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FCA dismisses appeal, patent not listable against STELARA SNDS

As previously reported, the Federal Court (FC) dismissed Janssen’s application for judicial review of the decision of the Office of Submissions and Intellectual Property (OSIP) refusing to list Canadian Patent No. 3,113,837...more

May 1 deadline to seek leave to intervene in PMPRB SOLIRIS rehearing

As previously reported, the Federal Court of Appeal set aside the Federal Court’s decision dismissing Alexion’s application for judicial review and remitted the matter of whether Alexion’s SOLIRIS (eculizumab) was sold at an...more

Supreme Court of Canada denies leave to appeal SOLIRIS PMPRB decision

On September 29, 2021, the Attorney General of Canada sought leave to appeal a decision of the Federal Court of Appeal (2021 FCA 157) setting aside the decision of the Federal Court dismissing Alexion’s application for...more

FCA remits pricing decision on ALEXION’S SOLIRIS to PMPRB

Update: On September 29, 2021, Canada applied to the Supreme Court of Canada for leave to appeal (Docket No. 39858). In September 2017, the Patented Medicine Prices Review Board (PMPRB or Board) decided (see article here)...more

Proposed amendments to the Patented Medicines (Notice of Compliance) Regulations would expand definition of “claim for the...

Update: Health Canada’s “Forward Regulatory Plan: 2023-2025” no longer lists the 2019 proposed amendments to the Food and Drug Regulations, “Regulations amending the Food and Drug Regulations (Improving Access to Generic...more

Federal Court of Appeal affirms prohibition order against Apotex regarding abiraterone

As previously reported, in the final decision released under the pre-amended Patented Medicines (Notice of Compliance) Regulations (Regulations), the Federal Court granted a prohibition order relating to Canadian Patent No....more

Federal Court dismisses motion for a fifth generic to be added to rivaroxaban trial of common issues under PMNOC Regulations

The Federal Court had previously allowed a concurrent trial on common invalidity issues in actions under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) against four generic manufacturers:...more

Federal Court issues two interlocutory decisions in section 8 pregabalin case

On October 10, 2019, Justice O’Reilly of the Federal Court issued two decisions relating to Pharmascience’s claim for section 8 damages under the pre-amended Patented Medicines (Notice of Compliance) Regulations for its...more

Amended PMNOC Regulations: Second Anniversary Update

September 21, 2019 was the second anniversary of the coming into force of the amended Patented Medicines (Notice of Compliance) Regulations (Regulations) heralding significant changes to the landscape for pharmaceutical...more

Rx IP Update - July 2019

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

Rx IP Update - June 2019

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

Amended PMNOC Regulations: First Anniversary Update

As previously reported, the amended Patented Medicines (Notice of Compliance) Regulations (“Regulations”) came into force on September 21, 2017, heralding significant changes to the landscape for pharmaceutical companies in...more

Rx IP Update - May 2018

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

Rx IP Update - March 2018

No Section 8 Liability for Valid and Infringed Patent in NEXIUM Proceeding - What happens when a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) (PMNOC)...more

Rx IP Update - January 2018

Apotex granted damages from contract research organization for delayed FDA approval of two products - Appeal of summary dismissal under PMNOC Regulations: dismissal order stayed...more

Rx IP Update - November 2017

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

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