Date: 20040430
Docket: T-812-02
Citation: 2004 FC 650
Ottawa, Ontario, this 30th day of April, 2004
PRESENT: THE HONOURABLE MR. JUSTICE JOHN A. O'KEEFE
BETWEEN:
APOTEX INC.
Applicant
- and -
THE MINISTER OF HEALTH, ASTRAZENECA AB and
ASTRAZENECA CANADA INC.
Respondents
REASONS FOR ORDER AND ORDER
O'KEEFE J.
[1] Apotex Inc. ("Apotex"), a generic drug manufacturer, has been attempting since 2001 to obtain regulatory approval from the respondent Minister of Health (the "Minister") to sell 20 mg Apo-Omeprazole capsules, which are a generic version of the 20 mg Losec capsules produced by the respondent, AstraZeneca Canada Inc. ("AstraZeneca").
[2] This matter was argued together with proceedings in Court file number T-2311-01, wherein AstraZeneca sought an order prohibiting the Minister from issuing a Notice of Compliance ("NOC") to Apotex in respect of 20 mg Apo-Omeprazole capsules until after the expiration of Canadian Letters Patent No. 2,133,762 (the "'762 Patent"), which is held by AstraZeneca.
[3] In an order dated December 30, 2003, I dismissed AstraZeneca's application for a prohibition order (see 2004 FC 313, [2004] F.C.J. No. 386 (QL)). I am now left to decide this matter, in which Apotex seeks two declarations, namely:
1. That if the '762 Patent is eligible for listing on the patent register pursuant to the Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133 (the "NOC Regulations"), it is eligible for listing only in respect of the New Drug Submission ("NDS") Control No. 059881, which resulted in the issuance of a Notice of Compliance ("NOC") to the respondent, AstraZeneca on June 4, 1999, and not in respect of any other submission for an NOC; and
2. That Apotex is not required to address the '762 Patent pursuant to the NOC Regulations, in respect of its NDS for an NOC for Apo-Omeprazole 20 mg capsules, and that Apotex has, in respect of the '762 Patent, satisfied the requirements of the NOC Regulations.
[4] Apotex also seeks its costs of this application.
Background
[5] The regulatory regime that governs this application is a complex one that has often been the subject of protracted litigation in this Court. Before setting out the specific factual background to this matter and the arguments of the parties, I feel it would assist in the coherence of these Reasons, to quote at some length, a recent decision of the Federal Court of Appeal which sets out the foundation of patent listing under the NOC Regulations. In Abbott Laboratories et al. v. The Minister of Health et al., 2004 FCA 154 (not yet indexed on QL), Richard C.J. for the Court set out at paragraphs 4 to 7 as follows:
The sale and marketing of pharmaceuticals in Canada is regulated by the Food and Drug Regulations C.R.C., c. 870. A manufacturer cannot sell or market its products without the regulatory approval of the Minister of Health, who must be satisfied that the manufacturer has complied with these regulations. In order to obtain approval, a manufacturer must submit a New Drug Submission (NDS) to the Minister. If the Minister is satisfied that the drug is safe, effective and otherwise complies with the regulations, a Notice of Compliance (NOC) will be issued to the manufacturer.
If an NDS has already been filed and the manufacturer subsequently makes changes to its drug such that the information contained in the NDS is now significantly different in respect of certain specified matters, a manufacturer must make a Supplemental New Drug Submission (SNDS) in respect of its product. The Minister's approval of an SNDS is also indicated by an NOC.
Submitting either an NDS or an SNDS, and obtaining an NOC, grants an administrative remedy to protect a manufacturer's pre-existing patent rights. Specifically, if the timing requirements in section 4 of the PM(NOC) Regulations are met, the manufacturer can file patent lists with the Minister. Listing an eligible patent gives the patent holder an opportunity to invoke the PM(NOC) Regulations that will shield the manufacturer's product against generic competition for a statutorily-specified period of time, as the PM(NOC) Regulations stipulate that a generic drug manufacturer cannot obtain an NOC for its product without proving that its product does not infringe a listed pharmaceutical patent.
As the preceding summary sets out, both of these regulatory regimes touch Canadian patented pharmaceutical products. The Food and Drug Regulations are concerned with the safety and effectiveness of pharmaceutical products. The PM(NOC) Regulations balance the rights of holders of pharmaceutical patents and generic drug manufacturers. This second regulatory regime is driven by concerns relating to intellectual property and the appropriate scope of protection that it should be afforded. However, the Food and Drug Regulations and the PM(NOC) Regulations are connected. Compliance with the former is required to obtain concomitant patent benefits under the latter regime.
[6] With this background in mind, I now turn to the facts of the matter before me.
Introduction
[7] AstraZeneca first received an NOC for its 20 mg capsule omeprazole product, known as Losec, on June 13, 1989. Since then, AstraZeneca has filed ten Supplemental New Drug Submissions ("SNDS") for Losec 20 mg capsules. As detailed below, three of these SNDS filings, dated April 28, 1993, July 27, 1993 (together referred to as the "1993 SNDS filings") and January 22, 1999 are relevant to this application.
[8] On April 20, 1993, AstraZeneca filed an application that ultimately resulted in the grant of the '762 Patent, which is titled, "Synergistic Combination of a Substance with Gastric Acid Secretion Inhibiting Effect and an Acid Degradable Antibiotic". The field of invention of the '762 Patent is stated as follows:
The present invention relates to a combination of a substance with inhibiting effect on gastric acid secretion, thus a substance which increases the intragastric pH e.g. a proton pump inhibitor or a histamine-H2-blocker, and one or more antibacterial compounds which are acid degradable.
[9] The '762 Patent includes claims to the use of omeprazole to treat gastritis and peptic ulcers caused by the bacteria Helicobacter pylori and to increase the bioavailability of antibiotics such as clarithromycin.
