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ARTICLE · 26 APRIL 2000

For Your Attention January 2000: Recent Judgment In Pharmaceutical Case Echoes New Amendments To NOC Regulations

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CanadaEnvironment
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By Adrienne M. Blanchard , [email protected]

By James E. Mills , [email protected]

Published 1/1/00

For Your Attention

New amendments to the Patented Medicines (Notice of Compliance) Regulations came into effect on October 1, 1999. The amendments were aimed at ensuring that a generic manufacturer who wishes to enter the market, when there are patents listed for an innovative product, must notify the innovator that it is seeking to enter the market. The amendments to the Regulations were inspired by the Minister of Health’s interpretation of the interplay between the Food and Drug Regulations and the NOC Regulations.

The policy underlying the Regulations is that there should be an opportunity for patent issues such as infringement to be decided in a summary manner prior to a generic manufacturer being able to enter the market. However, the decision of the Minister of Health to issue a NOC (marketing approval) to Nu-Pharm Inc., in February of 1999, for its generic version

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