Genpharm Inc . v. Canada (Minister of Health) (F.C.) [2004] 1 F.C. 375
Date: 20031003
Docket: T-1652-02
Citation: 2003 FC 1148
Ottawa, Ontario, October 3, 2003
Present: The Honourable Mr. Justice Blais
APPLICATION UNDER SECTION 18.1 OF THE FEDERAL COURT ACT,
R.S.C. 1985, c. F-7, as amended
BETWEEN:
GENPHARM INC.
Applicant
and
MINISTER OF HEALTH,
ATTORNEY GENERAL OF CANADA and
COMPANY X
Respondents
REASONS FOR ORDER
[1] This is an application for judicial review pursuant to section 18.1 of the Federal Court Act, R.S.C., c. F-7, in respect to the Minister of Health's ["the Minister"] refusal to remove Canadian Patent no. 2,049,368 ["the '368 patent"] from the Patent Register established pursuant to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 as amended ["the PM (NOC) Regulations"].
[2] The applicant Genpharm Inc. seeks a declaration that the '368 patent is improperly listed, as well as an order requiring the Minister to remove the '368 patent from the Register.
[3] In the alternative, Genpharm seeks an order requiring the Minister to comply with the Therapeutic Products Directorate's ["TPD"] undertaking to reconsider the decision not to delist the '368 patent and requiring that such reconsideration be done on proper principles.
PRELIMINARY MATTERS
[4] Counsel for the respondent Company X brought up the matter of the application being out of time, since the decision of the Minister not to delist the patent was dated May 29, 2002, but the application for judicial review was filed only September 27, 2002, beyond the 30 days limitation provided for in ss. 18.1 (2) of the Federal Court Act. This subsection reads as follows:
| (2) An application for judicial review in respect of a decision or order of a federal board, commission or other tribunal shall be made within thirty days after the time the decision or order was first communicated by the federal board, commission or other tribunal to the office of the Deputy Attorney General of Canada or to the party directly affected thereby, or within such further time as a judge of the Trial Division may, either before or after the expiration of those thirty days, fix or allow.
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(2) Les demandes de contrôle judiciaire sont à présenter dans les trente jours qui suivent la première communication, par l'office fédéral, de sa décision ou de son ordonnance au bureau du sous-procureur général du Canada ou à la partie concernée, ou dans le délai supplémentaire qu'un juge de la Section de première instance peut, avant ou après l'expiration de ces trente jours, fixer ou accorder. |
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[5] The decision was given on May 29, 2002; the applicant asked for a reconsideration of the decision on June 12, 2002 and received a letter from the Therapeutic Products Directorate ["TPD"], dated June 25, 2002, stating that the TPD would be willing to reconsider the decision once further advice had been received from the Canadian Intellectual Property Office ["CIPO"]. I find that this letter created a reasonable expectation in the applicant that the decision would be reviewed. The applicant was therefore justified in not filing an application by June 28, 2002, thirty days after the first decision. Since the TPD had not communicated any further on the matter by early September, the applicant sent a letter on September 10, 2002, to make enquiries. This letter was not answered, and the applicant filed an application on September 27, 2002. Subsection 18.1(2) allows me to extend the time granted to the applicant to file his application, and I find the applicant in this matter acted within a reasonable time. The application is therefore within the time limitation prescribed by the Federal Court Act.
[6] Prothonotary Lafrenière granted a Protective Order on October 4, 2002, amended November 25, 2002, following a motion from the applicant Genpharm. The order provided that any document or thing, relating to the identity of the drug, the identity of Company X who is the distributor of the drug, the identity, contents and review status of the applicant's Abbreviated New Drug Submission for the Genpharm drug, and the identity of the patent could be subject to this order. This explains the style of cause of the present proceeding. Pursuant to paragraph 19 of the Protective Order and subsection 152(3) of the Federal Court Rules, 1998, this Court has the discretion to vary this order. The present Reasons for Order identify the respondent Lundbeck Canada Inc., as well as the drug citalopram and the patent no. 2,049,368 at issue.
FACTS
[7] On December 3, 2001, Genpharm submitted an Abbreviated New Drug Submission ["ANDS"] in order to obtain the notice of compliance ["NOC"] for its generic version of the drug citalopram hydrobromide in tablets of 10mg, 20mg and 40mg strengths. This drug is to be used for the symptomatic treatment of depressive illness.
[8] Citalopram is an antidepressant of the Specific Serotonin Reuptake Inhibitor ["SSRI"] type. At this time, the only manufacturer and seller of this drug is Lundbeck Canada Inc. which markets it in strengths of 10 mg, 20 mg and 40 mg under the brand name Celexa®. Lundbeck was issued a NOC for Celexa in February 1999. The NOC specifies that Celexa is to be used only for symptomatic relief of depressive illness.
[9] Lundbeck holds two patents on citalopram tablets, one relating to a novel intermediate step, patent 1,237,147 ["the '147 patent"], and the other relating to the use of citalopram, patent 2,049,368 ["the '368 patent"]. In early December 2001, both patents were listed on the Patent Register for drugs which is maintained by the Minister.
[10] In its notice of allegation ["NOA"] addressed to Lundbeck and dated December 11, 2001, Genpharm indicated that it considered both patents improperly listed, patent '147 because it related to an intermediate process, and patent '368 because the use for which it had received its NOC, i.e. the symptomatic relief of depressive illness, was not among the uses protected by the patent and listed in the Register.
[11] Since the patent list submitted for the Register must set out a Canadian patent that contains a claim for the medicine itself or a claim for the use of the medicine, Genpharm requested that TPD remove the '147 patent since it included no claim to the medicine or the use of the medicine. TPD removed the '147 patent from the Patent Register on January 7, 2002.