[10] On April 28, 1993, AstraZeneca filed SNDS #14671 to approve a new manufacturing site for Losec. The Minister issued an NOC for this submission on June 30, 1993.
[11] On June 27, 1993, AstraZeneca filed SNDS #17495 to add a new indication for Losec, namely, maintenance therapy for reflux esophagitis. The Minister issued an NOC for this submission on July 15, 1994.
[12] On September 10, 1996, AstraZeneca notified the Minister that it had discontinued the sale of Losec 20 mg capsules from the Canadian market. AstraZeneca had marketed Losec 20 mg capsules in Canada since 1989.
[13] On January 22, 1999, AstraZeneca filed SNDS #059881 (the "1999 SNDS filing") to add a number of indications to the Losec product monograph, including Helicobacter pylori eradication. The Minister issued an NOC for this submission on June 4, 1999.
[14] The '762 Patent was issued to AstraZeneca on August 1, 2000.
[15] On August 31, 2000, AstraZeneca filed a patent list with the Minister listing the '762 Patent against its two 1993 SNDS filings and its 1999 SNDS filing, all of which were filed after the date of the '762 Patent application. The '762 Patent was added to the patent register by the Minister on September 1, 2000.
Apotex's Application for Regulatory Approval of Apo-Omeprazole Capsules
[16] By letter dated November 16, 2001, Apotex sent AstraZeneca a Notice of Allegation ("NOA") which made the following allegation of non-infringement:
We have submitted to the Minister a New Drug Submission for Apo-Omeprazole capsules containing omeprazole in 20 mg strength for oral administration.
With respect to patent 2133762 [the "762 Patent], we allege that 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 us of the said capsules.
[17] The Abbreviated New Drug Submission ("ANDS") filed by Apotex compared its Apo-Omeprazole capsules to AstraZeneca's Losec 20 mg capsules for the purpose of establishing bioequivalence.
[18] In response, AstraZeneca initiated a proceeding in Court file T-2311-01, seeking an order prohibiting the Minister from issuing an NOC to Apotex in relation to 20 mg Apo-Omeprazole capsules until after the expiry of the '762 Patent.
[19] By letter dated January 4, 2002, the Minister advised Apotex that review of its submission for Apo-Omeprazole was complete, but that an NOC would not be issued until the requirements of the NOC Regulations were met. Apotex requested clarification from the Minister regarding what requirements remained unfulfilled.
[20] By letter dated May 1, 2002, the Minister advised that Apotex was required to address the '762 Patent before its NOC for Apo-Omeprazole capsules could be issued.
[21] On May 14, 2002, the Minister was notified by AstraZeneca that 20 mg Losec capsules were once again being marketed in Canada.
[22] By notice of application dated May 23, 2002, Apotex initiated this proceeding, seeking declarations that the '762 Patent was only eligible to be listed against AstraZeneca's 1999 SNDS filing (not AstraZeneca's 1993 SNDS filings) and that under a correct interpretation of the NOC Regulations, Apotex is not required to address the '762 Patent for an NOC to be issued in relation to Apo-Omeprazole.
Apotex's Submissions
[23] Apotex submits that by requiring it to address AstraZeneca's '762 Patent in order to be issued an NOC for Apo-Omeprazole, the Minister misinterpreted the requirements of the NOC Regulations.
[24] The crux of Apotex's position is that AstraZeneca's '762 Patent is improperly listed on the patent register in relation to AstraZeneca's 1993 SNDS filings, and to the extent that the '762 Patent is properly listed against AstraZeneca's 1999 SNDS filing, Apotex is still not required to address the '762 Patent because no comparison was made to the drug product for which the '762 Patent was added to the patent register. Moreover, Apotex submits that the requirements of subsection 5(1) of the NOC Regulations were not triggered in this case because AstraZeneca's Losec 20 mg capsule product was not, at any material time, "marketed in Canada" so as to oblige Apotex to address the '762 Patent.
[25] Apotex emphasizes that 1998 amendments to the NOC Regulations make it clear that the timing requirements of filing a patent list are to be strictly observed. In Apotex's view, section 4 of the NOC Regulations permits patentees such as AstraZeneca to submit a patent list only at the time of first filing an NDS for a drug, or, where an application has been made for a patent prior to the filing of the NDS, within thirty days after issuance of the patent. Apotex emphasizes the importance of respecting the strict time lines for filing a patent list under the NOC Regulations, given the drastic consequences of requiring a generic manufacturer to serve an NOA and be impeded from entering the market until any subsequent prohibition proceedings are dismissed: Novopharm Ltd. v. Canada (Minister of National Health and Welfare) (1998), 78 C.P.R. (3d) 54, [1998] F.C.J. No. 130 (T.D.)(QL); Bristol Myers-Squibb Canada Inc. v. Canada (Attorney General) (2001), 10 C.P.R. (4th) 318 (F.C.T.D.), aff'd 2002 FCA 32.
[26] Apotex argues that the '762 Patent is improperly listed on the patent register in relation to AstraZeneca's 1993 SNDS filings, since the subject matter of the '762 Patent is not relevant to the subject matter of the two 1993 SNDS filings.
[27] Relying on Eli Lilly Canada Inc. v. Canada (Minister of Health) (2002), 16 C.P.R. (4th) 439, 2002 FCT 28 and Warner-Lambert Canada Inc. v. Canada (Minister of Health) (2001), 12 C.P.R. (4th) 129, 2001 FCT 514, Apotex submits that subsection 4(1) of the NOC Regulations clearly requires that patent lists be "product specific" in order to be listed on the patent register by the Minister. In Apotex's view, the subject matter of a patent submitted on a patent list must be relevant to the subject of the NDS and the resulting NOC, which is not the case in respect of the '762 Patent and AstraZeneca's 1993 SNDS filings. Apotex further submits that the '762 Patent can only have been validly listed with respect to the NOC which issued to AstraZeneca for its 1999 SNDS filing, because only this filing was relevant to the claims of the '762 Patent.
