Judgments

Decision Information

Sanofi-Aventis Canada Inc. v. Novopharm Ltd. (F.C.A.)

Collection	Judgments
Date	2007-04-23
Neutral citation	2007 FCA 163
Report citation	[2008] 1 F.C.R. 174
File numbers	A-413-06
Subjects	Patents - Practice
Notes	Full-Text Decision

Decision Content

A‑413‑06

2007 FCA 163

Sanofi‑Aventis Canada Inc. (Appellant) (Applicant)

Novopharm Limited and The Minister of Health (Respondents) (Respondents)

and

Schering Corporation (Respondent) (Respondent/ Patentee)

Indexed as: Sanofi‑Aventis Canada Inc. v. Novopharm Ltd. (F.C.A.)

Federal Court of Appeal, Nadon, Sexton and Sharlow JJ.A.—Toronto, January 9; Ottawa, April 23, 2007.

Patents — Practice — Abuse of process — Appeal from Federal Court decision reversing Prothonotary’s order and allowing Novopharm’s motion for summary dismissal of Sanofi‑Aventis’ application for prohibition order — Novopharm alleging Canadian patent No. 1341206 invalid — Arguing application for prohibition order abuse of process under Patented Medicines (Notice of Compliance) Regulations, s. 6(5)(b) as Sanofi‑Aventis already failed to show similar allegations of invalidity unjustified in previous proceeding against other generic manufacturer — Appeal dismissed (Nadon J.A. dissenting) — Permitting same innovator to relitigate same issues repeatedly posing severe threat to integrity of adjudicative process, principle of finality, efficiency of judicial system.

This was an appeal from a decision of the Federal Court reversing the Prothonotary’s order dismissing Novopharm Limited’s motion for the summary dismissal of Sanofi‑Aventis Canada Inc.’s application for an order prohibiting the Minister of Health from issuing a notice of compliance to Novopharm. Sanofi‑Aventis had made this application after receiving a notice of allegation (NOA) from Novopharm alleging the invalidity of Canadian patent No. 1341206 (the ′206 patent). The Federal Court held that Sanofi‑Aventis’ application was an abuse of process pursuant to paragraph 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations because Sanofi‑Aventis had already failed to show, in Aventis Pharma Inc. v. Apotex Inc., that similar allegations of invalidity made by another generic drug manufacturer (Apotex Inc.) with respect to the ′206 patent were unjustified.

Held (Nadon J.A. dissenting), the appeal should be dismissed.

Per Sexton J.A. (Sharlow J.A. concurring): The allegations in the Apotex and Novopharm NOAs were the same in their material respects, and Sanofi‑Aventis’ attempt to relitigate these allegations amounted to an abuse of process, even though the decision on sound prediction in Aventis Pharma was not binding as it involved a question of fact, and despite the fact that it was not possible to say that Sanofi‑Aventis’ application had no chance of success. This analysis was informed by the principles enunciated by the S.C.C. in Toronto (City) v. C.U.P.E., Local 79. Permitting the same innovator to relitigate the same issues repeatedly poses a severe threat to the integrity of the adjudicative process, the principle of finality, and the efficiency of the judicial system. Once relitigation has been established, no additional element of misconduct is required to find abuse of process in Canada.

While it is important in each case to ensure the application of the doctrine of abuse of process does not give rise to unfairness in the circumstances, no such unfairness resulted in the present case. All parties (innovators and generics) are held to the same standard: they must each put forward their entire case, complete with all relevant evidence, at first instance. The additional evidence adduced by Sanofi‑Aventis and Schering Corporation was a collateral attack on the Aventis Pharma finding as to sound prediction. It did not change the fact that they could not attempt to relitigate a claim they had already made. They were required to put their best foot forward in the earlier proceedings.

Per Nadon J.A. (dissenting): This was not a case where the doctrine of abuse of process should be applied. The parties to the proceedings herein were not the same as those in Aventis Pharma. The issue herein and in Aventis Pharma was primarily one of fact and, as a result, it was open to the trier of fact in this proceeding to come to a different conclusion. Sanofi‑Aventis, in seeking to prohibit the Minister from issuing an NOC to Novopharm, was simply exercising its rights under the Regulations, which do not expressly or implicitly prevent a patentee from relitigating an issue previously litigated against another generic drug manufacturer. There was also no “additional element” in the present matter that would have rendered Sanofi‑Aventis’ application abusive. Finally, Sanofi‑Aventis’ conduct did not call for the application of the doctrine of abuse of process, and the proceedings it commenced following service of Novopharm’s NOA were neither oppressive nor vexatious.

statutes and regulations judicially

considered

Federal Court Rules, C.R.C., c. 663, R. 419.

Federal Courts Rules, SOR/98‑106, rr. 1 (as am. by SOR/2004‑283, s. 2), 221.

Patent Act, R.S.C., 1985, c. P‑4.

Patented Medicines (Notice of Compliance) Regulations, SOR/93‑133, ss. 5 (as am. by SOR/98‑166, s. 4; 99‑379, s. 2), 6(1) (as am. by SOR/98‑166, s. 5), (2), (5)(b) (as am. idem; 2006‑242, s. 3), 7(2)(b).

cases judicially considered

applied:

J.M. Voith GmbH v. Beloit Corp. (1991), 36 C.P.R. (3d) 322; 128 N.R. 54 (F.C.A.); Toronto (City) v. C.U.P.E., Local 79, [2003] 3 S.C.R. 77; (2003), 232 D.L.R. (4th) 385; [2003] CLLC 220‑071; 17 C.R. (6th) 311 N.R. 201; 179 O.A.C. 291; 2003 SCC 63; Glaxo Group Ltd. v. Canada (Minister of Health), 2001 FCT 16.

considered:

Aventis Pharma Inc. v. Apotex Inc. (2005), 43 C.P.R. (4th) 161; 278 F.T.R. 1; 2005 FC 1283; affd (2006), 265 D.L.R. (4th) 308; 46 C.P.R. (4th) 401; 349 N.R. 183; 2006 FCA 64; leave to appeal to S.C.C. refused, [2006] 2 S.C.R. xi; David Bull Laboratories (Canada) Inc. v. Pharmacia Inc., [1995] 1 F.C. 588; (1994), 58 C.P.R. (3d) 209; 176 N.R. 48 (C.A.); Pfizer Canada Inc. v. Apotex Inc. (1999), 1 C.P.R. (4th) 358; 172 F.T.R. 81 (F.C.T.D.); Hunt v. Carey Canada Inc., [1990] 2 S.C.R. 959; (1990), 74 D.L.R. (4th) 321; [1990] 6 W.W.R. 385; 49 B.C.L.R. (2d) 273; 4 C.C.L.T. (2d) 1; 43 C.P.C. (2d) 105; 117 N.R. 321; Bradford & Bingley Building Society v. Seddon, [1999] 1 W.L.R. 1482 (C.A.); R. v. Power, [1994] 1 S.C.R. 601; (1994), 117 Nfld. & P.E.I.R. 269; 365 A.P.R. 269; 89 C.C.C. (3d) 1; 29 C.R. (4th) 1; 2 M.V.R. (3d) 161; 165 N.R. 241; R. v. Conway, [1989] 1 S.C.R. 1659; (1989), 49 C.C.C. (3d) 289; 70 C.R. (3d) 209; 40 C.R.R. 1; 96 N.R. 241; 34 O.A.C. 165; R. v. Scott, [1990] 3 S.C.R. 979; (1990), 61 C.C.C. (3d) 300; 2 C.R. (4th) 153; 1 C.R.R. (2d) 82; 116 N.R. 361; 43 O.A.C. 277; Danyluk v. Ainsworth Technologies Inc., [2001] 2 S.C.R. 460; (2001), 201 D.L.R. (4th) 193; 34 Admin. L.R. (3d) 163; 10 C.C.E.L. (3d) 1; 7 C.P.C. (5th) 199; 272 N.R. 1; 149 O.A.C. 1; 2001 SCC 44; Johnson v Gore Wood & Co, [2001] 2 WLR 72 (H.L.); Bragg v. Oceanus Mutual Underwriting Association (Bermuda) Ltd. and C. E. Heath & Co. (Marine) Ltd., [1982] 2 Lloyd’s Rep. 132 (C.A.); Janssen‑Ortho v. Novopharm Ltd. (2006), 57 C.P.R. (4th) 6; 2006 FC 1234; Janssen‑Ortho v. Novopharm Ltd. (2004), 35 C.P.R. (4th) 353; 264 F.T.R. 202; 2004 FC 1631; Hoffmann‑La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1998), 85 C.P.R. (3d) 50; 158 F.T.R. 135 (F.C.T.D.); Glaxo Group Ltd. v. Canada (Minister of National Health and Welfare) (2000), 6 C.P.R. (4th) 73; 188 F.T.R. 1 (F.C.T.D.); affd (2001), 11 C.P.R. (4th) 417; 273 N.R. 166; 2001 FCA 96.

referred to:

Housen v. Nikolaisen, [2002] 2 S.C.R. 235; (2002), 211 D.L.R. (4th) 577; [2002] 7 W.W.R. 1; 219 Sask. R. 1; 10 C.C.L.T. (3d) 157; 30 M.P.L.R. (3d) 1; 286 N.R. 1; 2002 SCC 33; Elders Grain Co. v. Ralph Misener (The), [2005] 3 F.C.R. 367; (2005), 334 N.R. 1; 2005 FCA 139; AB Hassle v. Apotex Inc., [2006] 4 F.C.R. 513; (2006), 265 D.L.R. (4th) 363; 47 C.P.R. (4th) 329; 350 N.R. 219; 2006 FCA 51; Apotex Inc. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; (2002), 219 D.L.R. (4th) 660; 21 C.P.R. (4th) 499; 296 N.R. 130; 2002 SCC 77; Bayer Inc. v. Apotex Inc. (1998), 85 C.P.R. (3d) 334 (F.C.T.D.); Hoffmann‑La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1999), 87 C.P.R. (3d) 251; 164 F.T.R. 22 (F.C.T.D.); GlaxoSmithKline Inc. v. Apotex Inc. (2003), 29 C.P.R. (4th) 350; 239 F.T.R. 32; 2003 FC 1055; Novartis A.G. v. Apotex Inc. (2002), 22 C.P.R. (4th) 450; 298 N.R. 348; 2002 FCA 440; Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2001), 11 C.P.R. (4th) 245; 266 N.R. 371 (F.C.A.); Toronto (City) v. Canadian Union of Public Employees, Local 791 (2001), 55 O.R. (3d) 541; 205 D.L.R. (4th) 280; 149 O.A.C. 213 (C.A.); Demeter v. British Pacific Life Insurance Co. (1983), 43 O.R. (2d) 33; 150 D.L.R. (3d) 249; 2 C.C.L.I. 246; 37 C.P.C. 277; [1983] I.L.R. 6498 (H.C.J.); affd (1984), 48 O.R. (2d) 266; 13 D.L.R. (4th) 318; 8 C.C.L.I. 286; [1985] I.L.R. 7151; 7 O.A.C. 143; Hunter v. Chief Constable of the West Midlands Police, [1982] A.C. 529 (H.L.); Franco v. White (2001), 53 O.R. (3d) 391; 198 D.L.R. (4th) 541; 3 C.P.C. (5th) 189; 142 O.A.C. 116 (C.A.); Stevenson v. Bomac Construction, [1986] 5 W.W.R. 21; 48 Sask. R. 62 (C.A.); Bjarnarson v. Manitoba (Government of) (1987), 38 D.L.R. (4th) 32; [1987] 4 W.W.R. 645; 48 Man. R. (2d) 149; 21 C.P.C. (2d) 304 (Man. Q.B.); affd (1987), 45 D.L.R. (4th) 766; [1988] 1 W.W.R. 422; 50 Man. R. (2d) 178; 21 C.P.C. (2d) 312 (Man. C.A.); AB Hassle v. Canada (Minister of National Health and Welfare), [2002] 3 F.C. 221; (2001), 16 C.P.R. (4th) 21; 213 F.T.R. 161; 2001 FCT 1264; affd (2002), 22 C.P.R. (4th) 1; 298 N.R. 323; 2002 FCA 421; AB Hassle v. RhoxalPharma Inc. (2002), 21 C.P.R. (4th) 298; 222 F.T.R. 48; 2002 FCT 780.