[12] The attempt by Genpharm to have patent '368 removed is the subject of the present proceedings.
[13] In a letter addressed to Genpharm's solicitors and dated May 29, 2002, TPD refused to remove patent '368 from the Register. The letter, signed by Anne Bowes, a patent officer with the TPD, states in part:
(...)
CELEXA contains the medicinal ingredient citalopram hydrobromide and is indicated for the treatment of depressive illness. Pursuant to paragraph 4(2)(b) of the Patented Medicines (Notice of Compliance) Regulations, the patent must contain a claim to the medicine, or to the use of the medicine, to be eligible for listing on the Patent Register. It is the Therapeutic Products Directorate's (TPD) position that only patents for indications which have been approved by TPD, should come under the scope of the Patented Medicines (Notice of Compliance) Regulations. As stated above, the approved indication for this drug is for the treatment of depressive illness.
The '368 patent, entitiled [sic] "Treatment of Cerebro-Vascular Disorders", contains 21 claims. Claims 1 to 7 are for the use of a compound of formula I, which includes citalopram, for the manufacture of a medicament for the treatment of cognitive disorders or amnesia associated with dementia and of cerebro-vascular. Claims 8 to 14 are for pharmaceutical composition or medicament for the treatment of dementia and cerebrovascular disorders. Claims 15 to 21 are directed to a method in the production of a pharmaceutical preparation useful in the treatment of dementia and cerebrovascular disorders.
(...) the Canadian Intellectual Property Office (CIPO) was asked for an opinion as to whether the '368 patent contained a claim for the use of citalpram [sic] for the treatment of depressive illness. It was concluded by the officials from CIPO that the '368 patent does contain claims to the use of citalopram for the treatment of depression. Specifically, in claim 8, the treatment of dementia and cerebrovascular disorders (which is not restricted as it is in claim 1), includes the treatment of depression. Therefore, the '368 patent contains a claim for the use of the medicine.
Accordingly, the '368 patent will remain listed on the Patent Register.
[emphasis added]
[14] Claim 8 of the '368 patent reads as follows:
8. A pharmaceutical composition or medicament for the treatment of dementia and cerebrovascular disorders comprising an amount of a1-[3-dimethylamino)propyl]-1-phenylphthalane of the formula: wherein R1 and R2 each are selected from the group consisting of halogen, trifluoromethyl, cyano and R-CO~; wherein R is an alkyl radical with 1 to 4 C-atoms inclusive, or a pharmaceutically-acceptable acid addition salt thereof, which is effective for such purpose, and a pharmaceutically-acceptable diluent or carrier.
[emphasis added]
[15] The opinion on which the TPD based its decision was given by Mr. Jim Freed from the CIPO. It simply asserts that the treatment of dementia includes the treatment of depression. The communication is by way of e-mail, reproduced in part below:
(...)
Claims 1 to 7 are not directed to the use of citalopram for the treatment of depression because it is limited to a medicament for the treatment of cognitive disorders or amnesia associated (...) with dementia and of cerebrovascular disorders. In other words, the claims are directed to the treatment of cognitive disorders or amnesia, which is not taught in the prior art.
Claims 8 to 14 do not have the restriction as defined in paragraph 1.
Claim 8 is directed towards I) the treatment of dementia and cerebrovascular disorders includes the treatment of depression and ii) the compound of formula I includes citalopram. Moreover, claim 14 which is directly dependent upon claim 8 refers to the compound of formula I being citalopram.
(...) Claim 15, again, is directed towards I) the treatment of dementia and cerebrovascular disorders includes the treatment of depression and ii) the compound of formula I includes citalopram. (...)
In conclusion, patent '368 contains claims to the use of citalopram for the treatment of depression and HC should be informed accordingly.
[16] On June 12, 2002, Genpharm addressed a letter to the CIPO, asking for a review of the opinion given by Jim Freed, as well as a letter to TPD, requesting that the Minister review her decision following reconsideration by CIPO.
[17] In a letter dated June 25, 2002, the TPD undertook to review the decision concerning the listing of the patent once the opinion of the CIPO would be received.
[18] There has been no further correspondence on the matter. Genpharm filed application for judicial review on September 27, 2002. In view of Lundbeck's interest in the listing of its patent, it was named respondent to the application along with the Minister.
ISSUES
[19] 1) Can a patent with a claim for the use of a medicine be listed in the Patent Register if that use has not been approved by the notice of compliance?
2) In the event that the Court decided that the patent should be delisted, or that the matter should be reconsidered by the Minister, what would be the proper relief?
i) by way of mandamus or a declaration?
ii) enjoining the Minister to reconsider her decision, on proper principles?
iii) under the PM (NOC) Regulations?
EVIDENCE
Expert Evidence
[20] Genpharm submitted evidence by way of affidavit from two experts, Dr. Lon S. Schneider and Dr. Joel Sadavoy. Both are qualified experts according to their resumes in the fields of psychiatry and geriatrics.
[21] Both experts agree that depression should not be subsumed under cerebrovascular diseases. Dr. Schneider, commenting on the opinion of Mr. Freed:
(...)
'depression as a sequela to cerebrovascular disease' (...) the validity of such a specific condition is not supported by science or fact. It postulates (although it doesn't go into detail) that there is a specific depression or depressive symptom that is a direct result, i.e. 'sequela', of a range of cerebrovascular disorders or Alzheimer's disease, and that this depression is different from other depressions or depressive symptoms, seen in association with other conditions. Such a claim would be termed 'pseudo-scientific', because it claims a specificity that is not valid. Second, even assuming for the moment the validity of a depression symptom as a sequela to cerebrovascular disorders, this is not depression described as the indication for citalopram in the monograph and prescribing information. (AR, Vol. I, tab 2c, p.78)
[22] Dr. Sadavoy, also reacting to the opinion of Mr. Freed:
(...)
