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ARTICLE · 23 AUGUST 2017

Proposed Amendments To The PM(NOC) Regulations Under CETA

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Proposed regulations to implement Bill C-30 were published on July 14, including proposed amendments to the Patented Medicines (Notice of Compliance) (PM(NOC)) Regulations.

CanadaIntellectual Property
Andrew Bernstein
Andrew Bernstein
Andrew Shaughnessy
Andrew Shaughnessy
Vanessa Komarnicki
Vanessa Komarnicki
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Comment period for proposed regulations only 15 days

Proposed regulations to implement Bill C-30 were published on July 14, including proposed amendments to the Patented Medicines (Notice of Compliance) (PM(NOC)) Regulations.1 While the regulations are not in force, the comment period is an unusually short 15 days. This bulletin provides an overview of the proposed amendments.

What You Need To Know

  • The purpose of the proposed amendments is to replace the existing summary proceedings with full actions resulting in final determinations of patent infringement and validity.
  • Within 45 days of receiving a generic manufacturer's (a second person's) notice of allegation (NOA), an innovative manufacturer (a first person) or patent owner must decide whether to bring an action against the second person. This action would be for a declaration of infringement of a listed patent or certificate of supplementary protection (CSP), an extension of the patent term being

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