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ARTICLE · 28 SEPTEMBER 2017

Certificates Of Supplemental Protection

Borden Ladner Gervais LLP
Borden Ladner Gervais LLP
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Borden Ladner Gervais LLP

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For the first time, as of September 21, 2017, Canada has a form of patent term restoration.

CanadaIntellectual Property

For the first time, as of September 21, 2017, Canada has a form of patent term restoration. This will restore part of a patent's term in relation to certain drug products in response to delays in receiving marketing authorization from Health Canada.

What You Need to Know

Eligible Authorizations for Sale

The Authorization for Sale is a Notice of Compliance ("NOC") issued pursuant to s. C.08.004 or C.08.004.01 of the Food and Drug Regulations.

It must be the first NOC issued for that medicinal ingredient or combination of medicinal ingredients. The NOC must have been issued on or after September 21, 2017.

If Canada is not the first country for which an application for marketing approval for that medicinal ingredient or combination has been submitted, the application for the NOC in Canada must have been filed within 12 months* of the earliest foreign application for marketing approval in:

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