On October 28, 2019, the Ontario Ministry of Health and Long-Term Care (the Ministry) published proposed changes to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee...more
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
The OHIP+ program, also known as Children and Youth Pharmacare program, was implemented on January 1, 2018 by the Province of Ontario to provide free prescription drug coverage for all children and youth 24 years of age or...more
On February 1, 2019, the Ontario Ministry of Health and Long-Term Care (“Ministry”) announced that CWC Pharmacies (Ontario) Ltd. (“Costco Pharmacies”), a subsidiary of Costco, was ordered to pay an Administrative Monetary...more
The Canadian Federal government’s proposed amendments to the Cannabis Act and Regulations were published last month. Until February 20, 2019, Health Canada will be accepting comments on the proposed amendments, which set out...more
1/28/2019
/ Advertising ,
Beer ,
Caffeine Products ,
Canada ,
Cannabis Act ,
Decriminalization of Marijuana ,
Drug Approvals ,
Food and Drug Administration (FDA) ,
Health Canada ,
Labeling ,
Licensing Rules ,
Marijuana-Infused Edibles ,
Product Packaging ,
Proposed Amendments ,
Public Comment ,
Wine & Alcohol
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 October 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) issued an interesting Environmental Scan on International Policies on the Appropriate Use of Biosimilar Drugs (Report). This Report outlines...more
11/30/2018
/ Biosimilars ,
CADTH ,
Canada ,
Drug Pricing ,
Global Market ,
Incentives ,
International Regulatory Standards ,
Pharmacies ,
Policies and Procedures ,
Prescribing Authority ,
Prescription Drugs
In her report on the 2008 Canadian listeriosis outbreak, Independent Investigator Sheila Weatherill highlighted the need for “substantial consolidation and modernization” of the legislative and regulatory framework governing...more
8/2/2018
/ Agricultural Sector ,
Canada ,
Canadian Food Inspection Agency (CFIA) ,
Exports ,
Food and Drug Administration (FDA) ,
Food Borne Bacteria ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Foreign Suppliers ,
FSMA ,
Health Canada ,
Imports ,
Licensing Rules ,
New Regulations ,
Reasonable Prevention Procedures ,
Safe Food for Canadians ,
Verification Requirements
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
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
After an unpredictable few weeks, Bill C-45, the Cannabis Act, received Royal Assent on June 21, 2018, and adult use cannabis will be legal in Canada as of October 17, 2018. Canada will be only the second country in the world...more