Date: 20010928
Docket: T-2294-00
Neutral Citation: 2001 FCT 1065
BETWEEN:
REDDY-CHEMINOR, INC.
Applicant
- and -
THE ATTORNEY GENERAL OF CANADA and
THE MINISTER OF HEALTH
Respondents
INTRODUCTION
[1] The central feature in this application by AstraZeneca Inc. ("AstraZeneca"), a successor to Astra Pharma, by which it seeks to be added as a party or, in the alternative, granted intervenor status in these proceedings, is the interrelationship between the Notice of Compliance provisions of the Food and Drug Regulations (the "FD Regulations") made under the Food and Drugs Act and the Patented Medicines (Notice of Compliance Regulations) (the "NOC Regulations") made under the Patent Act. In this proceeding, Reddy-Chemicor, as applicant, challenges by way of judicial review a decision made by the Minister of Health (the "Minister") not to process its abbreviated New Drug Submission ("ANDS") for a notice of compliance so as to enable it to market omeprazole capsules. Reddy-Chemicor also seeks (1) a declaration that its product is pharmaceutically equivalent to a product marketed by AstraZeneca, (2) that approval can be sought by way of the abbreviated new drug mechanism and, (3) if successful, its application should be reinserted into the review queue in such a way the applicant suffers no prejudice to the delay caused by the internal appeals and this application.
[2] Both the Minister and Reddy-Chemicor oppose AstraZeneca's application.
BACKGROUND
[3] Reddy-Chemicor, Inc. ("Chemicor") is a generic drug company. On March 1, 1999, it submitted to the Therapeutic Products Program ("TPP") of Health Canada an abbreviated new drug submission (ANDS) pursuant to section C.08.002.1 of the FD Regulations in order to obtain a notice of compliance ("NOC") to market for omeprazole capsules in strengths of 10mg and 20mg. The ANDS referred to omeprazole magnesium tablets marketed in Canada by AstraZeneca as the Canadian Reference Product.
[4] On July 2, 1999, the TPP issued a screening deficiency notice to Chemicor on the basis the medicinal ingredient in omeprazole in its ANDS was not pharmaceutically equivalent to that in the Canadian Reference Product (AstraZeneca's Losec tablets; omeprazole magnesium) and, as a result, an ANDS was not acceptable. Chemicor would have to proceed by way of a New Drug Submission ("NDS").
[5] Chemicor, through its consultants, on August 16, 1999, replied to the screening deficiency notice and asserted its ANDS was in compliance with the definition of Pharmaceutical Equivalence in the Food and Drug Regulations for the filing of an ANDS. That definition reads:
A new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients.
[6] Chemicor argued:
The medicinal ingredient in both ... omeprazole ... of Reddy-Chemicor, Inc. and Losec® (omeprazole magnesium) Delayed Release Tablets of Astra Pharma Inc. is omeprazole. In Attachment 1 to this response, we will prove on scientific and on legal grounds that it is omeprazole which is responsible for the safety and efficacy of the drug products for their intended conditions of use. Whether omeprazole is supplied as the base form of the molecule or as a salt is not related to safety and efficacy of the drug products for their intended conditions of use.
[7] Chemicor went on to argue the therapeutic equivalence of drug products containing omeprazole and omeprazole magnesium was established because Astra Pharma Inc. had demonstrated that Losec (omeprazole magnesium) 20mg tablets and Losec (omeprazole) 20mg capsules have an equivalent effect on the inhibition of stimulated acid secretion and on twenty-four hour intragastric pH. It pointed to Astra studies in patients which it said showed a similar adverse event profile between the two formulations.
[8] The TPP did not accept Chemicor's argument. Chemicor submitted a level one appeal in accordance with the TPP's internal review process. That appeal was rejected on February 14, 2000. Chemicor then made a level two appeal. On July 18, 2000, Chemicor was advised by Dr. Peterson, A/Director General of the TPP, the second level appeal was resolved in its favour.
[9] On July 28, 2000, the A/Director, Bureau of Pharmaceutical Assessment of the TPP, wrote a memo to Dr. Peterson recommending that his letter to Chemicor approving the processing of its ADNS be rescinded for the reasons set out.
