Federal Court Decisions

Date: 20020110

Docket: T-1212-00

                                                             Neutral Citation: 2002 FCT 28

BETWEEN:                                                                                                                 

                                 ELI LILLY CANADA INC.

                                                                                                   Applicant

                                                    - and -

THE MINISTER OF HEALTH

                                                                                               Respondent

                                  REASONS FOR ORDER

HANSEN J.

Introduction

[1]    Eli Lilly Inc. ("applicant") seeks judicial review of the June 8, 2000 decision of the Minister of Health ("Minister") to remove its Canadian Letters Patent # 1, 249, 969 (" '969 patent") from the Patent Register ("register"). The applicant seeks orders quashing the Minister's decision and directing the Minister to reinstate the '969 patent to the register.

Background

[2]    The '969 patent covers claims for pharmaceutical compositions comprised of ceftazidime pentahydrate ("ceftazidime") combined with amorphous lactose and a pharmaceutically acceptable base. It was first included on the Patent Register in 1993 in accordance with the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 ("1993 Regulations") in respect of the following drug products containing ceftazidime:

TAZIDIME, 500 mg, 1 g and 6 g/vial powder for solution; and

TAZIDIME ADD-VANTAGE, 1 g and 2 g/vial powder for solution.

[3]    The '969 patent was audited after the Regulations were amended in 1998. The Minister's representative responsible for the audit concluded that the '969 patent was not in compliance. On April 26, 2000, the Minister advised the applicant by letter that pursuant to its authority under the new Patented Medicines (Notice of Compliance) Regulations, SOR/98-166 ("NOC Regulations") and subject to any written representations submitted within 30 days, the '969 patent would be removed from the register. The Minister stated as follows:

To determine the eligibility of a patent for the Patent Register, the TPP must, pursuant to paragraph 4(2)(b) of the Patented Medicines (Notice of Compliance) Regulations [SOR/93-133 as amended] (Regulations), assess whether a patent contains a claim for a medicine or the use of a medicine in respect of the particular drug outlined in the submission for a Notice of Compliance. In addition, the patent should be relevant to the drug described in the submission for Notice of Compliance (NOC). As outlined in the Guideline on the Patented Medicines (Notice of Compliance) Regulations, the division "will compare the patent in the submission to determine whether the medicine described in the patent is intended for, or capable of being used for the drug described by the submission for which a NOC is issued. The patent must be relevant to the dosage form, strength and route of administration of the drug described in the submission for NOC".

The medicine in the drug product is ceftazidime. However, there is notably no amorphous lactose listed in the drug formulations summarized in the Product Monographs for TAZIDIME, and TAZIDIME ADD-VANTAGE.

The '969 patent is entitled "Pharmaceutical Formulations for Ceftazidime" and contains 9 claims. Claims 1 to 9 are directed to pharmaceutical formulations comprised of ceftazidime, amorphous lactose and a pharmaceutically acceptable base, sodium carbonate.

The '969 patent contains claims for the medicine, ceftazidime, when in a composition additionally containing amorphous lactose. Therefore the '969 patent is not relevant to the drug outlined in the submission for a NOC, as is evident by reference to the associated Product Monographs. This patent should not be included on the Patent Register against the above drug products.

[4]                 On May 25, 2000, the applicant responded to the Minister asserting the decision to remove the '969 patent from the register was contrary both to the Regulationsand to established case law. Counsel for the applicant wrote as follows:

... In your letter, you indicated that the Ceftazidime Formulation Patent contains claims to pharmaceutical formulations including the medicine ceftazidime combined with a pharmaceutically acceptable base, and amorphous lactose. The Minister has not taken the position that the Ceftazidime Formulation Patent is not relevant to the strength, dosage form or route of administration of the ceftazidime being sold by Lilly. The only reason provided for delisting is that the Lilly commercial formulation for TAZIDIME, as outlined in the product monograph, does not have amorphous lactose as claimed in the patent.

