As previously reported, the Federal Court of Appeal (FCA) dismissed Millennium Pharmaceuticals and Janssen’s appeal from a decision granting Teva’s claim for compensation under section 8 of the Patented Medicines (Notice of...more
2/13/2020
/ Appeals ,
Canada ,
Damages ,
Dismissals ,
Janssen Pharmaceuticals ,
Leave to Appeal ,
Notice of Compliance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Section 8 ,
Supreme Court of Canada ,
Teva Pharmaceuticals
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 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
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
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