APPEAL from a Federal Court decision ((2006), 56 C.P.R. (4th) 242; 2006 FC 1135) reversing the Prothonotary’s order and allowing Novopharm Limited’s motion for the summary dismissal of Sanofi‑ Aventis Canada Inc.’s application for a prohibition order. Appeal dismissed, Nadon J.A. dissenting.

appearances:

Gunars A. Gaikis, J. Sheldon Hamilton and Mark G. Biernacki for appellant (applicant).

Jonathan Stainsby and Mark Edward Davis for respondent (respondent) Novopharm Limited.

No one appearing for respondent (respondent) Minister of Health.

Anthony George Creber for respondent (respondent/patentee) Schering Corporation.

solicitors of record:

Smart & Biggar, Toronto, for appellant (applicant).

Heenan Blaikie LLP, Toronto, for respondent (respondent) Novopharm Limited.

Deputy Attorney General of Canada for respondent (respondent) Minister of Health.

Gowling Lafleur Henderson LLP, Ottawa, for respondent (respondent/patentee) Schering Corporation.

The following are the reasons for judgment rendered in English by

[1]Sexton J.A.: The principal issue in this case relates to the scope of the abuse of process provision in paragraph 6(5)(b) [as am. by SOR/98-166, s. 5] of the Patented Medicines (Notice of Compliance) Regula-tions, SOR/93‑133 (the NOC Regulations) and specifically whether the holder of a pharmaceutical patent, having failed to establish that an allegation of invalidity made by one generic drug manufacturer is not justified, abuses the NOC process by seeking to relitigate the same allegation of invalidity when it is made by a second generic company.

[2]This is an appeal from the decision of Tremblay‑ Lamer J. of the Federal Court in Sanofi‑Aventis Canada Inc. v. Novopharm Ltd. (2006), 56 C.P.R. (4th) 242 (F.C.). In the court below, Novopharm Limited (Novopharm) sought to appeal an order of Prothonotary Milczynski dated May 8, 2006 wherein she dismissed Novopharm’s motion for summary dismissal of an application brought by Sanofi‑Aventis Canada Inc. (Sanofi‑Aventis) regarding a notice of allegation (NOA) sent to Sanofi‑Aventis by Novopharm in respect of Canadian Patent No. 1341206 (the ′206 patent) for the drug ramipril. Tremblay‑Lamer J. reversed the Prothonotary’s decision and granted the motion for dismissal.

[3]The appellant in this appeal is Sanofi‑Aventis. In addition, although Schering Corporation (Schering) is listed as a respondent, it is the owner of the ′206 patent and its interests are aligned with those of Sanofi‑Aventis. Sanofi‑Aventis and Schering argue that Tremblay‑Lamer J. erred in dismissing the application on the basis that it is an abuse of process.

[4]For the reasons that follow, this appeal will be dismissed.

BACKGROUND

[5]The NOA at issue in these proceedings is not the first to target the ′206 patent. On June 20, 2003, Apotex Inc. (Apotex) served an NOA on Sanofi‑Aventis (the Apotex NOA) alleging that the ′206 patent was invalid on a number of grounds, including that the inventors could not have soundly predicted that the compounds claimed in the patent would be useful for the stated purpose. Sanofi‑Aventis responded to this NOA by bringing an application in accordance with subsection 6(1) [as am. idem] of the NOC Regulations before Mactavish J., but was unsuccessful in persuading Justice Mactavish that the allegations in the Apotex NOA were unjustified (Aventis Pharma Inc. v. Apotex Inc. (2005), 43 C.P.R. (4th) 161 (F.C.) (Apotex)). On appeal, Mactavish J.’s decision was upheld by this Court (Aventis Pharma Inc. v. Apotex Inc. (2006), 265 D.L.R. (4th) 308 (F.C.A.)).

[6]Prior to the conclusion of the proceedings concerning the Apotex NOA, Novopharm sent its own NOA to Sanofi‑Aventis (the Novopharm NOA), which, like the Apotex NOA, alleged that the ′206 patent was invalid on the basis of lack of sound prediction. Sanofi‑Aventis then initiated a second application pursuant to subsection 6(1) of the NOC Regulations seeking an order that the allegations in the Novopharm NOA were not justified. In response, Novopharm brought a motion under paragraph 6(5)(b) of the NOC Regulations to dismiss the application on the ground that it was redundant, scandalous, frivolous or vexatious or otherwise an abuse of process by virtue of the dismissal of the earlier application against Apotex. It is this motion that is the subject of this appeal.

DECISIONS BELOW

[7]Prothonotary Milczynski dismissed the motion on the basis that the application of the doctrines of res judicata, issue estoppel and abuse of process require that there be a final decision and that a decision is only final and binding when all available reviews have been exhausted or abandoned. In her analysis, the Apotex decision was not final because the Supreme Court of Canada had not finally disposed of the case.

[8]Tremblay‑Lamer J. disagreed with the Prothono-tary’s assessment that the decision was not final and in any event noted that there was no longer any doubt as to whether the decision was final because the Supreme Court had finally disposed of the case by refusing leave to appeal [[2006] 2 S.C.R. xi]. She therefore reviewed the matter de novo. In my view, she was correct to do so. She held [at paragraph 23] that an application would be dismissed as abusive under paragraph 6(5)(b) if it is one that is “so clearly futile that it has not the slightest chance of success” or if it is “plain and obvious” [at paragraph 24] that the applicant will not succeed. In her view, this test was satisfied on the facts of the present case. She held that the allegations in the Apotex and Novopharm NOAs were similar in all material respects and that Mactavish J.’s decision in the Apotex proceeding would be binding on the judge hearing the present application, regardless of the fact that Sanofi‑Aventis and Schering had attempted to adduce new evidence not before Mactavish J. Accordingly, Justice Tremblay‑Lamer concluded that Sanofi‑Aventis had no chance of success and therefore that its application was an abuse of process.

[9]Tremblay‑Lamer J. also held that Sanofi‑Aventis’ application was an inefficient use of judicial resources, undermined the integrity of the justice system and threatened the principle of finality that is crucial to the proper administration of justice. In addition, she emphasized that one of the purposes of the NOC Regulations is to curb unnecessary litigation. To allow repetitious litigation such as that attempted by Sanofi‑Aventis would, in her opinion, be contrary to this objective. Tremblay‑Lamer J. thus granted the motion and dismissed Sanofi‑Aventis’ application.

REGULATORY REGIME

[10]This appeal concerns the requirements set out in the NOC Regulations. The relevant sections of the NOC Regulations are as follows [s. 5 (as am. by SOR/98-166, s. 4; 99-379, s. 2]:

5. (1) Where a person files or has filed a submission for a notice of compliance in respect of a drug and compares that drug with, or makes reference to, another drug for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics and that other drug has been marketed in Canada pursuant to a notice of compliance issued to a first person and in respect of which a patent list has been submitted, the person shall, in the submission, with respect to each patent on the register in respect of the other drug,

. . .

(b) allege that

(i) the statement made by the first person pursuant to paragraph 4(2)(c) is false,

(ii) the patent has expired,

(iii) the patent is not valid, or

(iv) no claim for the medicine itself and no claim for the use of the medicine would be infringed by the making, constructing, using or selling by that person of the drug for which the submission for the notice of compliance is filed.

. . .

(3) Where a person makes an allegation pursuant to paragraph (1)(b) or (1.1)(b) or subsection (2), the person shall

(a) provide a detailed statement of the legal and factual basis for the allegation;

. . .

6. (1) A first person may, within 45 days after being served with a notice of an allegation pursuant to paragraph 5(3)(b) or (c), apply to a court for an order prohibiting the Minister from issuing a notice of compliance until after the expiration of a patent that is the subject of the allegation.

(2) The court shall make an order pursuant to subsection (1) in respect of a patent that is the subject of one or more allegations if it finds that none of those allegations is justified.

. . .

(5) In a proceeding in respect of an application under subsection (1), the court may, on the motion of a second person, dismiss the application

. . .

(b) on the ground that the application is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process.

In these reasons, I rely upon the version of the NOC Regulations in force prior to their amendment in October 2006 [SOR/2006-242]. The motions Judge apparently relied on these former provisions, her decision having been issued on September 25, 2006. Likewise, the parties appear to have relied on the former provisions and made no argument that the new version of the Regulations should apply. In any event, the amendments do not appear to make a material difference for the purposes of this case.

ISSUES

[11]This appeal raises the following four issues:

1. What is the standard of review?

2. Was Novopharm required to allege abuse of process and the factual basis for that allegation in its NOA?

3. Is there a material difference between the legal and factual basis of the allegations in the Novopharm NOA as compared with the Apotex NOA?

4. Is the application initiated by Sanofi‑Aventis in respect of the Novopharm NOA redundant, scandalous, frivolous or vexatious or otherwise an abuse of process within the meaning of paragraph 6(5)(b) of the NOC Regulations?

ANALYSIS

(1) Standard of Review

[12]In appellate review, the nature of the questions at issue determines the applicable standards of review. Generally, questions of law are reviewable on a standard of correctness (Housen v. Nikolaisen, [2002] 2 S.C.R. 235, at paragraph 8 (Housen)), and findings of fact will be set aside only for palpable and overriding error (Housen, at paragraph 10). For questions of mixed fact and law, the standard of palpable and overriding error applies unless the lower court judge wrongly characterized the correct legal standard or failed to apply the correct standard, in which case a standard of correctness applies (Housen, at paragraph 37).

[13]A decision to dismiss a proceeding as an abuse of process is a discretionary one. Such a decision will not be reversed on appeal unless there is an error of law or principle, or a failure to exercise the discretion judicially: Elders Grain Co. v. Ralph Misener (The), [2005] 3 F.C.R. 367 (F.C.A.), at paragraph 13; AB Hassle v. Apotex Inc., [2006] 4 F.C.R. 513 (F.C.A.), at paragraph 27.

(2) Sufficiency of the NOA

[14]The first ground on which Sanofi‑Aventis argues Tremblay‑Lamer J. erred was in failing to dismiss Novopharm’s motion for summary dismissal on the basis that Novopharm did not allege res judicata, issue estoppel or abuse of process in its NOA. I cannot agree.

[15]I agree with Sanofi‑Aventis that paragraph 5(3)(a) requires the generic drug manufacturer to provide a detailed statement of the legal and factual basis of the allegations made in the NOA. However, the types of allegations that must be described in the detailed statement are those relating to the patent in issue, not to potential procedural bars that the patent holder may raise in argument. The types of allegations requiring specification are listed in paragraph 5(1)(b) of the NOC Regulations:

. . .

(b) allege that

(i) the statement made by the first person pursuant to paragraph 4(2)(c) is false,

(ii) the patent has expired,

(iii) the patent is not valid, or

[16]Once an NOA is delivered by the generic drug manufacturer, it is the patent holder that may launch an application for an order that the allegations in the NOA are not justified (subsection 6(1)). Only then may the generic ask the court to dismiss the application under paragraph 6(5)(b) on the grounds that it is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process:

6. . . .

(5) In a proceeding in respect of an application under subsection (1), the court may, on the motion of a second person, dismiss the application

. . .

(b) on the ground that the application is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process.

[17]At the NOA stage, the generic drug manufacturer cannot possibly know whether the patent holder will initiate prohibition proceedings, or on what grounds. It makes no sense to require the generic to anticipate procedural remedies that may be open to it when the patent holder initiates a prohibition application, and there is no basis in the NOC Regulations for concluding that the NOA must do so.

(3) Similarity of the Allegations in the Novopharm and Apotex NOAs

[18]The next submission made by Sanofi‑Aventis and Schering is that the motions Judge was wrong to conclude that the Apotex and Novopharm NOAs contain similar allegations and consequently there is no basis for concluding that the present application is redundant or otherwise an abuse of process. Tremblay‑Lamer J. found that the Novopharm NOA was in all material respects the same as the Apotex NOA, allowing her to conclude that all of the same issues would be relitigated should Sanofi‑Aventis’ application be allowed to proceed. Sanofi‑Aventis and Schering challenge this conclusion, arguing that there are a number of different factual and legal bases for the allegations made in the Novopharm NOA. Specifically, they claim that while sound prediction is alleged in the Novopharm NOA, as it was in the Apotex NOA, the basis for this claim is not identical to that previously alleged. They maintain, therefore, that the Sanofi‑Aventis application would not involve a relitigation of the issues decided by Mactavish J. and accordingly, the application would not be an abuse of process. I do not agree.

