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ARTICLE · 25 AUGUST 2011

Intellectual Property Weekly Abstracts Alert - Week Of August 22, 2011

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

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Health Canada has published proposed revisions to the Guidance Document: Patented Medicines (Notice of Compliance) Regulations.

CanadaIntellectual Property

Edited by Chantal Saunders and Beverley Moore

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Health Canada has published proposed revisions to the Guidance Document: Patented Medicines (Notice of Compliance) Regulations. According to the proposed revisions, "only the originating NDS or originating ANDS (i.e. the licensor's drug submission) which directly or indirectly compares the drug with, or makes reference to, another drug marketed in Canada under an NOC issued to a first person, triggers the application of section 5 of the PM(NOC) Regulations and as such, the licensor must address any patents listed on the Patent Register in respect of the innovative product. However, subsequently filed administrative drug submissions that cross-reference the licensor's drug submission pursuant to a licensing agreement will not re-trigger section 5 of the PM(NOC) Regulations." Comments are to be provided to Health Canada within 60 days from the date of the notice, August 17, 2011.

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