[10] Some correspondence was exchanged between counsel for Chemicor and TPP subsequent to the July 28, 2000 memo. The matter was concluded when Dr. Peterson wrote to counsel for Chemicor to advise Chemicor's submission could not proceed as an ANDS. It is this decision that Chemicor challenges in respect of which AstraZeneca makes this application for status in the proceedings.
[11] When it first filed its application for judicial review, Chemicor said its application would be supported by the following materials:
1. the Respondent's files related to the Applicant's submission, the S/NDS submission for the Canadian Reference Product, and the NDS file for the Canadian Reference Product's own reference product;
2. such affidavit and other evidence, including access to information material obtained by the Applicant, and evidence as to the pharmaceutical equivalence of omeprazole and omeprazole magnesium, as counsel may advise... .
[12] Chemicor also made a Rule 317 request which included the TPP review file pertaining to its ANDS; the TPP's review file relating to the approval by the TPP by means of a supplemental new drug submission (S/NDS) AstraZeneca's omeprazole magnesium product and the TPP's review file relating to the reference product for AstraZeneca's S/NDS, i.e. the NDS file for AstraZeneca's omeprazole product.
[13] On February 9, 2001, Chemicor filed an amended notice of application. In that amended application, it seeks the same declaration and orders as were contained in its original application but in support of its application, Chemicor deleted the references to the TPP files related to AstraZeneca's S/NDS submission for omeprazole magnesium and the NDS file for AstraZeneca's omeprazole product. Also deleted from the Rule 317 request are those same TPP files. Chemicor maintained as an element of support to its application reference to Access to Information Act materials.
[14] Chemicor's evidence on pharmaceutical equivalence was filed through the affidavit of Dr. Thomas S. Foster.
[15] Chemicor's evidence obtained through the Access to Information Act was introduced by the affidavit of Heather Watts a student-at-law with the applicant's law firm. As appendix "A", she refers to the box received containing the access to information requests results; as Appendix "B" she extracted from this box a document concerning the SNDS of Astra for omeprazole magnesium capsules with a memo from Dr. Klein to Dr. Lee (both with the TPP in 1995) to the effect that since the TPP accepted "bio" and pharmacodynamic data for Losec tablets, the same conditions will apply to any generic preparation and as Appendix "C", a series of documents from the box of Access to Information Act materials and documents, received pursuant to Rule 317, concerning Chemicor's ADNS application and the Level I and Level II appeals including Health and Welfare analysis summaries as background to the appeal decisions.
[16] For sake of completeness, I mention that the respondents' counter on pharmaceutical equivalence is through the affidavit of Dr. Peterson, now Director General of the TPP.
[17] At the same time, Chemicor was pursuing its efforts with the TPP to obtain a Notice of Compliance by way of an A/NDS, it also took a step required under the NOC Regulations made under the Patent Act.
[18] On June 29, 1999, Chemicor's solicitors served on AstraZeneca a detailed statement of allegations (the "detailed statement") asserting the following by way of background:
2. For the purposes of this proceeding, the "drug" for which the First Person (AstraZeneca) claims to have been issued a Notice of Compliance is a 20mg formulation containing the medicine "omeprazole" identified by DIN number 00846503;
3. For the purposes of the proceeding, the "medicine" contained in that drug, according to the Regulations and the Patent List filed by ... (AstraZeneca), is omeprazole;
4. ... Chemicor Inc. intends to sell a drug containing the medicine, omeprazole, in Canada, and has applied for approval under the Food and Drugs Act for, inter alia, the following dosage form of 20mg Capsule.
[19] The detailed statement then referred to Canadian patent 1,338,377 (the "377 patent") owned by A.B. Hassle and licensed to AstraZeneca and asserted the following:
16. . . . the 377 patent does not contain a claim for the medicine itself or a claim for the use of the medicine, as required by the Regulations, s. 4(2), and as defined in section 2 of the Regulations. Claims 1-10 of the 377 patent are directed to a stabilized pharmaceutical composition comprising omeprazole, a basic inorganic salt stabilizing agent selected from the group consisting of potassium, sodium and aluminum salts and which is present in an amount effective to stabilize the composition and an enteric coating. These claims are not directed to the medicine itself or the use of the medicine.
