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Draft Guidance ,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
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
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
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
On December 2, 2017 Canada’s Governor-in-Council published proposed Regulations Amending the Patented Medicines Regulations (“the proposed Regulations”). The 75-day consultation period ends February 15, 2018. The proposed...more
12/5/2017
/ Canada ,
Consultation Periods ,
Drug Pricing ,
Health Canada ,
Life Sciences ,
Patent Act ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Pharmaceutical Industry ,
Proposed Regulation ,
Reporting Requirements ,
Third-Party
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
Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission -
On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...more
6/1/2017
/ Administrative Proceedings ,
Apotex ,
Appeals ,
Canada ,
CETA ,
Damages ,
Data Protection ,
Dismissals ,
Double Patent ,
Drug Approvals ,
Electronic Filing ,
Eli Lilly ,
Generic Drugs ,
Health Canada ,
Health Information Technologies ,
Judicial Review ,
Licenses ,
Life Sciences ,
Mandamus Petitions ,
Medical Devices ,
Obviousness ,
Patented Medicines ,
Patents ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Supreme Court of Canada ,
Teva Pharmaceuticals ,
Trials
Teva awarded section 8 damages regarding pregabalin and olanzapine -
On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of...more
4/29/2017
/ Amgen ,
Bristol-Myers Squibb ,
Calculation of Damages ,
Canada ,
Damages ,
Declaratory Rulings ,
Drug Approvals ,
Eli Lilly ,
Patent Invalidity ,
Patented Medicines ,
Patents ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Section 8 ,
Teva Pharmaceuticals
Federal Court of Appeal opines on the framework for analyzing obviousness-type double-patenting -
On November 4, 2016, the Federal Court of Appeal dismissed Apotex’s appeal in Apotex Inc v Eli Lilly Canada Inc, 2016 FCA...more
11/30/2016
/ Accounting ,
Amgen ,
Apotex ,
Appeals ,
AstraZeneca ,
Biosimilars ,
Breach of Contract ,
Canada ,
CETA ,
Covenant of Good Faith and Fair Dealing ,
Damages ,
Double Patent ,
Drug Pricing ,
Eli Lilly ,
Free Trade Agreements ,
GlaxoSmithKline ,
Health Canada ,
Intellectual Property Protection ,
Mootness ,
Motion To Strike ,
New Legislation ,
Obviousness ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Pleadings ,
Prescription Drugs ,
Reversal ,
Supreme Court of Canada ,
Utility Patents