Sanofi-Aventis Canada Inc. et al. v. Novopharm Ltd., 2010 FC 1210

• Judge: Simpson, J.
• Court: Federal Court (Canada)
• Case Date: June 14, 2010
• Jurisdiction: Canada (Federal)
• Citations: 2010 FC 1210;(2010), 377 F.T.R. 293 (FC)

Sanofi-Aventis Can. v. Novopharm Ltd. (2010), 377 F.T.R. 293 (FC)

MLB headnote and full text

Temp. Cite: [2010] F.T.R. TBEd. DE.023

Sanofi-Aventis Canada Inc. and Sanofi-Aventis Deutschland GmbH (plaintiffs) v. Teva Canada Limited (defendant)

Teva Canada Limited (plaintiff by counterclaim) v. Sanofi-Aventis Canada Inc. and Sanofi-Aventis Deutschland GmbH (defendants by counterclaim)

(T-1161-07; 2010 FC 1210)

Indexed As: Sanofi-Aventis Canada Inc. et al. v. Novopharm Ltd.

Federal Court

Simpson, J.

November 30, 2010.

Summary:

Sanofi-Aventis Canada Inc. (Sanofi Canada), Sanofi-Aventis Deutschland GmbH (Sanofi Germany) and Shering Corp. (collectively, the plaintiffs) commenced an action for patent infringement against Novopharm Ltd., in respect of Novopharm's alleged infringement of Canadian patent 1,341,206 (the '206 patent) and the sale of its Novo-ramipril product. The '206 patent, owned by Schering, claimed the compound ramipril. Novopharm counterclaimed for, inter alia, an order under s. 8 of the Patented Medicines (Notice of Compliance) Regulations requiring the plaintiffs to compensate Novopharm for losses suffered and/or an order for disgorgement of profits generated by the sale of ramipril during the period of time Novopharm was not in receipt of a Notice of Compliance due to prohibition proceedings that had been commenced under s. 6 of the Regulations. Sanofi Canada and Sanofi Germany moved for an order striking certain portions of the statement of defence and counterclaim, directing that Novopharm amend its pleadings to remove the claim related to the recovery of costs incurred during the proceedings under the Regulations and dismissing the action against Sanofi Germany. Schering moved for an order striking out certain portions of the statement of defence and counterclaim and dismissing the order against it.

A Prothonotary of the Federal Court, in a decision reported at 364 F.T.R. 122, ordered that the counterclaim against Schering be struck and dismissed. The Prothonotary struck certain portions of the statement of defence and counterclaim. The motion by Sanofi Canada and Sanofi Germany was otherwise dismissed. Novopharm Ltd. changed its name to Teva Canada Inc. Teva Canada appealed the Prothonotary's decision to strike the portions of its statement of defence and counterclaim (the Teva Counterclaim) which involved a claim for damages for permanent loss of market share. Sanofi Canada and Sanofi Germany appealed the Prothonotary's refusal to dismiss the Teva Counterclaim in its entirety as against Sanofi Germany.

The Federal Court dismissed Sanofi Canada and Sanofi Germany's appeal. Teva Canada's appeal was allowed in part. Certain portions of the statement of defence and counterclaim were reinstated to the extent that they referred to claims for damages incurred within the relevant period.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order - Compensation by first person - Sanofi-Aventis Canada Inc. (Sanofi Canada), Sanofi-Aventis Deutschland GmbH (Sanofi Germany) and Shering Corp. (collectively, the plaintiffs) commenced an action for patent infringement against Novopharm Ltd. (now Teva Canada Ltd.) - The patent, owned by Schering, claimed the compound ramipril - Sanofi Canada sold a ramipril product in Canada, under licence - Teva Canada counterclaimed for, inter alia, an order under s. 8 of the Patented Medicines (Notice of Compliance) Regulations requiring the plaintiffs to compensate Teva Canada for losses suffered and/or an order for disgorgement of profits generated by the sale of ramipril during the period of time Teva Canada was not in receipt of a Notice of Compliance due to prohibition proceedings that had been commenced under s. 6 of the Regulations - Sanofi Germany and Schering moved to strike the statement of defence and counterclaim as against them - Teva Canada was seeking damages from the plaintiffs alleging that each, jointly and severally, were liable as the "first person" for the purposes of s. 8 - Each of the plaintiffs submitted that the matter of who was the "first person" was a straightforward exercise of statutory interpretation, and that there could not be multiple first persons under the Regulations - The plaintiffs submitted that the first person was and could only be Sanofi Canada, and it was only Sanofi Canada that could be liable under the Regulations to pay s. 8 damages to the second person, in this case Teva Canada - The Prothonotary struck certain portions of the statement of defence and counterclaim - Sanofi Canada and Sanofi Germany appealed the Prothonotary's refusal to dismiss the Teva Counterclaim in its entirety as against Sanofi Germany - The Federal Court dismissed the appeal - In light of the Federal Court of Appeal's decision in Apotex Inc. v. Eli Lilly Co. (2004), it was not plain and obvious Teva Canada's interpretation of "first person" would fail - See paragraphs 38 to 50.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order - Compensation by first person - Sanofi-Aventis Canada Inc. (Sanofi Canada), Sanofi-Aventis Deutschland GmbH (Sanofi Germany) and Shering Corp. (collectively, the plaintiffs) commenced an action for patent infringement against Novopharm Ltd. (now Teva Canada Ltd.) - The patent, owned by Schering, claimed the compound ramipril - Sanofi Canada sold a ramipril product in Canada, under licence - Teva Canada counterclaimed for, inter alia, an order under s. 8 of the Patented Medicines (Notice of Compliance) Regulations requiring the plaintiffs to compensate Teva Canada for losses suffered and/or an order for disgorgement of profits generated by the sale of ramipril during the period of time Teva Canada was not in receipt of a Notice of Compliance due to prohibition proceedings that had been commenced under s. 6 of the Regulations - The plaintiffs moved to strike certain portions of the statement of defence and counterclaim, including its claim to "a permanent loss of market share" in paragraphs 135, 136 and 143 - A Prothonotary struck the impugned portions - Teva Canada appealed - The Federal Court allowed Teva Canada's appeal in part - The portions of paragraphs 135, 136 and 143 of the statement of defence and counterclaim were reinstated to the extent that they referred to claims for damages incurred within the relevant period - A second person could claim damages resulting from a loss of market share, but only for losses actually incurred within the period - Section 8 did not provide any entitlement to damages in respect of losses incurred outside the period - See paragraphs 54 to 62.