Mr. Freed links anxiety, depression, loss of memory, etc. into one category of psychiatric symptoms, implying that they achieve equal status in the diagnosis of the disorder. This is a misreading of the way clinicians deal with the diagnosis of dementia and its consequences, including that form caused by cerebrovascular disorder. (...) With regard to depression, the large majority of patients with dementia do not suffer from this secondary problem (...). Taking this into account, it is clinically strongly inadvisable to suggest that the treatment of dementia and cerebrovascular disorders routinely encompasses the treatment of depression with the same drug. Any drug that is available for the treatment of dementia is first and foremost a treatment of cognitive disorder. (...) There is no drug in the antidepressant family that addresses the cognitive and the depressive component of dementia at the same time.
With specific regard to the compound citalopram, this drug is not advocated for the primary treatment of dementia. (AR, Vol. I, tab 3c, p. 123)
[23] Lundbeck submitted the evidence of Dr Gauthier (also an expert witness in proceedings T-122-02).
[24] Dr. Gauthier speaks of the prevalence of depression in persons who suffer from dementia, and refers to the 1992 study to show that citalopram offers promise in the treatment of a wider array of symptoms than simply depression. His conclusions are reproduced below:
There is significant overlap between patients from dementia and those suffering depression.
There are sufficient data and biological plausibility to support a broader action of citalopram as an antidementia drug, above and beyond its original use as an antidepressant.
Many persons suffering from dementia are already being prescribed citalopram.
There is nothing stopping a physician, if he believes it is in the best interests of his patients, from prescribing citalopram for the treatment of dementia notwithstanding that citalopram has not been approved for this use by Health Canada. (Dr Gauthier's affidavit, doc. 39, Court File).
[25] With respect, these conclusions do not enlighten us as to the use of citalopram as something other than an antidepressant, which is its old, established use.
[26] Dr. Gauthier only refers to four studies that have looked at the effects of citalopram in depressed and non-depressed patients with Alzheimer's disease, and highlights one conducted in 1992. I note that the studies attached to his affidavit at tab 3b deal only with the treatment of depression in older adults; at tab 3c we find the 1992 study.
[27] "Biological plausibility" strikes me as a particularly vague term which would certainly not meet the requirements of safety and efficacy for human use. The fact that many persons suffering from dementia are already being prescribed citalopram simply follows on the first statement, that there is considerable overlap between dementia and depression. Without qualification, this last statement is meaningless. Is there overlap between disease and depression?
[28] Finally, as to the last conclusion, there is nothing stopping a physician from prescribing anything. The likelihood, however, of a physician treating dementia with citalopram, contrary to all the medical evidence we have seen so far, including Dr. Gauthier's submitted literature, is a matter Dr. Gauthier carefully avoids.
Interpretation of the PM (NOC) Regulations
[29] Genpharm and Lundbeck differ sharply on the proper interpretation of the PM (NOC) Regulations to determine whether or not the use protected by the patent list must be covered by the NOC. Adding to the confusion are some guidelines produced by the TPD.
[30] Richard Pike, Senior Vice-President of Research and Development and Regulatory Affairs at Genpharm, states the following in his affidavit:
In order for a patent to be eligible for inclusion on the Patent Register, it must contain a claim for the approved medicine or the approved use of a medicine in respect of the particular drug outlined in the submission for a NOC. The Minister has published guidances that make it clear that only patents claiming the approved medicine or an approved use of the medicine are eligible for listing.
(Richard Pike affidavit, p.4)
[31] In particular, Mr. Pike refers to the following documents, both published by the TPD:
1) "Guidance for Industry: Patented Medicines (Notice of Compliance) Regulations"; and
2) Issue Analysis Summary: Patented Medicines (Notice of Compliance) Regulations.
[32] The first document seeks to guide the industry as to the various requirements of the PM (NOC) Regulations to allow a patent to be listed on the Patent Register. It does state that the PM (NOC) Regulations take precedence.
[33] Under Patent Eligibility, section 3.2.3, one reads:
A patent will be eligible [for the Patent Register] where it is relevant to the drug as described by the dosage form, strength and route of administration. In general, the factors for determining the eligibility of a patent are :
a. the patent must contain a claim for the medicine itself or a claim for the use of the medicine. For purposes of this determination "the medicine" is as described in the related drug submission for which a Notice of Compliance is issued;
[34] In the second document, the following passage appears:
4.2.1 Therapeutic Use/Indication
(...)
Indication [of therapeutic use in the form used to apply for listing] is only used as a criteria of eligibility in the case of those patents that are limited in their application to a specific indication (s) to the exclusion of any others. Patents are listed against drugs which have received a NOC. Where an indication has not been subject to an NOC a patent limited to that indication should not be eligible for inclusion on the register.
In accordance with the Regulatory Impact Analysis Statement [SOR 133/93], the Regulations were established to link the granting of marketing approval for a drug that relies on the earlier approval of a related drug to the patent protection established by relevant product and use patents pertaining to the earlier approved medicine. As such, only patents with indication(s) which have been approved by Health Canada should come under the scope of the Regulations.
