September 21, 2024, marked the seventh anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the seventh year...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
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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
Manitoba has implemented a Biosimilars Initiative effective August 1, 2024. Manitoba is the last province in Canada to implement a biosimilar policy that requires patients receiving funding under the Manitoba Pharmacare...more
In the first half of 2024, 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
In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, and market access) since our March 2023 update....more
3/27/2024
/ Biologics ,
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Market Access Rule ,
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Trademark Litigation
On January 11, 2024, the Federal Court released its decision concluding that the Patented Medicine Prices Review Board (PMPRB or Board) was reasonable in its redetermination that the invention of Patent No. 2,478,237 (the 237...more
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
1/3/2024
/ Abuse of Process ,
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CADTH ,
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Statute of Monopolies ,
United States-Mexico-Canada Agreement (USMCA)
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
As previously reported, in the spring, the Canadian Agency for Drugs and Technologies in Health (CADTH) consulted on a process for time-limited reimbursement recommendations. The pan-Canadian Pharmaceutical Alliance (pCPA)...more
In the first half of 2023, 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 Standing Committee on Health (HESA) of the House of Commons met on Thursday, April 27, 2023, to begin its study of the Patented Medicine Prices Review Board (PMPRB). The Committee first heard from the Minister of Health,...more
The Canadian Agency for Drugs and Technologies in Health (CADTH) has released a consultation document for a Proposed Process for Time-limited Reimbursement Recommendations. The time-limited reimbursement recommendations would...more
Update: Health Canada has prepared an overview of its special access programs, and has finalized the Guidance Document: Sale of Drugs - Public or Canadian Armed Forces Health Emergencies.
On February 15, 2023, Regulations...more
In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, market access and competition) since our last update in June 2022....more
On December 20, 2022, Ontario announced it is implementing a biosimilars transition policy. Starting March 31, 2023, patients receiving coverage from the Ontario Drug Benefit plan for the following innovator biologics can...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
On December 5, 2022, the Federal Court of Appeal (FCA) dismissed Innovative Medicines Canada (IMC) and sixteen innovative pharmaceutical companies’ appeal regarding the validity of the amended basket of comparator countries...more
On November 21, 2022, the Minister of Health tabled the 2021 Annual Report of the Patented Medicine Prices Review Board (PMPRB). The Report includes information on the PMBRB’s regulatory activities, pharmaceutical sales and...more
On September 1, 2022, a Panel of the Patented Medicine Prices Review Board (PMPRB) issued a decision that the price of Horizon Pharma’s PROCYSBI (cysteamine delayed release capsules) was and is excessive under sections 83 and...more
On October 20, 2022, Saskatchewan announced it is introducing a biosimilars initiative.
For any new patients starting a biologic drug, the Saskatchewan Drug Plan will only offer coverage for the listed biosimilar version....more
September 21, 2022, marked the fifth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fifth year...more
Health Canada released a number of reports over the summer:
- Annual Health Product Highlights for 2021, which provides an overview of new health products, including drugs and medical devices, that Health Canada approved...more
On May 20, 2022, the Competition Bureau announced that it closed two investigations into pharmaceutical patent litigation settlement agreements as evidence gathered during the two investigations suggested the agreements did...more
As previously reported, on January 11, the Canadian Agency for Drugs and Technologies in Health (CADTH) posted a discussion paper regarding the proposed framework for a potential pan-Canadian formulary. The pan-Canadian...more