Thursday, January 24, 2013

Withdrawal of an NOA Normally Renders Application Moot

Eli Lilly Canada Inc v Teva Canada Ltd / pemetrexed (NOC) 2013 FC 28 Barnes J
            injectable pemetrexed disodium – Altima – 1,340,794

Lilly sought an order of prohibition in response to Teva’s NOA related to injectable pemetrexed disodium. Teva failed to file evidence in support of its allegation of invalidity, and subsequently withdrew its NOA. The question was whether an order of prohibition should be granted (Lilly’s position), or whether the application should be dismissed as moot (Teva’s position).

Barnes J held that the application should be dismissed for mootness. He acknowledged that it would be an abuse of process for Teva to withdraw its application solely to overcome its failure to file evidence, but he noted that there was no clear evidence as to what motivated Teva’s withdrawal in this case [10], and while “this Court could issue an Order of prohibition in circumstances similar to these. . . it is [generally] preferable to deal with abuse of process concerns as and when they arise” [13]. He noted that “[t]he withdrawal of a NOA renders the second person’s submission to the Minister for a NOC non-compliant,” so there is no risk that the Minister would issue the NOC despite the withdrawal if an order of prohibition were not granted. In response to Lilly’s concern about potential exposure to s 8 damages if a subsequent NOA were successfully filed, avoiding abuse of process concerns, he noted that the Court would be mindful of its obligations under subsection 8(4) and 8(5) [11]. Subsection 8(5) in particular provides that the Court may take account of all relevant matters, “including any conduct of the first or second person which contributed to delay the disposition of the application.” This implies that if the circumstances warranted, any s 8 damages would be assessed from the time of the filing of the second NOA.

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