[emphasis added]
[35] Ms. Louise Gariépy, Associate Director, Scientific and Regulatory Affairs at Lundbeck Canada Inc., testified as follows in her affidavit:
Notwithstanding that the notice of compliance issued to Lundbeck approves the use of the 10mg, 20mg and 40mg tablets of citalopram for the symptomatic relief of depressive illness, there is nothing in the relevant legislation which enjoins including in the patent list patents which neither claim a medicine for which a notice of compliance has been issued nor claim a use for which a notice of compliance has been issued. Indeed, the Patented Medicines (Notice of Compliance) Regulations (The Regulations) require only that the patent be relevant to the dosage form, strength and route of administration of the drug for which the notice of compliance was issued. The '368 patent claims a use for citalopram hydrobromide having the same dosage, strength and route of administration as that for which the notice of compliance was issued. (Louise Gariépy affidavit, p. 2, doc. 30)
SUBMISSIONS OF THE PARTIES
Genpharm
[36] The applicant submits that patent '368 is improperly listed and should be removed from the Patent Register. The claims for use of the medicine, dementia, ischemia, cerebrovascular disease and Alzheimer's, are not uses approved through the NOC process. The only use recognized by the NOC is for symptomatic relief of depressive illness. This use is an old use, and therefore not entitled to the protection offered by the Patent Register.
[37] The Minister is under a duty to maintain the Patent Register and should be required to delist the '368 patent. In the alternative, he should be ordered by the Court to reconsider, on proper principles, the decision not to delist the '368 patent.
[38] Mr. Freed's position, that the '368 patent covers the treatment of depression, thus rendering the listing valid, is untenable: nothing in the claims refers to the treatment of depression, and were the patent claims construed so as to include the treatment of depression, these claims would not give rise to an infringement since citalopram is a well-known antidepressant, in the words of the patent itself.
[39] The applicant argues that the proper construction of the PM (NOC) Regulations, as seen in the guidance documents published by the TPD, demonstrates the need for a link between the NOC and the patent list.
Lundbeck
[40] The respondent on the other hand, submits that the only requirements as to content for inclusion on the Register are found in sections 3 and 4; no mention is made of the need for the use claimed to be same use as is approved by the NOC. The conditions for the inclusion of a patent on the Register are as follows:
- the patent can only be included after issuance of the notice of compliance (3(3));
- a patent list can only be submitted in respect of a drug for which a notice of compliance has issued or has been applied for;(4(1))
- the patent list can only include a patent that contains a claim for the medicine itself or a claim for the use of the medicine; (4(2)(b))
- the patent must be relevant to the dosage form, strength and route of administration of the drug. (4(7)(b)
[41] The respondents submits that the requirements are fulfilled in this instance. In reply to Genpharm's arguments that the TPD published guidelines that seem to require that patented use be covered by the NOC, Lundbeck states that the Minister is usurping the role of the legislator in adopting the position that it would refuse to list patents for non-approved indications.
[42] The respondent also contends that CIPO has confirmed that the patent contains a claim for depression, the approved use of citalopram. Genpharm has not challenged the validity of the patent and the patent is presumed valid. Finally, Lundbeck argues that the issue is already being dealt with in application T-122-02.
Minister of Health
[43] The Minister relies on the Federal Court decision in Apotex et al. v.Canada (2000), 3 C.P.R. (4th) 1 (F.C.A.) to state that the judicial review application should be dismissed, because it does not constitute the appropriate forum for remedy.
[44] The Minister has complete discretion to add patent lists to or delete them from the Register. The PM (NOC) Regulations provide a complete regime to deal with a patent that may be ineligible for listing.
[45] Notwithstanding the fact that the Crown respondent argues the application should be dismissed, the Minister seems to support the idea that "where a patent is limited in scope to a particular indication, the patent is eligible for inclusion on the Register only if that indication is the subject of a Notice of Compliance".
[46] The only argument concerns the forum. According to the Minister, the PM (NOC) Regulations provide complete relief. If proceedings are instituted under ss. 6(1), the generic manufacturer may apply to the Court under para. 6(5)(a) to dismiss the 6(1) application because based on a patent that is ineligible for the Register. Paragraph 6(10)(b) further provides a remedy as to costs in the case of the inclusion on the certified patent list of a patent that should not have been included under section 4.
The standard of review of the Minister's decision is not correctness. The eligibility decision would be reviewable on a standard of correctness; however the Minister's decision not to add, or to delete, an ineligible patent is subject only to review on a deferential standard.
[47] The Crown respondent submits that the proper forum has already been constituted for Genpharm under T-122-02. Moreover, for the Court to refer the matter back to the Minister for reconsideration in light of the statement from TPD that it was prepared to reconsider its decision would be tantamount to issuing a mandamus or a declaration to which Genpharm is not entitled, because of the Apotex decision.
ANALYSIS
1) Can a patent with a claim for the use of a medicine be listed in the Patent Register if that use has not been approved by the Notice of Compliance?
Relevant Legislation
| Patented Medicines (Notice of Compliance) Regulations - SOR 93/133
INTERPRETATION
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; (revendication pour le médicament en soi)
"claim for the use of the medicine" means a claim for the use of the medicine for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof; (revendication pour l'utilisation du médicament)
"court" means the Federal Court of Canada or any other superior court of competent jurisdiction; (tribunal)
"expire" means, in relation to a patent, expire, lapse or terminate by operation of law; (expiré)
"first person" means the person referred to in subsection 4(1); (première personne) "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; (médicament)
"Minister" means the Minister of National Health and Welfare; (ministre)
"notice of compliance" means a notice issued under section C.08.004 of the Food and Drug Regulations; (avis de conformité)
"patent list" means a list of all patents that is submitted pursuant to section 4; (liste de brevets)
"register" means the register maintained by the Minister under section 3. (registre)
"second person" means the person referred to in subsection 5(1) or (1.1), as the case may be. (seconde personne)
REGISTER
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.
PATENT LIST
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.
