Sanofi-Aventis Inc. et al. v. Laboratoire Riva Inc. et al., 2007 FC 532

• Judge: Harrington, J.
• Court: Federal Court (Canada)
• Case Date: May 04, 2007
• Jurisdiction: Canada (Federal)
• Citations: 2007 FC 532;(2007), 315 F.T.R. 59 (FC)

Sanofi-Aventis v. Lab. Riva (2007), 315 F.T.R. 59 (FC)

MLB headnote and full text

Temp. Cite: [2007] F.T.R. TBEd. JN.032

Sanofi-Aventis Inc. and Sanofi-Aventis Deutschland GmbH (applicants) v. Laboratoire Riva Inc. and The Minister of Health (respondents) and Schering Corporation (respondent/patentee)

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

(T-1384-04; 2007 FC 532)

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

Federal Court

Harrington, J.

May 28, 2007.

Summary:

Laboratoire Riva Inc. sought approval to market its generic version of Ramipril, a drug used for the treatment of hypertension. Riva served a Notice of Allegation (NOA) on Sanofi-Aventis Inc. regarding the '206 patent for the preparation and use of Ramipril as a treatment for hypertension, alleging that the patent was invalid, and NOAs regarding three patents held by Sanofi that related to other uses of Ramipril. Sanofi applied for orders prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Riva for its generic version of Ramipril. Riva brought an abuse of process motion, submitting that because another generic drug company, Apotex Inc., had successfully alleged in prior NOC proceedings that patent '206 was invalid for lack of sound prediction, Sanofi could not relitigate the matter.

The Federal Court allowed Riva's abuse of process motion and dismissed Sanofi's applications for prohibition orders.

Courts - Topic 2015

Jurisdiction - General principles - Controlling abuse of its process - [See third Food and Drug Control - Topic 1105 ].

Estoppel - Topic 378

Estoppel by record (res judicata) - Res judicata as a bar to subsequent proceedings - Parties - [See first Food and Drug Control - Topic 1105 ].