[28] Based on these requirements regarding timing and product specificity under the NOC Regulations, Apotex submits that it cannot be required to address the '762 Patent in order to be issued an NOC for Apo-Omeprazole.
[29] In the alternative, Apotex relies on the Food and Drug Regulations, C.R.C., c. 870, which define a "new drug" to include a new use for a product. Accordingly, Apotex submits that the '762 Patent and the NOC which issued to AstraZeneca on June 4, 1999 relate to a new drug which is different from the drug which was previously marketed - the difference being the new approved uses. As Apotex has not made comparison to this new drug, it is submitted that the '762 Patent is irrelevant to Apotex's ANDS for Apo-Omeprazole.
[30] Moreover, Apotex submits that pursuant to the language of subsection 5(1) of the NOC Regulations, it cannot be required to address the '762 Patent because the product which is the subject of this patent was not, at any material time, "marketed in Canada". It is submitted that both at the time Apotex filed its ANDS and at the time the ANDS became approvable, no Losec 20 mg capsules were marketed pursuant to an NOC for the new uses of the '762 Patent. It is submitted that Apotex never compared its Apo-Omeprazole capsules to Losec capsules marketed pursuant to an NOC for the '762 Patent's new uses. Therefore, in Apotex's view, the conditions of subsection 5(1) were not engaged so no obligation to address the '762 Patent was triggered under the NOC Regulations.
[31] Apotex submits that to insist that subsection 5(1) of the NOC Regulations applies simply because Losec capsules were marketed in the past and the '762 Patent is now listed, several years after marketing ceased, is to misconstrue this subsection.
[32] It is submitted that at no material time were the requirements of subsection 5(1) with respect to Losec 20 mg capsules met and, accordingly, Apotex cannot be required to serve an NOA addressing the '762 Patent. In Apotex's view, even the fact that Losec 20 mg capsules are now marketed in Canada (post-May 14, 2002) does not alter the fact that at all times during which its ANDS for 20 mg Apo-Omeprezole capsules was being reviewed by the Minister, 20 mg Losec capsules were not marketed in Canada and, accordingly, the Minister ought to have processed Apotex's ANDS without requiring an allegation regarding the '762 Patent. It is submitted that the Minister's letter to Apotex dated January 4, 2002 indicated that a review of Apotex's ANDS was complete and as such, a NOC ought to have been issued to Apotex at that time.
[33] Apotex submits that by requiring it to address the '762 Patent, the Minister acted irrationally, arbitrarily, and unlawfully, and failed to act in accordance with his statutory duty.
Minister of Health's Submissions
[34] The Minister submits that Apotex ought to have dealt with the eligibility of the '762 Patent to be listed on the patent register as part of prohibition proceedings, not in a judicial review proceeding under section 18.1 of the Federal Courts Act, R.S.C. 1985, c. F-7. Relying on Apotex Inc. v. Canada (Minister of National Health and Welfare) (2000), 3 C.P.R. (4th)1 (F.C.A.), the Minister argues that the scheme of the NOC Regulations contemplates that ineligible patents may sometimes appear on the register and therefore provides remedies (summary dismissal, costs and damages) to generic manufacturers forced to respond to prohibition proceedings brought on the basis of ineligible patents. Since paragraph 6(5)(a) provides a judicial forum (i.e. prohibition proceedings) in which the eligibility of patents can be decided by the Court, the Minister argues that by bringing in this application, Apotex is making its arguments in the wrong forum.
[35] Contrary to Apotex's position, the Minister submits that the '762 Patent is properly listed on the patent register. Furthermore, the Minister states that there is no merit to the argument that Apotex is not obligated to address the '762 Patent in its NOA concerning Apo-Omeprazole.
[36] The Minister submits that filing of the '762 Patent on the patent register fell within the timing exception in subsection 4(4) of the NOC Regulations, since AstraZeneca's three SNDS filings post-dated the application date for the '762 Patent, which in turn was listed by AstraZeneca within thirty days of the issuance of the '762 Patent.
[37] The Minister recognizes that jurisprudence since 2001 has held that not all SNDS filings trigger an opportunity to file a patent list for inclusion on the patent register. This requirement for a degree of relevance between an SNDS and the accompanying patent list was not a criterion when the '762 Patent was added to the register. Regardless, it is submitted that the issue of whether the '762 Patent would now be considered eligible for listing against AstraZeneca's two 1993 SNDS filings was not an issue before the Minister.
[38] Even if the '762 Patent is ineligible for listing against AstraZeneca's two earlier NOCs, the Minister states that the '762 Patent was at least relevant to AstraZeneca's 1999 SNDS filing. Consequently, the Minister states that the '762 Patent is eligible for inclusion on the patent register, was listed at the material time and therefore triggered the subsection 5(1) requirement for Apotex to address it when alleging non-infringement by its Apo-Omeprazole product.
[39] The Minister submits that regardless of whether subsection 5(1) of the NOC Regulations is interpreted to require a link between the timing of the marketing a drug and the filing of the patent list, or whether there is no timing requirement, Apotex's position is without merit. First, the Minister submits that because the '762 Patent was listed against the NOCs issued to AstraZeneca (based on the two 1993 SNDS filings) and Losec was marketed until 1996, subsection 5(1) was engaged and Apotex is required to address the '762 Patent.
[40] Alternatively, the Minister urges this Court to interpret the requirements of engaging subsection 5(1) less restrictively than the interpretation proposed by Apotex. The Minister submits that subsection 5(1) does not require the marketing in Canada to occur at any particular time, so long as it occurred pursuant to an NOC. Furthermore, based on the wording of provision and the language chosen in the French version of the provision, the Minister submits that subsection 5(1) does not require the marketing of a drug to occur pursuant to the NOC that triggered the filing of a patent list in question. Given the facts of this case, the Minister submits that regardless of which interpretation this Court accepts, Apotex's position is without merit.