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Règlement sur les médicaments brevetés (avis de conformité)
DÉFINITIONS
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. (notice of compliance)
« expiré » Se dit du brevet qui est expiré, qui est périmé ou qui a pris fin par l'effet d'une loi. (expire)
« liste de brevets » Liste de brevets soumise aux termes de l'article 4. (patent list)
« 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. (medicine)
« ministre » Le ministre de la Santé nationale et du Bien-être social. (Minister)
« première personne » La personne visée au paragraphe 4(1). (first person)
« registre » Le registre tenu par le ministre conformément à l'article 3. (register)
« revendication pour le médicament en soi » S'entend notamment d'une revendication, dans le brevet, pour le médicament en soi préparé ou produit selon les modes du procédé de fabrication décrits en détail et revendiqués ou selon leurs équivalents chimiques manifestes. (claim for the medicine itself)
« revendication pour l'utilisation du médicament » Revendication pour l'utilisation du médicament aux fins du diagnostic, du traitement, de l'atténuation ou de la prévention d'une maladie, d'un désordre, d'un état physique anormal, ou de leurs symptômes. (claim for the use of the medicine)
« seconde personne » Selon le cas, la personne visée aux paragraphes 5(1) ou (1.1). (second person)
« tribunal » La Cour fédérale du Canada ou tout autre cour supérieure compétente. (court)
REGISTRE
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.
LISTE DE BREVETS
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.
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Construction of the PM (NOC) Regulations
[48] The proper construction of the PM (NOC) Regulations would seem to require that they be read as a whole. In particular, neither counsel has addressed the significance of ss. 3(3). Yet it is essential to the understanding of the link between the Register and the NOC.
[49] In French, ss. 3(3) reads:
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.
[50] It would appear difficult to reconcile that text with Lundbeck's argument that there is no necessary link between the uses claimed and the uses approved. The French "renseignement" is even more specific than the English "information". It is not a matter of the drug obtaining the NOC, and then any information regarding that drug (including unapproved claims) being entered on the Register, as Lundbeck seems to argue. It would seem possible to argue that the information in the Register must correspond to the information supplied for the NOC, which would include the use.
[51] The interpretation from the TPD and from the Minister would seem to confirm that construction. It seems that for CIPO too, it is important to find a link between a claim and the approved use (to the point of finding depression where none is claimed by the patent).
[52] Lundbeck argues that the only requirement relates to dosage form, strength and route of administration (para. 4(2)(a) and ss. 4(7). However this fails to take into account the reading of the PM (NOC) Regulations as a whole, one of the cardinal rules of statutory interpretation.
[53] Subsection 3(3) states that the information submitted pursuant to section 4 may only be included after issuance of the NOC in respect of which the information was submitted. Subsection 4(1) provides that once the NOC as been issued, or at least applied for, a patent list may be submitted to the Minister; this patent list must be certified in accordance with ss. 4(7). Paragraph 4(2)(b) states that the patent list must set out any Canadian patent that includes a claim for the medicine or a claim for the use of the medicine that the person wishes to have included on the Register. Finally, para. 4(7)(b) provides that the person submitting the patent list must certify that the patents are eligible for inclusion and are relevant to the dosage form, strength and route of administration. In other words, this last requirement is not the only one, and eligibility is more than dosage form, strength and route of administration. The fact that the latter requirement is repeated twice does not negate the importance of the NOC, which under ss. 3(3) is the prerequisite for the inclusion on the Register.
[54] In the Guidance for Industry document which it publishes, the TPD explains thus the link between the NOC and the patent list:
3.2.1 Patent Lists With Submissions:
At the time of filing of a submission for a Notice of Compliance (NOC), the first person may submit a list of granted patents which, in the belief of the first person, contain a claim for the medicine itself or a claim for the use of the medicine and which should embody the drug in respect of which the submission for NOC has been filed.
[55] And to further explain patent eligibility for the Register, the document states: (p. 5-6)
3.2.3 Patent Eligibility:
The Regulations and related jurisprudence determine the factors which are to be considered in adding (or removing) patents to the Patent Register.
A patent will be eligible where it is relevant to the drug as described by the dosage form, strength, and route of administration. In general, the factors for determining the eligibility of a patent are:
the patent must contain a claim for the medicine itself or a claim for the use of the medicine. For purposes of this determination "the medicine" is as described in the related drug submission for which a Notice of Compliance is issued;
[emphasis added]
Caselaw
[56] This is the first case to my knowledge where the issue concerns a claim to the use of the medicine. However, the issue of the link between the NOC and the patent list, which is at the core of this case, has been brought up in regards to the claim to the medicine itself, in two key decisions, Warner-Lambert Canada Inc. v. Canada (Minister of Health) (2001), 206 F.T.R. 177, 12 C.P.R. (4th) 129 (F.C.T.D.) and Eli Lilly Canada Inc. v. Canada (Minister of Health), [2003] F.C.J. No. 75, 2003 FCA 24. Given the similarity of the wording in paragraph 4(2)(b) - a claim for the medicine itself or a claim for the use of the medicine - I believe that these decisions apply to the present case and that I am bound by the decision of the Federal Court of Appeal.
[57] In Warner Lambert, the Minister had decided not to add patent lists related to two patents, and to remove the patent lists already on the Register for those same two patents because the patented composition of the drug had not been issued a NOC; rather a NOC had been issued for a drug containing the same medicine as the one contained in the drug for which the patent was listed. The drug in respect of which the NOC had issued contained the medicinal ingredient quinapril hydrochloride. The first patent was directed to a pharmaceutical composition containing that medicine and an ascorbic acid containing stabilizer; the second patent was directed to a composition containing the medicine and an ascorbic acid and/or sodium ascorbate. The two drugs for which the NOC had issued contained neither an ascorbic acid containing stabilizer nor an ascorbic acid and/or sodium ascorbate. Pinard J. came to the conclusion that because the drugs which had received approval through the NOC were not produced according to the patents, there was no reason to include the patents on the Register, and the Minister had been justified in his decision not to add the new patent lists and to remove those already there:
[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 in 1998:
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's market entry.