[19]After comparing the Apotex and Novopharm NOAs, as well as reviewing the reasons of Mactavish J., I am satisfied that the Novopharm NOA contains the allegations that were critical to Mactavish J.’s finding that Schering’s inventors did not have a sound basis for predicting the utility of their invention and therefore see no reason for departing from the conclusion of Tremblay‑Lamer J. on this issue.

[20]The allegations in the Novopharm NOA relating to sound prediction are undoubtedly longer, more detailed and more specific than those in the Apotex NOA, which contains only two paragraphs directed to the issue of sound prediction and couches its allegations in broad language. However, both NOAs suggest that the inventors of the compounds claimed in the ′206 patent lacked a sufficient basis for predicting that their invention would have the requisite level of activity or would be useful for therapeutic administration.

[21]Sanofi‑Aventis and Schering argue that the detailed allegations in the Novopharm NOA are narrower than those in the Apotex NOA, and that the Novopharm NOA raises several matters not advanced in the Apotex NOA, including the issue of the stereochemistry of the bridgehead carbons. Tremblay‑ Lamer J. found no merit to these arguments, and I see no basis for interfering with that conclusion. Mactavish J.’s holding that the invention disclosed by the ′206 patent lacked sound prediction turned on her finding that as of the relevant date, it would not have been possible for Schering inventors to predict the impact of chirality of the bridgehead carbons of the bicyclic ring system (Apotex, at paragraphs 140‑143). The contention of Sanofi‑Aventis and Schering that this issue was not raised in the Apotex NOA is a collateral attack on the decision of Mactavish J. because she already fully considered and rejected that argument in a decision that was upheld by this Court. It is therefore not open to Sanofi‑Aventis and Schering to argue in these proceedings that the Apotex NOA did not encompass an allegation that the inventors of the ′206 patent could not have soundly predicted the stereochemistry of the bridgehead carbons like the one advanced in the Novopharm NOA.

(4) Is Sanofi‑Aventis’ Application an Abuse of Process?

(a) Introduction

[22]Accepting the conclusion of Tremblay‑Lamer J. that the allegations in the Apotex and Novopharm NOAs are the same in their material respects, it is necessary to consider whether Sanofi‑Aventis’ attempt to relitigate these allegations amounts to an abuse of process. Paragraph 6(5)(b) of the NOC Regulations permits a second person, usually a generic, to bring a motion to dismiss an application by a first person in respect of an NOA “on the ground that it is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process in respect of one or more patents” [as am. by SOR/2006-242, s. 3].

(b) Arguments of the Parties

[23]Sanofi‑Aventis and Schering contend that the issue of whether an invention has been soundly predicted is a question of fact and that unlike questions of law, one court’s finding of fact is not binding on another judge considering a similar issue. Rather, Sanofi‑Aventis and Schering emphasize that each trier of fact must assess the evidence before her and make her own findings. In oral argument, Schering stressed that new evidence has been adduced in this application that mandates a different conclusion from that reached by Mactavish J. in the Apotex proceeding.

[24]Moreover, Sanofi‑Aventis and Schering contend that relitigation alone is not an abuse of process. In their view, for conduct to be abusive, there must be some other additional element of misconduct such as a collateral attack on the earlier decision, dishonesty, or unjust harassment. None of these factors, they say, is present in this case. Sanofi‑Aventis and Schering also argue that relitigation is permissible within the scheme of the regulations. They highlight the fact that although the drafters of the NOC Regulations contemplated that more than one generic could file an NOA with substantially the same allegations, there is no provision allowing for a second generic to rely on the successful NOA of the first. Had the Governor in Council intended to create an in rem finding of invalidity for the purposes of the NOC Regulations, they say, it would have done so expressly.

[25]Novopharm, on the other hand, argues that Tremblay‑Lamer J.’s order is consistent with the purposes behind the NOC Regulations, which, in part, are to promote fairness and effectiveness, and to reduce unnecessary litigation. Novopharm also emphasizes that if patentees are allowed to relitigate issues already judicially decided, there is a risk of different courts reaching inconsistent results in respect of the same issues, which threatens the integrity of the judicial process. Likewise, Novopharm stresses that relitigation is an inefficient use of judicial resources and threatens the principle of finality. In addition, Novopharm points to the fact that the NOC Regulations do not remove any of the patentee’s rights under the Patent Act [R.S.C., 1985, c. P-4], nor is a proceeding under the NOC Regulations dispositive of the issues in a patent infringement action. Lastly, Novopharm notes that it would be unfair to allow an innovator to relitigate with respect to issues it previously lost, thereby permitting it to improve its argument on the second attempt, particularly where the facts required to resolve the issues are in the exclusive knowledge of the innovator.

[26]I am persuaded that the position of Novopharm is the most consistent with the scheme of the NOC Regulations and the guidance from the Supreme Court of Canada on the doctrine of abuse of process. Permitting the same innovator to relitigate the same issues repeatedly poses a severe threat to the integrity of the adjudicative process, the principle of finality, and the efficiency of the judicial system. In my view the Governor in Council recognized this threat and enacted paragraph 6(5)(b) of the NOC Regulations to allow for the early dismissal of proceedings like the one at issue.

[27]Subsection 6(5) was introduced during 1998 amendments to the NOC Regulations to give generic manufacturers, referred to in the Regulations as “second person[s],” an opportunity to seek early dismissal of a patentee’s case in certain circumstances. Paragraph 6(5)(b) allows for the dismissal of an application when it is an abuse of process:

6. . . .

(5) In a proceeding in respect of an application under subsection (1), the court may, on the motion of a second person, dismiss the application:

. . .

(b) on the ground that the application is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process.

[28]At paragraphs 23‑24 of her reasons, Tremblay‑Lamer J. identified that two similar tests have generally been applied by the Federal Court to dismiss proceedings under paragraph 6(5)(b):

This Court has generally held that in order to strike out a proceeding for being redundant, scandalous, frivolous, vexatious or otherwise an abuse of process, the moving party must show that the case is “so clearly futile that it has not the slightest chance of success”. This test has been applied several times in s. 6(5)(b) cases: Pfizer Canada Inc. v. Apotex Inc. (1999), 1 C.P.R. (4th) 358 (F.C.T.D.), at paras. 28‑32; Bayer Inc. v. Apotex Inc. (1998), 85 C.P.R. (3d) 334 (F.C.T.D.), at paras. 23‑24; AB Hassle v. Apotex Inc., 2001 FCT 530, 12 C.P.R. (4th) 289 (F.C.T.D.), at para. 28; AstraZeneca AB v. Apotex Inc. 2002 FCT 1249, 23 C.P.R. (4th) 213 (F.C.T.D.), at para. 11.

When dealing with a paragraph 6(5)(b) motion, the courts have also applied the “plain and obvious” test such that an application will be dismissed where it is “plain and obvious” that the applicant has no chance of success: Apotex Inc. v. Merck Frosst Canada Inc. (1999), 87 C.P.R. (3d) 30 (F.C.A.), at paras. 5‑6; GlaxoSmithKline Inc. v. Apotex Inc., 2003 FC 1055, 29 C.P.R. (4th) 350, at paras. 12‑13. [Emphasis added.]

[29]In Tremblay‑Lamer J.’s view, any court hearing Sanofi‑Aventis’ present application would be bound by Mactavish J.’s decision in the Apotex case. She therefore concluded the application was an abuse of process because it was “clearly futile” and that it was “plain and obvious” that it would have no chance of success.

[30]While I agree with the motions Judge that Sanofi‑Aventis’ application is an abuse of process, I must respectfully disagree with her conclusion that the reason for this finding is that Mactavish J.’s decision, which was upheld by the Federal Court of Appeal, would be binding on the applications Judge. The issue in this case, as in the proceeding before Mactavish J., is whether the invention in the ′206 patent was soundly predicted. Sound prediction is a question of fact (Apotex Inc. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153, at paragraph 71). Factual questions are to be determined by triers of fact based on the evidence before them. Unlike questions of law, in regard to which lower courts are bound by the conclusions of appellate courts, questions of fact must be resolved based on the information adduced before each trier of fact. This principle was explained by this Court in J.M. Voith GmbH v. Beloit Corp. (1991), 36 C.P.R. (3d) 322 (F.C.A.), at page 330 as follows:

While a finding of fact in another proceeding, approved by an appellate court whose judgments are binding, may call for particular reflection before a contrary finding is made, it remains that the question is whether the second finding is supportable on the evidence properly before the second trial judge.

[31]Mactavish J.’s holding would therefore not be binding on the proceedings respecting the Novopharm NOA. Consequently, it cannot be said that the application, if allowed to proceed, would be “clearly futile” or that it is “plain and obvious” that it would have no chance of success. Nevertheless, I think Sanofi‑Aventis’ application must be held to be an abuse of process within the meaning of paragraph 6(5)(b) of the NOC Regulations.

[32]The “clearly futile” and “plain and obvious” tests found their way into the context of the NOC Regulations before paragraph 6(5)(b) was enacted. At that time there was no rule allowing for the dismissal of a notice of application and accordingly, in David Bull Laboratories (Canada) Inc. v. Pharmacia Inc., [1995] 1 F.C. 588 (C.A.), at page 600 this Court suggested that judicial review proceedings could be summarily dismissed in exceptional cases by analogy to Rule 419 of what were then the Federal Court Rules, C.R.C., c. 663 for striking out pleadings in an action:

For these reasons we are satisfied that the Trial Judge properly declined to make an order striking out, under Rule 419 or by means of the “gap” rule, as if this were an action. This is not to say that there is no jurisdiction in this court either inherent or through Rule 5 by analogy to other rules, to dismiss in summary manner a notice of motion which is so clearly improper as to be bereft of any possibility of success.¹⁰ See eg., Cynamid Agricultural de Puerto Rico, Inc. v. Commissioner of Patents et al. (1983), 74 C.P.R. (2d) 133 (F.C.T.D.); and the discussion in Vancouver Island Peace Society v. Canada, [1994] 1 F.C. 102 (T.D.), at pp. 120‑21.) Such cases must be very exceptional and cannot include cases such as the present where there is simply a debatable issue as to the adequacy of the allegations in the notice of motion. [Emphasis added.]

[33]Paragraph 6(5)(b) was added to the NOC Regulations in 1998 bearing similar language to that employed in the former Rule 419 of the Federal Court Rules and to that in rule 221 of the current Federal Courts Rules, SOR/98‑106 [r. 1 (as am. by SOR/2004-283, s. 2)]. Accordingly, the Federal Court adopted the principles that had been developed under Rule 419 for striking out pleadings in an action, as explained by Lemieux J. in Pfizer Canada Inc. v. Apotex Inc. (1999), 1 C.P.R. (4th) 358 (F.C.T.D.), at paragraphs 28‑30:

Paragraph 6(5)(b) of the Regulations has its source in paragraphs (b), (c) and (f) of Rule 221 of the Federal Court Rules, 1998, SOR/98‑106, which themselves were based on similar paragraphs of Rule 419 of the old Federal Court Rules, C.R.C. 1978, c. 663, which concerned actions rather than applications.

Counsel for Apotex argued Pfizer’s application was scandalous, frivolous and vexatious within the meaning of those words in paragraph 6(5)(b) of the Regulations. The test Apotex had to meet has been set out in a consistent line of cases interpreting former rule 419(1)(c).

In R. v. Creaghan, [1972] F.C. 732 (T.D.), Pratte J. (as he then was), said this about that aspect of Rule 419 (page 736):

Finally, in my view, a statement of claim should not be ordered to be struck out on the ground that it is vexatious, frivolous or an abuse of the process of the Court, for the sole reason that in the opinion of the presiding judge, plaintiff’s action should be dismissed. In my opinion, a presiding judge should not make such an order unless it be obvious that the plaintiff’s action is so clearly futile that it has not the slightest chance of succeeding, whoever the judge may be before whom the case could be tried. It is only in such a situation that the plaintiff should be deprived of the opportunity of having “his day in Court”. [Emphasis added.]