...

It is settled law that a claim to a pharmaceutical formulation including an active medicinal ingredient is a "claim to the medicine itself" within the meaning of the Patented Medicines (Notice of Compliance) Regulations...

...

There is no dispute that the Ceftazidime Formulation Patent claims formulations of ceftazidime and is a claim to the medicine itself within the meaning of the Regulations. The only issue left to be decided is whether it is a requirement of the Regulations that the Ceftazidime Formulation Patent contain a claim to the commercial formulation being sold by Lilly...

[5]                 On June 8, 2000, the Minister replied to the applicant's May 25, 2000 letter confirming the deletion of the '969 patent from the register, stating as follows:

... On the basis that there is notably no amorphous lactose in your drug formulation for TAZIDIME and TAZIDIME ADD-VANTAGE, I informed you in my April 26^th, 2000 letter that the '969 patent is not eligible for inclusion to the patent register, since it is not relevant to the drug described in the submission for notice of compliance ("NOC").

The position you have taken is that the '969 patent is properly listed against TAZIDIME and TAZIDIME ADD-VANTAGE since the patent contains a claim to the medicine ceftazidime itself or the use of ceftazidime, and that the patent is relevant to the dosage form, strength and route of administration of the drug described in the submissions. Further, you state that "there is no requirement in the Regulations that a formulation patent being listed claim the formulation being sold by a patentee"...

...

The '969 patent meets all the requirements for addition to the patent register except that it contains claims to a formulation for which approval was not sought by Eli Lilly.

...

The TPP objects to the listing of the '969 patent on the basis that TAZIDIME and TAZIDIME ADD-VANTAGE are not drugs which contain the formulation claimed in your patent. Eli Lilly has not yet sought or received the necessary approval for the drugs against which it might seek to add the patent.

Should Eli Lilly choose to apply for, and receive, a Notice of Compliance for the subject matter of the '969 patent, it could be re-added to the patent register at that time, subject to the requirements of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as amended.

Issues

[6]                 There are essentially no facts in dispute in this proceeding. The parties differ as to the situations in which the Minister may delist a formulation patent under the NOC Regulations .

Retroactivity

[7]                 The applicant submits that the Minister applied the 1998 amendments to the NOC Regulations in reaching his decision to delist a patent included on the Patent Register in 1993. The applicant maintains that this is contrary to the well established presumption that legislation is not to be applied retroactively.

Relevance

[8]                 The applicant also argues that the '969 patent is a formulation patent; it claims the medicine ceftazidime in combination with inactive ingredients. In the applicant's view, since a formulation patent is a "claim for the medicine itself", the '969 patent should be included on the register.

[9]                 The Minister accepts that a formulation patent fits within the definition of a "claim for the medicine itself". However, in the Minister's view, the '969 patent is not relevant to a drug for which a Notice of Compliance has issued and thus does not conform to the requirements of the NOC Regulations.

[10]            The Minister argues that TAZIDIME and TAZIDIME ADD-VANTAGE, approved by the Minister, do not contain amorphous lactose, which is an ingredient in the pharmaceutical formulation covered by the '969 patent. Therefore, the Minister takes the position that the '969 patent is not relevant to the drugs TAZIDIME and TAZIDIME ADD-VANTAGE.

Analysis

Regulatory Framework

[11]            The NOC Regulations exist to protect the rights of patent holders and, at the same time, to ensure that new drugs are not impeded from entering the marketplace once they have been shown not to infringe any patent rights. Section 3 of the NOC Regulations requires the Minister to maintain a register of information submitted. In doing this, the Minister may refuse to add or may delete any information that does not comply with section 4 of the NOC Regulations.