[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 (see Hoffman-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1995), 62 C.P.R. (3d) 58 (F.C.T.D.); aff'd (1995), 67 C.P.R. (3d) 25 (F.C.A.); application for leave to appeal to Supreme Court of Canada denied [1996] S.C.C.A. No. 65 (S.C.C.) (QL)).
[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.
[emphasis added]
[58] In the Eli Lilly case, however, Sharlow J.A., writing for the majority, ruled that there was no necessary link between the NOC and the patent list, beyond the requirements of section 4. Specifically, the "relevance" argument to which the Minister had referred and which had been the deciding factor in the Warner-Lambert decision had been given too broad an interpretation by Justice Pinard. The facts in Eli Lilly, according to Justice Sharlow, were "not distinguishable" from the facts in Warner-Lambert. At para. 32, she writes:
A review of the 1998 Regulatory Impact Analysis Statement as a whole indicates that the passage cited in Warner Lambert [above] refers specifically to paragraph 4(7)(b) of the PM (NOC) Regulations. From that I infer that the "relevance" mentioned in the quoted passage from the 1998 Regulatory Impact Analysis Statement relates to the new requirement for a certification of relevance as to dosage form, strength and route of administration. If that is so, then the desired "product specific patent list" will be achieved by ensuring compliance with paragraph 4(7)(b). I am not persuaded that the quoted passage has the broader significance for which the Minister has argued.
[59] And again, at para. 34, after quoting ss. 4(1) and (7) of the PM (NOC) Regulations:
I am unable to read those words as the Minister argues they should be read. Subsection 4(1) addresses the question of who may submit a patent list, not the permitted contents of the patent list. Similarly, the emphasized words in subsection 4(7)(b) do not describe any relationship between the drug named in the notice of compliance and the patents that may be included on the patent list. Rather, "the drug in respect of which the submission for a notice of compliance has been filed" is, simply, Tazidime.
[60] Claim construction principles are of little assistance here, since the issue raised by Genpharm is whether a patent with claims to unapproved uses can be listed. There is no dispute as to the fact that a) Lundbeck has been issued a NOC for Celexa for the "symptomatic relief of depressive illness", b) the approved use in an old use which cannot be protected by patent, and c) no NOC has issued for the patented uses of Celexa.
[61] The patent list has not been removed at Genpharm's request, not because, according to the evidence, there is no need to link the NOC and the patent list, but because, precisely, there exists a link, according to the CIPO: one of the claims for the use of the medicine includes the approved use of Celexa, i.e. depression.
[62] Mr. Freed's opinion in Lundbeck's hands is a double-edged sword - either the use is approved, and not patentable because it is an old use, or it is patentable because it is a new use, in which case it is not approved; no NOC would issue for this use to a generic manufacturer, and infringement is unlikely. Lundbeck argues that the depression covered by the new use is somehow different from the depression covered by the NOC, which could give rise to an infringement. This becomes a question of fact, related to the prohibition order, and is dealt with in the T-122-02 proceedings.
[63] One can imagine that there could be a new use protected by a NOC, in which case Genpharm would be properly prohibited from infringing. In that case, there would be a correspondence between the NOC and the patent list, which is the basis of Genpharm's argument here that the '368 patent is not properly listed, because there is no such correspondence. The fact is that the infringement issue can be approached in two ways. Either the patent is delisted so that there is no need for the generic manufacturer to allege non-infringement under s. 5 of the PM (NOC) Regulations, or non-infringement is alleged in regards to the claims in the patent list. I have come to the conclusion, for the reasons below, that the proper forum is the allegation of non-infringement. First, the direction given by the Federal Court of Appeal makes the delisting problematic. Second, as argued by the Crown respondent and supported by the Apotex decision, the PM (NOC) Regulations offer a full and complete remedy to the problem.
[64] Many arguments have been put forth by the applicant is to why a patent list unrelated to the NOC should not be eligible for the Register. I find these arguments rather compelling. As well, judging from the guidance document and the Regulatory Impact Analysis Statement, as well as the position which the Crown Respondent has taken in this case and the position of the Minister in Warner-Lambert (FCTD) and Eli Lilly, it appears that the applicant's position is based on more than simply its own interpretation of the PM (NOC) Regulations.
[65] However, the Federal Court of Appeal in Eli Lilly has clearly stated that the issue of relevance is to be defined strictly in terms of the explicit requirements of the PM (NOC) Regulations:
The Minister, in exercising authority under subsection 3(1), must consider whether the patent list meets the requirements of subsection 3(3), 4(1), 4(2) and 4(7) of the PM (NOC) Regulations. [para. 19]
Subsection 3(3) is intended to ensure that the Minister does not give effect to a patent list submitted in relation to a particular drug product until a notice of compliance has been issued for that product. [para. 21]
Subsection 4(1) tells the Minister who is entitled to file a patent list. That entitlement is given to a person who files or has filed a new drug submission to obtain a notice of compliance in respect of a "drug that contains a medicine", or a person who has been issued a notice of compliance in respect of a "drug that contains a medicine".[para. 22]
[66] The decision applies the requirements of subsections 3(3), 4(1), 4(2) and 4(7) and concludes that they have been met. The respondent argues that the same applies here, and on a strict interpretation of the provisions, reading them in isolation, I would tend to agree with the respondent.
[67] A NOC was issued for the drug Celexa (3(3)).