[41] Finally, it is submitted that Apotex is not entitled to the declaratory relief it has requested in this matter, since it lies within the sole and complete discretion of the Minister whether to delete a patent from the patent register. In the Minister's view, questions of eligibility of a patent to be placed on the register and the scope of the listing are simply not reviewable by this Court: Apotex Inc. v. Canada (Minister of National Health and Welfare) (2000), 3 C.P.R. (4th) 1 (F.C.A.).
[42] The Minister requests that this application be dismissed with costs.
AstraZeneca's Submissions
[43] It is submitted that AstraZeneca AB was not served with Apotex's Notice of Application and therefore only AstraZeneca Canada Inc. is a respondent to this proceeding.
[44] AstraZeneca submits that Apotex's application is moot, in whole or in part, for at least two reasons. First, it is submitted that even before this proceeding was commenced, Apotex had already addressed the '762 Patent and Court File T-2311-01 was brought in response. Given that Apotex had already addressed the '762 Patent, AstraZeneca states that there remains no live issue in this proceeding. Second, AstraZeneca states that this application was rendered moot by the recommencement of Losec marketing in May 2002. Given that the '762 Patent is, at the very least, properly listed against AstraZeneca's 1999 SNDS filing, AstraZeneca submits that the re-commencement of Losec marketing triggered subsection 5(2) of the NOC Regulations so as to require Apotex to address the subsequently filed patent.
[45] If a live issue does remain between the parties, AstraZeneca submits that based on section 18.5 of the Federal Courts Act, supra and the common-law doctrine of adequate alternate remedy, this Court ought to decline to deal with this application for judicial review. In AstraZeneca's view, the existence of adequate alternate remedies under the NOC Regulations to challenge the propriety of a patent listing, and Apotex's failure to pursue that remedy in the related prohibition proceedings, operates so as to bar this application.
[46] In AstraZeneca's view, a key issue for this Court to decide is whether a patent listed against a drug is specific to the particular approvals in respect of which the patent list is filed. It is AstraZeneca's position that the patent register is not "product specific", contrary to Apotex's submission. In particular, AstraZeneca points out that section 4 of the NOC Regulations permits the filing of a patent list in respect of a "drug", which is broadly defined and is not linked to regulatory approval or to the issuance of an NOC. Moreover, AstraZeneca argues that the word "drug" is clearly a reference to the physical product or dosage form and not a reference to a use for a product.
[47] AstraZeneca states that Apotex's interpretation of subsection 5(1) is nonsensical since, on that view, two omeprazole capsules which are physically identical would be treated as different "drugs" depending on the nature of their previous approvals.
[48] AstraZeneca states that the case law relied upon by Apotex to argue that patent listings are product specific is clearly distinguishable. In Warner-Lambert and Eli-Lilly, supra, the patents covered compositions which differed from the marketed formulation, which is not a consideration in the present case.
[49] Furthermore, AstraZeneca states that the language of subsection 4(7) does not support Apotex's view that listed patents must be relevant to the SNDS filings that accompany them. Although the provision requires patent holders to certify that listed patents are relevant to the dosage form, strength and route of administration of the drug in respect of which the SNDS filing is made, there is no requirement to certify that the patent to be filed is relevant to the use for which the submission is filed. As such, AstraZeneca argues that its 1993 SNDS filings were sufficient to support the listing of the '762 Patent.
[50] AstraZeneca submits that Apotex's arguments that it only compared Apo-Omeprazole to the 1996 version of Losec and that Losec was not marketed in Canada at any material time are flawed. It is submitted that there is no basis for Apotex's suggestion that it compared its proposed product to a different "new drug". It is submitted that Apotex compared its Apo-Omeprazole capsules to the omeprazole capsules of AstraZeneca, thereby triggering the obligation to make an allegation. Further, it is submitted that if this Court finds that it is a requirement that AstraZeneca has marketed pursuant to the 1999 submission to trigger an allegation by Apotex, AstraZeneca has done so beginning in May 2002. AstraZeneca submits that on the facts of these case, the NOC Regulations are clearly engaged and Apotex must address the '762 Patent.
[51] Finally, AstraZeneca submits that even if subsection 5(1) of the NOC Regulations is not triggered, subsection 5(1.1) clearly requires Apotex to make an allegation of non-infringement since it has filed a submission for a drug which contains a medicine found in another drug marketed in Canada pursuant to an NOC.
[52] AstraZeneca requests that this application be dismissed with costs..
Issue
[53] Should the relief sought by Apotex be granted?
Relevant Statutory Provisions
[54] The Food and Drug Act, R.S.C. 1985, c. F-27 states:
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2. In this Act,
. . .
"drug" includes any substance or mixture of substances manufactured, sold or represented for use in
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
(b) restoring, correcting or modifying organic functions in human beings or animals, or
(c) disinfection in premises in which food is manufactured, prepared or kept; |
2. Les définitions qui suivent s'appliquent à la présente loi.
. . .
