Canada is an attractive market for pharmaceutical manufacturers. While universal healthcare does not currently extend to drugs in an outpatient setting, most Canadian consumers have some form of drug coverage through...more
UPDATE: On January 13, 2021, the Minister of Health refused the application on reconsideration. Viiv sought but later discontinued a second application for judicial review (T-258-21).
In a decision dated July 10, 2020,...more
On November 21, 2019, the Patented Medicines Prices Review Board (“PMPRB”) released draft new Guidelines for consultation, together with a backgrounder. The new Guidelines are intended to operationalize the amended Patented...more
11/25/2019
/ Amended Regulation ,
Canada ,
Draft Guidance ,
Drug Approvals ,
Drug Pricing ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Public Comment
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
On August 21st, the long-awaited amendments to the Patented Medicines Regulations were published in Part II of the Canada Gazette. We have prepared an unofficial consolidated version of the Regulations incorporating the...more
8/25/2019
/ Amended Regulation ,
Canada ,
Confidential Information ,
Drug Pricing ,
Exemptions ,
IP License ,
Licensees ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Rebates ,
Reporting Requirements ,
Third-Party
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