The Great Green North: A Discussion on Canada’s Environmental Regulations
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
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
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
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
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
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 January 26, 2021 article, which links to the Canada Gazette copy of the further amendments and discusses proposed consequential modifications to the Guidelines definition of “gap medicine” and compliance...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
On October 27, 2020, the Patented Medicine Prices Review Board (PMPRB) released the National Drug Prescription Utilization System’s (NDPUIS) analytic study of the Canadian oncology market for 2010 to 2019. The study is...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
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
Update: See December 30, 2020 and January 26, 2021 articles discussing the further amendments which defer the coming into force date of the Amended Regulations until July 1, 2021. Further to our June 1, 2020 update,...more
Update: See our June 10, 2020 article here describing the amendments extending the deadline, and our articles here and here regarding the amendments further deferring the coming into force date until July 1, 2021, and our...more
The following provides an overview of the many developments regarding biosimilars in Canada (approvals, pending submissions, regulatory, litigation and market access) that have taken place since our last update in June 2018....more
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 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
Federal Court of Appeal requires PMPRB to re-determine whether patent ‘pertains to’ Galderma’s DIFFERIN - On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB...more
National Pharmacare Update: Publication of the final report of the Advisory Council - On June 12, 2019, the Minister of Health tabled the final report, A Prescription for Canada: Achieving Pharmacare for All, from the...more
An Update on Vanessa’s Law - This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...more
The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...more
PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more
On December 2, 2017 Canada’s Governor-in-Council published proposed Regulations Amending the Patented Medicines Regulations (“the proposed Regulations”). The 75-day consultation period ends February 15, 2018. The proposed...more
Canada’s new linkage litigation scheme: A comparison to Hatch-Waxman - The September 21, 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations (see our article here) introduced a new scheme for...more