[12]            Section 2 of the NOC Regulations defines the terms "claim for the medicine itself", and "medicine" as follows:

2. In these Regulations, "claim for the medicine itself" includes a claim in the patent for the medicine itself when prepared or produced by the methods or processes of manufacture particularly described and claimed or by their obvious chemical equivalents; "medicine" means a substance intended or capable of being used for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof;		2. Les définitions qui suivent s'appliquent au présent règlement. « avis de conformité » Avis délivré au titre de l'article C.08.004 du Règlement sur les aliments et drogues. « médicament » Substance destinée à servir ou pouvant servir 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.

[13]            Although the term "drug" is not defined in the NOC Regulations, it is defined in section 2 of the Food and Drug Act, R.S.C. 1985, c. F-27:

"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;		« 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.

[14]            Section 3 of the NOC Regulations, as amended, sets out the Minister's duty to maintain the register, as follows:

3. (1) The Minister shall maintain a register of any information submitted under section 4. To maintain it, the Minister may refuse to add or may delete any information that does not meet the requirements of that section. (2) The register shall be open to public inspection during business hours. (3) No information submitted pursuant to section 4 shall be included on the register until after the issuance of the notice of compliance in respect of which the information was submitted. (4) For the purpose of deciding whether information submitted under section 4 should be added to or deleted from the register, the Minister may consult with officers or employees of the Patent Office.		3. (1) Le ministre tient un registre des renseignements fournis aux termes de l'article 4. À cette fin, il peut refuser d'y ajouter ou en supprimer tout renseignement qui n'est pas conforme aux exigences de cet article. (2) Le registre est ouvert à l'inspection publique durant les heures de bureau. (3) Aucun renseignement soumis aux termes de l'article 4 n'est consigné au registre avant la délivrance de l'avis de conformité à l'égard duquel il a été soumis. (4) Pour décider si tout renseignement fourni aux termes de l'article 4 doit être ajouté au registre ou en être supprimé, le ministre peut consulter le personnel du Bureau des brevets.

[15]            Section 4 of the NOC Regulations, as amended, sets out the conditions under which a patent list may be submitted and the requirements for inclusion on the Patent Register. It states:

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. (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; (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. (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.		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). (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; 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. (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.

[16]            Paragraph 4(7)(b) requires a patent to be relevant to a drug for which a submission for a NOC has been filed. The amended Regulations include this stipulation to ensure a "product specific" patent list, an objective articulated in the Regulatory Impact Analysis Statement which accompanied the 1998 amendments to the NOC Regulations, as follows:

Patentees are required to certify that the patents submitted on the list for a drug are relevant to that particular version of the drug. This will ensure that patents that do not apply to the particular version of the drug will not impede the generic market's entry.

[17]            Thus, while the NOC Regulations exist to protect the innovator from patent infringement, this objective must be balanced with the countervailing interest of ensuring access to the market for generic manufacturers.

[18]            Section 3 of the NOC Regulations requires the Minister to maintain the Patent Register and confers expressly upon the Minister the discretion to delete non-conforming patents. This authority is in keeping with the objective of protecting the innovator's patent rights, without unreasonably fettering entry into the market by generic manufacturers. The Regulatory Impact Analysis Statement makes the following observation:

The amendments reinforce the balance between providing a mechanism for the effective enforcement of patent rights and ensuring that generic drug products enter the market as soon as possible.

Retroactivity

[19]            The presumption that legislation is not intended to have retroactive application is well established. This was noted by Dickson J., as he then was, for the Supreme Court of Canada in Gustavson Drilling (1964) Ltd. v. Minister of National Revenue, [1977] 1 S.C.R. 271 at page 279:

... The general rule is that statutes are not to be construed as having retrospective operation unless such a construction is expressly or by necessary implication required by the language of the Act...

[20]            Dickson J., also at page 279, went on to explain that the retroactive application of legislation would entail altering rights as of a past time:

... the repealing enactment in the present case, although undoubtedly affecting past transactions, does not operate retrospectively in the sense that it alters rights as of a past time... it does not reach into the past and declare that the law or the rights of parties as of an earlier date shall be taken to be something other than they were as of that earlier date...

