September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fourth year...more
9/28/2021
/ Amended Regulation ,
Apotex ,
Appeals ,
Canada ,
Dismissals ,
Judgment on the Merits ,
Patent Infringement ,
Patent Litigation ,
Patent Validity ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Sandoz ,
Teva Pharmaceuticals
UPDATE: On November 3, 2020, the Federal Court of Appeal dismissed Amgen’s appeal. See our article here.
On April 16, 2020, Justice Southcott of the Federal Court issued the first decision under the amended Patented...more
5/4/2020
/ Abuse of Process ,
Amgen ,
Apotex ,
Appeals ,
Canada ,
Motion to Dismiss ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Popular ,
Prior Use ,
Prior User Rights
On March 11, 2020, the Federal Court of Appeal dismissed Apotex’s appeal of the Federal Court’s decision ordering Apotex to pay over $61M from an accounting of profits from Apotex’s infringement of ADIR’s perindopril patent...more
In an action commenced by Allergan against Apotex in respect of ulipristal (Allergan’s FIBRISTAL) under the Patent Medicines (Notice of Compliance) Regulations (PMNOC Regulations), an issue arose as to the appropriate...more
2/10/2020
/ Affirmative Defenses ,
Allergan Inc ,
Apotex ,
Canada ,
International Litigation ,
Notice of Compliance ,
Patent Litigation ,
Patented Medicines ,
Pharmaceutical Patents ,
Pleadings ,
PMNOC Regulations
September 21, 2019 was the second anniversary of the coming into force of the amended Patented Medicines (Notice of Compliance) Regulations (Regulations) heralding significant changes to the landscape for pharmaceutical...more
10/3/2019
/ Allergan Inc ,
Amended Regulation ,
Amgen ,
Apotex ,
Bristol-Myers Squibb ,
Canada ,
Certificates of Supplementary Protection (CSPs) ,
Hatch-Waxman ,
Health Canada ,
Janssen Pharmaceuticals ,
Joinder ,
Leave to Appeal ,
Notice of Compliance ,
Patent Infringement ,
Patented Medicines ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Sandoz ,
Teva Pharmaceuticals ,
Trial Plan
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
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
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
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
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
Servier and its related company ADIR were successful in another chapter of patent litigation relating to perindopril (Servier’s COVERSYL): the Federal Court again dismissed Apotex’s non-infringing alternative defence, finding...more
4/30/2018
/ Apotex ,
Appeals ,
Calculation of Damages ,
Canada ,
Defense Strategies ,
Disgorgement ,
Non-Infringing Alternatives (NIAs) ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Profits ,
Reaffirmation ,
Suppliers ,
Third-Party
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
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
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
Pfizer obtains orders of prohibition on polymorphic form patent -
On September 22, the Federal Court, in a pair of decisions, granted Orders of prohibition under the Patented Medicines (Notice of Compliance) Regulations...more
10/30/2017
/ Apotex ,
Appeals ,
AstraZeneca ,
Canada ,
CETA ,
Competition Authorities ,
Health Canada ,
Health Care Providers ,
Judicial Review ,
Mandatory Disclosure Rules ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Supreme Court of Canada ,
Technical Errors
The Federal Court has issued its Public Judgment and Reasons concerning the financial compensation to be paid to AstraZeneca as a result of Apotex’s infringement of the omeprazole formulation patent (AstraZeneca’s LOSEC) in...more
9/13/2017
/ Abuse of Process ,
Apotex ,
AstraZeneca ,
Calculation of Damages ,
Canada ,
Concurrent Jurisdiction ,
Concurrent Litigation ,
Defense Strategies ,
Double Recovery ,
Forum Shopping ,
Lost Profits ,
Multi-Jurisdictional Litigation ,
Multiple Occurences ,
Non-Infringing Alternatives (NIAs) ,
Patent Infringement ,
Patents ,
Remedies ,
Section 8