17. Therefore, the 377 patent has no claim for the medicine itself, and no claim for the use of the medicine, that would be infringed by the making, constructing, using or selling by the Second Person [Chemicor] of the drug for which the submission for the Notice of Compliance is filed.
Canadian Patents ... 1,338,377 ... are not eligible for inclusion on the patent register, . . . and should be deleted from the Patent Register by the Minister pursuant to Section 3(1) of the Regulations.
[20] That same day, that is on June 29, 1999, the solicitors to Chemicor served an identical detailed statement but related to omeprazole in the 20mg capsule strength. The detailed statement refers to several Canadian patents on the Patent Register and argues for varying reasons that they contain no claim for the medicine itself and no claim for the use of the medicine and, as a result, no infringement would take place.
[21] In response to these two detailed statements, AstraZeneca's predecessor, Astra Pharma Inc., instituted two applications in this court pursuant to the NOC Regulations. Court file T-1444-99 relates to the 377 patent and Chemicor's 10mg omeprazole capsules. Court file T-1443-99 relates to several Canadian patents and Chemicor's 20mg omeprazole capsules. Astra Pharma seeks to prohibit the Minister of National Health and Welfare (the "Minister") from issuing a NOC to Chemicor until after the expiry of the relevant patents.
[22] The points which AstraZeneca makes as applicant in its applications before this Court in T-1443-99 and T-1444-99 are:
(1) Chemicor's allegations do not constitute a proper Notice of Allegation or a Detailed Statement of the Legal and Factual Basis for an Allegation as contemplated by the NOC Regulations;
(2) AstraZeneca has no knowledge or access to knowledge regarding the existence, contents or date of filing of any ANDS filed by Chemicor with the Minister with respect to any omeprazole product, including omeprazole capsules. More specifically, it has no knowledge or access to knowledge regarding the description of the dosage form, strength and route of administration of any omeprazole product in respect of which Chemicor may have filed an ANDS. Only Chemicor and the Minister have such knowledge;
(3) Chemicor's Notice of Allegation does not include, in breach of the NOC Regulations, a description of any route of administration of the omeprazole product;
(4) It is well established that pharmaceutical composition or formulation claims are claims for the medicine itself;
(5) The patent list refers to the patents filed by Astra Pharma in respect of capsules/tablets formulation containing omeprazole as the active ingredient. The medicine is not limited to omeprazole as alleged by Chemicor.
[23] In support of the application before me in which AstraZeneca seeks to be added as a party or, in the alternative, as an intervenor, AstraZeneca filed some response materials in Chemicor's record in court files T-1443-99 and T-1444-99, initiated by AstraZeneca pursuant to the NOC Regulations, namely, the affidavit of Robert Koprowski and Chemicor's memorandum of fact and law.
[24] Dr. Koprowski, in support of Chemicor's applications opposing AstraZeneca's applications under the NOC Regulations, examines the Patent List established under the NOC Regulations for omeprazole-based products and identifies there "several different drugs based on the active ingredient omeprazole". He observes that each strength (10, 20 and 40 mg) and dosage forms (capsule or tablet) of these drugs is identified by a different drug identification number (DIN) indicating that each is considered a different drug and has been the subject of a separate review and approval by the TPP. He asserts that Health Canada's Drug Product Data Base identifies only two drugs that are based on an active ingredient omeprazole that AstraZeneca has approval to sell in Canada, namely, omeprazole magnesium salt 10mg in tablet form and omeprazole magnesium salt 20mg also in tablet form. He notes the Drug Product Data Base indicates AstraZeneca has discontinued its 20mg capsule form of omeprazole in September, 1996.
[25] Dr. Koprowski then says he reviewed certain information obtained from Health Canada pursuant to a request made under the Access to Information Act. He attaches as exhibit "A" to his affidavit a copy of a letter dated December 20, 1995 from AstraZeneca (then Astra) to the TPP confirming the 10mg omeprazole capsule was never "introduced to the market in Canada" and that it was Astra's intention to withdraw the 20mg capsule in favour of the 20mg tablets.
