BETWEEN:
and
MINISTER OF HEALTH, THE ATTORNEY GENERAL OF CANADAand NOVOPHARM LIMITED
REASONS FOR ORDER
[1] This is an appeal from an Order of a Prothonotary wherein one paragraph of the prayer for relief and certain paragraphs of the narrative portion of the Notice of Application herein, were struck out.
[2] The application deals with a Notice of Compliance (NOC) issued by the Respondent Minister of Health to the Respondent Novopharm Limited, under the provisions of the Food and Drugs Regulations, C.R.C. 870 in respect of a generic version of a drug containing enoxaparin sodium as the active ingredient.
[3] The Applicant in these proceedings, Aventis Pharma Inc. sells in Canada an innovative version of a drug containing enoxaparin sodium under the LOVENOX brand. It had received at an earlier time, a Notice of Compliance from the Minister to sell such drug in Canada and, until the issuance to Novopharm of its NOC, was the only person approved by the Minister to sell such drug in Canada. In other words Aventis had a de facto monopoly until issuance of the NOC to Novopharm in respect of a drug containing enoxaparin sodium.
[4] Aventis also has a patent which it asserts has claims directed to a drug containing enoxaparin sodium but, that patent was not initially listed under the provisions of the Patented Medicines (Notice of Compliance) Regulations, C.R.C. c. 870. To rectify this situation Aventis filed a Supplementary New Drug Submission (SNDS) and sought to list its patent at this time. Meanwhile Novopharm was seeking and obtained its NOC on the basis of an Abbreviated New Drug Submissions (ANDS) which it had filed. The timing of the issuance of Novopharm's NOC having regard to the filing of Aventis' SNDS is the subject of another portion of this Application not struck out by the Prothonotary.
[5] Novopharm in seeking the NOC for its generic drug, did so by filing an ANDS in which it referenced the NOC previously granted to Aventis for LOVENOX, on the basis that Novopharm's generic drug was the "pharmaceutical equivalent" of LOVENOX. The provisions of parts of section C.08.002.1 of the Food and Drug Regulations are pertinent to this situation; they say:
| C.08.002.1.(1) A manufacturer of a new drug may file an abbreviated new drug submission for the new drug where, in comparison with a Canadian reference product, (a) the new drug is the pharmaceutical equivalent of the Canadian reference product; |
C.08.002.1.(1) Le fabricant d'une drogue nouvelle peut déposer à l'égard de celle-ci une présentation abrégée de drogue nouvelle si, par comparaison à un produit de référence canadien : (a) la drogue nouvelle est un équivalent pharmaceutique du produit de référence canadien;
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(2) An abbreviated new drug submission shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug, including the following: |
(2) La présentation abrégée de drogue nouvelle doit contenir suffisamment de renseignements et de matériel pour permettre au ministre d'évaluer l'innocuité et l'efficacité de la drogue nouvelle, notamment :
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| (c) evidence from the comparative studies conducted in connection with the submission that the new drug is (i) the pharmaceutical equivalent of the Canadian reference product
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(c) les éléments de preuve, provenant des études comparatives menées dans le cadre de la présentation, établissant que la drogue nouvelle : (i) d'une part, est un équivalent pharmaceutique du produit de référence canadien
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[6] The Food and Drug Regulations make no provision for participation by the party who is the proprietor of the referenced drug used as a comparitor. It is for the Minister to make a determination as to whether the drug which is the subject of the ANDS is the "pharmaceutical equivalent" of the referenced drug.
[7] In the portions of the Notice of Application filed by Aventis as struck out by the Prothonotary, Aventis sought to have the decision of the Minister to issue an NOC to Novopharm declared invalid on the basis that the Minister's finding that the generic drug was a "pharmaceutical equivalent" of LOVENOX, was erroneous. The portion struck out from Aventis' prayer for relief, paragraph 1(b), reads:
(b) a declaration that the Minister erred in his interpretation and application of the provisions of the FD Regulations in concluding that Novo-enoxaparin is the "pharmaceutical equivalent" of Aventis' LOVENOX brand of enoxaparin sodium.
[8] The portions struck out from the narrative of the Notice of Application are paragraphs 6, 7, 8, 19 to 22, 26 and 27(i) which read:
6. On or before September 18, 2003 and March 22, 2004, Aventis raised with the Therapeutic Products Directorate of Health Canada ("TPD") safety and efficacy concerns about the approval of a generic enoxaparin sodium product based on an ANDS where the generic product is not made by the same or an equivalent process used to make LOVENOX.
7. On December 21, 2004, Aventis also submitted information to TPD relating to the structure of LOVENOX and a tightening of the enoxaparin sodium drug substance specifications.
8. However, the TPD has improperly and unlawfully failed to take required steps in respect of Aventis' submissions on matters relating to LOVENOX and its pharmacological, safety and efficacy profile, as well as the enoxaparin sodium drug substance specifications.
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19. While Novo-enoxaparin is within the claims of the '433 patent, it is not made by the same or an equivalent manufacturing process used to make LOVENOX. Accordingly, Novo-enoxaparin cannot contain identical amounts of the identical medicinal ingredients contained in LOVENOX, and therefore, cannot be considered a "pharmaceutical equivalent" to LOVENOX pursuant to the FD Regulations.
20. Novo-enoxaparin will have a different chemical structure and a different pharmacological, safety and efficacy profile in comparison to LOVENOX.
21. Despite the foregoing, by a decision effective February 28, 2005, the Minister improperly and unlawfully issued a NOC to Novopharm for its Novo-enoxaparin. Aventis first learned of the decision on March 5, 2005.
22. The issuance of the NOC for Novo-enoxaparin was contrary to the FD Regulations as Novo-enoxaparin is not the pharmaceutical equivalent of LOVENOX.
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26. Additionally, given that Novo-enoxaparin is intended to be used in the treatment of life-threatening conditions, a serious public interest in the correctness of the Decision arises and there is no other reasonable and effective way to bring this issue before the Court, other than by way of the application herein.
27. In view of all of the foregoing, in issuing a NOC to Novopharm for Novo-exonaparin the Minister:
(i) erred in fact and law in concluding that Novo-enoxaparin was the pharmaceutical equivalent of Aventis' LOVENOX, given that the two products do not contain identical amounts of the identical medicinal ingredients as required by the FD Regulations.
[9] In reading the Prothonotary's Reasons for striking out these paragraphs, it is evident that the thrust of Aventis' argument before her was that it was somehow treated unfairly by the Minister, thereby giving Novopharm an advantage in that it received its NOC before Aventis' SNDS could trigger the listing of its patent. The Prothonotary's Reasons read, in part:
Counsel for the Applicant readily concedes the validity of the Crown's position that Aventis Pharma Inc, ("Aventis") has no standing to question, in a judicial review application, the validity of the Minister's decision to issue a notice of compliance to theRespondent Novopharm Limited ("Novopharm") on the basis of non-compliance by the Minister with the Food and Drugs Act, R.S.C. 1985, c.F-27 or the Food and Drug Regulations, C.R.C. c.870, as amended (the "FD Regulations"), more particularly, as regards their provisions relating to safety and effectiveness
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The Applicant however seeks to temper the broad and absolute application of this principle on the basis of words used by the Federal Court of Appeal in Merck & Co. et al v. Minister of Health et al, (1999), 3 C.P.R. (4th) 286 in determining that an applicant lacks standing to challenge the issuance of a notice of compliance "on the sole basis that the Minister's findings as regards the safety and efficacy of the drug would have been reached in an unsatisfactory manner" (at paragraph [2] , my emphasis). The grounds upon which Aventis challenges the Minister's issuance of the NOC to Novopharm do not rest "solely" on the Minister's application of the Food and Drug Regulations, says the Applicant, but in the alleged unfair and unequal treatment of the Applicant's and Novopharm's contemporaneous submissions. In Aventis' argument, the Minister's processing of Novopharm's submission under the FD Regulations is interrelated with his treatment of the Applicant's submission under the FD Regulations and the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended ("PM (NOC) Regulations"). In effect, and as argued before me at the hearing, the Applicant holds the Minister's alleged unlawful application of the FD Regulations to Novopharm's submission as part of a pattern of inequitable dealing in the processing of the submissions or as evidence that the Minister unlawfully gave preferential treatment to Novopharm to the prejudice of the Applicant. Put another way, the safety and efficacy issues raised in the notice of application are neither the focus of this judicial review application, nor even the basis of the application to quash the NOC issued to Novopharm, but part of a pattern of unfairness in the treatment of the co-pending applications. At the very least, says the Applicant, if the allegations cannot serve as grounds for judicial review they at least provide context for the main allegations of unfair treatment.
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In order to find that the Minister's non-compliance with the FD Regulations can validly be raised as part of a pattern or as evidence of unfair treatment, the Court would first have to read into the notice of application a ground for judicial review which it does not, even by a generous reading, contain, to wit: that the Minister not only failed to comply with the FD Regulations but that he did so with the intent or for the improper purpose of providing to Novopharm the advantage of avoiding triggering the provisions of the NOC Regulations to the prejudice of Aventis. As it stands, the notice of application clearly raises the Minister's alleged non-compliance with the FD Regulations solely as grounds to challenge the validity of the issuance of the NOC to Novopharm and not as grounds to challenge the timing of its issuance. As such, and based on a constant jurisprudence of this Court, it is plain and obvious that this aspect of the judicial review application is bereft of any possibility of success and will be struck.
[10] Aventis has, on this appeal, shifted the emphasis of its argument somewhat. It no longer argues unfairness, rather, it says, it is a person "directly affected" by the Minister's decision to issue an NOC to Novopharm in that it was the proprietor of the allegedly "pharmaceutically equivalent" drug and had, until that time, enjoyed a de facto monopoly in the Canadian marketplace for such a drug. As such, Aventis argues, it has status to challenge the Minister's decision to issue an NOC to Novopharm under the provisions of section 18.1 of the Federal Courts Act, R.S.C. 1985, c.F-7. The Minister and Novopharm argue that Aventis has no status to challenge the Minister's decision since it was not a party to the processes under the Food and Drug Regulations and has no property interest at stake, at best it has a commercial interest which, they say, is insufficient so as to confer status upon Aventis.
[11] First, it is clear law that, in dealing with an appeal from a decision of a Prothonotary, unless the decision goes to a matter vital to a final issue in the proceeding, or, if it was a discretionary matter, the decision was made upon a wrong principle or misapprehension of the facts, this Court, on appeal should not interfere with the decision (Merck & Co. v. Apotex Inc., (2003), 30 C.P.R. (4th) 40 (F.C.A.).
[12] The decision to strike out paragraph 1(b) of the claim to relief does relate to a matter vital to a final issue, thus will be dealt with by this Court de novo.
[13] This Court, and the Federal Court of Appeal have on several occasions held that a person who was not a party to a decision taken by a Minister but was affected only in the commercial sense, has no status to seek judicial review of that decision under section 18.1 of the Federal Courts Act or its predecessor provisions. Here the decision of the Minister does not affect the NOC previously granted to Aventis, nor does it impose any additional legal burden upon Aventis. The decision will permit Novopharm to put a generic version of the drug in question on the marketplace in Canada. However Aventis can always bring an ordinary patent action in that regard. What Aventis cannot do is take advantage of the Patented Medicines (Notice of Compliance) Regulations but that is because its patent was not listed there in a timely fashion. That issue is the subject of the portions of the Notice of Application not struck out by the Prothonotary.
