In the first half of 2024, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to June and...more
Eli Lilly v Teva, Pharmascience, Riva, Apotex, Mylan (tadalafil, CIALIS) – Following a summary trial, Lilly’s infringement actions were dismissed: composition claims directed to “a physiologically acceptable salt” of...more
1/3/2024
/ Abuse of Process ,
Appeals ,
Biosimilars ,
CADTH ,
Canada ,
Compliance ,
Data Protection ,
Life Sciences ,
Medical Devices ,
Patent Act ,
Patent Infringement ,
Patent Term Adjustment ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Agenda ,
Regulatory Standards ,
Statute of Monopolies ,
United States-Mexico-Canada Agreement (USMCA)
In the first half of 2023, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to June and...more
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
Below are highlights from the Rx IP’s team’s 2022 updates (see also our Top 10 Rx IP Update Reads of 2022):
Contents:
1. Patent decisions on the merits
2. PMNOC Regulations: Fifth-year anniversary of major amendments,...more
1/5/2023
/ Biosimilars ,
Canada ,
Data Protection ,
Generic Drugs ,
Health Canada ,
Intellectual Property Protection ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Popular ,
Section 8 ,
Statute of Monopolies ,
Supreme Court of Canada
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 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 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
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
In the first half of 2022, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to July and...more
7/25/2022
/ Biosimilars ,
Canada ,
Competition ,
Data Protection ,
Facebook ,
Generic Drugs ,
Health Canada ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Pan-Canadian Framework ,
Patent Infringement ,
Patent Litigation ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Popular ,
Targeted Digital Advertising
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
In the fall of 2021, the Rx IP Update team celebrated its 20thyear of monthly updates on Canadian life sciences IP and regulatory law. Below are highlights from our team’s 2021 updates...more
1/5/2022
/ Access to Information (ATI) ,
Apotex ,
Biosimilars ,
CADTH ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
Class Action ,
Corporate Counsel ,
Damages ,
Data Protection ,
Excessive Pricing ,
Generic Drugs ,
Health Canada ,
Intellectual Property Protection ,
Life Sciences ,
Litigation Funding ,
Natural Products ,
Pan-Canadian Framework ,
Patent Infringement ,
Patent Litigation ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Statute of Monopolies
In the first half of 2021, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to June and...more
7/9/2021
/ Biosimilars ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
Coronavirus/COVID-19 ,
Data Protection ,
Dismissals ,
Health Canada ,
Life Sciences ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Proposed Amendments ,
Statute of Monopolies
As previously reported... on September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the ISAD Interim Order), which...more
4/16/2021
/ Canada ,
Coronavirus/COVID-19 ,
Deadlines ,
Health Canada ,
Intellectual Property Protection ,
Manufacturers ,
Minister of Health ,
Patented Medicines ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Vaccinations
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: 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: See our article here regarding transitional measures.
On September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to...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
This article was last updated on July 10, 2020.
In view of COVID-19, we have compiled a list of important updates as it relates to the pandemic and its impact on Life Sciences. We will continue to update this page as new...more
7/14/2020
/ Amended Rules ,
Canada ,
Canadian Intellectual Property Office (CIPO) ,
Coronavirus/COVID-19 ,
Court Closures ,
Court Schedules ,
Filing Deadlines ,
Food and Drug Act ,
Health Canada ,
Industrial Design ,
Life Sciences ,
Medical Supplies ,
Patents ,
Pharmaceutical Industry ,
Pharmacies ,
Time Extensions ,
Trademarks
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