« drogue » Sont compris parmi les drogues les substances ou mélanges de substances fabriqués, vendus ou présentés comme pouvant servir:
a) au diagnostic, au traitement, à l'atténuation ou à la prévention d'une maladie, d'un désordre, d'un état physique anormal ou de leurs symptômes, chez l'être humain ou les animaux;
b) à la restauration, à la correction ou à la modification des fonctions organiques chez l'être humain ou les animaux;
c) à la désinfection des locaux où des aliments sont gardés. |
[55] The Food and Drug Regulations, C.R.C. c. 870 provide as follows:
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C.08.001. For the purposes of the Act and this Division, "new drug" means
(a) a drug that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug;
(b) a drug that is a combination of two or more drugs, with or without other ingredients, and that has not been sold in that combination or in the proportion in which those drugs are combined in that drug, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that combination and proportion for use as a drug; or
(c) a drug, with respect to which the manufacturer prescribes, recommends, proposes or claims a use as a drug, or a condition of use as a drug, including dosage, route of administration, or duration of action and that has not been sold for that use or condition of use in Canada, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that use or condition of use of that drug. |
C.08.001. Pour l'application de la Loi et du présent titre, « _drogue nouvelle_ » désigne:
a) une drogue qui est constituée d'une substance ou renferme une substance, sous forme d'ingrédient actif ou inerte, de véhicule, d'enrobage, d'excipient, de solvant ou de tout autre constituant, laquelle substance n'a pas été vendue comme drogue au Canada pendant assez longtemps et en quantité suffisante pour établir, au Canada, l'innocuité et l'efficacité de ladite substance employée comme drogue;
b) une drogue qui entre dans une association de deux drogues ou plus, avec ou sans autre ingrédient, qui n'a pas été vendue dans cette association particulière, ou dans les proportions de ladite association pour ces drogues particulières, pendant assez longtemps et en quantité suffisante pour établir, au Canada, l'innocuité et l'efficacité de cette association ou de ces proportions employées comme drogue; ou
c) une drogue pour laquelle le fabricant prescrit, recommande, propose ou déclare un usage comme drogue ou un mode d'emploi comme drogue, y compris la posologie, la voie d'administration et la durée d'action, et qui n'a pas été vendue pour cet usage ou selon ce mode d'emploi au Canada pendant assez longtemps et en quantité suffisante pour établir, au Canada, l'innocuité et l'efficacité de cet usage ou de ce mode d'emploi pour ladite drogue. |
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C.08.003(3) A supplement to a new drug submission or to an abbreviated new drug submission, with respect to the matters that are significantly different from those contained in the submission, shall contain sufficient information and material to enable the Minister to assess the safety and effectiveness of the new drug in relation to those matters. |
C.08.003(3) Le supplément à la présentation de drogue nouvelle ou à la présentation abrégée de drogue nouvelle doit contenir, à l'égard des éléments qui diffèrent sensiblement de ce qui figure dans la présentation, les renseignements et le matériel nécessaires pour permettre au ministre d'évaluer l'innocuité et l'efficacité de la drogue nouvelle relativement à ces éléments. |
[56] The Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133 provide:
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4. (1) A person who files or has filed a submission for, or has been issued, a notice of compliance in respect of a drug that contains a medicine may submit to the Minister a patent list certified in accordance with subsection (7) in respect of the drug.
4.(2) A patent list submitted in respect of a drug must
(a) indicate the dosage form, strength and route of administration of the drug;
(b) set out any Canadian patent that is owned by the person, or in respect of which the person has an exclusive licence or has obtained the consent of the owner of the patent for the inclusion of the patent on the patent list, that contains a claim for the medicine itself or a claim for the use of the medicine and that the person wishes to have included on the register; |
4. (1) La personne qui dépose ou a déposé une demande d'avis de conformité pour une drogue contenant un médicament ou qui a obtenu un tel avis peut soumettre au ministre une liste de brevets à l'égard de la drogue, accompagnée de l'attestation visée au paragraphe (7).
4.(2) La liste de brevets au sujet de la drogue doit contenir les renseignements suivants:
a) la forme posologique, la concentration et la voie d'administration de la drogue;
b) tout brevet canadien dont la personne est propriétaire ou à l'égard duquel elle détient une licence exclusive ou a obtenu le consentement du propriétaire pour l'inclure dans la liste, qui comporte une revendication pour le médicament en soi ou une revendication pour l'utilisation du médicament, et qu'elle souhaite voir inscrit au registre; |
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(c) contain a statement that, in respect of each patent, the person applying for a notice of compliance is the owner, has an exclusive licence or has obtained the consent of the owner of the patent for the inclusion of the patent on the patent list;
(d) set out the date on which the term limited for the duration of each patent will expire pursuant to section 44 or 45 of the Patent Act; and
(e) set out the address in Canada for service on the person of any notice of an allegation referred to in paragraph 5(3)(b) or (c), or the name and address in Canada of another person on whom service may be made, with the same effect as if service had been made on the person.
(3) Subject to subsection (4), a person who submits a patent list must do so at the time the person files a submission for a notice of compliance.
(4) A first person may, after the date of filing of a submission for a notice of compliance and within 30 days after the issuance of a patent that was issued on the basis of an application that has a filing date that precedes the date of filing of the submission, submit a patent list, or an amendment to an existing patent list, that includes the information referred to in subsection (2).
(5) When a first person submits a patent list or an amendment to an existing patent list in accordance with subsection (4), the first person must identify the submission to which the patent list or the amendment relates, including the date on which the submission was filed. |
c) une déclaration portant, à l'égard de chaque brevet, que la personne qui demande l'avis de conformité en est le propriétaire, en détient la licence exclusive ou a obtenu le consentement du propriétaire pour l'inclure dans la liste;
d) la date d'expiration de la durée de chaque brevet aux termes des articles 44 ou 45 de la Loi sur les brevets;
e) l'adresse de la personne au Canada aux fins de signification de tout avis d'allégation visé aux alinéas 5(3)b) ou c), ou les nom et adresse au Canada d'une autre personne qui peut en recevoir signification avec le même effet que s'il s'agissait de la personne elle-même.
(3) Sous réserve du paragraphe (4), la personne qui soumet une liste de brevets doit le faire au moment du dépôt de la demande d'avis de conformité.
(4) La première personne peut, après la date de dépôt de la demande d'avis de conformité et dans les 30 jours suivant la délivrance d'un brevet qui est fondée sur une demande de brevet dont la date de dépôt est antérieure à celle de la demande d'avis de conformité, soumettre une liste de brevets, ou toute modification apportée à une liste de brevets, qui contient les renseignements visés au paragraphe (2).
