Wednesday, December 19, 2012

Statute of Monopolies Redux?

Apotex Inc. v. Warner-Lambert Company LLC / quinapril 2012 FCA 323 Nadon JA: Sharlow, Dawson JJA rev’g 2012 FC 202 Lemieux J

Is the Statute of Monopolies alive and well and hiding in Ontario? In 2009 Apotex brought an impeachment action seeking a declaration that two patents, including the ‘615 patent, are invalid. The ‘615 patent expired in August 2011, and the patentee, Parke Davis, moved to have the action dismissed in respect of it on the grounds of mootness. Apotex responded that the issue was not moot because the question was whether the ‘615 patent was ever valid, and the answer would affect its entitlement to a remedy under both the Statute of Monopolies of Ontario RSO 1897, c 323, and under s 8 of the NOC Regulations.

In the decision under appeal (blogged here), Lemieux J granted the motion on the basis that it was well established that subsequent success in an infringement or impeachment action could not affect a generic’s entitlement to s 8 damages, which are conditioned on success in the NOC proceedings themselves. However, Lemieux J did not address the Statute of Monopolies argument at all. 

In this decision, the FCA has held that Lemieux J erred in failing to address the Statute of Monopolies argument. The FCA then went on to allow the appeal on the basis that it was not clear that Apotex’s action based on the Statute of Monopolies could not possibly succeed. The Statute of Monopolies of Ontario, “reproduces in somewhat altered form, the original Statute of Monopolies enacted in 1624, 21 James I, Chap. 3,” originally appeared as Ch. 1 of the Statutes of Upper Canada, 1792, and is one of the unrepealed statutes remaining in force in Ontario: Gilbert v Horner (1960), 34 C.P.R. 17 (OCA). In holding that it might possibly form the basis for a remedy in favour of Apotex, the FCA relied on Gilbert v Horner, in which the OCA held that the interpretation of the statute was difficult, and there was almost no relevant case law, so that it could not be said that there was no prospect of success. As this was sufficient to allow the appeal, the FCA did not address the NOC arguments.

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