Sanofi-Aventis Canada Inc. et al. v. Laboratoire Riva Inc. et al., 2008 FC 291

• Judge: Martineau, J.
• Court: Federal Court (Canada)
• Case Date: January 15, 2008
• Jurisdiction: Canada (Federal)
• Citations: 2008 FC 291;(2008), 331 F.T.R. 259 (FC)

Sanofi-Aventis Can. v. Lab. Riva Inc. (2008), 331 F.T.R. 259 (FC)

MLB headnote and full text

Temp. Cite: [2008] F.T.R. TBEd. MR.021

Sanofi-Aventis Canada Inc. and Sanofi-Aventis Deutschland GmbH (applicants) v. Laboratoire Riva Inc. and The Minister of Health (respondents)

(T-127-07; 2008 FC 291)

Indexed As: Sanofi-Aventis Canada Inc. et al. v. Laboratoire Riva Inc. et al.

Federal Court

Martineau, J.

March 4, 2008.

Summary:

A drug manufacturer (Sanofi-Aventis) applied for an order prohibiting the Minister of Health from issuing a notice of compliance to a generic drug manufacturer (Laboratoire Riva) for the sale of ramipril before the expiry of Sanofi-Aventis's patents. Laboratoire Riva asserted that the patents would not be infringed where it was seeking a Notice of compliance to sell ramipril only for the treatment of essential hypertension, the "old" minor use, and not for any of the "new" uses claimed by the patents. Sanofi-Aventis asserted that Laboratoire Riva would induce physicians, pharmacists and patients to infringe the patents through "off-label" use.

The Federal Court dismissed the application.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - Laboratoire Riva (Riva) filed a notice of allegation respecting patents owned by Sanofi-Aventis (Sanofi) for ramipril (Patented Medicines (Notice of Compliance) Regulations, s. 5(1)) - Riva asserted that the patents would not be infringed where it was seeking a notice of compliance to sell Riva-Ramipril only for the treatment of essential hypertension, the "old" minor use, and not for any of the "new" uses claimed by the patents - Sanofi applied for an order of prohibition, asserting that Riva would induce infringement through "off-label" use - The Federal Court dismissed the application - The court assumed, without deciding, that the taking, prescription or dispensing of Riva-Ramipril for a new use would infringe the patents - However, infringement by patients, physicians or pharmacists was not contemplated by s. 5(1) - Sanofi could educate about its patent rights and demand that those rights be respected - Induced infringement was not established - Statements in Riva's notice of allegation were presumed to be true absent evidence to the contrary - The fact that Riva's draft product monograph (PM) did not include a disclaimer was not evidence to the contrary - References in the PM to Sanofi's PM and to a comparative bioavailability study with Sanofi's drug was also insufficient - Although off-label use was likely to occur, Riva was not required to seek a limited interchangeability in the provincial drug formularies - Something more than simply making the product available was required - Passive recognition that off-label use would occur was not something more - Although Riva intended to negotiate exclusive supply contracts with pharmacists, the exclusivity would relate to other generics and be for the authorized use.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order - Dismissal of application for - [See Food and Drug Control - Topic 1105 ].

Cases Noticed:

Aventis Pharma Inc. v. Apotex Inc. et al. (2005), 278 F.T.R. 1; 2005 FC 1283, affd. (2006), 349 N.R. 183; 2006 FCA 64, leave to appeal dismissed (2006), 358 N.R. 391 (S.C.C.), refd to. [para. 7].

Sanofi-Aventis Canada Inc. v. Novopharm Ltd. et al. (2006), 306 F.T.R. 56; 2006 FC 1135, affd. (2007), 364 N.R. 325; 2007 FCA 163, leave to appeal dismissed (2007), 380 N.R. 397 (S.C.C.), refd to. [para. 7].

Aventis Pharma Inc. et al. v. Apotex Inc. et al. (2005), 283 F.T.R. 1; 2005 FC 1461, affd. (2006), 354 N.R. 383; 2006 FCA 357, leave to appeal dismissed (2007), 370 N.R. 392 (S.C.C.), refd to. [para. 7].

Sanofi-Aventis Canada Inc. et al. v. Novopharm Ltd. et al., [2006] F.T.R. Uned. 903; 2006 FC 1547, revd. (2007), 366 N.R. 231; 2007 FCA 167, refd to. [para. 7].

Aventis Pharma Inc. et al. v. Pharmascience Inc. et al. (2006), 296 F.T.R. 141; 2006 FC 861, refd to. [para. 7].

Sanofi-Aventis Inc. et al. v. Laboratoire Riva Inc. et al. (2007), 315 F.T.R. 59; 2007 FC 532, refd to. [para. 8].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 362 N.R. 91; 2007 FCA 140, refd to. [para. 11].

Aventis Pharma Inc. et al. v. Pharmascience Inc. et al., [2007] 2 F.C.R. 103; 352 N.R. 99; 2006 FCA 229, leave to appeal denied (2007), 370 N.R. 391 (S.C.C.), refd to. [para. 11].

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al. (2001), 213 F.T.R. 161; 2001 FCT 1264, affd. (2002), 298 N.R. 323; 2002 FCA 421, leave to appeal dismissed (2003), 313 N.R. 199 (S.C.C.), refd to. [para. 23].

Statutes Noticed:

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 5(1) [para. 10].

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

Counsel:

Gunars A. Gaikis and Junyi Chen, for the applicants;

Arthur B. Renaud, for the respondent (Laboratoire Riva Inc.).

Solicitors of Record:

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

Bennett Jones LLP, Toronto, Ontario, for the respondent (Laboratoire Riva Inc.).

This application was heard at Toronto, Ontario, on January 15, 2008, by Martineau, J., of the Federal Court, who delivered the following decision on March 4, 2008.