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
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
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
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: 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
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 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
This article was last updated on June 26, 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
5/28/2020
/ Appeals ,
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 ,
Patent Act ,
Patents ,
Pharmaceutical Industry ,
Public Health Emergency ,
Time Extensions ,
Trademarks ,
Videoconference
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)
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
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
In 2018 we reported on a number of developments in life sciences IP and regulatory law. Our most-read articles were: #1 a June update on biosimilars (authored by Urszula Wojtyra); #2 a “live” summary chart of Vanessa’s Law...more
1/8/2019
/ Apotex ,
Appeals ,
AstraZeneca ,
Biosimilars ,
CADTH ,
Calculation of Damages ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
Damages ,
Eli Lilly ,
Health Canada ,
International Litigation ,
International Treaties ,
Janssen Pharmaceuticals ,
Judicial Review ,
Life Sciences ,
Lost Profits ,
Patent Act ,
Patent Infringement ,
Patent Litigation ,
Patent Validity ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prejudgment Interest ,
Proposed Amendments ,
Section 8 ,
Teva Pharmaceuticals ,
United States-Mexico-Canada Agreement (USMCA) ,
Vanessa's Law
In This Issue:
Ontario Court of Appeal allows Sanofi and Schering to plead that Federal Court ramipril patent invalidity decision was flawed due to “promise doctrine” -
In an action by Apotex for compensation from...more
12/6/2018
/ Apotex ,
Appeals ,
Biosimilars ,
CADTH ,
Canada ,
Eli Lilly ,
Lack of Novelty ,
Leave to Appeal ,
Life Sciences ,
Motion To Strike ,
Patent Invalidity ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Promise Doctrine ,
Proposed Amendments ,
Remedies ,
Sandoz ,
Supreme Court of Canada ,
Teva Pharmaceuticals
In this special mid-year edition, we take a look at the major highlights in Canadian life sciences and intellectual property law that we have reported on over the last six months, starting with one of the most closely-watched...more
7/11/2018
/ Appeals ,
Biosimilars ,
CADTH ,
Canada ,
Cannabis Act ,
Certificates of Supplementary Protection (CSPs) ,
Commercial Marketing ,
Damages ,
Health Canada ,
Intellectual Property Litigation ,
Life Sciences ,
Nexium ,
Patent Infringement ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmacies ,
PMNOC Regulations ,
Prescription Drug Coverage ,
Proposed Amendments ,
Section 8 ,
Teva Pharmaceuticals
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
On December 2, 2017 Canada’s Governor-in-Council published proposed Regulations Amending the Patented Medicines Regulations (“the proposed Regulations”). The 75-day consultation period ends February 15, 2018. The proposed...more
12/5/2017
/ Canada ,
Consultation Periods ,
Drug Pricing ,
Health Canada ,
Life Sciences ,
Patent Act ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Pharmaceutical Industry ,
Proposed Regulation ,
Reporting Requirements ,
Third-Party
Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission -
On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...more
6/1/2017
/ Administrative Proceedings ,
Apotex ,
Appeals ,
Canada ,
CETA ,
Damages ,
Data Protection ,
Dismissals ,
Double Patent ,
Drug Approvals ,
Electronic Filing ,
Eli Lilly ,
Generic Drugs ,
Health Canada ,
Health Information Technologies ,
Judicial Review ,
Licenses ,
Life Sciences ,
Mandamus Petitions ,
Medical Devices ,
Obviousness ,
Patented Medicines ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Supreme Court of Canada ,
Teva Pharmaceuticals ,
Trials