[34]Likewise, the Federal Court has on several occasions invoked the following principle from the Supreme Court of Canada’s decision in Hunt v. Carey Canada Inc., [1990] 2 S.C.R. 959 [at page 980], to strike out a notice of application under paragraph 6(5)(b) where it is “plain and obvious” the patentee has no chance of success:

Thus, the test in Canada governing the application of provisions like Rule 19(24)(a) of the British Columbia Rules of Court is the same as the one that governs an application under R.S.C. O. 18, r. 19: assuming that the facts as stated in the statement of claim can be proved, is it “plain and obvious” that the plaintiff’s statement of claim discloses no reasonable cause of action? As in England, if there is a chance that the plaintiff might succeed, then the plaintiff should not be “driven from the judgment seat”. Neither the length and complexity of the issues, the novelty of the cause of action, nor the potential for the defendant to present a strong defence should prevent the plaintiff from proceeding with his or her case. Only if the action is certain to fail because it contains a radical defect ranking with the others listed in Rule 19(24) of the British Columbia Rules of Court should the relevant portions of a plaintiff’s statement of claim be struck out under Rule 19(24)(a). [Emphasis added.]

(See e.g. Bayer Inc. v. Apotex Inc. (1998), 85 C.P.R. (3d) 334 (F.C.T.D.), at paragraph 23; Hoffmann‑La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1999), 87 C.P.R. (3d) 251 (F.C.T.D.), at paragraph 2; GlaxoSmithKline Inc. v. Apotex Inc. (2003), 29 C.P.R. (4th) 350 (F.C.), at paragraphs 12‑13.)

[35]Despite these authorities, this Court’s analysis with respect to abuse of process must now be informed by the principles enunciated by the Supreme Court of Canada in Toronto (City) v. C.U.P.E., Local 79, [2003] 3 S.C.R. 77 (C.U.P.E.). In C.U.P.E., Arbour J. provided a thorough explanation of the doctrine of abuse of process as it relates to attempts by parties to relitigate issues already adjudicated. She held that relitigation of an issue can constitute abuse of process and stressed that the key concern motivating the doctrine of abuse of process is preserving the integrity of the adjudicative process [at paragraphs 37-38, 51]:

In the context that interests us here, the doctrine of abuse of process engages “the inherent power of the court to prevent the misuse of its procedure, in a way that would . . . bring the administration of justice into disrepute” (Canam Enterprises Inc. v. Coles (2000), 51 O.R. (3d) 481 (C.A.), at para. 55, per Goudge J.A., dissenting (approved [2002] 3 S.C.R. 307, 2002 SCC 63)). Goudge J.A. expanded on that concept in the following terms at paras. 55‑56:

The doctrine of abuse of process engages the inherent power of the court to prevent the misuse of its procedure, in a way that would be manifestly unfair to a party to the litigation before it or would in some other way bring the administration of justice into disrepute. It is a flexible doctrine unencumbered by the specific requirements of concepts such as issue estoppel. See House of Spring Gardens Ltd. v. Waite, [1990] 3 W.L.R. 347 at p. 358, [1990] 2 All E.R. 990 (C.A.).

One circumstance in which abuse of process has been applied is where the litigation before the court is found to be in essence an attempt to relitigate a claim which the court has already determined.

As Goudge J.A.’s comments indicate, Canadian courts have applied the doctrine of abuse of process to preclude relitigation in circumstances where the strict requirements of issue estoppel (typically the privity/mutuality requirements) are not met, but where allowing the litigation to proceed would nonetheless violate such principles as judicial economy, consistency, finality and the integrity of the administration of justice. (See, for example, Franco v. White (2001), 53 O.R. (3d) 391 (C.A.); Bomac Construction Ltd. v. Stevenson, [1986] 5 W.W.R. 21 (Sask. C.A.); and Bjarnarson v. Government of Manitoba (1987), 38 D.L.R. (4th) 32 (Man. Q.B.), aff’d (1987), 21 C.P.C. (2d) 302 (Man. C.A.).) . . . .

The policy grounds supporting abuse of process by relitigation are the same as the essential policy grounds supporting issue estoppel (Lange, supra, at pp. 347‑48):

The two policy grounds, namely, that there be an end to litigation and that no one should be twice vexed by the same cause, have been cited as policies in the application of abuse of process by relitigation. Other policy grounds have also been cited, namely, to preserve the courts’ and the litigants’ resources, to uphold the integrity of the legal system in order to avoid inconsistent results, and to protect the principle of finality so crucial to the proper administration of justice.

. . .

Rather than focus on the motive or status of the parties, the doctrine of abuse of process concentrates on the integrity of the adjudicative process. Three preliminary observations are useful in that respect. First, there can be no assumption that relitigation will yield a more accurate result than the original proceeding. Second, if the same result is reached in the subsequent proceeding, the relitigation will prove to have been a waste of judicial resources as well as an unnecessary expense for the parties and possibly an additional hardship for some witnesses. Finally, if the result in the subsequent proceeding is different from the conclusion reached in the first on the very same issue, the inconsistency, in and of itself, will undermine the credibility of the entire judicial process, thereby diminishing its authority, its credibility and its aim of finality.

[36]Proceedings in which the case for the patent holder is clearly futile or plainly has no chance of success because of an earlier, binding authority continue to be impermissible as abuses of process because such proceedings will waste judicial resources and impose hardship on generic drug manufacturers without any corresponding benefit such as a more accurate result. However, applying the principles outlined by Arbour J., it is evident that the types of proceedings that constitute abuses of process go beyond those that are clearly futile to include cases such as the one at present. Many of the concerns raised by Arbour J. are applicable to this appeal. Allowing Sanofi‑Aventis to proceed with its application will give rise to the possibility of inconsistent judicial decisions, with one judge holding that the inventors of the ′206 patent lacked a sound basis for predicting the utility of their invention and another holding that there was sound prediction. Thus one generic would receive an NOC because of invalidity based on lack of sound prediction while another would be refused an NOC even though its NOA raised the same allegation. As Arbour J. identified, permitting that type of inconsistency would threaten the credibility of the adjudicative process. Likewise, as Arbour J. noted, there is no reason to think that a second proceeding under section 6 of the NOC Regulations will lead to a more accurate result than the first. This scenario is in contrast to an action for a declaration of patent invalidity, where because the parties have the benefit of a full trial and all the attendant procedural safeguards, a more accurate result may arise. That is why the courts have on numerous occasions stated the principle that decisions rendered under the NOC Regulations are not binding on actions for patent infringement or to declare a patent invalid (see e.g. David Bull Laboratories (Canada) Inc. v. Pharmacia Inc.; Novartis A.G. v. Apotex Inc. (2002), 22 C.P.R. (4th) 450 (F.C.A.), at paragraph 9; Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2001), 11 C.P.R. (4th) 245 (F.C.A.), at paragraph 25).

[37]In the context of the NOC Regulations, encouraging the efficient use of scarce judicial resources is also of particular concern. Judicial resources are already taxed considerably by the voluminous proceedings brought under the Regulations. An attempt to further strain the resources of parties and of the courts through repetitious litigation without any compelling justification strongly favours a finding of abuse of process.

[38]Therefore, despite the fact that Mactavish J.’s decision would not dictate the outcome of the present application and consequently, that it is not possible to say that Sanofi‑Aventis has no chance of success, I nevertheless am compelled to hold that the application in respect of the Novopharm NOA is an abuse of process and therefore should be dismissed.

[39]In C.U.P.E., at paragraphs 52‑53, Arbour J. noted that there may be situations where fairness dictates that a duplicitous proceeding should not be held to be abusive:

In contrast, proper review by way of appeal increases confidence in the ultimate result and affirms both the authority of the process as well as the finality of the result. It is therefore apparent that from the system’s point of view, relitigation carries serious detrimental effects and should be avoided unless the circumstances dictate that relitigation is in fact necessary to enhance the credibility and the effectiveness of the adjudicative process as a whole. There may be instances where relitigation will enhance, rather than impeach, the integrity of the judicial system, for example: (1) when the first proceeding is tainted by fraud or dishonesty; (2) when fresh, new evidence, previously unavailable, conclusively impeaches the original results; or (3) when fairness dictates that the original result should not be binding in the new context. This was stated unequivocally by this Court in Danyluk, supra, at para. 80.

The discretionary factors that apply to prevent the doctrine of issue estoppel from operating in an unjust or unfair way are equally available to prevent the doctrine of abuse of process from achieving a similar undesirable result. There are many circumstances in which the bar against relitigation, either through the doctrine of res judicata or that of abuse of process, would create unfairness. If, for instance, the stakes in the original proceeding were too minor to generate a full and robust response, while the subsequent stakes were considerable, fairness would dictate that the administration of justice would be better served by permitting the second proceeding to go forward than by insisting that finality should prevail. An inadequate incentive to defend, the discovery of new evidence in appropriate circumstances, or a tainted original process may all overcome the interest in maintaining the finality of the original decision (Danyluk, supra, at para. 51; Franco, supra, at para. 55). [Emphasis added.]

[40]While it is important in each case to ensure the application of the doctrine of abuse of process does not give rise to unfairness in the circumstances, in my view, no such unfairness would result in the present case. Prohibition proceedings under the NOC Regulations do not prevent patentees from enforcing their patent rights through actions for patent infringement in accordance with the Patent Act. Moreover, the findings from any such prohibition proceedings have no bearing on patent infringement actions.

[41]Sanofi‑Aventis and Schering argue that a finding of abuse of process is inappropriate in this case because relitigation alone is insufficient to give rise to abuse of process, because they have adduced new evidence in these proceedings not before Mactavish J. that warrants a different result, and because the scheme of the NOC Regulations permits repetitive applications against different generics. I am not persuaded by these submissions.

[42]Sanofi‑Aventis and Schering first challenged the test laid out above for dismissing an application under paragraph 6(5)(b). They argue that relitigation alone can never be enough to give rise to abuse of process. Rather, they say that there must be some additional element of misconduct before a court will render a proceeding abusive. For this proposition they cite the following passage from the English Court of Appeal’s decision in Bradford & Bingley Building Society v. Seddon, [1999] 1 W.L.R. 1482 (C.A.), at pages 1492‑1493 (Bradley):

In my judgment, mere “re”‑litigation, in circumstances not giving rise to cause of action or issue estoppel, does not necessarily give rise to abuse of process. Equally, the maintenance of a second claim which could have been part of an earlier one, or which conflicts with an earlier one, should not, per se, be regarded as an abuse of process. Rules of such rigidity would be to deny its very concept and purpose. As Kerr L.J. and Sir David Cairns emphasised in Bragg v. Oceanus Mutual Underwriting Association (Bermuda) Ltd. [1982] 2 Lloyd’s Rep. 132, 137, 138‑139 respectively, the courts should not attempt to define or categorise fully what may amount to an abuse of process; see also per Stuart‑Smith L.J. in Ashmore v. British Coal Corporation [1990] 2 Q.B. 338, 352. Sir Thomas Bingham M.R. underlined this in Barrow v. Bankside Agency Ltd. [1996] 1 W.L.R. 257, stating, at 263b, that the doctrine should not be “circumscribed by unnecessarily restrictive rules” since its purpose was the prevention of abuse and it should not endanger the maintenance of genuine claims; see also per Saville L.J., at 266d-e.

Some additional element is required, such as a collateral attack on a previous decision (see e.g. Hunter v. Chief Constable of the West Midlands Police [1982] A.C. 529; Bragg’s case [1982] 2 Lloyd’s Rep. 132, per Kerr L.J. and Sir David Cairns, at pp. 137 and 139 respectively; and Ashmore’s case [1990] 2 Q.B. 338), some dishonesty (see e.g. per Stephenson L.J. Bragg’s case, at p. 139; and Potter L.J. in Morris v. Wentworth‑Stanley [1999] 2 W.L.R. 470, 480 and 481; or successive actions amounting to unjust harassment (see e.g. Manson v. Vooght, The Times, 20 November 1998; Court of Appeal (Civil Division) Transcript No. 1610 of 1998, per May L.J.). [Emphasis added.]

[43]However, in C.U.P.E., Arbour J. considered whether there was a collateral attack on the earlier judgment. She found that there was no such collateral attack. Furthermore, in the C.U.P.E. case, although Arbour J. noted that it was important to take into account such considerations as judicial economy, consistency, finality and the integrity of the administration of justice, she found no additional element of misconduct so as to come within the requirements of Bradley. Nevertheless, Arbour J. found there to be abuse of process. Consequently it cannot be said that any additional element of misconduct is required to find abuse of process in Canada.

