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Drug price negotiations: pCPA consulting on a Temporary Access Process (pTAP)

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By Sarah Pennington & Kristin Wall on July 19, 2023

The pan-Canadian Pharmaceutical Alliance (pCPA) has recently published a set of principles and conditions for a pCPA Temporary Access Process (pTAP) which will inform the negotiation process and potential product listing agreements (PLAs) for…

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Canada implements patent term adjustment as Bill C-47 becomes law

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By Kristin Wall, Anna Wilkinson & Paul Jorgensen on June 26, 2023

On June 22, 2023, Canada’s federal government passed legislation (Bill C-47) introducing a system of general patent term adjustment (PTA). The provisions amending the Patent Act to introduce PTA passed without substantive amendment and are scheduled…

PMPRB Update: Consultation on Amendment to the Interim Guidance re New Medicines

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By Kristin Wall & Christopher A. Guerreiro on June 20, 2023

The Patented Medicine Prices Review Board (PMPRB) has launched a 60-day consultation on proposed changes to the price-review process set out in its Interim Guidance of August 18, 2022 (Interim Guidance). The proposed changes would affect…

Health Canada releases updated Certificate of Supplementary Protection guidance

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By Sarah Pennington, Paul Jorgensen & Kristin Wall on May 29, 2023

On May 12, 2023, Health Canada announced the release of an updated version of the Guidance Document: Certificates of Supplementary Protection (CSP Guidance).  The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale”…

The Ontario Superior Court dismisses a generic manufacturer’s claim for damages under section 8 of the PM(NOC) Regulations

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By David Yi & William Chalmers on May 4, 2023

The Ontario Superior Court (ONSC) has dismissed a claim for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations) brought by Apotex Inc. (Apotex) for lost sales of its Apo-Atomoxetine…

Supreme Court denies leave to appeal in generic Statute of Monopolies case

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By Christopher A. Guerreiro, David Yi & William Chalmers on May 4, 2023

On April 27, 2023, the Supreme Court of Canada dismissed an application by Apotex Inc. and Apotex Pharmachem Inc. (Apotex) for leave to appeal from a decision of the Ontario Court of Appeal (ONCA), dismissing its…

PMPRB Update: Federal Standing Committee on Health begins review of the Board

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By Kristin Wall & Christopher A. Guerreiro on May 2, 2023

The Standing Committee on Health (HESA) has begun a study on the Patented Medicine Prices Review Board (PMPRB). HESA is made up of 12 Members of Parliament representing the four main parties in the House of…

Bill C-47 introduces patent term adjustment: Proposed term to run concurrently with term of Certificate of Supplementary Protection

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By Paul Jorgensen, Anna Wilkinson & Kristin Wall on May 1, 2023

On April 20, 2023, the federal government tabled legislation (Bill C-47) that would amend the Patent Act to bring, for the first time, a system of general patent term adjustment (PTA) into Canada. Canada is required…

U.S. Trade Representative cites Canada’s “IP problems” including pharmaceutical patent protection

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By Kristin Wall & Paul Jorgensen on April 27, 2023

On April 26, 2023, the Office of the United States Trade Representative (USTR) released its 2023 Special 301 Report on intellectual property. The report keeps Canada on a Watch List of 29 U.S. trading partners that “merit bilateral attention…

Federal Court of Appeal rejects elevated standard of proof for induced infringement in paliperidone case

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By Kristin Wall, Christopher A. Guerreiro & Pharma in Brief team on April 21, 2023

The Federal Court of Appeal (FCA) has allowed an appeal concerning induced infringement in an action under the Patented Medicines (Notice of Compliance) Regulations (Regulations). The FCA found that the Federal Court (FC) had…

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