Friday, December 20, 2013

When is an Allegation an Undertaking?

Apotex Inc v Takeda Canada Inc / pantoprazole (NOC s 8) 2013 FC 1237 Phelan J
            PANTOLOC / pantoprazole / 2,092,694 and 2,089,748
Underling NOC decision Solvay Pharma Inc v Apotex Inc / pantoprazole (NOC), 2008 FC 308 Gauthier J

Takeda’s ‘748 patent claims the use of pantoprazole in combination with a helicobacter-inhibiting anti-microbial (so-called triple therapy). Apotex’s NOA stated that Apotex’s product would not be marketed for triple therapy [178]:

Each of the claims of the ’748 Patent includes as an essential element a Helicobacter-inhibiting anti-microbial agent. Our sodium pantoprazole tablets shall not contain said agent, as that term is construed in accordance with the claims of the ’748 Patent, nor shall our tablets be marketed or promoted to doctors, pharmacists or others to be used in combination with a Helicobacter-inhibiting anti-microbial agent or as part of a medicament package comprising said agent. As such, our tablets shall not infringe any of the claims of the ’748 patent.

Takeda argued that (1) this and other similar assertions in the NOA amounted to an undertaking; (2) Gauthier J relied on this undertaking in concluding that Takeda had not succeeded in establishing infringement; (3) Apotex in fact acted in breach of the undertaking, and (4) the Court should therefore exercise its discretion under s 8(5) to deny Apotex any damages [176].

Phelan J held against Takeda on the first point:

[182] While statements in an NOA may rise to the level of an undertaking to be relied on by a court, such statements must be clear and unequivocal undertakings specifically or by inference.

Phelan J discussed two cases in which an allegation did amount to an undertaking, and then continued:

[186] The case law does not support the proposition that a bare pleading in an NOA constitutes an enforceable undertaking. In my view, there must be more than just the allegation unless it is phrased as an undertaking.

[187] If an undertaking was so clearly in Justice Gauthier’s mind or if an undertaking was critical to her decision, she would have so stated it. I cannot believe that such a knowledgeable and experienced judge would not have stated an undertaking as the basis for the decision if that had been intended.

While Phelan J did not say so explicitly, his decision suggests that the gravity of an allegation of a breach of an undertaking [177] is the reason why such specificity is required.

Phelan J did not make a clear determination on the remaining issues, in party because he considered the terms of the putative undertaking to be unclear [202], but his discussion suggests that Takeda had at least a good arguable case on the other point. His holding that there was no undertaking was determinative [202].

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