[14] In Rothmans of Pall Mall Canada Ltd v. Canada(Minister of National Revenue), [1976] 2 F.C. 500 (F.C.A.) LeDain J.A. for the Court said at paragraphs 12 and 13:
12 The complaint of the appellants is that the change in departmental policy was adopted without first giving them an opportunity to be heard and that it had the effect of conferring a competitive advantage on the respondent companies by permitting them to market a longer cigarette for the same amount of excise duty as is paid by the appellants. The appellants do not contend, nor is there any evidence to suggest, that they themselves have had any interest in marketing a cigarette with a tobacco portion of less than four inches but an overall length, including the filter tip, of more than four inches. They do not seek the interpretation which they contend to be the correct one in order to permit them to do anything in particular that they are not able to do now, but rather to prevent the respondent companies from doing something which is thought to give the latter a commercial advantage.
13 I am in agreement with the learned Trial Judge that such an interest is not sufficient to give the appellants the required status or locus standi to obtain any of the relief sought in their application. The appellants do not have a genuine grievance entitling them to challenge by legal proceedings the interpretation which the respondent officials have given to the definition of "cigarette" in section 6 of the Excise Act for purposes of their administrative application of the Act. Such interpretation does not adversely affect the legal rights of the appellants nor impose any additional legal obligation upon them. Nor can it really be said to affect their interests prejudicially in any direct sense. If it permits the respondent companies to do something which the appellants are not doing, it is because the appellants choose not to do it
[15] Aventis attempts to distinguish this case on the basis that there the applicant had no equivalent product on the market whereas here Aventis does. While this is a factual distinction, it is not a distinction affecting the legal principle that a party seeking to protect a commercial advantage only has no status to challenge the Minister's decision in matters of this kind.
[16] In Merck Frosst Canada Inc v. Canada(Minister of Health and Welfare)(1998), 146 F.T.R. 249, Hugessen J. in the Trial Division said at paragraphs 10 and 11:
10 Turning now to the specifics of the present case, it is my view that the law is clear that Merck, as a patentee and holder of an NOC for a medicine does not have any right to raise non-compliance by the Minister with the Food and Drug Act or the Regulations made thereunder in respect of the issuance or proposed issuance of an NOC to another drug manufacturer. Specifically, Merck does not have the right to object to the issuance of an NOC to Apotex for the same medicine for which Merck holds an NOC on the grounds of non-compliance with that Act and those Regulations by either Apotex or the Minister. I think that that proposition flows clearly and unequivocally from two decisions of the Court of Appeal confirming two decisions by Trial judges of this Court: Glaxo Canada Inc. v. Canada (1990), 31 C.P.R. (3d) 25, affirming (1987), 18 C.P.R. (3d) 206, and Merck Frost Canada Inc. v. Canada (1994), 55 C.P.R. (3d) 302, affirming (1994), 53 C.P.R. (3d) 368. There are other decisions of the Trial Division of this Court to the same effect. I am not persuaded that any of these decisions were given per incuriam.
11 Some of the cases have used concepts such as absence of standing and non-justiciability as a convenient shorthand to describe this limitation on the patentee's rights. Seizing on this the applicants argue, based on such cases as Canada v. Finlay, [1986] 2 S.C.R. 607, Canada v. Borowski, [1981] 2 S.C.R. 575 and Operation Dismantle v. Canada, [1985] 1 S.C.R. 441, that they do indeed have standing and that the issues that they raise are, in fact, justiciable. The argument mistakes the form for the substance. It is not lack of standing or justiciability in the strict sense of those words which prevents the applicants from raising non-compliance with the health and safety concerns of the Food and Drug Act, and Regulations; it is simply that those matters are of no concern to them and cannot be raised by them in an attack on a decision of the Minister to issue an NOC. It is the Minister himself who is charged with the protection of the public health and safety and no private interest of the applicants arises from his alleged failure to perform his duties with respect to other persons.