[26] Chemicor's memorandum of fact and law in the two proceedings launched by AstraZeneca under the NOC Regulations bases its facts on the affidavit of Dr. Koprowski. Chemicor claims there are only two issues: (1) whether the Notice of Allegation complied with the NOC Regulations; and (2) does the patent contain a claim for the medicine itself.
ANALYSIS
(1) The Rules
[27] A necessary respondent to the judicial review application is specified in subsection 303(1) of the Rules which reads:
| 303. (1) Subject to subsection (2), an applicant shall name as a respondent every person (a) directly affected by the order sought in the application, other than a tribunal in respect of which the application is brought; or(b) required to be named as a party under an Act of Parliament pursuant to which the application is brought. [emphasis mine] |
303. (1) Sous réserve du paragraphe (2), le demandeur désigne à titre de défendeur : a) toute personne directement touchée par l'ordonnance recherchée, autre que l'office fédéral visé par la demande; b) toute autre personne qui doit être désignée à titre de partie aux termes de la loi fédérale ou de ses textes d'application qui prévoient ou autorisent la présentation de la demande. |
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[28] The adding of parties is dealt with under subsection 104(1) which reads:
| 104. (1) At any time, the Court may (a) order that a person who is not a proper or necessary party shall cease to be a party; or (b) order that a person who ought to have been joined as a party or whose presence before the Court is necessary to ensure that all matters in dispute in the proceeding may be effectually and completely determined be added as a party, but no person shall be added as a plaintiff or applicant without his or her consent, signified in writing or in such other manner as the Court may order. |
104. (1) La Cour peut, à tout moment, ordonner : a) qu'une personne constituée erronément comme partie ou une partie dont la présence n'est pas nécessaire au règlement des questions en litige soit mise hors de cause; b) que soit constituée comme partie à l'instance toute personne qui aurait dû l'être ou dont la présence devant la Cour est nécessaire pour assurer une instruction complète et le règlement des questions en litige dans l'instance; toutefois, nul ne peut être constitué codemandeur sans son consentement, lequel est notifié par écrit ou de telle autre manière que la Cour ordonne. |
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[29] Interventions are covered by Rule 109 which reads:
| 109. (1) The Court may, on motion, grant leave to any person to intervene in a proceeding. Contents of notice of motion 109(2) (2) Notice of a motion under subsection (1) shall (a) set out the full name and address of the proposed intervener and of any solicitor acting for the proposed intervener; and (b) describe how the proposed intervener wishes to participate in the proceeding and how that participation will assist the determination of a factual or legal issue related to the proceeding. Directions 109(3) (3) In granting a motion under subsection (1), the Court shall give directions regarding (a) the service of documents; and (b) the role of the intervener, including costs, rights of appeal and any other matters relating to the procedure to be followed by the intervener. |
109. (1) La Cour peut, sur requête, autoriser toute personne à intervenir dans une instance. Avis de requête 109(2) (2) L'avis d'une requête présentée pour obtenir l'autorisation d'intervenir : a) précise les nom et adresse de la personne qui désire intervenir et ceux de son avocat, le cas échéant; b) explique de quelle manière la personne désire participer à l'instance et en quoi sa participation aidera à la prise d'une décision sur toute question de fait et de droit se rapportant à l'instance. Directives de la Cour 109(3) (3) La Cour assortit l'autorisation d'intervenir de directives concernant : a) la signification de documents; b) le rôle de l'intervenant, notamment en ce qui concerne les dépens, les droits d'appel et toute autre question relative à la procédure à suivre. |
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[30] In order to be directly affected by the orders Chemicor seeks in the judicial proceeding, AstroZeneca must point to how a sufficient interest in terms of legal rights or otherwise would be adversely impacted or prejudiced by them. See Rothman of Pall Mall Canada Limited et al. v. Minister of National Revenue et al., [1976] 2 F.C. 500 (F.C.A.).
