Publication of Final Regulations on Patent Linkage and Term Restoration related to CETA

by Urszula Wojtyra, Nancy Pei and Daphne Lainson

Earlier today, September 7, 2017, the Government of Canada published final pharmaceutical regulations flowing from CETA. According to an Order in Council, the new regulations will be in force on September 21, 2017.

These amended regulations herald a significant change to the landscape and environment in Canada for pharmaceutical companies, with long lasting impact to innovators in terms of exclusivity and drug product life-cycle management.

Read our article for an overview of the comparison between the final and draft:

  1. Regulations Amending the Patented Medicines (Notice of Compliance) Regulations, 2017 and

  2. Certificate of Supplementary Protection Regulations which, together with the amendments to the Patent Act in the Canada-European Union Comprehensive Economic and Trade Agreement Implementation Act will compensate innovators for lost patent term due to regulatory delays.

Click here to read full article »

Webinar: September 26th
New Regulations & Impacts for Pharma Patents in Canada

The final pharmaceuticals regulations to implement CETA will take effect on September 21, 2017 and will impact Pharma innovators in terms of exclusivity and drug product life-cycle management.

Join our Life Sciences partners Daphne Lainson and Sheldon Hamilton for a webinar on September 26th to learn more about the new PMNOC Regulations and the CSP Regulations.

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For more information or to request a copy of any decision, pleading or legislation, please contact:

Nancy Pei (Editor)




Andrew Mandlsohn
Kevin Siu

Urszula Wojtyra

Brandon Heard

Abigail Smith

Gunars Gaikis
Nancy Pei

Steven Garland
Mark Biernacki

Sheldon Hamilton
Jeremy Want

Yoon Kang
Colin Ingram

Christopher Robinson
David Schwartz

Yoon Kang
Mark Pidkowich

Daphne Lainson

Thuy Nguyen

Nancy Pei

Daphne Lainson




The preceding is intended as a timely update on Canadian intellectual property and regulatory law of interest to the pharmaceutical industry. The contents of this newsletter are informational only and do not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.

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