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. Shire successfully had the two proceedings partially consolidated[2] by way of motion in order to avoid the spectre of parallel proceedings between the same parties concerning the same patent. In the result, the Action and Application were decided based on the common evidence that was adduced at trial.

Apotex's initial invalidity allegations included a plea of inutility based on "false promise". Apotex amended its pleading following the Supreme Court's 2017 AstraZeneca v Apotex [Esomeprazole] decision[3] (where the SCC abolished the Promise Doctrine) by attempting to "shoehorn" its promise allegations into "each and every ground of invalidity known to law", including by restating its utility attack without the language of "promise". While this recast allegation survived a motion to strike,[4] Apotex eventually dropped its utility attack on the eve of trial.

The decision - No asserted claim is invalid

Fothergill J. benefited from the viva voce testimony of two inventors and four expert witnesses.

With respect to claim construction/overbreadth, an issue arose as to the scope of the term "L-lysine-d-amphetamine" used in claim 1. Claim 1 of the 646 Patent is to the compound "L-lysine-d-amphetamine", while claim 5 sets out a picture of a compound that the PSIA would understand to be L-lysine-d-amphetamine.

By making reference to the principle of claim differentiation, Apotex's witnesses advocated for a construction of claim 1 which encompassed numerous possible compounds in order to avoid redundancy with claim 5. However, this construction led to the "absurdity" of including within its scope compounds that the PSIA would know cannot exist. Fothergill J. rejected Apotex's construction, holding that claims should be construed to avoid redundancy if possible, but that claims of equivalent scope may occur in certain circumstances when reasonable. Avoiding the absurd construction advanced by Apotex constituted such a situation.

Apotex's remaining arguments of anticipation, obviousness, and insufficiency were largely decided on the facts. With respect to obviousness, Apotex advanced various arguments relying on the Federal Court of Appeal's decision in SNF v Ciba-Specialties.[5] However, regardless of the framework utilized, the prior art did not suggest making (and in fact taught away from) the compound L-lysine-d-amphetamine, and L-lysine-d-amphetamine's properties were unpredictable.

Impact

This litigation exemplifies the impact of the Supreme Court's Esomeprazole decision. Litigation that initially concerned allegations that numerous purported "promises" were not met became a trial in which inutility was not pursued at all. Given that the 646 Patent contains bare chemical compound claims that have undisputed utility in fact, this is a welcome and just result.

Gowling WLG represented Shire with a team that included Jay Zakaib, Jennifer Wilkie, Alex Gloor, Adam Heckman, Justin Smith and Cole Meagher

[5] 2017 FCA 225