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
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
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
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)
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
An Update on Vanessa’s Law -
This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...more
5/26/2018
/ Anti-Monopoly ,
Apotex ,
Appeals ,
Canada ,
Clinical Trials ,
Consumer Protection Laws ,
Damages ,
Drug Safety ,
Drug Testing ,
Eli Lilly ,
Food and Drug Act ,
Gilead Sciences ,
Health Canada ,
Jurisdiction ,
Leave to Appeal ,
Motion to Dismiss ,
New Regulations ,
Opioid ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Pharmacies ,
PMNOC Regulations ,
Post-Market Approval ,
Prescription Drugs ,
Regulatory Reform ,
Section 8 ,
Supreme Court of Canada ,
Teva Pharmaceuticals
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
Federal Court of Appeal dismisses Teva’s levofloxacin damages appeal -
On February 8, 2018, the Federal Court of Appeal issued public reasons for its decision dismissing Teva’s appeal relating to the damages and costs...more
3/1/2018
/ Appeals ,
Biosimilars ,
CADTH ,
Canada ,
CPTPP ,
Damages ,
Drug Pricing ,
Generic Drugs ,
Graphical User Interface ,
Health Canada ,
Medical Devices ,
Patent Infringement ,
Patent Term Extensions ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Promise Doctrine ,
Supreme Court of Canada ,
Teva Pharmaceuticals ,
Trans-Pacific Partnership
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
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
Teva awarded section 8 damages regarding pregabalin and olanzapine -
On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of...more
4/29/2017
/ Amgen ,
Bristol-Myers Squibb ,
Calculation of Damages ,
Canada ,
Damages ,
Declaratory Rulings ,
Drug Approvals ,
Eli Lilly ,
Patent Invalidity ,
Patented Medicines ,
Patents ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Section 8 ,
Teva Pharmaceuticals
Tribunal dismisses Eli Lilly’s NAFTA challenge on promise utility doctrine -
As previously reported, Eli Lilly submitted claims to international arbitration under the North American Free Trade Agreement (NAFTA) seeking...more
3/27/2017
/ Abbott Laboratories ,
Apotex ,
Appeals ,
Canada ,
CETA ,
Damages ,
Dismissals ,
Health Canada ,
NAFTA ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Summary Judgment ,
Takeda Pharmaceuticals ,
Teva Pharmaceuticals ,
Utility Patents
Apotex’s Infringement of AstraZeneca’s Omeprazole Formulation Patent Upheld -
As previously reported, the Federal Court of Appeal, in a unanimous decision released on January 12, 2017 (2017 FCA 9), has affirmed the...more
2/4/2017
/ Apotex ,
Appeals ,
Canada ,
Canadian Institute for Health Information (CIHI) ,
Canadian Intellectual Property Office (CIPO) ,
CETA ,
Competition Authorities ,
Damages ,
Double Patent ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Hearsay ,
Jurisdiction ,
Medical Devices ,
Mergers ,
Motions to Quash ,
Noninfringement ,
Notice of Compliance ,
Obviousness ,
Patent Applications ,
Patent Invalidity ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Supreme Court of Canada
Federal Court of Appeal opines on the framework for analyzing obviousness-type double-patenting -
On November 4, 2016, the Federal Court of Appeal dismissed Apotex’s appeal in Apotex Inc v Eli Lilly Canada Inc, 2016 FCA...more
11/30/2016
/ Accounting ,
Amgen ,
Apotex ,
Appeals ,
AstraZeneca ,
Biosimilars ,
Breach of Contract ,
Canada ,
CETA ,
Covenant of Good Faith and Fair Dealing ,
Damages ,
Double Patent ,
Drug Pricing ,
Eli Lilly ,
Free Trade Agreements ,
GlaxoSmithKline ,
Health Canada ,
Intellectual Property Protection ,
Mootness ,
Motion To Strike ,
New Legislation ,
Obviousness ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Pleadings ,
Prescription Drugs ,
Reversal ,
Supreme Court of Canada ,
Utility Patents