Eli Lilly v Teva, Pharmascience, Riva, Apotex, Mylan (tadalafil, CIALIS) – Following a summary trial, Lilly’s infringement actions were dismissed: composition claims directed to “a physiologically acceptable salt” of...more
On October 25, 2023, the Patented Medicine Prices Review Board (PMPRB) announced that it will launch the first phase of consultations on new guidelines. The first phase will include a policy roundtable with stakeholders on...more
The Patented Medicine Prices Review Board (PMPRB) recently published its Meds Pipeline Monitor 2022 report, which highlights medicines in the pipeline that may impact future clinical practice and drug spending in Canada if...more
On June 20, 2023, the Patented Medicine Prices Review Board (PMPRB) released a proposal to amend the Interim Guidance, which sets out the approach for reviewing the prices of patented medicines under the July 1, 2022...more
2022 was an active year in Canadian patent law. Claim fees were introduced for the first time; changes were made to regulations providing remedies for excessive pricing of patented medicines; and a range of court decisions...more
Below are highlights from the Rx IP’s team’s 2022 updates (see also our Top 10 Rx IP Update Reads of 2022): Contents: 1. Patent decisions on the merits 2. PMNOC Regulations: Fifth-year anniversary of major amendments,...more
The Patented Medicine Prices Review Board (PMPRB) has advised that the new Guidelines will not be implemented on January 1, 2023, and that the Interim Guidance issued by the Board on August 18, 2022 will remain in place until...more
The amended PMPRB regulations came into force on July 1, 2022, and at that time an interim approach to pricing was proposed. The interim approach proposed a “status quo” to pricing until Guidelines could be established...more
In the first half of 2022, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to July and...more
As previously announced, the amended Patented Medicines Regulations will be coming into force on July 1, 2022 in substantially revised form. As we previously reported, the new basket of countries for Patented Medicine Prices...more
The coming into force date of the amended Patented Medicines Regulations governing the Patented Medicine Prices Review Board (PMPRB) has been deferred for the fourth time, now until July 1, 2022. The news was announced on...more
In the fall of 2021, the Rx IP Update team celebrated its 20thyear of monthly updates on Canadian life sciences IP and regulatory law. Below are highlights from our team’s 2021 updates...more
In the first half of 2021, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to June and...more
The coming into force of the amended Patented Medicines Regulations has been delayed a third time, now until January 1, 2022. The amendments, once in force, will add new price regulatory factors, revise the list of...more
Revised compliance timelines for Grandfathered and Gap medicines - On April 16, 2021, in view of COVID-19, the Patented Medicine Prices Review Board (PMPRB) reversed its position on compliance timelines for Grandfathered...more
Update: See our April 29, 2021 article reporting an update to compliance timelines for Grandfathered and Gap medicines. Further updates, including to the definition of “Gap medicine” are presently in consultation (see article...more
Update: See our March 30, 2021 article, which reports the outcome of the consultation, and our April 29, 2021 article reporting an update to compliance timelines for Grandfathered and Gap medicines. Further updates, including...more
In 2020, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: Table of Contents 1. COVID-19: CIPO, Federal Courts, Health Canada 2. PMPRB:...more
On November 23, 2020, Innovative Medicines Canada (IMC) and a number of research-based pharmaceutical companies commenced an application for judicial review (T-1419-20) of the final Patented Medicine Prices Review Board...more
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
Federal Court decision appealed - Both the applicants and the respondent have appealed the June 29, 2020 decision striking subsection 3(4) of the Regulations Amending the Patented Medicines Regulations (Additional Factors...more
UPDATE: On September 10, 2020, the applicants (Innovative Medicines Canada and the company applicants) appealed Justice Manson’s decision (A-215-20). On September 21, 2020, the Attorney General of Canada cross-appealed. As...more
On May 7, 2020, the Patented Medicines Prices Review Board (PMPRB or Board) ordered Galderma to file prescribed sales and financial information for DIFFERIN (0.1% adapalene) until the expiry of the 237 patent (2,478,237),...more
Update: See our article here regarding the final October 2020 Guidelines. On November 23, Innovative Medicines Canada and a number of pharmaceutical companies commenced an application for judicial review of the final...more
UPDATE: See June 23, 2020 article here describing the notable changes. See our article here regarding the final October 2020 Guidelines. On November 23, Innovative Medicines Canada and a number of research-based...more