(5) Lorsque la première personne soumet, conformément au paragraphe (4), une liste de brevets ou une modification apportée à une liste de brevets, elle doit indiquer la demande d'avis de conformité à laquelle se rapporte la liste ou la modification, en précisant notamment la date de dépôt de la demande. |
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(6) A person who submits a patent list must keep the list up to date but may not add a patent to an existing patent list except in accordance with subsection (4).
(7) A person who submits a patent list or an amendment to an existing patent list under subsection (1) or (4) must certify that
(a) the information submitted is accurate; and
(b) the patents set out on the patent list or in the amendment are eligible for inclusion on the register and are relevant to the dosage form, strength and route of administration of the drug in respect of which the submission for a notice of compliance has been filed.
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,
(a) state that the person accepts that the notice of compliance will not issue until the patent expires; or
(b) allege that |
(6) La personne qui soumet une liste de brevets doit la tenir à jour mais ne peut ajouter de brevets à une liste que si elle le fait en conformité avec le paragraphe (4).
(7) La personne qui soumet une liste de brevets ou une modification apportée à une liste de brevets aux termes des paragraphes (1) ou (4) doit remettre une attestation portant que:
a) les renseignements fournis sont exacts;
b) les brevets mentionnés dans la liste ou dans la modification sont admissibles à l'inscription au registre et sont pertinents quant à la forme posologique, la concentration et la voie d'administration de la drogue visée par la demande d'avis de conformité.
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:
a) soit une déclaration portant qu'elle accepte que l'avis de conformité ne sera pas délivré avant l'expiration du brevet;
b) soit une allégation portant que, selon le cas: |
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(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.
(1.1) Subject to subsection (1.2), where subsection (1) does not apply and where a person files or has filed a submission for a notice of compliance in respect of a drug that contains a medicine found in another drug that 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 included on the register in respect of the other drug containing the medicine, where the drug has the same route of administration and a comparable strength and dosage form,
(a) state that the person accepts that the notice of compliance will not issue until the patent expires; or
(b) allege that
(i) the statement made by the first person pursuant to paragraph 4(2)(c) is false,
(ii) the patent has expired, |
(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.
(1.1) Sous réserve du paragraphe (1.2), lorsque le paragraphe (1) ne s'applique pas, la personne qui dépose ou a déposé une demande d'avis de conformité pour une drogue contenant un médicament que l'on trouve dans une autre drogue qui a été commercialisée au Canada par suite de la délivrance d'un avis de conformité à la première personne et à l'égard de laquelle une liste de brevets a été soumise doit inclure dans la demande, à l'égard de chaque brevet inscrit au registre visant cette autre drogue contenant ce médicament, lorsque celle-ci présente la même voie d'administration et une forme posologique et une concentration comparables:
a) soit une déclaration portant qu'elle accepte que l'avis de conformité ne soit pas délivré avant l'expiration du brevet;
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, |
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(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.
(2) Where, after a second person files a submission for a notice of compliance but before the notice of compliance is issued, a patent list or an amendment to a patent list is submitted in respect of a patent pursuant to subsection 4(4), the second person shall amend the submission to include, in respect of that patent, the statement or allegation that is required by subsection (1) or (1.1), as the case may be.
. . .
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.
(3) The first person shall, within the 45 days referred to in subsection (1), serve the Minister with proof that an application referred to in that subsection has been made.
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(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.
(2) Lorsque, après le dépôt par la seconde personne d'une demande d'avis de conformité mais avant la délivrance de cet avis, une liste de brevets ou une modification apportée à une liste de brevets est soumise à l'égard d'un brevet aux termes du paragraphe 4(4), la seconde personne doit modifier la demande pour y inclure, à l'égard de ce brevet, la déclaration ou l'allégation exigées par les paragraphes (1) ou (1.1), selon le cas.
. . .
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.
(3) La première personne signifie au ministre, dans la période de 45 jours visée au paragraphe (1), la preuve que la demande visée à ce paragraphe a été faite. |
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(4) Where the first person is not the owner of each patent that is the subject of an application referred to in subsection (1), the owner of each such patent shall be made a party to the application.
(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
(a) if the court is satisfied that the patents at issue are not eligible for inclusion on the register or are irrelevant to the dosage form, strength and route of administration of the drug for which the second person has filed a submission for a notice of compliance; or
(b) on the ground that the application is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process. |
(4) Lorsque la première personne n'est pas le propriétaire de chaque brevet visé dans la demande mentionnée au paragraphe (1), le propriétaire de chaque brevet est une partie à la demande.
(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:
a) il estime que les brevets en cause ne sont pas admissibles à l'inscription au registre ou ne sont pas pertinents quant à la forme posologique, la concentration et la voie d'administration de la drogue pour laquelle la seconde personne a déposé une demande d'avis de conformité;
b) il conclut qu'elle est inutile, scandaleuse, frivole ou vexatoire ou constitue autrement un abus de procédure. |
Analysis and Decision
[57] Apotex sought the following relief in its notice of application:
1. A declaration that if the Canadian Letters Patent No. 2,133,762 (the "'762 Patent") is eligible for listing on the patent register maintained pursuant to the Patented Medicines (Notice of Compliance) Regulations (the "NOC Regulations"), it is eligible for listing only in respect of the New Drug Submission ("NDS"), Control No. 059881, which resulted in the issuance of a Notice of Compliance ("NOC") to the respondent, AstraZeneca Canada Inc. ("AstraZeneca"), on June 4, 1999 and not in respect of any other submission for an NOC;
2. A declaration that in respect of its NDS for an NOC for Apo-Omeprazole capsules 20 mg, Apotex is not required to address the '762 Patent pursuant to the NOC Regulations and that Apotex has, in respect of the '762 Patent, satisfied the requirements of the NOC Regulations;
3. Costs of this application; and
4. Such further and other relief as counsel may advise and this Honourable Court may permit.
[58] Apotex's arguments for granting this relief were:
1. The '762 Patent was Ineligible for Listing - Out of Time
The '762 Patent was ineligible to be listed on the Patent Register because AstraZeneca's SNDS filings did not trigger an opportunity for a patent list to be filed. The listing of the '762 Patent, therefore, did not meet the strict timing requirements of the NOC Regulations and is therefore invalid.
