drug Pricing ,
Duty to Mitigate ,
Exports ,
Food & Drug Regulations ,
Generic Drugs ,
Hatch-Waxman ,
Health Canada ,
India ,
Jurisdiction ,
Life Sciences ,
Patent Infringement ,
Patent Terms ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pfizer ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Promise Doctrine ,
Proposed Amendments ,
Supreme Court of Canada ,
Teva Pharmaceuticals
PMPRB News -
PMPRB releases scoping paper relating to proposed amended Regulations -
As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more
12/20/2017
/ Amended Regulation ,
Apotex ,
Appeals ,
Biosimilars ,
Canada ,
Constitutional Challenges ,
Controlled Substances ,
Disclosure Requirements ,
Dismissals ,
Drug Approvals ,
Financial Statements ,
Health Canada ,
Health Care Providers ,
Leave to Amend ,
Medical Devices ,
Medical Marijuana ,
New Guidance ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
PMNOC Regulations ,
Prescription Drugs ,
Public Consultations ,
Reversal ,
Supreme Court of Canada ,
Tortious Interference
Canada’s new linkage litigation scheme: A comparison to Hatch-Waxman -
The September 21, 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations (see our article here) introduced a new scheme for...more
12/2/2017
/ Annual Reports ,
Appeals ,
Canada ,
Drug Approvals ,
Drug Pricing ,
Hatch-Waxman ,
Health Canada ,
Intellectual Property Protection ,
Linkage Litigation Schemes ,
Litigation Funding ,
Motions to Quash ,
Patent Infringement ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations