Sanofi-Aventis Canada Inc. v. Novopharm Limited

Sanofi-Aventis Canada Inc. v. Novopharm Limited
Court (s) Database
Federal Court of Appeal Decisions
Date
2007-04-23
Neutral citation
2007 FCA 163
File numbers
A-413-06
Notes
Reported Decision
Decision Content
Date: 20070423
Docket: A-413-06
Citation: 2007 FCA 163
CORAM: NADON J.A.
SEXTON J.A.
SHARLOW J.A.
BETWEEN:
SANOFI-AVENTIS CANADA INC.
Appellant
(Applicant)
and
NOVOPHARM LIMITED and THE MINISTER OF HEALTH
Respondents
(Respondents)
and
SCHERING CORPORATION
Respondent
(Respondent/Patentee)
Heard at Toronto, Ontario, on January 9, 2007.
Judgment delivered at Ottawa, Ontario, on April 23, 2007.
REASONS FOR JUDGMENT BY: SEXTON J.A.
CONCURRED IN BY: SHARLOW J.A.
DISSENTING REASONS BY: NADON J.A.
Date: 20070423
Docket: A-413-06
Citation: 2007 FCA 163
CORAM: NADON J.A.
SEXTON J.A.
SHARLOW J.A.
BETWEEN:
SANOFI-AVENTIS CANADA INC.
Appellant
(Applicant)
and
NOVOPHARM LIMITED and THE MINISTER OF HEALTH
Respondents
(Respondents)
and
SCHERING CORPORATION
Respondent
(Respondent/Patentee)
REASONS FOR JUDGMENT
SEXTON J.A.
[1] The principal issue in this case relates to the scope of the abuse of process provision in paragraph 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations, 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 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 Limited et al., 2006 FC 1135. 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. 1,341,206 (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) 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. et al. (2005), 43 C.P.R. (4th) 161, 2005 FC 1283 (“Apotex ”). On appeal, Mactavish J.’s decision was upheld by this Court (Aventis Pharma Inc. v. Apotex Inc. (2006), 46 C.P.R. (4th) 401, 2006 FCA 64).
[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 Prothonotary’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. She therefore reviewed the matter de novo. In my view, she was correct to do so. She held 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” 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’s application.
REGULATORY REGIME
[10] This appeal concerns the requirements set out in the Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133 (the “NOC Regulations”). The relevant sections of the NOC Regulations are as follows:
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.
5. (1) Lorsqu’une personne dépose ou a déposé une demande d’avis de conformité pour une drogue et la compare, ou fait référence, à une autre drogue pour en démontrer la bioéquivalence d’après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, cette autre drogue ayant été commercialisée au Canada aux termes d’un avis de conformité délivré à la première personne et à l’égard de laquelle une liste de brevets a été soumise, elle doit inclure dans la demande, à l’égard de chaque brevet inscrit au registre qui se rapporte à cette autre drogue :
[…]
b) soit une allégation portant que, selon le cas :
(i) la déclaration faite par la première personne aux termes de l’alinéa 4(2)c) est fausse,
(ii) le brevet est expiré,
(iii) le brevet n’est pas valide,
(iv) aucune revendication pour le médicament en soi ni aucune revendication pour l’utilisation du médicament ne seraient contrefaites advenant l’utilisation, la fabrication, la construction ou la vente par elle de la drogue faisant l’objet de la demande d’avis de conformité.
[…]
(3) Lorsqu’une personne fait une allégation visée aux alinéas (1)b) ou (1.1)b) ou au paragraphe (2), elle doit :
a) fournir un énoncé détaillé du droit et des faits sur lesquels elle se fonde;
[…]
6. (1) La première personne peut, dans les 45 jours après avoir reçu signification d’un avis d’allégation aux termes des alinéas 5(3)b) ou c), demander au tribunal de rendre une ordonnance interdisant au ministre de délivrer un avis de conformité avant l’expiration du brevet visé par l’allégation.
(2) Le tribunal rend une ordonnance en vertu du paragraphe (1) à l’égard du brevet visé par une ou plusieurs allégations si elle conclut qu’aucune des allégations n’est fondée.