2. Subject Matter Argument
Since the subject matter of the '762 Patent is not relevant to the 1993 SNDS filings made by AstraZeneca, the '762 Patent is not eligible under subsection 5(1) of the NOC Regulations for listing on the Register against the NOCs issued for those filings. The requirement for Apotex to address the '762 Patent in an NOA was therefore not triggered.
3. Comparison Argument
To the extent the '762 Patent is properly listed on the Patent Register against the NOC issued based on AstraZeneca's 1999 SNDS filing, the subsection 5(1) requirements were not triggered because Apotex never made comparison to Losec capsules that were marketed pursuant to an NOC for the new uses of the '762 Patent. Since a "new drug" includes a new use for a product, Losec marketed pursuant to the 2000 NOC constitutes a new drug to which Apotex never compared Apo-Omeprazole. Again, the preconditions to subsection 5(1) being triggered were not met on the facts of this case.
4. Subsection 5(1) not Engaged Because Losec was not Marketed at the Material Time
To the extent the '762 Patent is properly listed on the Patent Register against the NOC
issued based on AstraZeneca's 1999 SNDS filing, the subsection 5(1) requirements were not triggered because the patented product was not, at any material time, "marketed in Canada". At the time Apotex filed its submissions for Apo-Omeprazole, and at the time the submission became approvable, AstraZeneca was not marketing Losec capsules pursuant to an NOC for the new uses of the '762 Patent. The marketing of Losec in Canada since May 2002 is irrelevant.
[59] The Minister submitted that all of Apotex's arguments should have been dealt with in the context of prohibition proceedings by Apotex pursuant to paragraph 6(5)(a) of the NOC Regulations and not by way of an application for judicial review. For ease of reference, paragraph 6(5)(a) states:
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6.(5) In a proceeding in respect of an application under subsection (1), the court may, on the motion of a second person, dismiss the application
(a) if the court is satisfied that the patents at issue are not eligible for inclusion on the register or are irrelevant to the dosage form, strength and route of administration of the drug for which the second person has filed a submission for a notice of compliance; or
. . . |
6.(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:
a) il estime que les brevets en cause ne sont pas admissibles à l'inscription au registre ou ne sont pas pertinents quant à la forme posologique, la concentration et la voie d'administration de la drogue pour laquelle la seconde personne a déposé une demande d'avis de conformité;
. . . |
[60] In Apotex Inc. v. Canada (Minister of National Health and Welfare) (2000), 3 C.P.R. (4th) 1 (F.C.A.), the Court of Appeal refused to interfere with the Minister's discretion to refuse to delete patents from the patent list register, due to the scheme of the NOC Regulations. The Court ruled that the NOC Regulations provided a comprehension scheme for dealing with ineligible patents being included on the register and for dealing with the damage, loss and costs suffered by generic manufacturers as a result of ineligible patents being included on the register. The Court of Appeal stated at paragraphs 22 and 23:
2. Scheme of the Regulations
22. Our second reason for not interfering with the discretion exercised by the Minister in this case relates to the scheme of the Regulations themselves. The Regulations expressly provide a process by which generic manufacturers may obtain relief in the event they are prejudiced by reason of ineligible patents being included on the Register. Subsection 6(1) and paragraph 6(5)(a) provide in relevant part:
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.
. . .
(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
(a) if the court is satisfied that the patents at issue are not eligible for inclusion on the register . . .
23. It is apparent that in enacting paragraph 6(5)(a) of the Regulations, the Governor in Council was aware of, and allowed for, the possibility that ineligible patents may find their way onto the Register and may not be readily capable of being deleted under subsection 3(1). Paragraph 6(5)(a) provides generic drug manufacturers [page10] with the opportunity, if and when prohibition proceedings are commenced by a patent holder in respect of a Notice of Allegation served by the generic, to apply to the Court to dismiss the prohibition application because it is based on an ineligible patent included on the Register.
Furthermore, at paragraphs 27, 28, 29 and 30, the Court stated:
27. Paragraph 8(1)(a) specifically provides that a patent holder whose prohibition application is dismissed is liable for the loss suffered by a generic manufacturer for the delay incurred in the issuance of a Notice of Compliance to the generic by reason of the prohibition application. Under subsection 8(4), the Court has been given jurisdiction to make an award of damages or lost profits. Section 8 of the Regulations makes it apparent that the Governor in Council recognized that generic manufacturers could be subject to unjustified prohibition applications, including applications based upon ineligible patents on the Register and provided a remedy in the form of an award of damages or lost profits in such circumstances.
28. In sum, there is a comprehensive scheme provided in the Regulations which specifically addresses ineligible patents on the Register and the costs, loss and damage suffered by generic manufacturers arising from such ineligible patents being included on the Register. Having regard to the scheme and its recognition that ineligible patents may be included on the Register, it follows that there is no unlawful refusal to exercise discretion by the Minister in not deleting such patents from the Register under subsection 3(1).
Conclusion
29. Although ineligible patents may be included on the Register, there is no duty on the Minister to delete such patents and no unlawful refusal to exercise discretion by the Minister in not deleting such patents under subsection 3(1) and, therefore, no basis for mandamus or injunctive relief. Nor is there a basis for a declaration that decisions by the Minister to include the 063 patent or other allegedly ineligible patents on the Register are ultra vires. [page12].