[21]            In this case, the applicant's allegation that the Minister erred in applying the NOC Regulations retroactively is unsupported. In applying the 1998 provisions to information submitted under the previous Regulations, the Minister is not changing the law as it relates to past events nor is the Minister altering the law as of an earlier date. The Minister has an ongoing duty to maintain the Patent Register to ensure that all patent lists are in compliance with the Regulations currently in effect. In my view, the Minister, in applying the amended NOC Regulations, is giving effect to the Regulations as they apply to facts currently in existence. Therefore, I am satisfied that the Minister's decision does not amount to retroactive application of the NOC Regulations in this case.

[22]            It is important to note that subsection 4(1) of the 1993 Regulations stated:

A person who files, or before the coming into force of these Regulations 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.		La personne qui dépose ou qui, avant la date d'entrée en vigueur du présent règlement, a déposé une demande d'avis de conformité à l'égard d'une drogue qui contient un médicament ou a obtenu un tel avis peut soumettre au ministre une liste de brevets.

[23]            As well, the 1993 Regulations contained the same provision as the amended NOC Regulations in subsection 3(3):

No information submitted pursuant to section 4 shall be included on the register until after the issuance of the notice of compliance in respect of which the information was submitted.		Aucun renseignement soumis aux termes de l'article 4 n'est consigné au registre avant la délivrance de l'avis de conformité à l'égard duquel il a été soumis.

[24]            Therefore, the requisite issuance of a Notice of Compliance with respect to the '969 patent was in effect pursuant to the 1993 Regulations. This requirement for the patent to be relevant to an approved drug was further refined by the 1998 amendments with the addition of three criteria to paragraph 4(7)(b): dosage form, strength, and route of administration. Now, in addition to the patent being relevant to a drug for which a NOC has issued, the patent also must be relevant to the dosage form, strength and route of administration of that drug. The amended paragraph 4(7)(b) states:

(7) A person who submits a patent list or an amendment to an existing patent list under subsection (1) or (4) must certify that ... (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.		(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 : ... 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.

[25]            In conclusion, the applicant's argument with respect to retroactivity is without merit. In any event, the 1993 Regulations contained the same requirement as the amended NOC Regulations with respect to the issuance of a Notice of Compliance for a relevant drug.

Relevance

[26]            The applicant submits it is settled law that a claim to a pharmaceutical formulation comprising an active ingredient with inactive ingredients is a "claim for the medicine itself". In Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1995), 62 C.P.R. (3d) 58, aff'd (1995), 67 C.P.R. (3d) 25 (FCA), Noel J.A., as he then was, commented as follows at page 74:

Against this background, it seems clear that the words "drug" and "medicine" as they appear in s. 4(1) of the Regulations are not used in contradistinction and are not intended to draw a line between an active ingredient and a preparation or composition which includes an active ingredient. Both types of substances when capable or intended to be used for the treatment or prevention of a disease are a "medicine" within the meaning of the Regulations and a claim for the medicine itself, whether in the form of a single active ingredient or in the form of a composition comes within the ambit of the Regulations.

... Keeping in mind that the Regulations are intended to prevent infringements, and that the defined meaning of the word "medicine" is a substance or substances capable of therapeutic effect, I must conclude that a claim for such substance or substances in the form of a composition is "a claim for the medicine itself".

[27]            The Minister agrees that a formulation patent is a "claim for the medicine itself". Further, while the Minister does not dispute that the '969 patent contains a "claim for the medicine itself" within the meaning of subsection 4(2), the Minister submits that the '969 patent is not relevant to a drug for which a Notice of Compliance has issued.

[28]            The NOC Regulations require that a person submitting a patent list certify that the patents are "relevant to the strength, dosage form and route of administration of the drug in respect of which the submission for a notice of compliance has been filed" (section 4(7)(b)). Further, subsection 3(3) of the NOC Regulations precludes inclusion of patents on the register until a Notice of Compliance is issued in respect of that information.

