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ARTICLE · 20 JULY 2018

Shire Defends Canadian Vyvanse® Patent Against Apotex's Impeachment Attacks

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Apotex's invalidity allegations regarding Shire's Canadian Patent 2,527,646 covering the active ingredient in Shire's ADHD medication VYVANSE®...

CanadaIntellectual Property
Alexander Camenzind
Alexander Camenzind
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Apotex's invalidity allegations regarding Shire's Canadian Patent 2,527,646 covering the active ingredient in Shire's ADHD medication VYVANSE® have been rejected following a 17-day trial before Justice Fothergill of the Federal Court.1 Fothergill J. held that each of the claims in issue of the 646 Patent are not invalid on any of the grounds of obviousness, anticipation, overbreadth, or insufficiency of specification. Shire also succeeded in obtaining an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex for its proposed Apo-Lisdexamfetamine product.

PROCEDURAL HISTORY

Fothergill J.'s decision concerned both an action brought by Apotex to impeach the 646 Patent (the "Action") and an application brought under the PM(NOC) Regulations (the "Application"). In 2016, Apotex commenced the Action by way of Statement of Claim mere days after the Application was initiated in response to a NOA sent by Apotex concerning the same patent.

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