Federal Court of Appeal requires PMPRB to re-determine whether patent ‘pertains to’ Galderma’s DIFFERIN -
On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB...more
8/1/2019
/ Adverse Action Report ,
Annual Reports ,
Appeals ,
Biosimilars ,
CADTH ,
Canada ,
Dismissals ,
Draft Guidance ,
Drug Pricing ,
Guidance Update ,
Health Canada ,
Hospitals ,
Interlocutory Appeals ,
Judicial Review ,
Patent Act ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Public Consultations ,
Teva Pharmaceuticals
On June 12, 2019, the Minister of Health tabled the final report, A Prescription for Canada: Achieving Pharmacare for All, from the Advisory Council on the Implementation of National Pharmacare (the Council) (see also: news...more
IN THIS ISSUE:
- Federal Court dismisses Servier's application for order of prohibition regarding salt patent for perindopril arginine
- FCA upholds issuance of NON-W letter and cancellation of reconsideration process...more
6/14/2019
/ Adverse Events ,
Amended Regulation ,
Appeals ,
Canada ,
Dismissals ,
Emergency Rooms ,
Health Canada ,
New Guidance ,
Notice of Appeal ,
Notice of Compliance ,
Orders of Prohibition ,
Patent Infringement ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Supreme Court of Canada
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Draft Guidance ,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
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
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
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
Certificate of Supplementary Protection Regime: First Anniversary Update -
September 21, 2018 marked the first anniversary of the certificate of supplementary protection (CSP) regime. CSPs, which provide an additional...more
10/4/2018
/ Canada ,
Certificates of Supplementary Protection (CSPs) ,
Customer-Loyalty Programs ,
FDA Approval ,
Imports ,
Interim Rule ,
Leave to Appeal ,
Medical Devices ,
Patented Medicine Prices Review Board (PMPRB) ,
Pharmacist ,
PMNOC Regulations ,
Prescription Drugs ,
Prohibition Applications ,
Supreme Court of Canada
IN THIS ISSUE:
- Shire’s VYVANSE patent valid, prohibition order issued
- First judicial consideration of Vanessa’s Law: Health Canada must disclose requested clinical trial data
- PMPRB News
- Patented Medicine...more
8/1/2018
/ CADTH ,
Canada ,
Canadian Patent Office ,
Clinical Trials ,
Constitutional Challenges ,
Disclosure Requirements ,
Discovery Disputes ,
Drug Approvals ,
Health Canada ,
Leave to Appeal ,
Motion to Compel ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Tobacco ,
Tobacco Regulations ,
Vanessa's Law
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
No Section 8 Liability for Valid and Infringed Patent in NEXIUM Proceeding -
What happens when a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) (PMNOC)...more
4/4/2018
/ Calculation of Damages ,
Canada ,
Corporate Misconduct ,
Costco ,
Dismissals ,
Eli Lilly ,
Janssen Pharmaceuticals ,
Medical Devices ,
Motion To Strike ,
Patent Infringement ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Patents ,
Pharmacies ,
PMNOC Regulations ,
Prescription Drugs ,
Rebates ,
Section 8 ,
Teva Pharmaceuticals
Apotex granted damages from contract research organization for delayed FDA approval of two products -
Appeal of summary dismissal under PMNOC Regulations: dismissal order stayed...more
2/2/2018
/ Administrative Proceedings ,
Apotex ,
Appeals ,
Biologics ,
Biosimilars ,
Canada ,
Damages ,
Dismissals ,
Drug Approvals ,
Electronic Filing ,
FDA Approval ,
Foreign Patent Applications ,
Health Canada ,
Patent Applications ,
Patented Medicines ,
PMNOC Regulations ,
Prescription Drugs ,
Stays
PMPRB News -
PMPRB releases scoping paper relating to proposed amended Regulations -
As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more
12/20/2017
/ Amended Regulation ,
Apotex ,
Appeals ,
Biosimilars ,
Canada ,
Constitutional Challenges ,
Controlled Substances ,
Disclosure Requirements ,
Dismissals ,
Drug Approvals ,
Financial Statements ,
Health Canada ,
Health Care Providers ,
Leave to Amend ,
Medical Devices ,
Medical Marijuana ,
New Guidance ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
PMNOC Regulations ,
Prescription Drugs ,
Public Consultations ,
Reversal ,
Supreme Court of Canada ,
Tortious Interference
The following provides an update on biosimilars in Canada.
Health Canada’s guidance on biosimilars -
In November 2016, Health Canada issued a Guidance Document: Information and Submission Requirements for Biosimilar...more