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - Laboratoire Riva Inc. served a Notice of Allegation on Sanofi-Aventis Inc. regarding the '206 patent for the preparation and use of Ramipril as a treatment for hypertension, alleging that the patent was invalid for, inter alia, lack of sound prediction - Asserting that the allegations of invalidity were not justified, Sanofi applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Riva for its generic version of Ramipril - At issue was whether Riva was a privy of Pharmascience Inc., which had unsuccessfully alleged in prior NOC proceedings that patent '206 was invalid on the grounds of double patenting - Sanofi asserted that because Pharmascience could not relitigate the issue by adding a new ground of invalidity, neither could Riva, as Pharmascience's privy - The Federal Court held that Riva was not privy to Pharmascience and was entitled to allege that patent '206 was invalid for lack of sound prediction - The facts had not established that there was a relevant community or privity of interest between the two corporations - All that was established was that there was a trade relationship between them - That was not enough to satisfy the requirements of the doctrine of issue estoppel - See paragraphs 21 to 30.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - Laboratoire Riva Inc. served a Notice of Allegation on Sanofi-Aventis Inc. regarding the '206 patent for the preparation and use of Ramipril as a treatment for hypertension, alleging that the patent was invalid for, inter alia, lack of sound prediction - Asserting that the allegations of invalidity were not justified, Sanofi applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Riva for its generic version of Ramipril - Riva brought an abuse of process motion, submitting that because another generic drug company, Apotex Inc., had successfully alleged in prior NOC proceedings that patent '206 was invalid for lack of sound prediction, Sanofi could not relitigate the matter, even though the parties were not the same - The Federal Court allowed Riva's motion and dismissed Sanofi's applications on the basis that it was bound by the decision in Sanofi-Aventis Canada Inc. v. Novopharm Ltd. et al. (F.C.A.), which held that it was an abuse of process for a patent holder to relitigate an allegation of invalidity against a generic where that allegation had been held to be well founded in an earlier proceeding against a different generic - However, given that an application for leave to appeal the Novopharm decision was pending, the court went on to consider the allegations of invalidity - On the basis of evidence that was not before the court in the Apotex decision, the court found that the allegation of lack of sound prediction was not justified - See paragraphs 31 to 65.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - Laboratoire Riva Inc. served a Notice of Allegation on Sanofi-Aventis Inc. regarding the '206 patent for the preparation and use of Ramipril as a treatment for hypertension, alleging that the patent was invalid for, inter alia, lack of sound prediction - Asserting that the allegations of invalidity were not justified, Sanofi applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Riva for its generic version of Ramipril - Riva brought an abuse of process motion, submitting that because another generic drug company, Apotex Inc., had successfully alleged in prior NOC proceedings that patent '206 was invalid for lack of sound prediction, Sanofi could not relitigate the matter, even though the parties were not the same - The Federal Court allowed Riva's motion and dismissed Sanofi's applications on the basis that it was bound by the decision in Sanofi-Aventis Canada Inc. v. Novopharm Ltd. et al. (F.C.A.), which held that it was an abuse of process for a patent holder to relitigate an allegation of invalidity against a generic where that allegation had been held to be well founded in an earlier proceeding against a different generic - The Novopharm decision marked a clear development in the law applicable in NOC proceedings - Once a specific allegation of patent invalidity had been finally found to be justified in the NOC context, as long as the same allegation and the same patent were in issue in another NOC proceeding, that was the end of it - The integrity of the judicial process took precedence - Consequently, Sanofi was barred from arguing that the allegation that patent '206 was invalid for lack of sound prediction was not justified - See paragraphs 66 to 86.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - Laboratoire Riva Inc. sought approval to market its generic version of Ramipril, a drug used for the treatment of hypertension - Riva served Notices of Allegation (NOA) on Sanofi-Aventis Inc. regarding three patents held by Sanofi that related to other uses of Ramipril - Riva asserted that it would not infringe those patents as it would limit its marketing efforts to the treatment of hypertension - Sanofi applied for orders prohibiting the Minister of Health from issuing Notices of Compliance (NOC) to Riva, submitting that Riva's NOAs were insufficiently detailed or that Riva would infringe by inducing or procuring others to do so - The Federal Court dismissed Sanofi's applications - The NOAs were sufficiently detailed - If, as Sanofi alleged, provincial governments, physicians and others infringed the patents, Sanofi's remedy was to sue for patent infringement - The remedy was not to prohibit the Minister from allowing the generic onto the market - The mere presence of a generic drug on the market, coupled with the fact that it could be used for purposes other than those for which the NOC was obtained, did not constitute patent infringement - Factual statements made in the NOA were presumed to be true in the absence of evidence to the contrary - The only evidence here was that Riva intended to market Ramipril only for treating hypertension - The only possible basis for suggesting inducement to infringe was passing references in the materials concerning contraindications or drug interaction - That did not constitute infringement - See paragraphs 87 to 104.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order - Dismissal of application for (incl. compensation by first person) - [See all Food and Drug Control - Topic 1105 ].

Cases Noticed:

Biolyse - see Bristol-Myers Squibb Co. et al. v. Canada (Attorney General) et al.

Bristol-Myers Squibb Co. et al. v. Canada (Attorney General) et al., [2005] 1 S.C.R. 533; 334 N.R. 55; 39 C.P.R.(4th) 449, refd to. [para. 4].

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Welfare) et al., [1998] 2 S.C.R. 193; 227 N.R. 299; 80 C.P.R.(3d) 368, refd to. [para. 4].

Ferring Inc. v. Canada (Minister of Health) et al. (2007), 310 F.T.R. 185; 2007 FC 300, refd to. [para. 4].

Aventis Pharma Inc. et al. v. Pharmascience Inc. et al, [2005] 4 F.C.R. 301; 270 F.T.R. 187; 38 C.P.R.(4th) 441; 2005 FC 340, affd. [2007] 2 F.C.R. 103; 352 N.R. 99; 53 C.P.R.(4th) 453; 2006 FCA 229, leave to appeal refused (2007), 370 N.R. 391 (S.C.C.), refd to. [para. 8].