[31] Justice McGillis in Apotex Inc. v. Canada (Minister of Health) (2000), 4 C.P.R. (4th) 421, Justice McGillis comprehensively commented upon certain of the rules relied upon by AstraZeneca to obtain added party or intervenor status in these proceedings. In the case before her, Justice McGillis was dealing with several motions for intervenor status in a proceeding launched by Apotex against the Minister of Health who refused to process its ANDS for the unnamed product X. The minister refused to process the submission because he was of the view Apotex was required to comply with section 5 of the NOC Regulations by sending a notice of allegation to the patentee of the Canadian reference product, in this case the patentee of the Canadian approved product. Before the hearing, Apotex disclosed the product and consented to limited participation by the Canadian patentee, Bristol Myers.
[32] Justice McGillis ruled Bristol Myers was entitled to full participation because there was nothing in the Rules which authorized a proper party's participation to be limited or, alternatively, she ruled Bristol Myers was entitled to full participation because the relief sought by Apotex "will require the Court to interpret section 5 of the Patented Medicines (Notice of Compliance) Regulations, as well as irrelevant provisions of the Food and Drug Regulations...".
[33] In terms of Rule 109 -- the conferring of intervenor status -- Justice McGillis, looking at paragraph 109(2)(b) said the fundamental issue to be determined on a motion for intervention is whether the participation of the proposed intervenor will assist the Court in determining a factual or legal issue related to the proceeding. She came to a negative conclusion being satisfied the patentee and the Minister are able to adduce all of the relevant evidence necessary to assist the Court in determining the factual and legal issue related to the proceeding and was of the view the approach taken in the jurisprudence concerning interventions under the various rules in the previous Federal Court Rules should be approached with caution. She added this at paragraph 11:
However, some of the factors outlined in the previous jurisprudence continue to be relevant, on a motion for intervention under Rule 109, in assessing whether the participation of the proposed intervener will assist the Court in determining a factual or legal issue related to the proceeding. For example, the Court may consider, among other things, the nature of the evidence to be adduced, the ability of the existing parties to adduce all of the relevant evidence or to adequately advance the position of the proposed intervener, and whether the Court can hear and decide the case on its merits without the assistance of the proposed intervener.
[34] In Eli Lilly Canada Inc. v. Canada (Minister of Health), [2001] F.C.A. 108, the Federal Court of Appeal was dealing with an appeal from a motions judge who refused intervenor status to Apotex in a judicial review proceeding initiated by Eli Lilly challenging a decision of the Minister of Health to remove a patent listed by it from the Patent Register administered pursuant to the NOC Regulations.
[35] Chief Justice Richard pointed to Rule109 and to the decision of the Federal Court of Appeal in CUPE v. Canadian Airlines International Ltd., February 15, 2000, A-346-99, and said this:
At paragraph 8 of CUPE, the Court of Appeal set out the factors relevant to a motion to intervene. They include:
(1) Is the proposed intervenor directly affected by the outcome;
(2) Does there exist a justiciable issue and a veritable public interest;
(3) Is there an apparent lack of any other reasonable and/or efficient means to submit the question to the Court;
(4) Is the position of the proposed intervenor adequately defended by one of the parties to the case;
(5) Are the interests of justice better served by the intervention of the proposed third party;
(6) Can the Court hear and decide the proceeding on its merits without the proposed intervenor.
(2) The legal perspective of the drug regulatory regime
[36] In deciding this application, I am guided by what Justice Hugessen wrote in Merck Frosst Canada Inc. et al. v. The Minister of Health et al. (1997), 80 C.P.R. (3d) 550, sustained by the Federal Court of Appeal in [2000] 3 C.P.R. (4th) 288, a case involving a motion to compel answers to questions and for documentation to be produced in an application for judicial review by Merck Frosst challenging the decision of the Minister of Health to issue a NOC to Apotex after the Court had dismissed its application for an order of prohibition under the NOC Regulations. Justice Hugessen, expanding on what he had said as a member of the Federal Court of Appeal in Merck Frosst Canada Inc. et al. v. The Minister of Health and Welfare (1994), 55 C.P.R. (3d) 302, a case involving an application by Merck under the NOC Regulations to prohibit the issuance of a NOC to Apotex, then embarked on a discussion of the regulatory regime governing the marketing of drugs in Canada, anchored on the Food and Drugs Act, with its primary purpose being health and safety concerns. He wrote this at paragraphs 10 and 11:
[10] ... 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 Drugs 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 ... .
