On February 23, 2024, Health Canada announced that it will expand the information available on the Generic Submissions Under Review (GSUR) list to include the following...more
On September 1, 2021, Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) (the “Regulations”) were published in Part II of the Canada Gazette. These amendments are intended to provide...more
As previously reported... on September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the ISAD Interim Order), which...more
4/16/2021
/ Canada ,
Coronavirus/COVID-19 ,
Deadlines ,
Health Canada ,
Intellectual Property Protection ,
Manufacturers ,
Minister of Health ,
Patented Medicines ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Vaccinations
Update: In the Mid-year update: Health products approved in 2021, Health Canada reported the approval of two additional cancer drugs in collaboration with Project Orbis partners between January and June 2021 – Retevmo...more
On September 24, 2020, the Supreme Court of Canada denied leave to Apotex (Docket No. 39172) with respect to a decision affirming the quantum of profits payable to the Plaintiffs ADIR and Servier for infringement of ADIR’S...more
11/2/2020
/ Apotex ,
Appeals ,
Canada ,
Health Canada ,
Leave to Appeal ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Profits ,
Supreme Court of Canada
UPDATE: UPDATE: On December 10, 2020, the Supreme Court of Canada dismissed Pfizer’s application for leave to appeal (Docket No. 39150) (see article here).
Pfizer seeks leave in pregabalin section 8 case
As previously...more
6/8/2020
/ Apotex ,
Appeals ,
Canada ,
Dismissals ,
Health Canada ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Janssen Pharmaceuticals ,
Leave to Appeal ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pfizer ,
Pharmaceutical Patents ,
Section 8 ,
Supreme Court of Canada
UPDATE: The Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 was made on March 1, 2021 and repeals and replaces the Interim Order Respecting Drugs, Medical...more
4/22/2020
/ Canada ,
Clinical Trials ,
Controlled Substances ,
Coronavirus/COVID-19 ,
Expedited Approval Process ,
Food and Drug Act ,
Guidance Documents ,
Health Canada ,
Medical Devices ,
Personal Protective Equipment ,
Pharmacies ,
Prescribing Authority ,
Prescription Drugs ,
Public Health Emergency ,
Relief Measures ,
Temporary Regulations ,
Transparency ,
Vaccinations ,
Virus Testing
On September 17, 2019, the combination therapy of Eisai’s LENVIMA (lenvatinib) and Merck’s KEYTRUDA (pembrolizumab) for the treatment of advanced endometrial carcinoma received simultaneous approvals by Health Canada, the...more
11/8/2019
/ Australia ,
Canada ,
Collaboration ,
Combination Products ,
Drug Approvals ,
Food and Drug Administration (FDA) ,
Health Canada ,
International Relations ,
Multinationals ,
Pharmaceutical Industry ,
Popular ,
Project Orbis