[44]In my view, even if the requirement of an element additional to relitigation was required in Canada, it does not lie in the mouths of Sanofi‑Aventis and Schering to suggest that they have not attempted to attack collaterally the decision of Mactavish J. and the approval of that decision by the Federal Court of Appeal. In oral argument, Schering counsel stressed that Sanofi‑Aventis’ application was not an abuse of process because in these proceedings Sanofi‑Aventis and Schering have tendered evidence that was not before Mactavish J. in the Apotex proceeding and that would lead a trier of fact to reach the opposite conclusion on the issue of sound prediction. Sanofi‑Aventis and Schering say that in the previous proceeding, they were not put on notice that Apotex would be challenging the predictability of the chirality of the bridgehead carbons in the compounds covered by the ′206 patent, an issue that became a critical factor in Mactavish J.’s conclusion that the compounds disclosed in the ′206 patent were not soundly predicted. Consequently, they say it would be unjust to prevent them from tendering additional evidence on that issue in the present proceedings. In their view, the additional evidence adduced in these proceedings establishes that the chirality of the bridgehead carbons was soundly predicted and accordingly, the patent is not invalid for lack of sound prediction.

[45]This argument is itself a collateral attack on Justice Mactavish’s decision. In the Apotex case, the parties fully argued whether the Apotex NOA was sufficient with respect to the issue of sound prediction. Mactavish J. concluded that it was and went on to dispose of the case based on the allegations made in the NOA. Sanofi‑Aventis and Schering attempted to challenge Mactavish J.’s conclusion as to the sufficiency of the Apotex NOA on appeal to this Court and their argument was rejected. On this issue, Mactavish J. held as follows, at paragraphs 102, 105-108:

Aventis asserts that Apotex’s NOA is deficient as it relates to the issue of sound prediction. Aventis says that the sum total of Apotex’s argument that Schering did not have a sound basis for its prediction as contained in its NOA was its assertion that Schering failed to provide test data. According to Aventis, subsequent to serving the NOA, Apotex amplified its argument to argue that Schering should have demonstrated utility by testing in order to establish matters such as potency, toxicity, bioavailability, selectivity and so on.

. . .

A review of Apotex’s NOA reveals that Apotex put Aventis on notice that it would be arguing that Schering failed to conduct the tests necessary to establish that the compounds covered by the ′206 patent possessed the requisite level of activity and the requisite pharmacological and toxicological profile. What do these terms mean? Clearly the ‘level of activity’ relates to the potency of the compounds in question. The use of the phrase ‘toxicological profile’ clearly puts Aventis on notice that the issue of toxicity was in issue. Finally, the ‘requisite pharmacological profile’ can be reasonably understood to relate to issues such as bioavailability and selectivity.

Moreover, a review of Aventis’ Notice of Application reveals that it understood Apotex’s position in relation to these issues, as it responds to it.

Finally, it should be noted that no affidavit was filed on behalf of Aventis asserting that it was not in a position to decide whether to challenge Apotex’s NOA in relation to this issue because of the statement’s lack of specificity: see AstraZeneca AB v. Apotex Inc., [2005] F.C.J. No. 842 (QL), 2005 F.C.A. 183, 39 C.P.R. (4th) 289, para. 13.

In these circumstances, I am therefore satisfied that Aventis was sufficiently aware of the basis on which Apotex was claiming that the ′206 patent was invalid as it related to the first two elements of the test for sound prediction

[46]On appeal, Chief Justice Richard stated the following at paragraphs 11-12, 16‑17:

Aventis/Schering contend that Justice Mactavish erred by finding that Apotex’s NOA, with respect to sound prediction, was legally sufficient.

I am satisfied that Justice Mactavish properly determined the claim of sufficiency of Apotex’s NOA, based on the jurisprudence of this Court and on the evidentiary record.

. . .

Aventis/Schering specifically focus on the words “requisite level of activity” in the NOA. Justice Mactavish determined that “level of activity” relates to the potency of the compounds in question and therefore whether the compounds lacked any activity at all. In addition, Justice Mactavish considered the lack of an affidavit filed on behalf of Aventis with respect to the alleged lack of specificity in the Apotex NOA to be telling, as per AstraZeneca AB.

The decision of Justice Mactavish was supported by the evidentiary record. As Justice Mactavish made no palpable and overriding error, her determination with respect to the sufficiency of Apotex’s NOA should not be interfered with.

[47]In any event, the additional evidence adduced by Sanofi‑Aventis and Schering in these proceedings does not change the fact that in the circumstances, they cannot attempt to relitigate a claim they have already made. Sanofi‑Aventis and Schering were required to put their best foot forward in the earlier proceedings. They can have no relief in these new proceedings for having failed to do so. The doctrine of abuse of process calls for the innovator to bring forth all its evidence on each ground of invalidity raised. It should not be allowed to hold back evidence and then use that as a ground for allowing a second application to proceed. Even though in Glaxo Group Ltd. v. Canada (Minister of Health), 2001 FCT 16, at paragraph 16, the two cases involved the same parties, nevertheless the quote of Hansen J. is apposite:

In Hofffman[sic]‑LaRoche, supra, the factors that led Rothstein J. to conclude there was an abuse of process are analogous to the facts before me. The applicants and the patents are the same in both proceedings, the Notices of Allegation are in all material respects identical, and the issues were fully litigated in the first proceeding. The only distinguishing aspect between the first and current applications is that Glaxo believes it has a better evidentiary basis on which to litigate the issues. Litigants who have already litigated a matter, but lost, should not be permitted to re‑litigate because they have acquired new evidence. This, in my view, is an abuse of the Court’s process. [Emphasis added.]

[48]Another argument relied upon by Sanofi‑Aventis and Schering is that the scheme of the NOC Regulations suggests that generics are not entitled to rely upon prior findings of justified allegations in respect of NOAs previously issued by other generics. Had the drafters of the regulations intended to bar duplicative proceedings, Sanofi‑Aventis and Schering argue, they would have included a scheme under which later generics could rely on successful allegations made previously by other generics, such as by de‑listing the patent. In making this argument, what Sanofi‑Aventis and Schering fail to appreciate is that the NOC Regulations have provided a way for subsequent generics to rely on the successful NOAs of earlier generics. By enacting paragraph 6(5)(b), the Governor in Council has signaled the importance of curtailing redundant proceedings that threaten the integrity of the adjudicative process. Generics can invoke this provision where other generics have successfully made allegations the subsequent generics seek to make.

[49]Sanofi‑Aventis and Schering also emphasize that proceedings under the NOC Regulations are of a preliminary nature and are accompanied by limited procedural safeguards. While this argument may be sufficient to establish that decisions made in the context of the NOC Regulations should not be binding on judges adjudicating actions for patent infringement or declarations of patent invalidity, it does not change the fact that relitigation by a first person of an issue already decided against it within the context of the NOC Regulations is generally not permissible. As I have already said, the possibility of different judges adjudicating equivalent proceedings concerning the same issue reaching different results threatens the integrity of the adjudicative process. The nature of the proceedings does not change this reality.

[50]Finally, Sanofi‑Aventis and Schering argue that a finding of abuse of process in this case will lead to unfairness. They say that while first persons will not be permitted to defend against allegations by subsequent generics after the same allegation made by an earlier generic has been found to be justified, subsequent generics will be permitted to repeat allegations already made earlier by other generics even if the earlier allegations were found to be unjustified. However, there is no unfairness in this scenario. All parties are held to the same standard: they must each put forward their entire case, complete with all relevant evidence, at first instance. The innovator is prevented from relitigating an issue already decided in a proceeding to which it was a party with the aid of additional evidence it chose not to adduce in the earlier proceedings. Generics likewise must put forward their full case at the first opportunity. Multiple NOAs issued by the same generic relating to a particular drug and alleging invalidity of a particular patent will generally not be permitted, even if different grounds for establishing invalidity are put forward in each. However, where one generic has made an allegation but has failed to put forward the requisite evidence and argument to illustrate the allegation is justified, it would be unjust to preclude a subsequent generic, who is apprised of better evidence or a more appropriate legal argument, from introducing it. Although this situation may give rise to the possibility of an inconsistent result, this concern is overridden by the potential for unfairness to the generic that is barred from bringing forward its case simply because another generic’s approach was inadequate. In each situation, it is necessary to balance the effect of a proceeding on the administration of justice against the unfairness to a party from precluding it from bringing forward its case.

CONCLUSION

[51]For the foregoing reasons, I would dismiss the appeal with costs.

Sharlow J.A.: I agree.

* * *

The following are the reasons for judgment rendered in English by

[52]Nadon J.A. (dissenting): I cannot agree with Sexton J.A. that the appellant’s application for an order prohibiting the Minister of Health (the Minister) from issuing a notice of compliance (an NOC) to the respondent Novopharm Limited (the respondent) constitutes an abuse of process. As a result, I would allow the appeal.

[53]The relevant facts and the proceedings below are carefully reviewed by Sexton J.A. in his reasons and I need not refer to them, except to make clear one matter. As Sexton J.A. explains at paragraph 3 of his reasons, the appellant herein is Sanofi‑Aventis Canada Inc. and the owner of the patent at issue, named as a respondent, is Schering Corporation. Since Schering’s interests in this appeal are the same as those of Sanofi‑Aventis, I will, for ease of reference, simply refer to these parties as “the appellant.”

[54]As Sexton J.A. makes clear at the outset of his reasons, the issue before us arises by reason of paragraph 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93‑133 (the NOC Regulations), which allows a second person, i.e. a generic drug manufacturer, to seek the dismissal of a patentee’s application for an order of prohibition on the ground that the application is, inter alia, an abuse of process.

[55]In seeking to obtain such an order against the appellant, the respondent says that the allegations of invalidity, i.e. that the inventors did not have a sound basis for predicting the utility of their invention, concerning the appellant’s patent 1341206 (the ′206 patent) found in its notice of allegation (NOA) are, for all intents and purposes, indistinguishable from those made by Apotex Inc. which Mactavish J., in Aventis Pharma Inc. v. Apotex (2005), 43 C.P.R. (4th) 161 (F.C.), found to be justified. Mactavish J.’s decision was upheld by this Court in Aventis Pharma Inc. v. Apotex Inc. (2006), 265 D.L.R. (4th) 308 (F.C.A.).

[56]At paragraph 1 of his reasons, Sexton J.A. frames the issue as being “whether the holder of a pharmaceutical patent, having failed to establish that an allegation of invalidity made by one generic drug manufacturer [Apotex] is not justified, abuses the NOC process by seeking to relitigate the same allegation of invalidity when it is made by a second generic company [the respondent Novopharm].”

[57]The appellant frames the question in a different manner at paragraph 1 of its memorandum of fact and law:

1. This appeal raises the novel question of whether a finding that one generic’s allegation of invalidity is justified bars litigation of the same allegation against all other generic manufacturers, thereby exhausting a first person’s rights under the Patented Medicines (Notice of Compliance) Regulations (“Regulations”) and effectively delisting the patent at issue.

[58]I begin by setting out those points in regard to which I am in agreement with Sexton J.A.

[59]First, I am in agreement with Sexton J.A. that the NOC Regulations do not require a second person to allege, in its NOA, the issues of res judicata, issue estoppel or abuse of process.

[60]Second, I am satisfied that the respondent’s NOA and that of Apotex in Aventis Pharma [cited as Apotex by Sexton J.A.], in similar allegations with respect to the validity of the ′206 patent. I would, however, add that the evidence on which the appellant relies in the present matter is, in some respects, different from that adduced before Mactavish J. in Aventis Pharma.