Aventis Pharma Inc. v. Apotex Inc. et al. (2005), 278 F.T.R. 1; 43 C.P.R.(4th) 161; 2005 FC 1283, affd. (2006), 349 N.R. 183; 265 D.L.R.(4th) 308; 46 C.P.R.(4th) 401; 2006 FCA 64, leave to appeal refused (2006), 358 N.R. 391 (S.C.C.), refd to. [para. 9].

Sanofi-Aventis Canada Inc. v. Novopharm Ltd. et al. (2007), 364 N.R. 325; 2007 FCA 163, affing. (2006), 306 F.T.R. 56; 2006 FC 1135, folld. [paras. 12, 68].

Hoffmann-La Roche Ltd. et al. v. Canada (Minister of National Health and Welfare) and Nu-Pharm Inc., [1997] 2 F.C. 681; 126 F.T.R. 21; 72 C.P.R.(3d) 362 (T.D.), refd to. [para. 21].

Angle v. Minister of National Revenue, [1975] 2 S.C.R. 248; 2 N.R. 397; 47 D.L.R.(3d) 544, refd to. [para. 21].

Pharmascience Inc. v. Sanofi-Aventis Canada Inc. et al., [2006] N.R. Uned. 81; 2006 FCA 210, refd to. [para. 26].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 362 N.R. 91; 2007 FCA 140, refd to. [para. 26].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 9 C.P.R.(4th) 168, refd to. [para. 39].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 9 C.P.R.(4th) 129, refd to. [para. 39].

Biovail Pharmaceuticals Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (2005), 267 F.T.R. 243; 37 C.P.R.(4th) 487 (F.C.), refd to. [para. 39].

Burton Parsons Chemicals Inc. et al. v. Hewlett-Packard (Canada) Ltd. et al., [1976] 1 S.C.R. 555; 3 N.R. 553; 17 C.P.R.(2d) 97, refd to. [para. 44].

Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390; 56 C.P.R.(2d) 145, appld. [para. 65].

Toronto (City) v. Canadian Union of Public Employees, Local 79 et al., [2003] 3 S.C.R. 77; 311 N.R. 201; 179 O.A.C. 291, consd. [para. 70].

AstraZeneca Canada Inc. et al. v. Manitoba et al. (2006), 201 Man.R.(2d) 263; 366 W.A.C. 263; 2006 MBCA 21, refd to. [para. 94].

Procter & Gamble Pharmaceuticals Canada Inc. et al. v. Canada (Minister of Health) et al. (2002), 291 N.R. 339; 20 C.P.R.(4th) 1 (F.C.A.), refd to. [para. 95].

Sanofi-Aventis Canada Inc. et al. v. Novopharm Ltd. et al. (2007), 366 N.R. 231; 2007 FCA 167, refd to. [para. 100].

Authors and Works Noticed:

Patchett, A.A., et al., A new class of angiotensin-converting enzyme inhibitors (1980), 288 Nature 280, generally [para. 55].

Counsel:

Gunars A. Gaikis, J. Sheldon Hamilton and A. David Morrow, for the applicants;

No one appeared for the respondent, the Minister of Health;

Arthur B. Renaud, for the respondent, Laboratoire Riva Inc;

Anthony G. Creber, for the respondent, Schering Corporation.

Solicitors of Record:

Smart & Biggar, for the applicants;

John H. Sims, Q.C., Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent, the Minister of Health;

Bennett Jones LLP, for the respondent, Laboratoire Riva Inc;

Gowling Lafleur Henderson LLP, for the respondent, Schering Corporation.

These applications were heard at Toronto, Ontario, on April 16-20, 2007, and at Ottawa and Toronto, Ontario, by teleconference call on May 4, 2007, by Harrington, J., of the Federal Court, who delivered the following amended reasons for order on May 28, 2007.