[29]            The ministerial audit of the register and comparison of the patent claims with the TAZIDIME and TAZIDIME ADD-VANTAGE product monograph revealed that a Notice of Compliance has never been sought for the '969 patent formulation containing ceftazidime with amorphous lactose. However, the applicant has received Notices of Compliance for ceftazidime and another compound. The applicant asserts that the presence of ceftazidime in the drugs is sufficient to establish the patent's eligibility for inclusion on the register.

[30]            At the heart of this assertion lies the question of whether ceftazidime without amorphous lactose meets the definition of "the medicine itself". The applicant concedes that ceftazidime has a tendency to polymerize, that is to degrade and link with other degraded ceftazidime molecules. In animal testing, this chemical process results in adverse toxicological effects. The '969 patent sets out the applicant's publicly available solution to this polymerization problem, namely, the formulation of ceftazidime, amorphous lactose, and a pharmaceutically acceptable base. However, the applicant does not use this formulation in its drug products TAZIDIME and TAZIDIME ADD-VANTAGE and has not obtained a NOC with respect to the '969 patent formulation.

[31]            The applicant argues that the amorphous lactose is a non-medicinal or inactive ingredient. As such, its deletion from the formulation of the drug should not affect the eligibility of the '969 patent for inclusion on the register. Given the polymerization problem, however, it seems clear that without the amorphous lactose, the ceftazidime would not meet the definition of a medicine. The adverse effects of the ceftazidime absent the amorphous lactose would make it impossible for it to be considered "a substance intended or capable of being used for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof" as defined in section 2 of the NOC Regulations. Furthermore, the '969 patent does not contain a claim to the "medicine" ceftazidime. It contains only a claim to ceftazidime when combined with amorphous lactose and a pharmaceutically acceptable base.

[32]            Therefore, I am not persuaded by the applicant's argument that it is sufficient for inclusion of the '969 patent on the Patent Register that TAZIDIME and TAZIDIME ADD-VANTAGE contain ceftazidime, even though they are formulated without the amorphous lactose. Section 2 of the Regulations provides that a patent making a "claim for the medicine itself" includes: "the claim in the patent for the medicine itself when prepared or produced by the methods or processes of manufacture particularly described or by their obvious chemical equivalents". In my opinion, therefore, TAZIDIME and TAZIDIME ADD-VANTAGE do not contain "the medicine itself" as described in the '969 patent. TAZIDIME and TAZIDIME ADD-VANTAGE are manufactured by what one can only surmise is a different process or formulation, detailed in a confidential New Drug Submission filed with the Minister. No Notice of Compliance has issued for the claim in the '969 patent: ceftazidime, amorphous lactose, and a pharmaceutically acceptable base.

[33]            The applicant relies on the reasons of McGillis J. in Apotex Inc. v. Minister of Health et al. (1999), 87 C.P.R. (3d) 271. The applicant submits that the Court in Apotex, supra, held it is irrelevant to the listing of a patent whether the patentee is using the patented formulation to prepare its commercial formulation of a particular product. The rationale behind this finding, in the applicant's view, is that a formulation patent should be listed if it could be used by a generic drug manufacturer to produce a pharmaceutically equivalent formulation of a product sold by the patentee.

[34]            In my view, the facts in Apotex, supra, can be distinguished from the facts before me. The applicant, Apotex, argued that the Minister should have de-listed the patent because it was not relevant to the drug for which a NOC had issued. McGillis J., however, found that the patent was relevant to a drug for which a NOC had issued. The patent contained a claim for the medicine paroxetine, a process to prepare paroxetine tablets, and a claim to paroxetine tablets prepared in the absence of water. Notices of Compliance had issued in relation to PAXIL tablets, a drug containing the medicine paroxetine. The applicant's argument on this point differed from the one being forwarded here: in Apotex, supra, the drug for which a NOC had issued was prepared by a different process than specified in the patent. Therefore, the medicine claimed in the patent, paroxetine, was the same medicine present in the drug PAXIL, for which a NOC had issued.