30. In coming to this conclusion, we are not unmindful of prior jurisprudence which might be interpreted to place upon the Minister a mandatory duty to delete ineligible patents from the Register under subsection 3(1) of the Regulations as it read prior to the amendments to the Regulations brought into force on March 12, 1998. See, for example Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), [1997] 3 F.C. 752 at 779, 74 C.P.R. (3d) 307 (T.D.), per Nadon J., Novopharm Ltd. v. Canada (Minister of National Health and Welfare) (1998), 78 C.P.R. (3d) 54 (F.C.T.D.) at para. 19 and 20, per Hugessen J. However, the March 12, 1998 Regulations have clarified the discretionary nature of the Minister's authority under subsection 3(1). In our respectful opinion, the March 12, 1998 Regulations have superseded those prior decisions.
[61] The Court also dealt with whether or not the Minister was unlawfully exercising or declining to exercise his discretion to refuse to add or to delete patents from the register and found that the Minister had not done so.
[62] In the present case, Apotex filed an NOA dated November 16, 2001 which stated in part that with respect to the '762 Patent, no claim for the use of the medicine or no claim for the medicine itself would be infringed by Apotex's Apo-Omeprazole capsules. AstraZeneca then applied to the Court for an order prohibiting the Minister from issuing an NOC to Apotex.
[63] As a result of the filing of patent lists, the '762 Patent was added to the patent register.
[64] I am of the opinion that the issues raised by Apotex should have been dealt with as part of prohibition proceedings pursuant to paragraph 6(5)(a) of the NOC Regulations, which provide a complete scheme for dealing with whether or not a patent, in this case, the '762 Patent, should be on the patent register so as to have required Apotex to file an NOA. The Court of Appeal has clearly indicated that this is the manner in which such questions are to be dealt with.
[65] Alternatively, if the timing and comparison arguments raised by Apotex are not covered by the procedure outlined by paragraph 6(5)(a) of the NOC Regulations, I wish to deal further with these issues.
[66] Timing
Apotex argued that the marketing of the drug must take place after the issuance of the NOC associated with the patent list in order to have subsection 5(1) of the NOC Regulations apply. Apotex argued that if the '762 Patent was properly listed, it was only in relation to Supplemental New Drug Submission #059881. The NOC for this submission was granted on June 4, 1999. AstraZeneca discontinued the sale of its 20 mg Lozec capsules in 1996 and did not start to sell Lozec again until May 14, 2002. Apotex submits that subsection 5(1) of the NOC Regulations did not apply to it because the capsules were not marketed in Canada pursuant to the June 4, 1999 NOC for which a patent list had been submitted.
[67] The Minister submitted that subsection 5(1) of the NOC Regulations does not require that the marketing in Canada take place at any particular time as long as it occurred pursuant to an NOC and also that the marketing need not take place pursuant to the NOC in connection with which the patent list was submitted.
[68] Based on the facts of this case, I need not decide which of these interpretations is correct, as I believe that with either interpretation of subsection 5(1) of the NOC Regulations, subsection 5(1) will apply and require Apotex to address the '762 Patent.
[69] AstraZeneca filed a patent list on August 31, 2000, listing the '762 Patent and referencing Supplemental New Drug Submissions 14671, 17495 and 059881 for which NOCs were issued on June 30, 1993, July 15, 1994 and June 4, 1999 respectively.
[70] The '762 Patent was added to the patent register on September 1, 2000. As AstraZeneca did not cease marketing Losec in Canada until 1996, AstraZeneca did market Losec in Canada pursuant to NOCs associated with the patent list, namely, the NOCs issued June 30, 1993 and July 15, 1994. Subsection 5(1) was triggered, obliging Apotex to address the '762 Patent in an NOA.
[71] Comparison
Apotex also submitted that subsection 5(1) of the NOC Regulations did not apply because the drug to which its comparison was made was not the drug with respect to which the '762 Patent was issued. Based on the definition of a new drug in the Food and Drug Regulations, supra, Apotex claims that because the patent issued for a new use of the drug, it became a new drug. As I read subsection 5(1) of the NOC Regulations, it simply refers to "drug" and does not deal with uses of the drug. I agree with AstraZeneca's submission that subsection 5(1) refers to a physical product, not the uses or new uses of a product.
[72] I am of the view that the drug in question is Losec 20 mg capsules which is the drug to which Apotex compared its 20 mg Apo-Omeprazole capsules. Accordingly, subsection 5(1) applies to Apotex.
[73] Accordingly, I am not prepared to grant the declarations requested by Apotex.
[74] Apotex requested that I consider the issues raised in this matter to be moot, given my decision in Court File T-2311-01, however, I was not prepared to so rule.
[75] Apotex's application is dismissed with costs to AstraZeneca and the Minister.
ORDER
[76] IT IS ORDERED that:
1. Apotex's application is dismissed.
2. AstraZeneca and the Minister shall have their costs of the application.
"John A. O'Keefe"
J.F.C.
Ottawa, Ontario
April 30, 2004
FEDERAL COURT
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-812-02
STYLE OF CAUSE: Apotex Inc.
Applicant
and
AstraZeneca AB and
AstraZeneca Canada Inc.
The Minister of Health
Respondents
PLACE OF HEARING: Toronto, Ontario
DATE OF HEARING: September 16-17, 2003 and November 3- 5, 2003
REASONS FOR ORDER AND ORDER: O'Keefe J.
APPEARANCES:
H. B. Radomski
Andrew Brodkin
Ildiko Mehes
For the Applicant
Gunars Gaikis
Yoon Kang
For the Respondents,
AstraZeneca AB and
AstraZeneca Canada Inc.
F.B. Woyiwada
For the Respondent,
The Minister of Health
SOLICITORS OF RECORD:
Goodmans LLP
Toronto, Ontario
For the Applicant
Smart & Biggar
Toronto, Ontario
For the Respondent,
AstraZeneca AB and
AstraZeneca Canada Inc.
Morris Rosenberg, Q.C.
Deputy Attorney General of Canada
For the Respondent,
The Minister of Health