As we previously reported, on December 19, 2024, the Patented Medicine Prices Review Board (PMPRB) released its Draft Guidelines for PMPRB Staff regarding Administrative Process for Excessive Price Hearing Recommendation...more
The pharmacy landscape has evolved considerably over the past year, shining a spotlight on pharmacy “patient steering”, the practice of directing patients to certain preferred pharmacies. Though Quebec has long required that...more
Explore skinny labelling & obviousness in Canada and Australia -
If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more
8/30/2024
/ Australia ,
Canada ,
Cross-Border ,
FDA Approval ,
Hatch-Waxman ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Litigation Strategies ,
Obviousness ,
Patent Applications ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Webinars
Explore skinny labelling & obviousness in Canada and Australia -
If you are an intellectual property (IP) owner, a litigator or an in-house legal professional managing IP litigation in multiple jurisdictions, don’t miss...more
8/30/2024
/ Australia ,
Canada ,
Cross-Border ,
FDA Approval ,
Hatch-Waxman ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Litigation Strategies ,
Obviousness ,
Patent Applications ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Webinars
In a public decision dated August 8, 2024, Justice Furlanetto of the Federal Court found Boehringer Ingelheim’s Canadian Patent No. 2,591,083 (the 083 patent) valid and infringed by JAMP in an action under the Patented...more
As previously reported, the Patented Medicine Prices Review Board (PMPRB) published a Discussion Guide for Phase 2 Consultations on New Guidelines as part of a three-phase consultation process that started in September 2023....more
For World IP Day 2024, we asked three of our practitioners three questions, all related to the World Intellectual Property Organization’s 2024 theme of IP and the SDGs: Building our common future with innovation and...more
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 January 23, 2023, the Federal Court released a decision by Associate Judge Tabib denying Takeda’s motion to consolidate two actions commenced under the Patented Medicines (Notice of Compliance) Regulations (PMNOC...more
As previously reported, the Federal Court quashed a second decision by the Minister of Health (Minister) to issue a Notice of Compliance (NOC) to Médunik Canada (Médunik) for its amifampridine product, RUZURGI, following the...more
As previously reported, the Federal Court found Janssen’s Canadian Patent No. 2,661,422 (the 422 patent) invalid on the basis of obviousness and dismissed its actions against Apotex, Dr. Reddy’s Laboratories, and...more
In a decision rendered on August 17, 2022, the Federal Court granted Sandoz Canada Inc (Sandoz) leave to amend its Statement of Defence to add new allegations, contingent on an adjournment of the trial and an extension of a...more
9/27/2022
/ Bayer ,
Canada ,
Leave to Amend ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Sandoz
On May 31, 2022, the Federal Court released a decision by Justice Pallotta in a patent infringement action pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations in relation to macitentan...more
On April 27, 2022, the Competition Bureau announced that it has reached a settlement agreement with NuvoCare Health Sciences Inc and its founder (collectively “NuvoCare”), who were found to have made marketing claims that...more
On March 10, 2022, for the second time, the Federal Court set aside a decision by the Minister of Health (Minister) to issue Médunik Canada (Médunik) a Notice of Compliance (NOC) for its amifampridine product, RUZURGI,...more
On January 11, 2022, the Patented Medicine Prices Review Board (PMPRB) released a report entitled Expensive Drugs for Rare Diseases: Canadian Trends and International Comparisons, 2011-2020 as part of the National...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
Update: On November 10, 2021, the Minister rejected Janssen’s second request for data protection for SPRAVATO, which was submitted following the coming into force of the Canada-United States-Mexico Agreement (CUSMA). The...more
On June 9, 2021, the Federal Court of Appeal (FCA), following grant of leave to hear Sunovion’s appeal, dismissed Sunovion’s appeal from a Federal Court (FC) decision of Furlanetto J. (2021 FC 37) granting Taro leave to amend...more
6/17/2021
/ Appeals ,
Canada ,
Dismissals ,
Intellectual Property Protection ,
Leave to Amend ,
Patent Infringement ,
Patent Litigation ,
Patent Validity ,
Patented Medicines ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Section 8
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
On January 14, 2020, the Federal Court released a decision by Phelan J. in patent infringement actions pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) relating to...more
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: On September 30, 2020, Eli Lilly appealed both decisions by Justice St-Louis: Eli Lilly v Apotex (A-234-20 and A-239-20); Eli Lilly v Pharmascience and Riva (A-236-20); Eli Lilly v Mylan (A-237-20); and Eli Lilly v...more
10/5/2020
/ Anticipation ,
Canada ,
Eli Lilly ,
Enablement Inquiries ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Validity ,
Patents ,
Pharmaceutical Patents ,
Popular
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