Tuesday, April 10, 2018

NEXIUM Saga Is Not Over Yet

AstraZeneca Aktiebolag v Apotex Inc 2018 FC 185 Locke J
            2,139,653 / esomeprazole / NEXIUM

While the SCC abolished the promise doctrine in AstraZeneca v Apotex 2017 SCC 36 rev’g 2015 FCA 158 rev’g 2014 FC 638, the associated litigation is not over yet. To recap, Apotex had prevailed in NOC proceedings (2010 FC 714). The subsequent infringement action was bifurcated to carve out any experimental and regulatory use exemption, as well as the quantum of any damages or profits [5]. In the first part of the bifurcated action, AstraZeneca initially lost, on the basis that the 653 patent was invalid for lack of utility, but then ultimately won when the SCC in AstraZeneca abolished the promise doctrine. At first instance, Rennie J had held that the 653 patent was invalid for failure to meet the promised utility, but had rejected all other validity attacks. The FCA had upheld the decision on the basis of lack of promised utility, but did not address Apotex’s appeal of the other validity attacks. In the meantime, Apotex brought a s 8 action consequent on its victory in the NOC proceeding. This went to trial before Locke J, after the SCC hearing but before its decision [9]. The parties agreed that Locke J should not issue his decision until after the SCC had issued its decision [10]. When the SCC decision issued, and after hearing supplemental submissions, Locke J dismissed Apotex’s s 8 NOC claim: 2018 FC 181. The second part of the birfurcated infringement action is ongoing, and this decision concerned motions as to how to proceed in light of the SCC AstraZeneca decision. The difficulty is that SCC had concluded its decision by holding that “The `653 patent is not invalid for want of utility” [64]. Apotex argued that this was not the same as a holding that the patent was valid, and the trial should be re-opened to allow the parties an opportunity to address the validity issues, in particular those which had not been addressed by the FCA, with additional evidence [27]. AstraZeneca, on the other hand, argued that the SCC decision had finally determined the validity of the 653 patent, and consequently the second part of the bifurcated trial, should proceed. Locke J ruled in favour of AstraZeneca, on the basis that he had decided in dismissing Apotex’s s 8 claim, in 2018 FC 181, [30]-[36] that “the validity of the 653 Patent was finally decided by the SCC, and that there remains no other validity issue to debate” [29].

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