[35]            On the facts before me, the medicine claimed in the patent is ceftazidime combined with amorphous lactose and a pharmaceutically acceptable base. The medicine in TAZIDIME and TAZIDIME ADD-VANTAGE, for which NOCs have issued, is ceftazidime in another formulation. Ceftazidime alone, as noted earlier, cannot meet the definition of a medicine and, in particular, is not "the medicine itself" claimed in the '969 patent. Therefore, while McGillis J. held, prior to the 1998 amendment, that the process used to formulate a drug for which a NOC has issued need not be the same as the one specified in the patent for the patent to be included on the register, she did not find that the medicine need not be the same.

[36]            Furthermore,Apotex, supra, was a judicial review of a decision made by the Minister before the 1998 amendments. In the present case, I must be mindful of the Minister's obligation to fulfill his duties to maintain the Patent Register in light of the legislative purpose of the NOC Regulations, keeping in mind that the 1998 Regulatory Impact Analysis Statement stressed the importance of a "product specific" patent register.

[37]            The respondent, subsequent to the hearing of this matter brought to my attention a decision that deals squarely with the issue raised in the present case. In Warner-Lambert Canada Inc. v. Canada (Minister of Health), [2001] F.C.J. No. 801 (F.C.T.D), Pinard J. upheld the Minister's decision to remove two patents from the Patent Register. The patents both contained claims to a drug component and specifically named stabilizers. He noted as follows at paragraphs 17, 18 and 19:

17. To me, the language of subsections 4(1), (2) and (7) of the Regulations is clear : for a patent set out on a patent list to be eligible for inclusion on the register, it must be relevant to a drug for which a submission for a notice of compliance has been filed. This requirement obviously contributes to ensuring a "product-specific" patent list, which is an objective clearly stated in the Regulatory Impact Analysis Statement accompanying the amendments to section 4 of the Regulations ...

18. In the case at bar, the evidence shows that the '023 and '024 patents contain claims for pharmaceutical compositions which are considered, within the meaning of the Regulations, drugs that contain claims for a medicine.

19. However, the evidence also shows that the specific drugs covered by the '023 and '024 patents have never been the subject of a drug submission (NOC) under the Food and Drug Regulations, C.R.C., c. 870, as amended. Further, the evidence shows that the ACCUPRIL and ACCURETIC drug products for which drug submissions have been filed and approved by the Minister do not contain an ascorbic acid containing stabilizer, ascorbic acid or sodium ascorbate, which are the stabilizers found in the pharmaceutical compositions covered by the '023 and '024 patents. As such, the later patents are not relevant to the drug products for which a submission for a notice of compliance has been filed. As a result, they do not meet the eligibility requirements contained in subsections 4(1), (2) and (7) of the Regulations. Consequently, it was correct for the Minister to conclude that the '023 and '024 patents were ineligible for inclusion on the register.

(Citations omitted)

[38]            The facts in issue before Pinard J. are on all fours with the case before me. For a patent to remain on the register, it must be relevant to a drug for which a NOC has issued. Pinard J. held that where the pharmaceutical composition claimed in the patent differs from the composition in the drug, the patent is not "relevant" to the drug.

[39]            In the present case, the medicine claimed in the '969 patent is not the same medicine used in TAZIDIME and TAZIDIME ADD-VANTAGE. Therefore, I find that the Minister's interpretation of the NOC Regulations is correct, and the decision to remove the '969 patent from the Patent Register is correct.

Disposition

[40]            Accordingly, the application for judicial review is dismissed with costs to the respondent.

                                                                                "Dolores M. Hansen"            

                                                                                                      J.F.C.C.                      

Ottawa, Ontario

January 10, 2002