Update: Health Canada’s “ Forward Regulatory Plan: 2023-2025” no longer lists some of the below initiatives, including the 2019 proposed amendments to the Food and Drug Regulations, “Regulations amending the Food and Drug...more
6/29/2022
/ Artificial Intelligence ,
Canada ,
Exports ,
Fees ,
Food & Drug Regulations ,
Generic Drugs ,
Health Canada ,
Machine Learning ,
Medical Devices ,
Natural Products ,
Pharmaceutical Industry ,
Prescription Drugs
As previously reported, a proposed class action proceeding against over 50 generic drug manufacturers was commenced in 2020. The proposed class action alleges that the defendants conspired to “allocate the market, fix prices...more
9/30/2021
/ Antitrust Division ,
Bid Rigging ,
Class Action ,
Collusion ,
Competition Act ,
Criminal Penalties ,
Department of Justice (DOJ) ,
Generic Drugs ,
Guilty Pleas ,
Litigation Funding ,
Market Allocation Scheme ,
Pharmaceutical Industry ,
Price-Fixing
On June 3, 2020, a proposed class action was commenced against over 50 generic drug manufacturers... The claim alleges that the generic drug manufacturers violated the Competition Act by conspiring to allocate the market, fix...more
6/29/2020
/ Antitrust Conspiracies ,
Antitrust Investigations ,
Antitrust Litigation ,
Bid Rigging ,
Class Action ,
Competition Act ,
Generic Drugs ,
Generic Marks ,
Market Allocation Scheme ,
Pharmaceutical Industry ,
Prescription Drugs ,
Price-Fixing
An interesting procedural question under the amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) is the extent to which separate actions against multiple generic manufacturers can proceed...more
6/2/2020
/ Appeals ,
Canada ,
Generic Drugs ,
Health Canada ,
Intellectual Property Protection ,
Patent Litigation ,
Patent Validity ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Rule 105
The following provides an overview of the many developments regarding biosimilars in Canada (approvals, pending submissions, regulatory, litigation and market access) that have taken place since our last update in June 2018....more
11/1/2019
/ Biosimilars ,
CADTH ,
Canada ,
Competition Authorities ,
Drug Approvals ,
Generic Drugs ,
Health Canada ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Pharmaceutical Industry ,
Pharmaceutical Patents
PMPRB amendments expected to come into force no earlier than Spring 2020 -
On April 1, 2019, Health Canada released Forward Regulatory Plan 2019-2021: Regulations Amending the Patented Medicines Regulations. This brief...more
5/3/2019
/ Appeals ,
Biosimilars ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
Conflicts of Laws ,
Drug Safety ,
Food and Drug Act ,
Generic Drugs ,
Health Canada ,
Labeling ,
Online Sales Bans ,
Patent Invalidity ,
Patented Medicine Prices Review Board (PMPRB) ,
PMNOC Regulations ,
Prescription Drugs ,
Proposed Amendments ,
Public Comment
Health Canada released proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (“proposed Regulations”) on March 30, 2019. Comments may be submitted until June 8, 2019....more
4/30/2019
/ Amended Regulation ,
ANDS ,
Biologics ,
Canada ,
Draft Guidance ,
Drug Approvals ,
Equivalency Determinations ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Canada ,
Innovation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Labels ,
Proposed Amendments ,
Public Consultations
Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal -
As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more
3/5/2019
/ Apotex ,
Appeals ,
Biologics ,
Canada ,
Costco ,
Damages ,
Dismissals ,
FDA Approval ,
Filing Deadlines ,
Fines ,
Generic Drugs ,
Health Canada ,
Health Insurance ,
Janssen Pharmaceuticals ,
Leave to Appeal ,
Marketing ,
Medical Devices ,
Minor Children ,
Mylan Pharmaceuticals ,
New Guidance ,
Novartis ,
Orders of Prohibition ,
Patent Applications ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Pharmacies ,
PMNOC Regulations ,
Post-Market Approval ,
Prescription Drug Coverage ,
Prescription Drugs ,
Rebates ,
Risk Assessment ,
Supreme Court of Canada ,
Teva Pharmaceuticals
IN THIS ISSUE:
-Abbott/Takeda permitted to plead that a third party’s patent would be infringed by alleged non-infringing alternative
- PMPRB News:
**PMPRB issues a Notice of Hearing for allegations of excessive...more
2/1/2019
/ Abbott Laboratories ,
Administrative Orders ,
Administrative Proceedings ,
Apotex ,
Appeals ,
Canada ,
Drug Approvals ,
Excessive Pricing ,
Generic Drugs ,
Health Canada ,
Judicial Review ,
Leave to Appeal ,
Medical Devices ,
Motions to Quash ,
Non-Infringing Alternatives (NIAs) ,
Novelty ,
Patent Infringement ,
Patented Medicine Prices Review Board (PMPRB) ,
Pharmaceutical Patents ,
Pleadings ,
PMNOC Regulations ,
Promise Doctrine ,
Section 8 ,
Takeda Pharmaceuticals ,
Third-Party
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)
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