[61]Third, I am also of the view that Tremblay‑Lamer J. erred in concluding that she was bound by the decision of Mactavish J. in Aventis Pharma. In disposing of this issue, Sexton J.A., at paragraphs 30-31 of his reasons, makes the following remarks:

While I agree with the motions Judge that Sanofi‑Aventis’ application is an abuse of process, I must respectfully disagree with her conclusion that the reason for this finding is that Mactavish J.’s decision, which was upheld by the Federal Court of Appeal, would be binding on the applications Judge. The issue in this case, as in the proceeding before Mactavish J., is whether the invention in the ′206 patent was soundly predicted. Sound prediction is a question of fact (Apotex Inc. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153, at paragraph 71). Factual questions are to be determined by triers of fact based on the evidence before them. Unlike questions of law, in regards to which lower courts are bound by the conclusions of appellate courts, questions of fact must be resolved based on the information adduced before each trier of fact. This principle was explained by this Court in J.M. Voith GmbH v. Beloit Corp. (1991), 36 C.P.R. (3d) 322 (F.C.A.), at page 330 as follows:

Mactavish J.’s holding [in Aventis Pharma Inc. v. Apotex Inc.] would therefore not be binding on the proceedings respecting the Novopharm NOA. Consequently, it cannot be said that the application, if allowed to proceed, would be “clearly futile” or that it is “plain and obvious” that it would have no chance of success. Nevertheless, I think Sanofi‑Aventis’ application must be held to be an abuse of process within the meaning of paragraph 6(5)(b) of the NOC Regulations. [Emphasis added.]

[62]Although he concludes that Tremblay‑Lamer J. was wrong in holding that the appellant’s application was an abuse of process because it was “clearly futile” and that it was “plain and obvious” that it could not succeed, Sexton J.A. nonetheless concludes, on other grounds, that the appellant’s application “must be held to be an abuse of process within the meaning of paragraph 6(5)(b) of the NOC Regulations”.

[63]Sexton J.A. reaches this conclusion after a careful review of the Supreme Court of Canada’s decision in Toronto (City) v. C.U.P.E. Local 79, [2003] 3 S.C.R. 77. Specifically, Sexton J.A. takes note of paragraphs 37 and 51 of the Supreme Court’s decision, emphasizing those passages where Arbour J., writing for the Court, opined that abuse of process was a flexible doctrine, not restricted by concepts such as issue estoppel, and that one of the circumstances where the doctrine had been applied was where proceedings constituted an attempt to relitigate a point already decided by the courts.

[64]Applying these principles to the matter before us leads Sexton J.A. to the conclusion that the appellant’s application falls within the ambit of the doctrine of abuse of process. First, my colleague points to the real possibility of inconsistent decisions with regard to whether the inventors of the ′206 patent lacked a sound basis for predicting the utility of the invention. Thus, should conflicting decisions be rendered by the Court, notwithstanding the similarity of the allegations found in the respective NOAs, the Minister would issue an NOC to one generic drug manufacturer but would refuse it to another. Hence, in Sexton J.A.’s view, such a scenario would threaten the credibility of the judicial process.

[65]Sexton J.A. then goes on to say that, in such circumstances, allowing a second application for an order of prohibition to proceed to a hearing does not constitute an efficient use of scarce judicial resources. He makes the point that disposing of the appellant’s application in the manner which he proposes does not bring about unfairness to the appellant, as the NOC Regulations do not prevent it from enforcing its rights by way of an action for infringement against either Apotex or another generic drug manufacturer.

[66]At paragraphs 44-47 of his reasons, Sexton J.A. dismisses an argument by the appellant to the effect that since part of the evidence adduced in these proceedings was not before Mactavish J. in Aventis Pharma, which evidence could lead a trier of fact to a conclusion different from that reached by the learned Judge, there is no basis for the application of the doctrine of abuse of process.

[67]In dismissing the appellant’s argument, my colleague remarks that such additional evidence is of no help to the appellant because it cannot relitigate a claim already decided by the courts. In his view, the appellant was bound to make its best case with respect to the issue of the validity of the ′206 patent in Aventis Pharma, and that it cannot now attempt to improve its lot by commencing a new application for prohibition. At paragraph 47, Sexton J.A. says:

The doctrine of abuse of process calls for the innovator to bring forward all its evidence on each ground of invalidity raised. It should not be allowed to hold back evidence and then use that as a ground for allowing a second application to proceed.

[68]Finally, in Sexton J.A.’s view, the appellant’s application herein amounts to a collateral attack on Mactavish J.’s decision in Aventis Pharma.

[69]Before setting out my specific reasons for dissent and before addressing Sexton J.A.’s grounds for concluding in favour of the application of the doctrine of abuse of process, a brief review of the principles enunciated by the courts with respect to that doctrine will be helpful. I accept, as I must, the guidelines given by the Supreme Court in C.U.P.E., and particularly those that Sexton J.A. has reproduced in his reasons, namely, paragraphs 37, 51, 52 and 53 of Arbour J.’s reasons.

[70]The common-law doctrines of abuse of process and collateral attack are interrelated and in many cases more than one doctrine may support a particular outcome. However, although a collateral attack may properly be viewed as a particular application of a broader doctrine of abuse of process, the two are not always entirely interchangeable (see: C.U.P.E., at paragraph 22).

[71]The doctrine of abuse of process seeks to prevent relitigation in situations where the strict requirements of issue estoppel are not met, but where permitting the litigation to proceed would be contrary to the integrity of the court’s process and to the good administration of justice (see: Doherty J.A.’s reasons in Toronto (City) v. Canada Union of Public Employees, Local 791 (2001), 55 O.R. (3d) 541 (C.A.), at paragraph 65; Demeter v. British Pacific Life Insurance Co. (1983), 43 O.R. (2d) 33 (H.C.J.), at pages 48-49; affd (1984), 48 O.R. (2d) 266 (C.A.); Hunter v. Chief Constable of the West Midlands Police, [1982] A.C. 529 (H.L.), at page 536; Franco v. White (2001), 53 O.R. (3d) 391 (C.A.); Stevenson v. Bomac Construction, [1986] 5 W.W.R. 21 (Sask. C.A.); and Bjarnarson v. Manitoba (Government of) (1987), 38 D.L.R. (4th) 32 (Man. Q.B.); affd (1987), 45 D.L.R. (4th) 766 (Man. C.A.)).

[72]The concept of abuse of process was described at common law as proceedings “unfair to the point that they are contrary to the interest of justice” (see: R. v. Power, [1994] 1 S.C.R. 601, at page 616) and as “oppressive treatment” (see: R. v. Conway, [1989] 1 S.C.R. 1659, at page 1667). McLachlin J. (as she then was) expressed it this way in R. v. Scott, [1990] 3 S.C.R. 979, at page 1007:

. . . abuse of process may be established where: (1) the proceedings are oppressive or vexatious; and (2) violate the fundamental principles of justice underlying the community’s sense of fair play and decency. [Emphasis added.]

[73]In Danyluk v. Ainsworth Technologies Inc., [2001] 2 S.C.R. 460, the Supreme Court held, at paragraph 80, that there may be instances where relitigation will enhance rather than impeach the integrity of the judicial system, for example: (1) when the first proceeding is tainted by fraud or dishonesty; (2) when fresh, new evidence, previously unavailable, conclusively impeaches the original results; or (3) when fairness dictates that the original result should not be binding in the new context. Those discretionary factors apply to prevent the doctrine of abuse of process from operating in an unjust or unfair way.

[74]Because the main purpose of the doctrine of abuse of process is focused on the integrity of the adjudicative process, the motive or interest of the party who seeks to relitigate, whether as a plaintiff or a defendant, cannot be decisive factors in determining if relitigation should be permitted.

[75]I now turn to a brief review of English case law which, in my view, provides helpful guidance in resolving the issue before us. In Johnson v Gore Wood & Co, [2001] 2 WLR 72, the House of Lords thoroughly reviewed the doctrine of abuse of process as enunciated and applied by English courts. At pages 89-90 of his reasons, Lord Bingham of Cornhill, with whom the other law lords agreed on this point, summarized the doctrine in the following terms:

It may very well be, as has been convincingly argued (Watt, “The Danger and Deceit of the Rule in Henderson v Henderson: A new approach to successive civil actions arising from the same factual matter” (2000) 19 CLJ 287), that what is now taken to be the rule in Henderson v Henderson has diverged from the ruling which Wigram V‑C made, which was addressed to res judicata. But Henderson v Henderson abuse of process, as now understood, although separate and distinct from cause of action estoppel and issue estoppel, has much in common with them. The underlying public interest is the same, that there should be finality in litigation and that a party should not be twice vexed in the same matter. This public interest is reinforced by the current emphasis on efficiency and economy in the conduct of litigation, in the interests of the parties and the public as a whole. The bringing of a claim or the raising of a defence in later proceedings may, without more, amount to abuse if the court is satisfied (the onus being on the party alleging abuse) that the claim or defence should have been raised in the earlier proceedings if it was to be raised at all. I would not accept that it is necessary, before abuse may be found, to identify any additional elements such as a collateral attack on a previous decision or some dishonesty, but where those elements are present the later proceedings will be much more obviously abusive, and there will rarely be a finding of abuse unless the later proceeding involves what the court regards as unjust treatment of a party. It is, however, wrong to hold that because a matter could have been raised in early proceedings it should have been, so as to render the raising of it in later proceedings necessarily abusive. That is to adopt too dogmatic an approach to what should in my opinion be a broad, merits‑based judgment which takes account of the public and private interests involved and also takes account of all the facts of the case, focusing attention on the crucial question whether, in all the circumstances, a party is misusing or abusing the process of the court by seeking to raise before it the issue which could have been raised before. As one cannot comprehensively list all possible forms of abuse, so one cannot formulate any hard and fast rule to determine whether, on given facts, abuse is to be found or not. Thus while I would accept that lack of funds would not ordinarily excuse a failure to raise in earlier proceedings an issue which could and should have been raised then, I would not regard it as necessarily irrelevant, particularly if it appears that the lack of funds has been caused by the party against whom it is sought to claim. While the result may often be the same, it is in my view preferable to ask whether in all the circumstances a party’s conduct is an abuse than to ask whether the conduct is an abuse and then, if it is, to ask whether the abuse is excused or justified by special circumstances. Properly applied, and whatever the legitimacy of its descent, the rule has in my view a valuable part to play in protecting the interests of justice. [Emphasis added.]

[76]One of the cases reviewed by Lord Bingham in Johnson, is the English Court of Appeal’s decision in Bradford & Bingley Building Society v. Seddon, [1999] 1 W.L.R. 1482, to which Sexton J.A. makes reference, at paragraph 42 of his reasons. Specifically, my colleague quotes the remarks which Auld L.J. made, at pages 1492 and 1493, to the effect that abuse of process does not arise by reason of mere litigation where the circumstances of the case do not give rise to cause of action or issue estoppel. In such circumstances, according to Auld L.J., “[S]ome additional element is required, such as a collateral attach on the previous decision . . . some dishonesty . . . or successive actions amounting to unjust harassment . . .”.

[77]In making these remarks in Bradford & Bingley, Auld L.J. refers with approval to the following words of Sir David Cairns found at pages 138 and 139 of his reasons in Bragg v. Oceanus Mutual Underwriting Association (Bermuda) Ltd. and C.E. Heath & Co. (Marine) Ltd., [1982] 2 Lloyd’s Rep. 132 (C.A.):

I do not accept the proposition advanced by Counsel for the appellant Heath that when an issue has already been decided in proceedings between A and B it is prima facie an abuse of the process of the Court for B to seek to have the issue decided afresh in proceedings between himself and C and that in such circumstances there is an onus on B to show some special reason why he should be allowed to raise the issue against C.

On the contrary, I consider that it is for him who contends that the retrial of the issue is an abuse of process to show some special reason why it is so. Since the cases in which the retrial of an issue (in the absence of an estoppel) has been disallowed as an abuse of process are so few in number, it would be dangerous to attempt to define fully what are the circumstances which should lead to a finding of abuse of process. Features tending that way clearly include the fact that the first trial was before the most appropriate tribunal or between the most appropriate parties for the determination of the issue, or that the purpose of the attempt to have it retried is not the genuine purpose of obtaining the relief sought in the second action, but some collateral purpose.

It would in my judgment be a most exceptional course to strike out the whole or part of a defence in a commercial action, or to refuse leave to amend a defence in such an action, simply because the issue raised or sought to be raised had been decided in another commercial action brought against the same defendant by a different plaintiff. The facts that the first action had been fairly conducted and that the issue had been the subject of lengthy evidence and argument would not, in my view, be sufficient in themselves to deprive the defendant of his normal right to raise any issue which he is not estopped from raising.

If further the defendant was at some disadvantage in the earlier proceedings from which he would be free in the later ones, that is a positive reason why he should not be deprived of the opportunity of raising the issue afresh. [Emphasis added.]