[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 patentees' rights... . 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 Drugs 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.
[37] Justice Hugessen then pointed out the NOC Regulations whose clear intention is to facilitate the protection of private commercial patent rights had been grafted the food and drug regulatory regime as an exception to the performance of the Minister's functions to issue a NOC under the Food and Drugs Act giving the green light to the marketing of the drug in Canada.
[38] Of the NOC Regulations, Justice Hugessen wrote this at paragraph 12:
The "linkage" Regulations -- do give the Merck applicants a right, at the very least by implication, to enforce compliance by both Apotex and the Minister with those Regulations and to object to the issuance of an NOC on grounds of non-compliance therewith.
[39] Justice Hugessen went on to say this:
The linkage regulations, however, do not have the effect of incorporating into themselves the whole of the Food and Drugs Act and Regulations so as to create any right for the applicants to enforce the latter. Their clear and evident purpose is to provide an additional patent protection to the patentee in respect of his intellectual property rights and they have absolutely nothing whatsoever to do with public health and safety. [emphasis mine]
[40] Justice Hugessen then addressed Merck's principal contentions in the judicial review proceedings and identified those contentions being non-compliance with the NOC Regulations, as a result of the non-concordance or lack of sequence in the timing as between Apotex's new drug submissions and its notices of allegation and detailed statements made pursuant to the NOC Regulations. He ruled Merck had the right to raise the point.
[41] The Federal Court of Appeal continues to create a buffer between the NOC Regulations and the FD Regulations (see for example Eli Lilly & Co. v. Novopharm Ltd. (2000), 3 C.P.R. (4th) 476 (per Strayer J.A.), Merck and Co. v. The Minister of Health, [2000] 3 C.P.R. (4th) 78 (per Marceau J.A.) and A.B. Hassle v. Canada (Minister of National Health and Welfare), [2000] 3 C.P.R. (4th) 73 (per Décary J.A.).
[42] I take from the cases reviewed that AstraZeneca has no right to enforce the FD Regulations but has the right to object to the issuance of a NOC on the grounds of non-compliance with the NOC Regulations which Justice Hugessen calls the linkage regulations because their purpose is to provide additional patent protection.
[43] In particular, I take from what Justice Strayer said in Eli Lilly, supra, that it is improper for the court in a prohibition proceeding under the NOC Regulations to examine the propriety of an NDS but rather the Court should assume that the Minister would refuse to issue a NOC under the FD Regulations in the absence of a proper NDS and that no possible need would arise for a prohibition order until the NDS was completed.
[44] I also take from Justice Décary's reasons for judgment in A.B. Hassle, supra, that the Court, unless there is evidence to the contrary, should assume a Minister will not ignore his legal duties under the NOC Regulations.
[45] As a result, the test I frame for the determination whether AstraZeneca ought to be granted party status is whether AstraZeneca has shown that, in the judicial review proceedings initiated by Reddy-Chemicor, a matter arises which affects AstraZeneca's patent protection rights provided for in the NOC Regulations. The answer to this question determines, in my view, whether AstraZeneca is directly affected by the Court's decision in that proceeding or ought to have been joined as a party.
(3) Application to this case
(i) Request for party status
[46] For the reasons set out below, I conclude AstraZeneca's request for party status should be refused because it is not directly affected by the judicial review proceedings launched by Chemicor nor is its presence necessary to ensure that all matters in dispute in that proceeding may be effectually and completely determined. The essence of Chemicor's judicial review application does not affect AstraZeneca's patent rights under the NOC Regulations. This is what distinguishes this case from the treatment accorded by Justice McGillis to Bristol Myers in Apotex, supra.
