On April 14, 2022, the Minister of Health announced that the amendments to the Patented Medicines Regulations (the “Regulations”), originally released on August 18, 2019, would come into force on July 1, 2022 in a...more
On February 18, 2022, the Court of Appeal of Quebec released its decision in Merck Canada Inc c Procureur général du Canada (2022 QCCA 240). This is the appeal of the Quebec Superior Court decision declaring price and revenue...more
Update: The decision has been appealed.
On December 18, 2020, the Quebec Superior Court issued its decision from a constitutional challenge to the Patented Medicine Prices Review Board (PMPRB) provisions of the Patent Act...more
12/23/2020
/ Amended Regulation ,
Canada ,
Constitutional Challenges ,
Drug Pricing ,
Health Canada ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Rebates ,
Reporting Requirements
Update: On November 23, Innovative Medicines Canada and a number of pharmaceutical companies commenced an application for judicial review of the final Guidelines. See also the PMPRB’s November 20, 2020 webinar slides here....more
11/5/2020
/ Canada ,
Drug Pricing ,
Health Canada ,
Life Sciences ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Rebates ,
Vaccinations
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
On August 9, 2019, Health Canada announced the final amendments to the Patented Medicines Regulations (see news release here and RIAS here). These amendments represent the first substantive revision to the Regulations since...more
8/12/2019
/ Amended Regulation ,
Canada ,
Drug Pricing ,
Exemptions ,
Final Rules ,
Health Canada ,
Patent Act ,
Patented Medicine Prices Review Board (PMPRB) ,
Patented Medicines ,
Patents ,
Rebates ,
Reporting Requirements