[78]In his separate reasons in Bragg, Stephenson L.J. also concluded that the attempt by one of the defendants to put forward amendments to its defence before trial did not constitute an abuse of process. At page 139, he states:

It would be a strong thing for a Judge to refuse to allow a party to put forward by amendment before trial a clearly arguable defence to a plaintiff’s claim, and to refuse it as an abuse of the process of the Court on the single ground that it had already been litigated and decided against the party in earlier proceedings brought by another plaintiff. It would be a still stronger thing for an appeal Court to reverse a Judge’s decision, in the exercise of his discretion to allow amendments, that the defendant was not abusing the process of the Court.

Yet it is the duty of the Judge and the Court of Appeal to shut out the defence if it is an abuse of the Court’s procedure to repeat it, in accordance with decisions of this Court. . . .Every repetition of a defence (or claim) may be said to amount to a collateral attack on a previous judicial decision, and to invite those derogatory references to “a side wind” or “a back door” which are in favour with advocates whose clients are not open to a frontal attack. But in my judgment it is only those defences (or claims) that are sham and not honest and not bona fide which abuse the process of the Court and call for the exercise of its inherent jurisdiction to prevent such abuse . . . [Emphasis added.]

[79]The third member of the Bragg panel, Kerr L.J., at page 137, summed up the authorities as follows:

To take the authorities first, it is clear that an attempt to relitigate in another action issues which have been fully investigated and decided in a former action may constitute an abuse of process, quite apart from any question of res judicata or issue estoppel on the ground that the parties or their privies are the same. It would be wrong to attempt to categorize the situations in which such a conclusion would be appropriate. However, it is significant that in the cases to which we were referred, where this conclusion was reached, the attempted relitigation had no other purpose than what Lord Diplock described as:

. . . mounting a collateral attack upon a final decision . . . which has been made by another court of competent jurisdiction in previous proceedings in which . . . (the party concerned) had a full opportunity of contesting the decision of the court by which it was made.

[80]What clearly stands out from the authorities is that there is no hard and fast rule for the application of the doctrine of abuse of process. Whether or not the doctrine will find application in a given case depends on the particular facts of that case. I would, however, add that the remarks of Auld L.J. in Bradford & Bingley—to the effect that “mere ‘re’-litigation, in circumstances not giving rise to cause of action or issue estoppel, does not necessarily give rise to abuse of process” (at page 1492) and that “[S]ome additional element is required, such as a collateral attack on a previous decision” (at page 1493)—must be correct.

[81]Needless to say, courts must be cautious in concluding that relitigation constitutes an abuse of process. At page 1496 in Bradford & Bingley, Auld L.J. dealt with that point in the following terms:

The need for caution

A further pointer in the direction of requiring the party raising the issue of abuse to establish it, and against that of obligating the claimant to persuade the court that there are “special circumstances for his “re”‑litigation, is the need for caution before striking out claims without a full hearing on their merits and demerits. May L.J. said in Manson v. Vooght that “it is axiomatic that the court will only strike out a claim as an abuse after most careful consideration.” The following passage from Drake J.’s judgment in North West Water Ltd. v. Binnie & Partners [1990] 3 All E.R. 547, 561 is to like effect:

“I find it unreal to hold that the issues raised in two actions arising from identical facts are different solely because the parties are different or because the duty of care owed to different persons is in law different. However, I at once stress my use of the word ‘solely.’ I think that great caution must be exercised before shutting out a party from putting forward his case on the grounds of issue estoppel or abuse of process. Before doing so the court should be quite satisfied that there is no real or practical difference between the issues to be litigated in the new action and that already decided, and the evidence which may properly be called on those issues in a new action.” [Emphasis added.]

[82]The question is then whether, in the circumstances of this case, the appellant should be stopped in its tracks. As the question cannot be answered without taking a close look at the NOC Regulations, I now move on to that task.

[83]As the appellant suggests—correctly, in my view—the NOC Regulations have features which distinguish them from other proceedings and, in particular, from actions on infringement or actions seeking a declaration that a patent is invalid. Proceedings under the NOC Regulations proceed by way of a notice of application. Discovery, either oral or documentary, is not available nor is viva voce evidence admissible. The NOA served upon the patentee by the generic manufacturer defines and limits the issues which will be before the Court.

[84]Another relevant feature of the NOC Regulations is the fact that a patentee has only 45 days from service of the NOA to commence its application for an order of prohibition and that the matter must be concluded within 24 months thereof. Further, the patentee has no right to file reply evidence, which approach is substantially different from that prevailing in infringement proceedings, where the party alleging invalidity has the burden of proof.

[85]Hence, under the NOC Regulations, the Court must decide, on a summary basis, whether the Minister should be prohibited from issuing an NOC to a particular generic manufacturer for a particular product. That is precisely the order which Mactavish J. rendered in Aventis Pharma. She did not finally decide the issue of the validity of the ′206 patent.

[86]It is of interest to point out that pursuant to paragraph 7(2)(b) of the NOC Regulations, where a declaration of non‑infringement or invalidity is granted, the statutory stay is terminated. Thus, although the NOC Regulations recognize the link between proceedings under the NOC Regulations and those under an action, they are silent with respect to the consequences of a decision which allows a generic company to obtain an NOC. Accordingly, even if the Court concludes that an allegation of invalidity by a generic is justified, the NOC Regulations do not provide for nor permit the delisting of the patent. Furthermore, the NOC Regulations do not contain any provision permitting a generic to allege invalidity in its NOA on the ground that a similar allegation by another generic has been found to be justified.

[87]This Court, on a number of occasions, has held that a decision under the NOC Regulations does not finally determine the issues of the validity of the patent or the infringement thereof. In David Bull Laboratories (Canada) Inc. v. Pharmacia Inc., [1995] 1 F.C. 588 (C.A.), Strayer J.A., writing for the Court, remarked as follows at pages 599-600:

It will be noted that the Regulations nowhere create or abolish any rights of action between the parties: instead they confer a right on the patentee to bring an application for prohibition against the Minister of National Health and Welfare. That is, the Regulations pertain to public law, not private rights of action. Of course the real adversary in such a prohibition proceeding is the generic company which served the notice of allegation.

If the Governor in Council had intended by these Regulations to provide for a final determination of the issues of validity or infringement, a determination which would be binding on all private parties and preclude future litigation of the same issues, it surely would have said so. This Court is not prepared to accept that patentees and generic companies alike have been forced to make their sole assertion of their private rights through the summary procedure of a judicial review application. As the Regulations direct that such issues as may be adjudicated at this time must be addressed through such a process, this is a fairly clear indication that these issues must be limited or preliminary in nature. If a full trial of validity or infringement issues is required this can be obtained in the usual way of commencing an action. [Emphasis added.]

(See also the authorities referred to by Sexton J.A., at paragraph 36 in fine of his reasons.)

[88]In this regard, it is interesting to note that recently in Janssen‑Ortho v. Novopharm Ltd. (2006), 57 C.P.R. (4th) 6, Hughes J. of the Federal Court concluded that the patent at issue was valid, notwithstanding that in the context of the NOC Regulations, Mosley J. (in Janssen‑Ortho Inc. v. Novopharm Ltd. (2004), 35 C.P.R. (4th) 353 (F.C.)) had held that the generic manufacturer’s allegations of invalidity regarding the same patent were justified. More particularly, in Janssen‑Ortho, Mr. Justice Hughes, at paragraph 116, made the following remarks:

I appreciate that this finding is different than that arrived at by my brother, Mosley J., in the earlier NOC proceeding between these parties. He did not have the benefit of the extensive evidence that I now have before me, nor of seeing and hearing the witnesses in person.

[89]That is the context in which the appellant’s application finds itself. In stating why I believe this case is not one where the doctrine of abuse of process should apply, I will deal with the grounds put forward by my colleague in reaching a different conclusion.

[90]It is not disputed that there is no res judicata, cause of action or issue estoppel in the present matter. Further, as my colleague says in his reasons, the issue in this case is that of sound prediction, i.e. a question of fact. As a result, should this matter go to a hearing on the merits, the trier of fact would not be bound by the decision of Mactavish J. in Aventis Pharma, and consequently, could conclude in favour of the appellant. As this Court stated in J.M. Voith GmbH v. Beloit Corp. (1991), 36 C.P.R. (3d) 322 (F.C.A.), at page 330:

[91]My review of the authorities satisfies me that the relitigating of an issue with a different party is not, per se, an abuse of process. There must be, in the words of Auld L.J. in Bradford & Bingley, “[s]ome additional element.” In my view, there is no such element present in this case.

[92]First, let me give two examples of what courts have found to be the “additional element” sufficient to bring about the application of the doctrine of abuse of process where a party was attempting to relitigate an issue. In C.U.P.E., the issue before the Supreme Court was whether a labour arbitrator could, in the context of a grievance, reconsider the issue of guilt of a person convicted of sexual assault and, as a result, dismissed from his employment. In concluding that the person’s guilt could not be relitigated, the Supreme Court applied the doctrine because Mr. Oliver, a recreation instructor employed by the City of Toronto who had been found guilty of sexually assaulting a boy under his supervision, was attempting to adduce before the arbitrator evidence proving his innocence with respect to the charges for which he had been convicted to 15 months in prison.

[93]After a careful review of the relevant case law on abuse of process, Arbour J. held, at paragraph 54 of her reasons that the considerations which arise in the case law “are particularly apposite when the attempt is to relitigate a criminal conviction. Casting doubt over the validity of a criminal conviction is a very serious matter.” She goes on to say, at paragraphs 56-58:

I am of the view that the facts in this appeal point to the blatant abuse of process that results when relitigation of this sort is permitted. The grievor was convicted in a criminal court and he exhausted all his avenues of appeal. In law, his conviction must stand, with all its consequent legal effects. Yet as pointed out by Doherty J.A. (at para. 84):

Despite the arbitrator’s insistence that he was not passing on the correctness of the decision made by Ferguson J., that is exactly what he did. One cannot read the arbitrator’s reasons without coming to the conclusion that he was convinced that the criminal proceedings were badly flawed and that Oliver was wrongly convicted. This conclusion, reached in proceedings to which the prosecution was not even a party, could only undermine the integrity of the criminal justice system. The reasonable observer would wonder how Oliver could be found guilty beyond a reasonable doubt in one proceeding and after the Court of Appeal had affirmed that finding, be found in a separate proceeding not to have committed the very same assault. That reasonable observer would also not understand how Oliver could be found to be properly convicted of sexually assaulting the complainant and deserving of 15 months in jail and yet also be found in a separate proceeding not to have committed that sexual assault and to be deserving of reinstatement in a job which would place young persons like the complainant under his charge.

As a result of the conflicting decisions, the City of Toronto would find itself in the inevitable position of having a convicted sex offender reinstated to an employment position where he would work with the very vulnerable young people he was convicted of assaulting. An educated and reasonable public would presumably have to assess the likely correctness of one or the other of the adjudicative findings regarding the guilt of the convicted grievor. The authority and finality of judicial decisions are designed precisely to eliminate the need for such an exercise.

In addition, the arbitrator is considerably less well equipped than a judge presiding over a criminal court—or the jury —, guided by rules of evidence that are sensitive to a fair search for the truth, an exacting standard of proof and expertise with the very questions in issue, to come to a correct disposition of the matter. Yet the arbitrator’s conclusions, if challenged, may give rise to a less searching standard of review than that of the criminal court judge. In short, there is nothing in a case like the present one that militates against the application of the doctrine of abuse of process to bar the relitigation of the grievor’s criminal conviction. The arbitrator was required as a matter of law to give full effect to the conviction. As a result of that error of law, the arbitrator reached a patently unreasonable conclusion. Properly understood in the light of correct legal principles, the evidence before the arbitrator could only lead him to conclude that the City of Toronto had established just cause for Oliver’s dismissal. [Emphasis added.]

[94]In my view, there is simply no possible comparison between the circumstances which led the Supreme Court in C.U.P.E., to conclude that the doctrine of abuse of process applied and the circumstances in the present matter. In C.U.P.E., the Supreme Court found that the arbitrator was bound, as a matter of law, to give effect to the criminal conviction. Hence, the arbitrator could not conclude that Mr. Oliver had not been dismissed for just cause. Further, Arbour J., at paragraph 56 of her reasons, cited with approval the words of Doherty J.A. of the Ontario Court of Appeal to the effect that the “reasonable observer” would find it odd that Mr. Oliver could be found guilty beyond a reasonable doubt in a criminal proceeding but found to be innocent in a labour arbitration of having committed the very act which led to his conviction.

