In 2024, the Rx IP Update team at Smart & Biggar reported on a number of developments in Canadian life sciences IP and regulatory law. Highlights from 2024 are below; see also our top ten Rx IP Update reads of 2024....more
1/8/2025
/ Biosimilars ,
Data Protection ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent Term Adjustment ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs
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 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 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
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
Federal Court finds invalidity allegations relating to patent for metformin formulations not justified -
On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of...more
4/6/2019
/ Administrative Procedure ,
Apotex ,
Appeals ,
CADTH ,
Canada ,
Clinical Evaluations ,
Competition Authorities ,
Delisting ,
Enforcement Guidance ,
Federal Budget ,
Final Guidance ,
Final Rules ,
Health Canada ,
India ,
Intellectual Property Litigation ,
Judicial Review ,
Leave to Appeal ,
Medical Devices ,
Minister of Health ,
National Pharmacare ,
Patent Invalidity ,
Patent Litigation ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Premarket Approval Applications ,
Prescription Drugs ,
Proposed Regulation ,
Public Access Laws ,
Reversal ,
Scientific Evidence ,
Supreme Court of Canada
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
FCA overturns cefaclor damages decision on prejudgment interest issue, provides guidance on NIA defence -
On November 23, 2018, the Federal Court of Appeal (FCA) allowed in part Apotex’s appeal of a decision awarding Eli...more
12/22/2018
/ Amended Rules ,
Appeals ,
Biologics ,
Canada ,
Damages ,
Food and Drug Administration (FDA) ,
Free Trade Agreements ,
Generic Drugs ,
Health Canada ,
Intellectual Property Protection ,
International Litigation ,
Non-Infringing Alternatives (NIAs) ,
Notice Requirements ,
Patent Litigation ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prejudgment Interest ,
Prescription Drugs ,
United States-Mexico-Canada Agreement (USMCA)
Apotex not permitted to plead promise-based invalidity grounds in Ontario section 8 lansoprazole action -
This motion arose in the context of a section 8 action in which Apotex claims damages for delay in the issuance of...more
Teva succeeds in section 8 bortezomib action; infringement counterclaim dismissed -
On July 18, 2018, Justice Locke of the Federal Court granted Teva’s claim for compensation under section 8 of the Patented Medicines...more
9/4/2018
/ Apotex ,
Appeals ,
CADTH ,
Canada ,
Data Protection ,
Drug Pricing ,
Eli Lilly ,
Health Canada ,
Motion to Dismiss ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Premarket Approval Applications ,
Public Comment ,
Teva Pharmaceuticals
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
Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing -
While common among member countries of the Organisation for Economic Co-operation and Development...more
5/4/2018
/ Apotex ,
Appeals ,
AstraZeneca ,
CADTH ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
Clinical Evaluations ,
Confidential Information ,
Damages ,
Discovery ,
Drug Approvals ,
EU ,
Health Canada ,
Healthcare Reform ,
Leave to Appeal ,
Medical Devices ,
Medical Marijuana ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patent Term Extensions ,
Patent Validity ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drug Coverage ,
Prescription Drugs ,
Public Consultations ,
Section 8 ,
Summary Judgment ,
Supreme Court of Canada
On October 31, 2016, the day following the signing of CETA, the Canadian Minister of International Trade, the Honourable Chrystia Freeland, tabled Bill C-30, An Act to implement the Comprehensive Economic and Trade Agreement...more
11/2/2016
/ Appeals ,
Canada ,
Canadian Patent Office ,
CETA ,
EU ,
Exports ,
Foreign Patent Applications ,
Patent Applications ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Patents ,
Proposed Legislation ,
Supplementary Protection Certificate ,
Trade Agreements