[…]
(5) Lors de l’instance relative à la demande visée au paragraphe (1), le tribunal peut, sur requête de la seconde personne, rejeter la demande si, selon le cas :
[…]
b) il conclut qu’elle est inutile, scandaleuse, frivole ou vexatoire ou constitue autrement un abus de procédure.
In these Reasons, I rely upon the version of the NOC Regulations in force prior to their amendment in October 2006. 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:
What is the standard of review? Was Novopharm required to allege abuse of process and the factual basis for that allegation in its NOA? Is there a material difference between the legal and factual basis of the allegations in the Novopharm NOA as compared with the Apotex NOA? 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 SCC 33 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. M/V Ralph Misener (The) (C.A.), [2005] F.C.A. 367 at paragraph 13; AB Hassle v. Apotex Inc. (C.A.), [2006] 4 F.C.R. 513, 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 subparagraph 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:
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.
5. (1) Lorsqu’une personne dépose ou a déposé une demande d’avis de conformité pour une drogue et la compare, ou fait référence, à une autre drogue pour en démontrer la bioéquivalence d’après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, cette autre drogue ayant été commercialisée au Canada aux termes d’un avis de conformité délivré à la première personne et à l’égard de laquelle une liste de brevets a été soumise, elle doit inclure dans la demande, à l’égard de chaque brevet inscrit au registre qui se rapporte à cette autre drogue :
[…]
b) soit une allégation portant que, selon le cas :
(i) la déclaration faite par la première personne aux termes de l’alinéa 4(2)c) est fausse,
(ii) le brevet est expiré,
(iii) le brevet n’est pas valide,
(iv) aucune revendication pour le médicament en soi ni aucune revendication pour l’utilisation du médicament ne seraient contrefaites advenant l’utilisation, la fabrication, la construction ou la vente par elle de la drogue faisant l’objet de la demande d’avis de conformité.
[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:
(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.
(5) Lors de l’instance relative à la demande visée au paragraphe (1), le tribunal peut, sur requête de la seconde personne, rejeter la demande si, selon le cas :
[…]
b) il conclut qu’elle est inutile, scandaleuse, frivole ou vexatoire ou constitue autrement un abus de procédure.
[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.”
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, 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.
c) Abuse of Process in Paragraph 6(5)(b)
[27] Subsection 6(5) was introduced during 1998 amendments to the NOC Regulations to give generic manufacturers, referred to in the regulations as “second persons,” 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:
(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.
(5) Lors de l’instance relative à la demande visée au paragraphe (1), le tribunal peut, sur requête de la seconde personne, rejeter la demande si, selon le cas :
[…]
b) il conclut qu’elle est inutile, scandaleuse, frivole ou vexatoire ou constitue autrement un abus de procédure.
[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):
[23] 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, (2001), 12 C.P.R. (4th) 289 (F.C.T.D.) at para. 28; AstraZeneca AB v. Apotex Inc. 2002 FCT 1249, (2002), 23 C.P.R. (4th) 213 (F.C.T.D.) at para. 11.
[24] 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, (2003), 29 C.P.R. (4th) 350 (F.C.) 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 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, 2002 SCC 77 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 at 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 Pharmacia Inc. v. Canada (Minister of National Health and Welfare) (1994), 58 C.P.R. (3d) at 217 (F.C.A.), 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. 1978, 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: see, for example, Cynamid Agricultural de Puerto Rico Inc. v. Commissioner of Patents (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 at pp. 120-21, 64 F.T.R. 126, 19 Admin. L.R. (2d) 91 (T.D.). 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 that in Rule 221 of the current Federal Courts Rules, SOR/98-106. 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 at paragraphs 29-30 (F.C.T.D.):
[28] 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.
[29] 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).
[30] 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 in original.]
[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, 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 at paragraph 23; Hoffman-La Roche Ltd. v. Canada (Minister of Health and Welfare) (1999), 87 C.P.R. (3d) 251 at paragraph 2; GlaxoSmithKline Inc. v. Apotex Inc. (2003), 29 C.P.R. (4th) 350 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, 2003 SCC 63 (“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:
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. [Emphasis in original.]
[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. Pharmacia Inc. v. Canada (Minister of National Health and Welfare) (1994), 58 C.P.R. (3d) 209; Novartis A.G. v. Apotex Inc., 2002 FCA 440 at paragraph 9; Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2001), 11 C.P.R. (4th) 245 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 stra