[95]It is thus clear, in my view, on the facts which prevailed in C.U.P.E., that no other conclusion was possible. The Supreme Court could not allow a finding by the arbitrator that Mr. Oliver had not committed the acts in respect of which he had been convicted in a criminal court.

[96]My second example is that found in Hoffmann‑La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1999), 87 C.P.R. (3d) 251 (F.C.T.D.), where Sharlow J. (as she then was) dismissed, as an abuse of process, a patentee’s application for an order of prohibition.

[97]Before Sharlow J., the generic drug manufacturer argued that the patentee’s application was futile on the ground that on four prior occasions, on facts undistinguishable from those in the case before her, the patentee had failed to obtain an order of prohibition from the Court. On three of these attempts, the application was dismissed after a hearing on the merits. On the fourth one (see: Hoffmann‑La Roche v. Canada (Minister of National Health and Welfare) (1998), 85 C.P.R. (3d) 50 (F.C.T.D.)), the application was dismissed by Rothstein J. (as he then was), whose view it was that the application was an abuse of process. At paragraph 14 of his reasons, Rothstein J. remarked as follows:

In view of the prior decisions involving Nu‑Pharm and Apotex and the fact that the evidence filed by the applicants in this application adds nothing new to assist in the construction of the relevant words of the patent, the issue in this litigation is the exact same issue as in the Nu‑Pharm and Apotex cases. The applicants for prohibition are the same, the patent at issue is the same, and the notice of allegations are virtually identical. This litigation is an abuse of the process in that it attempts to retry the same issue which has already been determined in three separate proceedings against the applicants. [Emphasis added.]

[98]It is important to note that Rothstein J. dismissed the patentee’s application because the issue raised by the application was identical to the one raised in three prior matters in regard to which the evidence adduced “adds nothing new to assist in the construction of the relevant words of the patent”. Not only was the issue before the Court one of law, i.e. patent construction, but the application constituted the patentee’s fourth attempt to relitigate the same issue.

[99]It is therefore not surprising that Sharlow J. concluded that the patentee’s further application was abusive. I do not believe that it was possible for Sharlow J., on the facts before her, to reach any other conclusion.

[100]Other examples could be given to show that there must be more than just relitigation of the same issue to lead to a conclusion of abuse of abuse. In my view, however, these two examples are sufficient to show that relitigation, per se, does not attract the application of the doctrine.

[101]I now proceed to address the grounds upon which Sexton J.A. relies to conclude that the application is an abuse of process. The grounds put forward by my colleague are the following:

a. the possibility of inconsistent decisions will threaten the credibility of the judicial process;

b. the result in the second proceeding will be no more accurate than that reached in the first one;

c. allowing the appellant, and patentees in general, to relitigate an issue fought in a first proceeding will use judicial resources already taxed by “voluminous proceedings brought under the regulations”;

d. the appeal is a collateral attack on Mactavish J.’s decision in Aventis Pharma;

e. the appellant was obliged to submit all of its evidence regarding the allegations of invalidity of its patent in the first proceeding and cannot now be allowed to adduce additional or different evidence;

f. concluding that the application is an abuse of process does not cause any unfairness to the appellant because it is open to it to commence an infringement action against Apotex or other generic manufacturers who obtain a notice of compliance from the Minister.

[102]I begin with the possibility of conflicting decisions. It cannot be denied that this is a real possibility and, in fact, there have already been conflicting decisions of the Federal Court on issues of infringement and validity where a patentee, in the context of the NOC Regulations, has litigated the same patent against different generics (see, for example: AB Hassle v. Canada (Minister of National Health and Welfare), [2002] 3 F.C. 221 (T.D.); affd (2002), 22 C.P.R. (4th) 1 (F.C.A.); AB Hassle v. RhoxalPharma Inc. (2002), 21 C.P.R. (4th) 298 (F.C.T.D.)).

[103]There is the further fact that patentees and generic manufacturers are not bound by the decisions rendered in the context of the NOC Regulations as concerns the validity of the patents or the infringement thereof.

[104]In my view, conflicting decisions have arisen and will arise on occasion because of the regulatory scheme in place. Under that scheme, judges of the Federal Court are asked to determine, on a summary basis, whether the Minister should be prohibited from issuing an NOC to a generic manufacturer for a specific product. On the evidence adduced in that context, the judge will either prohibit the Minister from issuing the NOC or he will refuse to do so. As a result, the generic manufacturer may or may not obtain an NOC. Such a decision will not, however, determine any other rights or questions. Further, as I pointed out earlier, the NOC Regulations do not allow a generic manufacturer to take advantage of another generic’s successful litigation with respect to the same patent.

[105]Be that as it may, the real question, in my view, is whether the possibility of conflicting decisions, in the words of McLachlin J., in R. v. Scott, “violate[s] the fundamental principles of justice underlying the community’s sense of fair play and decency” (at page 1007). This statement is in line with that made by Doherty J.A., quoted by Arbour J., at paragraph 56 of her reasons in C.U.P.E., where he states that the “reasonable observer” would not likely understand how it could be that Mr. Oliver could be reinstated by a labour arbitrator after having been found guilty beyond a reasonable doubt in criminal proceedings. If I have properly understood what the Supreme Court has said in C.U.P.E., the labour arbitrator could not be allowed to consider Mr. Oliver’s evidence concerning the commission of the acts in regard to which he was found guilty because that “would violate the community’s sense of fair play and decency.”

[106]With respect to the contrary opinion, I cannot see how one could come to a similar conclusion in the present matter, considering that the true cause of the occurrence of conflicting decisions is the regulatory scheme itself. I am therefore satisfied that the possibility of conflicting decisions in the present matter does not and will not threaten the credibility of the judicial process.

[107]The second ground relied upon by my colleague is that there is no likelihood that the second decision will be more accurate than the first one. In my view, that is not a relevant consideration. The second proceeding is litigation between parties which are not the same as in the first proceeding and the trier of fact will decide the issues on the basis of the evidence before him. The fact that the second decision might not be more accurate than the first one does not render the proceedings oppressive or vexatious and will not offend the community’s sense of fair play and decency.

[108]The next ground pertains to the use of scarce judicial resources. My first remark is that the “voluminous proceedings” referred to by Sexton J.A., at paragraph 37 of his reasons, are a consequence of the regulatory scheme and not the result of misbehaviour on the part of patentees who are seeking to assert their rights under the NOC Regulations. As a result, I have difficulty with my colleague’s proposal that we must stop patentees from relitigating an issue fought against a different generic manufacturer because it will drain our resources. Even if that were the case, it cannot justify a conclusion of abuse of process when the proceedings are those which the NOC Regulations expressly provide for. Simply put, the NOC Regulations allow patentees to challenge a generic manufacturer’s NOA and unless the exercise of their rights amounts to an abuse of process, they should be entitled to have their day in court.

[109]The next ground is that of collateral attack. In my view, the appellant’s application does not constitute a collateral attack on the decision of Mactavish J. in Aventis Pharma. It must not be forgotten that the order made by Mactavish J. is the dismissal of the order of prohibition sought by the appellant with respect to the obtention by Apotex of an NOC from the Minister. The learned Judge did not dispose of the issues of the patent’s validity or of its infringement.

[110]It cannot be said, in my view, that the appellant’s application is an attempt to circumvent Mactavish J.’s decision in Aventis Pharma. At paragraph 34 of her reasons in C.U.P.E., Arbour J. defined a prohibited collateral attack in the following terms:

Prohibited “collateral attacks” are abuses of the court’s process. However, in light of the focus of the collateral attack rule on attacking the order itself and its legal effect, I believe that the better approach here is to go directly to the doctrine of abuse of process.

[111]I am satisfied that Arbour J. disposed of the issue in C.U.P.E., on the ground of abuse of process because of her view that Mr. Oliver’s attempt to introduce evidence of his innocence before the labour arbitrator did not constitute a collateral attack on the criminal court’s decision.

[112]In the present matter, the appellant does not seek either a reversal, a variation or an annulment of Mactavish J.’s decision. Should this matter go to a hearing on the merits, a successful result for the appellant will not in any way impact on Mactavish J.’s decision which, I again point out, does not have any effect regarding the issues of validity and infringement.

[113]The next ground is that the patentee was obliged to adduce all of its evidence on the issues raised by Apotex NOA in the first proceeding and that, as a result, it cannot be allowed to relitigate these issues, even on the basis of additional or different evidence, in a second proceeding. In support of that assertion, Sexton J.A. relies on Hansen J.’s decision in Glaxo Group Ltd. v. Canada (Minister of Health), 2001 FCT 16, where the learned Judge held that parties should not be allowed to relitigate an issue by reason of new evidence. In Hansen J.’s view, such an attempt constitutes an abuse of process.

[114]First, I do not believe that Hansen J.’s decision is relevant to the issue before us in this appeal since the parties before her were Glaxo and Apotex, the same parties who had litigated the same issue on a previous occasion (see O’Keefe J.’s decision in Glaxo Group Ltd. v. Canada (Minister of National Health and Welfare) (2000), 6 C.P.R. (4th) 73 (F.C.T.D.); affd by the Federal Court of Appeal in (2001), 11 C.P.R. (4th) 73). Thus, in that context, I have no difficulty in accepting Hansen J.’s proposition that Glaxo, having litigated a first time the issue against Apotex, should not, as a matter of principle, be allowed to relitigate the same issue on a second occasion.

[115]With respect, however, I do not believe that Hansen J.’s assertion is a correct one where, as here, the parties are not the same as in the first proceeding. If Hansen J.’s view were correct with respect to the situation herein, it would mean that once a party has litigated an issue with A, it could never litigate that issue with B, C or D. That, in my view, cannot be correct.

[116]I now turn to the last ground, i.e. that the dismissal of its application will not cause any unfairness to the appellant. I cannot agree with that view.

[117]First, the appellant will be deprived of the right given to it under the NOC Regulations to oppose and challenge the respondent’s NOA. Second, I do not think that I can be accused of speculating when I say that there is a real possibility that the appellant has or will be commencing proceedings against Apotex with respect to the infringement of the ′206 patent. Consequently, there will ultimately be a decision by the Federal Court, after a trial on the merits, with respect to the issues of infringement and validity. I cannot say whether the appellant will succeed or not, but that possibility exists. Hence, there may well be, in the near future, a declaration by the Federal Court that patent ′206 is valid. Should that situation occur, would this Court still be of the view that the appellant’s attempt to obtain an order prohibiting the Minister from issuing an NOC to a generic drug manufacturer in respect of the ′206 patent amounts to abuse of process? With respect, I do not think so.

[118]Further, should the appellant succeed on an action for infringement against Apotex, it will have been deprived in the interval, by reason of the order which Sexton J.A. proposes we make, of its right to challenge NOAs received from generic drug manufacturers, including the one made by Novopharm.

[119]To sum up, I conclude that this is not a case where the doctrine of abuse of process should be applied. First, the parties to the proceedings herein are not the same as those that were before Mactavish J. in Aventis Pharma. Second, the issue herein and that before Mactavish J. is primarily one of fact and, as a result, it would be open to the trier of fact in this proceeding to come to a different conclusion. Third, the appellant, in seeking to prohibit the Minister from issuing an NOC to Novopharm, is simply exercising its rights under the NOC Regulations which, as I have explained, do not expressly or implicitly prevent a patentee from relitigating an issue previously litigated against another generic drug manufacturer. Fourth, there is no “additional element” in the present matter which would make of the appellant’s application an abuse of process. Contrary to the situation in Hoffmann‑La Roche, it cannot be said that in litigating a second time the issue which it litigated against Apotex in Aventis Pharma, the appellant’s conduct calls for the application of the doctrine of abuse of process. Fifth, it cannot be concluded that the proceedings commenced by the appellant, following service of Novopharm’s NOA, are either oppressive or vexatious.

[120]For these reasons, I would allow the appeal, set aside the decision of the Federal Court dated September 25, 2006 and I would reinstate the order of Prothonotary Milczynski dated May 8, 2006 which dismissed Novopharm’s motion for summary dismissal of the appellant’s application for an order of prohibition. I would also allow the appellant (Sanofi‑Aventis Canada Inc. and Schering Corporation) its costs on this appeal and in the proceedings below.

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