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ARTICLE · 01 NOVEMBER 2012

FCA Describes Specificity Requirements For Listing Patents On The Patent Register

McCarthy Tétrault
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The Federal Court of Appeal has clarified that there must be a "high threshold of consistency" between the content of a new drug submission and a patent’s claims in order for the patent to be listed on the patent register pursuant to section 4(2)(a) of the PM(NOC) Regulations.

CanadaIntellectual Property
Steven Tanner
Steven Tanner
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The Federal Court of Appeal has clarified that there must be a "high threshold of consistency" between the content of a new drug submission and a patent's claims in order for the patent to be listed on the patent register pursuant to section 4(2)(a) of the PM(NOC) Regulations.

This decision, Gilead Sciences Canada Inc. v. The Minister of Health and The Attorney General of Canada, 2012 FCA 254 (Gilead), presents additional challenges for innovative pharmaceutical companies seeking to protect new innovations by listing patents on the patent register.

The Facts of Gilead

On October 4, 2010, Gilead filed a new drug submission (NDS) with the Minister for the drug Complera, to be used for the treatment of HIV infections. As described in the NDS, Complera contains three medicinal ingredients: (1) tenofovir disoproxil fumarate (tenofovir); (2) emtricitabine; and (3) rilpivirine.  Health Canada issued an NOC in respect of this NDS which triggered the listing

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