[17] On appeal (1999), 3 C.P.R. (4th) 286, Marceau J.A. for the Federal Court of Appeal said at paragraph 2:
2 In our judgment, the learned motions judge was right in denying the appellant standing to question before the Court, in these proceedings, the validity of the Minister's decision to issue the Notice of compliance on the sole basis that the Minister's findings as regard the safety and efficacy of the drug would have been reached in an unsatisfactory manner. By deciding as he did, the motions judge was simply abiding by principles set down by many rulings of this Court and based, in our opinion, on a proper understanding of the type of responsibilities assigned to the Minister by Parliament in this context, as well as the nature of the judicial process and the role of a court of law.
[18] Aventis says that this decision relates only to decisions of the Minister as to safety and efficacy, which are public issues, and not to pharmaceutical equivalence, which is of concern only to the party whose pharmaceutical is used as a comparison for that purpose. This supposed distinction turns on a very narrow reading of the Court's reasons and the Food and Drug Regulations. The Regulations are concerned with "safety and effectiveness" (see section C.08.002.1 supra) and, for that purpose, a "pharmaceutically equivalent" drug may be referenced. It is a form of shortcut permitted by an Abbreviated New Drug Submission (ANDS). The reasoning of both Courts in Merck supra is equally applicable to the question of "pharmaceutical equivalence".
[19] The case of Reddy-Cheminor Inc v. Canada (Attorney General), (2001), 15 C.P.R. (4th) 215 (F.C.) affirmed on appeal 2002 F.C.A. 179 follows Rothmans and Merck above and was distinguished by Aventis only on the basis that it failed to distinguish those cases as Aventis would have this Court now do. These are small distinctions, as discussed, but the legal principles are clear: a commercial interest alone is insufficient to permit a person who was not a party to the application before the Minister for an NOC, to seek relief from this Court under section 18.1 of the Federal Courts Act.
[20] The Prothonotary was correct is striking out paragraph 1(b) of the Notice of Application, a finding which this Court makes de novo.
[21] As to the striking of the remaining paragraphs 6, 7, 8, 19 to 22, 26 and 27(i) to the extent that they serve only to support the relief sought in paragraph 1(b), they were also properly struck out. To the extent that they are simply narrative of factual matters the Prothonotary had a discretion which was properly exercised and should not be disturbed on appeal. It must be remembered that a Notice of Application while required by Rule 301(e) to set out "a complete and concise statement of the grounds included to be argued" is not a pleading in the sense of a Statement of Claim and is not to be viewed with the same rigour. The Prothonotary's decision in respect of those paragraphs will not be disturbed on appeal.
[22] The parties raised an issue as to the production of documents from the files and records of the Minister. It was agreed by Counsel for all parties that any further activity in this regard will await this decision, including any decision from a possible appeal. At that time Aventis will, if so advised, take further steps to request documents from the Minister. The formal Order herein will, therefore, make no reference to this issue having regard to Counsel's agreement.
[23] As to costs, the parties were agreed that they should follow the event. The Respondents, The Minister of Health and The Attorney General of Canada were represented by one Counsel and collectively referred to themselves as the Crown. They shall have one set of costs, including disbursements and GST, only. Novopharm shall have its costs including disbursements and GST. Assessment shall be made on a Column III basis.
Ottawa, Ontario
October 12, 2005
FEDERAL COURT
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-586-05
STYLE OF CAUSE: AVENTIS PHARMA INC. and MINISTER OF
HEALTH, THE ATTORNEY GENERAL OF
CANADA and NOVOPHARM LIMITED
PLACE OF HEARING: Ottawa, Ontario
DATE OF HEARING: October 11, 2005
REASONS FOR : The Honourable Mr. Justice Hughes
APPEARANCES:
Mr. A. David Morrow APPLICANT
Mr. Jonathan Stainsby RESPONDENT (NOVOPHARM LTD)
Mr. F.B. (Rick Woyiwada) RESPONDENT (CROWN)
SOLICITORS OF RECORD:
SMART AND BIGGAR APPLICANT
Ottawa, Ontario
HEENAN BLAIKIE RESPONDENT
Toronto, Ontario (NOVOPHARM LTD)
Mr. John H. Sims, Q.C. RESPONDENT (CROWN)
Deputy Attorney General of Canada