Canada is an attractive market for pharmaceutical manufacturers. While universal healthcare does not currently extend to drugs in an outpatient setting, most Canadian consumers have some form of drug coverage through...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
The amended PMPRB regulations came into force on July 1, 2022, and at that time an interim approach to pricing was proposed.
The interim approach proposed a “status quo” to pricing until Guidelines could be established...more
As previously announced, the amended Patented Medicines Regulations will be coming into force on July 1, 2022 in substantially revised form. As we previously reported, the new basket of countries for Patented Medicine Prices...more
7/5/2022
/ Amended Regulation ,
Canada ,
Comment Period ,
Drug Pricing ,
New Regulations ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Public Comment ,
Reporting Requirements
The coming into force date of the amended Patented Medicines Regulations governing the Patented Medicine Prices Review Board (PMPRB) has been deferred for the fourth time, now until July 1, 2022. The news was announced on...more
In the first appellate decision relating to Certificates of Supplementary Protection (CSPs), the Federal Court of Appeal has allowed the appeal of the Minister of Health (the Minister), setting aside the lower court...more
4/29/2021
/ Appeals ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
CETA ,
Health Canada ,
Minister of Health ,
Patent Act ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Standard of Review
Update: On November 23, Innovative Medicines Canada and a number of pharmaceutical companies commenced an application for judicial review of the final Guidelines. See also the PMPRB’s November 20, 2020 webinar slides here....more
11/5/2020
/ Canada ,
Drug Pricing ,
Health Canada ,
Life Sciences ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Rebates ,
Vaccinations
UPDATE: On January 13, 2021, the Minister of Health refused the application on reconsideration. Viiv sought but later discontinued a second application for judicial review (T-258-21).
In a decision dated July 10, 2020,...more
UPDATE: See July 15, 2020 article here describing the decision in more detail. On September 10, 2020, the applicants (Innovative Medicines Canada and the company applicants) appealed Justice Manson’s decision (A-215-20). On...more
Update: See our article here regarding the final October 2020 Guidelines. On November 23, Innovative Medicines Canada and a number of pharmaceutical companies commenced an application for judicial review of the final...more
UPDATE: See June 23, 2020 article here describing the notable changes. See our article here regarding the final October 2020 Guidelines. On November 23, Innovative Medicines Canada and a number of research-based...more
Update: See December 30, 2020 and January 26, 2021 articles discussing the further amendments which defer the coming into force date of the Amended Regulations until July 1, 2021.
Further to our June 1, 2020 update,...more
6/12/2020
/ Amended Regulation ,
Canada ,
Drug Pricing ,
Health Canada ,
New Amendments ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Reporting Requirements
Update: See our June 10, 2020 article here describing the amendments extending the deadline, and our articles here and here regarding the amendments further deferring the coming into force date until July 1, 2021, and our...more
The first decision considering the scope and meaning of the provisions in the Patent Act relating to Certificates of Supplementary Protection (CSPs) has now been released. Justice Barnes of the Federal Court in...more
5/14/2020
/ Canada ,
Certificates of Supplementary Protection (CSPs) ,
CETA ,
EU ,
GlaxoSmithKline ,
Health Canada ,
Patent Act ,
Patent Litigation ,
Patented Medicines ,
Patents ,
Vaccinations
On November 21, 2019, the Patented Medicines Prices Review Board (“PMPRB”) released draft new Guidelines for consultation, together with a backgrounder. The new Guidelines are intended to operationalize the amended Patented...more
11/25/2019
/ Amended Regulation ,
Canada ,
Draft Guidance ,
Drug Approvals ,
Drug Pricing ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Public Comment
On August 9, 2019, Health Canada announced the final amendments to the Patented Medicines Regulations (see news release here and RIAS here). These amendments represent the first substantive revision to the Regulations since...more
8/12/2019
/ Amended Regulation ,
Canada ,
Drug Pricing ,
Exemptions ,
Final Rules ,
Health Canada ,
Patent Act ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Rebates ,
Reporting Requirements
September 21, 2018 marked the first anniversary of the certificate of supplementary protection (CSP) regime. CSPs, which provide an additional patent-like protection term, are intended to partly compensate innovators for the...more
10/2/2018
/ Canada ,
Certificates of Supplementary Protection (CSPs) ,
CETA ,
Data Protection ,
Drug Approvals ,
Health Canada ,
Innovation ,
Medical Research ,
Notice of Compliance ,
Patent Expiration ,
Patents ,
Pharmaceutical Patents ,
Research and Development
Federal Court of Appeal Applies Supreme Court’s Utility Test to SPRYCEL Patent -
In its first decision to consider the Supreme Court of Canada’s landmark decision in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36...more
On September 7, 2017, the Government of Canada published final pharmaceutical regulations flowing from CETA. According to an Order in Council, the new regulations will be in force on September 21, 2017....more
The Patented Medicine Prices Review Board (PMPRB) regulates the price of patented medicines in Canada by determining whether a price is excessive. The Board is revisiting its approach to pricing, and has now released a...more
Bill C-30 was passed by the Senate yesterday, May 11, 2017 without amendment. Bill C-30 is the bill that will implement the Canada-European Union Comprehensive Economic and Trade Agreement (CETA). As reported here, this...more
The following are highlights of developments in Canadian life sciences intellectual property and regulatory law in 2016, updating our 2016 mid-year highlights.
1. Substantive patent law developments -
Utility and...more
1/11/2017
/ Administrative Proceedings ,
Anti-Competitive ,
Apotex ,
Arbitration ,
AstraZeneca ,
Bayer ,
Biologics ,
Biosimilars ,
CADTH ,
Calculation of Damages ,
CETA ,
Competition Authorities ,
Constitutional Challenges ,
Data Protection ,
Double Patent ,
Eli Lilly ,
Generic Drugs ,
Health Canada ,
Leave to Appeal ,
Life Sciences ,
NAFTA ,
New Guidance ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent Terms ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pfizer ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Supreme Court of Canada ,
Teva Pharmaceuticals ,
Trans-Pacific Partnership ,
Unjust Enrichment ,
Utility Patents