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ARTICLE · 22 JANUARY 2025

Timing Is Everything: Risks Of Delayed Patent List Submission In Canada

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In EMD Serono v The Minister of Health and Apotex, the Federal Court of Canada determined that the relevant date for assessing whether a patent must be addressed by a "second person"...

CanadaIntellectual Property
Eileen McMahon
Eileen McMahon
Teresa Reguly
Teresa Reguly
Henry Mah
Henry Mah
Yu Seon Gadsden-Chung
Yu Seon Gadsden-Chung
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In EMD Serono v The Minister of Health and Apotex, the Federal Court of Canada determined that the relevant date for assessing whether a patent must be addressed by a "second person" who seeks to market a generic version of a patented drug is the date the patent is listed on the patent register by the Minister of Health (Minister), rather than the date the patent is submitted for listing by the "first person" (i.e. the innovative drug manufacturer).

What you need to know

  • A "second person" who seeks to market a generic version of a patented drug must address patents listed on the Health Canada patent register (the Register), the Canadian equivalent of the U.S. "Orange Book" for pharmaceutical patents1.

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