[47] The first argument made by AstraZeneca for party status was that Chemicor's judicial review proceeding relates to whether it filed a proper ANDS and, if the Court rules that it did not and the Minister was correct, its decision makes the two prohibition proceedings launched by it moot thus affecting its right to receive an allegation and a determination which product as between omeprazole or omeprazole magnesium gets the allegation. I do not see how AstraZeneca's rights under the NOC Regulations are affected by that determination. If there is no valid ANDS, the Minister cannot issue a NOC to Chemicor and there is no need for the prohibition applications. On the other hand, if the ANDS is proper, the NOC Regulations have been engaged with AstraZeneca's two prohibition applications continuing as appropriate as a consequence.
[48] The second reason invoked for party status by AstraZeneca relates to Chemicor's request to be reinserted in its proper place in the review queue. AstraZeneca argues such requests may affect its right to receive an allegation in respect of additional patents added to the patent list subsequent to its receiving from Chemicor the detailed statements of allegations on June 29, 1999. This submission must be rejected because it assumes the Minister will ignore his legal duties under the NOC Regulations in respect of AstraZeneca's rights.
[49] The third ground invoked by AstraZeneca for the grant of party status is based on what AstraZeneca characterized as an attack by Chemicor on the legitimacy of the regulatory approval process by which AstraZeneca received its NOC from the Minister enabling it to market omeprazole magnesium tablets. If I had been satisfied Chemicor or the Minister was advancing such proposition, I would have been inclined to grant AstraZeneca party status on the authority of Justice Simpson's decision in Apotex Inc. v. Attorney General for Canada et al. (1994), 56 C.P.R. (3d) 261, who conferred party status to Merck in order to enable Merck to answer the allegations of bad faith on Merck's part as well as allegations that Merck was involved in misleading the Court.
[50] I am satisfied, from an examination of the record and the representations by counsel for Chemicor that no attack on the legitimacy of AstraZeneca's NOC for omeprazole magnesium is engaged in its judicial review proceedings but rather what it is advancing is that it should have the same interchangeability Health Canada granted to AstraZeneca, a matter related to the administration of the FD Regulations.
[51] AstraZeneca then argued it was directly affected by Chemicor's judicial review proceedings because a declaration of pharmaceutical equivalency by the Court could impact upon the insertion of Chemicor's product on the provincial drug formularies. I agree with counsel for Chemicor and the Minister that this result, whether AstraZeneca is right or wrong on the point, is irrelevant to a judicial review proceedings which are now engaged and only relate to commercial and not patent matters.
[52] Finally, AstraZeneca then argued its participation was necessary in order to be bound by the determination of pharmaceutical equivalence between Chemicor's omeprazole base and AstraZeneca's omeprazole magnesium salt. To accept this submission would, in my view, trench upon the clear separation between the FD Regulations and the NOC Regulations which is impermissible.
(ii) Intervenor status
[53] Weighing the factors identified by Justice McGillis in Apotex, supra, and what Chief Justice Richard said in Eli Lilly, supra, I have come to the conclusion AstraZeneca's alternative requesting a grant of intervenor status should be rejected.
[54] AstraZeneca argued it should be granted leave to intervene to file evidence and legal argument on the pharmaceutical equivalence between Chemicor's omeprazole capsules and AstraZeneca's omeprazole magnesium tablets are not pharmaceutically equivalent. AstraZeneca said it intends to prepare and file expert evidence on the differences in physical and chemical properties of omeprazole and omeprazole magnesium as well as pharmaco kinetic and therapeutic matters not discussed by the parties to this proceeding. It would bring a different perspective to the issue. Moreover, it should be entitled to address the impact of the relief sought by Chemicor by way of reinsertion into the review queue.
[55] I agree with counsel for the Minister there is no need for AstraZeneca's presence as an intervenor to assist the Court. I accept her argument there is no relevant evidentiary gap, the Minister has his own expertise and does not need AstraZeneca's support. More importantly, she argued and I accept that the grant of intervenor status in a case such as this one is not contemplated by the Food and Drugs Act and Regulations and crosses the dividing line established by the case law. The Court can hear and decide the proceedings on its merits without the proposed intervenor and the position of AstraZeneca is appropriately covered by the Minister's position.
DISPOSITION
[56] For all of these reasons, AstraZeneca's application for party or intervenor status is dismissed with costs.
"François Lemieux"
J U D G E
OTTAWA, ONTARIO
SEPTEMBER 28, 2001