[68] The respondent is a person who has been issued a NOC in respect of a drug (Celexa) that contains a medicine (citalopram), and may therefore submit a patent list certified in accordance with subsection 4(7) in respect of the drug. (4(1))
[69] The patent list submitted in respect of the drug indicates the dosage form, strength and route of administration of the drug; the patent contains a claim for the use of the medicine. (4(2))
[70] The person who has submitted the patent list has certified that the information submitted is accurate, that the patents are eligible for inclusion and are relevant to the dosage form, strength and route of administration of the drug in respect of which the submission for a NOC has been filed. (4(7))
[71] In Eli Lilly, the majority concludes thus as to the inclusion of the patent on the Register:
Based on the foregoing ordinary and grammatical reading of the PM (NOC) Regulations, the 969 patent should be eligible for inclusion on the patent lists for Tazidime. That is the interpretation that should be adopted unless the words of the PM (NOC) Regulations can reasonably bear a different meaning that would accord better with the purpose of the PM (NOC) Regulations.
[72] This strict interpretation, states the majority ruling, is in accordance with the intent of the PM (NOC) Regulations, which is the protection of patent.
[73] In a strongly-worded dissent, Isaac J.A. concludes "contrary to what my colleague has asserted, [...] the requirements for subsection 3(3) have not been met". [para. 51]
[74] Isaac J.A. disagrees with Sharlow J.A. "that because the appellant has been issued a notice of compliance in respect of Tazidime, that contains a ceftazidime, it is permitted to submit a patent list in respect of the drug Tazidime". [para. 52] The "medicine itself", according to Isaac J.A., cannot be ceftazidime, which alone would not correspond to the definition of "medicine" (ceftazidime on its own is toxic). The claim to the medicine itself, protected by the patent list, must be for the patented formula , itself a medicine under the definition. The problem is that no NOC has issued for the patented version, and therefore the drug covered by the NOC is not the same as the drug covered by the patent list, so that the condition set by ss. 3(3) is not fulfilled.
[75] In addition, Isaac J.A disagrees with Sharlow J.A. when she states that the Regulatory Impact Analysis Statement "can do no more than explain in very general terms the objective of the PM (NOC) Regulations to which they relate" and cites three decisions where the Regulatory Impact Analysis Statement was used to interpret the accompanying PM (NOC) Regulations (RJR MacDonald Inc. v. Canada (Attorney General), [1994] 1 S.C.R. 311 at 353; Friesen v. Canada, [1995] 3 S.C.R. 103 at 139; Bayer Inc. v. Canada (Attorney General), [1999] 87 C.P.R. (3d) 293 (F.C.A.) at 296). In her reasons, Sharlow J.A. dismissed the Regulatory Impact Analysis Statement, and interpreted the PM (NOC) Regulations only as a means to protect patentees' rights. Isaac J.A. writes:
In accepting, in paragraphs 34 and 35 of her reasons, that the sole purpose of the PM (NOC) Regulations is to prevent patent infringement, my colleague gives no weight to the following statement, contained in the 1998 Regulatory Impact Analysis Statement that accompanied the amended PM (NOC) Regulations, which demonstrates its dual purpose:
The link between the patent status of a drug and approval for a generic version of the drug is being maintained, to provide effective enforcement of patent rights, while at the same time ensuring that generic drugs can enter the market as soon as possible; either as soon as it is determined that they are not covered by a patent, or, where they are covered by a patent, immediately after the expiry of the patent...
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. [para. 73]
[76] The Federal Court of Appeal has not yet rendered a decision on the exact issue in this case, whether "a claim to the use of the medicine" referred to in para. 4(2)(b) of the PM (NOC) Regulations must be related to the uses approved by Health Canada in the NOC procedure. Logic would seem to dictate that such should be the case; the Eli Lilly decision appears to indicate the opposite approach.
[77] For now, I believe that I am bound by the Eli Lilly decision, and that I must rule that the necessary requirements for inclusion on the Register are fulfilled and allow Lundbeck to list the '368 patent for the product Celexa. No doubt clearer language in the PM (NOC) Regulations would go a long way to dispel the fog we find ourselves in, and prevent the abundant litigation which is sure to continue as long as the ambiguity remains.
2) The appropriate remedy
[78] Even if in this case it has been decided that the patent is eligible to be listed, the issue of what would constitute the proper relief had the decision gone otherwise must be put to rest. In particular, can the Court order the Minister to add a patent list to or delete it from the Register? Is declaratory relief available as a remedy in such an instance? In the alternative, can the Court enjoin the Minister to make a decision, based on proper procedures, following the TPD's undertaking to review the decision not to remove the patent list from the Register? Here we find clear guidance in a decision of the Federal Court of Appeal, Apotex Inc. et al. v. Minister of National Health and Welfare et al. [1999] F.C.J. No. 1978, (2000) 3 C.P.R. (4th) 1(F.C.A.).
i) Can the Court order the Minister to add a patent list or delete it from the Register?
[79] In Apotex, the appellants argued that since process claims were not eligible for inclusion on the Register, as decided in Deprenyl Research Ltd. v. Apotex Inc. (1995), 60 C.P.R. (3d) 501 (F.C.A.), the Minister was under a duty to refuse to add or to delete such patents from the Register. The Court answered the argument thus, at paras. 11 and 12:
¶ 11 The Minister is under a mandatory duty under subsection 3(1) to maintain the Register. However, by reason of the term "may refuse to add or may delete" in subsection 3(1), the Minister's authority to refuse to add or to delete a patent is discretionary. It is clear that the Governor in Council did not impose a mandatory duty on the Minister under subsection 3(1) to refuse to add or to delete patents. The Minister says this was because of the prima facie obligation placed on him under subsection 3(1) to maintain a Register of information submitted under subsection 4(1), i.e. a patent list submitted under subsection 4(1). Whether or not a patent was eligible for inclusion on the Register could, in some cases, be difficult to determine and the Minister was thought by the Governor in Council to require flexibility in dealing with when and whether he should refuse to add or to delete such patents. Without addressing, at this point, the validity of the Minister's argument, it is clear that the Minister's authority to refuse to add or to delete patents from the Register under subsection 3(1) is discretionary.
