CETA Draft Regulations Published on Patent Linkage and Term Restoration – 15 Day Public Comment Period

by Sheldon Hamilton, Lynn Ing and Daphne C. Lainson

The government has published the long anticipated draft regulations regarding:

  1. changes to the Patented Medicines (Notice of Compliance) Regulations [“PMNOC Regulations”], and

  2. proposed Regulations to implement Certificates of Supplementary Protection (CSPs) [“CSP Regulations”] to compensate innovators for lost patent term due to regulatory delays.

There is a short 15-day period for public comment ending on July 30, 2017.

The proposed changes to the PMNOC Regulations and the new CSP Regulations will herald a new environment for pharmaceutical companies, with long lasting impact.

Companies should immediately consider the proposed changes, and submit comments within the time frame.

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