September 21, 2019 marked the second anniversary of the certificate of supplementary protection (CSP) regime in Canada. CSPs provide an additional term of patent-like protection of up to two years. In our first anniversary...more
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Draft Guidance ,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
National Pharmacare Update: Publication of the final report of the Advisory Council -
On June 12, 2019, the Minister of Health tabled the final report, A Prescription for Canada: Achieving Pharmacare for All, from the...more
7/3/2019
/ CADTH ,
Canada ,
Cancer ,
Clinical Trials ,
Drug Pricing ,
European Medicines Agency (EMA) ,
Food and Drug Administration (FDA) ,
Health Canada ,
Life Sciences ,
Medical Devices ,
National Pharmacare ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
PMNOC Regulations
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
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
As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their generic o-desmethyl-venlafaxine (ODV) succinate products (Pfizer’s PRISTIQ) until expiry of...more
3/2/2019
/ Anticipation ,
Apotex ,
Appeals ,
Canada ,
Dismissals ,
Evidence ,
Hearsay ,
Obviousness ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art ,
Reaffirmation ,
Teva Pharmaceuticals ,
Trial Court Orders ,
Writ of Prohibition
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 This Issue:
Ontario Court of Appeal allows Sanofi and Schering to plead that Federal Court ramipril patent invalidity decision was flawed due to “promise doctrine” -
In an action by Apotex for compensation from...more
12/6/2018
/ Apotex ,
Appeals ,
Biosimilars ,
CADTH ,
Canada ,
Eli Lilly ,
Lack of Novelty ,
Leave to Appeal ,
Life Sciences ,
Motion To Strike ,
Patent Invalidity ,
Patented Medicine Prices Review Board (PMPRB) ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Promise Doctrine ,
Proposed Amendments ,
Remedies ,
Sandoz ,
Supreme Court of Canada ,
Teva Pharmaceuticals
In an action by Apotex for compensation from Sanofi and Schering under the Ontario Statute of Monopolies, U.K. Statute of Monopolies and the Trade-marks Act, the Ontario Court of Appeal has overturned a motion judge’s...more
12/3/2018
/ Apotex ,
Appeals ,
AstraZeneca ,
Canada ,
Collateral Attack ,
Damages ,
Estoppel ,
Issue Preclusion ,
Leave to Amend ,
Monopolization ,
Obviousness ,
Patent Invalidity ,
Pharmaceutical Patents ,
Pleadings ,
PMNOC Regulations ,
Promise Doctrine ,
Res Judicata ,
Reversal ,
Sanofi ,
Section 8 ,
Statute of Monopolies ,
Trade Marks Act
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
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
On July 18, 2018, Justice Locke of the Federal Court granted Teva’s claim for compensation under section 8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for losses suffered while market...more
8/29/2018
/ Canada ,
Counterclaims ,
Damages ,
Dismissals ,
Janssen Pharmaceuticals ,
Obviousness ,
Patented Medicines ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Section 8 ,
Teva Pharmaceuticals
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
On June 29, 2018, Justice Fothergill of the Federal Court granted Shire’s application under the pre-amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for an order prohibiting the Minister of...more
7/31/2018
/ Anticipation ,
Apotex ,
Canada ,
Counterclaims ,
Declaratory Relief ,
Dismissals ,
Foreign Judgments ,
Impeachment ,
Noninfringement ,
Notice of Compliance ,
Obviousness ,
Patent Expiration ,
Patent Infringement ,
Patent Invalidity ,
Patented Medicines ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prior Art ,
Prohibited Transactions ,
Trial Court Orders
Canada continues the march towards legal recreational “adult use” cannabis, recently publishing federal regulations affecting producers and others within the thriving industry. These include the Cannabis Regulations,...more
7/26/2018
/ Advertising ,
Brand ,
Canada ,
Decriminalization of Marijuana ,
Health Care Providers ,
Labeling ,
Licensing Rules ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Medical Marijuana ,
Pharmacist
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
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
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
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
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
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
Following release of a white paper in March, on December 9, 2017, Health Canada released proposed amendments to the Food and Drug Regulations under which “clinical summaries, reports and supporting data of clinical trials...more