¶ 12 There being no mandatory duty on the Minister to refuse to add or to delete patents from the Register under subsection 3(1), there is no basis for the mandamus, injunctive or declaratory relief as sought by the appellants.
[80] In Apotex Inc. v. Canada (Minister of National Health and Welfare) [1998] F.C.J. No. 1096 (F.C.T.D.), Gibson J. reviewed the conditions under which relief in the nature of mandamus is available. The fifth condition relates to the fact that there is no other remedy. Gibson J. wrote the following in a passage that applies equally well to the case at bar:
I note the fifth condition cited above, that no other adequate remedy is available to the applicant. The applicants herein are concerned about the potential delay in their market entry in respect of generic versions of drugs by otherwise unnecessary prohibition proceedings in respect of patents on the Register, but not eligible for inclusion on, the Register. In my view, this is a valid and justiciable concern which is more properly raised in prohibition proceedings themselves and in relation to which provisions for summary dismissals and costs awards with regard to patents improperly included on the Register have recently been added to the Regulations. The applicants therefore have alternative remedies that I conclude are "adequate". (para. 34)
ii) Can the Court enjoin the Minister to decide on proper principles?
[81] The applicant in the present case cites two cases, Baker v. Canada (M.C.I.) (1999), 174 D.L.R. (4th) 193, [1999] 2 S.C.R. 817, and Conille v. Canada (M.C.I.),[1999] 2 F.C. 33 (F.C.T.D.), to argue that the Minister has a duty to act and cannot delegate that responsibility. In this instance, the TPD wrote a letter to the applicant to state that it would reconsider the decision of not deleting patent '368 once the opinion of CIPO was received. The applicant argues that the failure to act on this promise is a denial of procedural fairness.
[82] In the Apotex decision, there was a question as to "whether the Minister was unlawfully exercising or declining to exercise his discretion to refuse to add or to delete patents from the Register. Arguably, mandamus, injunctive or even declaratory relief might be available in such circumstances." (para. 13)
[83] Although in this case there is the additional factor of the "undertaking", I do not believe that such an undertaking by the TPD alters the legal duty of the Minister by transforming his discretionary power into a duty to act. As stated in Baker, although discretionary decisions must be made within the bounds of jurisdiction conferred by statute, the courts must afford considerable deference to discretionary decision-makers. The Minister "may consult with officers or employees of the Patent Office"; he is under no obligation to do so. The fact that the TPD states that the decision will be reviewed once CIPO has given its advice does not force the Minister to act in any haste, especially since in these proceedings, contrary to what was the case in the decisions cited by the applicant, Baker and Conille, other remedies are available.
[84] I believe that even if patent '369 was ineligible for the Patent Register, the "alternative remedies" Gibson J. refers to in Apotex [1998] F.C.J. No. 1096 would be sufficient to resolve the case at bar.
iii) Remedies offered by the PM (NOC) Regulations
[85] In the Apotex (FCA) decision, the Court stated that there exists relief in the case where a generic manufacturer is prejudiced by the inclusion of ineligible patents on the Register. Specifically, with the amendments enacted in 1998, paragraph 6(5)(a) allows the Court to dismiss the application where it is satisfied that the patents at issue are not eligible for inclusion on the Register. Moreover, ss. 6(10) provides that one of the factors which the Court may take into account in making an order as to costs is, at 6(10)(b) "the inclusion on the certified patent list of a patent that should not have been included under section 4. Commenting the first of those two provisions the Court stated at paras. 23 and 24:
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 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. (...) the remedy provided by paragraph 6(5)(a) does directly address the problem of a generic manufacturer having to compare its product with the drug of a patent holder whose drug is based on an ineligible patent. It provides a judicial forum in which the eligibility of the specific patent or patents at issue can be decided by the Court after hearing from the patent holder and the generic competitor.
[86] In regards to the second provision, at para. 25, the Court found:
Again, it is apparent that the Regulations contemplate that ineligible patents may be included on the Register and a remedy in costs is provided when unnecessary proceedings have taken place on the basis of an ineligible patent.
[87] Finally, section 8 provides for the possibility of the Court awarding damages or profits for losses incurred because of a section 6(1) application. This completes the scheme which according to the Court of Appeal is sufficient to remedy the harm which could occur if an ineligible patent is listed, or if the application to prohibit the issuance of the NOC is unwarranted:
¶ 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).
[88] In the instant case, the issue of remedies for ineligibility of the patent is moot, since it appears that the patent is eligible. However, for the reasons given in proceedings T-122-02, although the patent is eligible for the list, it cannot protect against the use for which the NOC has been applied for by Genpharm.
[89] The application should be dismissed.
Pierre Blais
J.F.C.
FEDERAL COURT OF CANADA
TRIAL DIVISION
NAMES OF COUNSEL AND SOLICITORS OF RECORD
STYLE OF CAUSE: Genpharm In.
v.
Minister of Health et al.
PLACE OF HEARING: Montreal
DATE OF HEARING: September 16 & 17, 2003
APPEARANCES:
Me Tim Gilbert FOR APPLICANT
Me Marie Lafleur FOR RESPONDENT
"Company X"
Me Marie Crowley FOR RESPONDENTS
"Minister of Health &
Attorney General of
Canada"
SOLICITORS OF RECORD:
GILBERT'S
Toronto, Ontario FOR APPLICANT
FASKEN, MARTINEAU
DUMOULIN LLP FOR RESPONDENT
Toronto, Ontario "Company X"
DEPARTMENT OF
JUSTICE CANADA FOR RESPONDENTS
Ottawa, Ontario "Minister of Health &
Attorney General of
Canada"