Monday, March 4, 2013

Experimental and Regulatory Use Defence Available on the Facts in Imatinib

Teva Canada Ltd v Novartis AG / imatinib 2013 FC 141, Snider J
            GLEEVEC / imatinib mesylate / 2,093,203

Having successfully established the validity of its patent, Novartis sought a declaration of infringement in respect of certain volumes of bulk imatinib held by Apotex. Snider J held that the defence of regulatory use (s 55.2(1)) or the common law experimental use defence, preserved by s 55.2(6), was applicable in respect of bulk imatinib used for the following purposes [395]:

(a) developing suitable formulations and processes;
(b) obtaining regulatory approval to sell commercial formulations; and
(c) demonstrating that its manufacturing process could be carried out on a commercial scale.

Snider J did not deal with the statutory and common law defences separately, though she ultimately held that both were applicable [401.1]. This result is generally consistent with the cases following Micro Chemicals [1972] SCR 506, especially Merck / lisinopril, 2006 FCA 323 [109-13]. The facts on this case are very similar to those in Merck / lovastatin 2010 FC 1265, [631-32] in which Snider J also held the regulatory or common law defence to be available. As Snider J stated in Servier v Apotex / perindopril, “Of critical importance, in my view, none of the raw material or the actual formulations that were made in the course of that development process were ever sold or used for a commercial purpose” 2008 FC 825 [166] aff’d 2009 FCA 222 [24]. 

The importance of lack of commercial use was emphasized by Snider J’s holding with respect to a certain volume of bulk imatinib held in Apotex’s inventory. The defence was not available for this inventory material, so the material was infringing, but Snider J nonetheless declined to exercise her discretion to order delivery up [401.2]. This was primarily because the evidence indicated that this material would not be used for commercial purposes [397], and, importantly, Dr Sherman gave an formal undertaking, which was incorporated in the judgement, that the inventory bulk imatinib would never be used commercially [399-400].

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