On May 26, 2023, the Minister of Health determined that Biosimilar Collaborations Ireland Limited was entitled to the benefit of section 5 of the Patented Medicines (Notice of Compliance) Regulations (Regulations), including...more
On August 9, 2019, the Minister of Health denied Merck’s application for a Certificate of Supplementary Protection (CSP) for Canadian Patent No 2,670,892 relating to the drug suvorexant (Merck’s BELSOMRA). On September 29,...more
On April 1, 2021, the fee for filing a Certificate of Supplementary Protection (CSP) will increase from $9,564 to $9,756 in accordance with subsection 9(1) of the Certificate of Supplementary Protection Regulations...more
On September 30, 2020, the Canadian Agency for Drugs and Technologies in Health (CADTH) announced the launch of new Procedures for CADTH Drug Reimbursement Reviews (updated October 29, 2020), which harmonize procedures under...more
Update: On September 1, 2020, BRDD revised its Report to correct the “Biosimilars: Market Authorizations” tables....more
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Draft Guidance ,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
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
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
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
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
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
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
Canada’s new linkage litigation scheme: A comparison to Hatch-Waxman -
The September 21, 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations (see our article here) introduced a new scheme for...more
12/2/2017
/ Annual Reports ,
Appeals ,
Canada ,
Drug Approvals ,
Drug Pricing ,
Hatch-Waxman ,
Health Canada ,
Intellectual Property Protection ,
Linkage Litigation Schemes ,
Litigation Funding ,
Motions to Quash ,
Patent Infringement ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations
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