Practice - Topic 2230

Pleadings - Striking out pleadings - Grounds - Failure to disclose a cause of action or defence - [See both Food and Drug Control - Topic 1108.2 ].

Cases Noticed:

Apotex Inc. v. Eli Lilly & Co. et al. (2004), 328 N.R. 87; 2004 FCA 358, refd to. [para. 16].

Apotex Inc. v. Merck & Co. et al. (2009), 391 N.R. 336; 2009 FCA 187, leave to appeal denied (2010), 404 N.R. 396 (S.C.C.), refd to. [para. 17].

Merck Frosst Canada Ltd. v. Apotex Inc. - see Apotex Inc. v. Merck & Co. et al.

Merck & Co. et al. v. Apotex Inc. (2003), 315 N.R. 175; 2003 FCA 488, refd to. [para. 21].

Canada v. Aqua-Gem Investments Ltd., [1993] 2 F.C. 425; 149 N.R. 273 (F.C.A.), refd to. [para. 22].

White (Peter G.) Management Ltd. v. Canada (2007), 314 F.T.R. 284; 2007 FC 686, refd to. [para. 23].

Ridgeview Restaurant Ltd. v. Canada (Attorney General) et al. (2010), 368 F.T.R. 255; 2010 FC 506, refd to. [para. 23].

White (Peter G.) Management Ltd. v. Canada (Minister of Canadian Heritage) et al. (2006), 350 N.R. 113; 2006 FCA 190, refd to. [para. 33].

Hunt v. T & N plc et al., [1990] 2 S.C.R. 959; 117 N.R. 321, refd to. [para. 38].

Hunt v. Carey Canada Inc. - see Hunt v. T & N plc et al.

Pawar et al. v. Canada (1997), 132 F.T.R. 44 (T.D. Protho.), affd. (1997), 137 F.T.R. 321 (T.D.), refd to. [para. 52].

Harris et al. v. Minister of National Revenue (2001), 220 F.T.R. 8; 2001 FCT 748 (T.D.), refd to. [para. 52].

Coca-Cola Ltd. et al. v. Pardhan et al. (1997), 139 F.T.R. 223 (T.D.), affd. (1999), 240 N.R. 211; 85 C.P.R.(3d) 489 (F.C.A.), leave to appeal dismissed (1999), 256 N.R. 197 (S.C.C.), refd to. [para. 52].

Apotex Inc. v. Merck & Co. et al. (2008), 335 F.T.R. 255; 2008 FC 1185, refd to. [para. 55].

Statutes Noticed:

Patented Medicines (Notice of Compliance) Regulations - see Patent Act Regulations (Can.).

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 8 [para. 11 et seq.].

Counsel:

Sheldon Hamilton and Andrew Mandlsohn, for the plaintiffs;

Mark Edward Davis and Keya Dasgupta, for the defendant.

Solicitors of Record:

Smart & Biggar, Toronto, Ontario, for the plaintiffs;

Heenan Blaikie LLP, for the defendant.

These appeals were heard on June 14, 2010, at Toronto, Ontario, by Simpson, J., of the Federal Court, who delivered the following judgment on November 30, 2010.