On October 6, 2022, the Patented Medicine Prices Review Board (PMPRB) released its revised draft Guidelines to give effect to the July 1, 2022 amendments to the Patented Medicines Regulations. Submissions are due by December...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
On April 14, 2022, the Minister of Health announced that the amendments to the Patented Medicines Regulations (the “Regulations”), originally released on August 18, 2019, would come into force on July 1, 2022 in a...more
On February 18, 2022, the Court of Appeal of Quebec released its decision in Merck Canada Inc c Procureur général du Canada (2022 QCCA 240). This is the appeal of the Quebec Superior Court decision declaring price and revenue...more
In 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below:
Table of Contents
1. COVID-19: CIPO, Federal Courts, Health Canada
2. PMPRB:...more
1/5/2021
/ Amended Regulation ,
Antitrust Conspiracies ,
Biologics ,
Biosimilars ,
Canada ,
Canadian Intellectual Property Office (CIPO) ,
Certificates of Supplementary Protection (CSPs) ,
Coronavirus/COVID-19 ,
Damages ,
Data Protection ,
Generic Drugs ,
Health Canada ,
Judicial Review ,
Life Sciences ,
Patent Expiration ,
Patent Infringement ,
Patent Litigation ,
Patent Validity ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Popular ,
Price-Fixing ,
Reporting Requirements ,
Section 8
Update: See our January 26, 2021 article, which links to the Canada Gazette copy of the further amendments and discusses proposed consequential modifications to the Guidelines definition of “gap medicine” and compliance...more
Update: The decision has been appealed.
On December 18, 2020, the Quebec Superior Court issued its decision from a constitutional challenge to the Patented Medicine Prices Review Board (PMPRB) provisions of the Patent Act...more
12/23/2020
/ Amended Regulation ,
Canada ,
Constitutional Challenges ,
Drug Pricing ,
Health Canada ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Rebates ,
Reporting Requirements
UPDATE: See our article here highlighting changes relative to the June 2020 draft Guidelines.
This morning, the PMPRB released the final Guidelines operationalizing the amended Patented Medicines Regulations (Amended...more
In the first half of 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review the following top developments...more
7/23/2020
/ Amended Regulation ,
Canada ,
Canadian Competition Act ,
Canadian Intellectual Property Office (CIPO) ,
Class Action ,
Coronavirus/COVID-19 ,
Court Closures ,
Court Schedules ,
Damages ,
Generic Drugs ,
Health Canada ,
Jurisdiction ,
Life Sciences ,
Lost Profits ,
Mootness ,
Motions to Quash ,
Patent Expiration ,
Patent Infringement ,
Patented Medicine Prices Review Board (PMPRB) ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Price-Fixing ,
Section 8
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 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
In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below:
1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more
1/10/2020
/ Amended Regulation ,
Annual Reports ,
Biologics ,
Biosimilars ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
Clinical Trials ,
Competition Authorities ,
Damages ,
Data Protection ,
Draft Guidance ,
EU ,
File Wrapper Estoppel ,
Food and Drug Act ,
Global Code of Ethics ,
Health Canada ,
Life Sciences ,
Medical Devices ,
National Pharmacare ,
New Rules ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Pharmacies ,
PMNOC Regulations ,
Popular ,
Rebates ,
Section 8 ,
Statute of Monopolies ,
Supreme Court of Canada ,
United States-Mexico-Canada Agreement (USMCA)
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
Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more
7/10/2019
/ Amended Regulation ,
Apotex ,
Appeals ,
Biosimilars ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
Clinical Trials ,
Competition Authorities ,
CUSMA ,
Damages ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Canada ,
Health Insurance ,
Intellectual Property Protection ,
International Litigation ,
Life Sciences ,
Medical Devices ,
National Pharmacare ,
Patent Litigation ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drug Coverage ,
Prescription Drugs ,
Section 8 ,
Statute of Monopolies
IN THIS ISSUE:
- Federal Court dismisses Servier's application for order of prohibition regarding salt patent for perindopril arginine
- FCA upholds issuance of NON-W letter and cancellation of reconsideration process...more
6/14/2019
/ Adverse Events ,
Amended Regulation ,
Appeals ,
Canada ,
Dismissals ,
Emergency Rooms ,
Health Canada ,
New Guidance ,
Notice of Appeal ,
Notice of Compliance ,
Orders of Prohibition ,
Patent Infringement ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Supreme Court of Canada