Judgments

     T-1652-02

    2003 FC 1148

Genpharm Inc. (Applicant)

v.

Minister of Health, Attorney General of Canada and Company X (Respondents)

Indexed as: Genpharm Inc. v. Canada (Minister of Health) (F.C.)

Federal Court, Blais J.--Montréal, September 16, 17; Ottawa, October 3, 2003.

Patents -- Practice -- Listing of patents on Patent Register in accordance with Patented Medicines (Notice of Compliance) Regulations -- On strict interpretation of PM(NOC) Regulations, listed patent need not be directly relevant to drug, use thereof as approved by Health Canada through NOC, as decided by F.C.A. in Eli Lilly v. Canada (Minister of Health) -- Latter decision not giving any weight to dual purpose of Regulations as stated in Regulatory Impact Analysis Statement i.e. prevent infringement at same time as ensuring generic drugs enter market as soon as possible -- Although patent eligible for list, it cannot protect against use (different than that listed) for which NOC applied for by generic drug manufacturer.

In February 1999, the respondent Lundbeck Canada Inc. (Company X in the style of cause) obtained a notice of compliance (NOC) for "Celexa" (its brand name for citalopram, an antidepressant of the Specific Serotonin Reuptake Inhibitor type) to be used only for symptomatic relief of depressive illness. That approved use was an old use that could not be protected by patent. In early December 2001, the patent was listed (for the treatment of dementia and cerebrovascular disorders) on the Patent Register for drugs that is maintained by the Minister. In December 2001, the applicant Genpharm, a generic drug manufacturer, submitted an abbreviated new drug submission (ANDS) in order to obtain the NOC for its generic version of the drug citalopram hydrobromide for the symptomatic treatment of depressive illness. In its notice of allegation (NOA) of December 2001 addressed to Lundbeck, Genpharm indicated that it considered the patent to be improperly listed because the use for which it had received the NOC was not among the uses protected by the patent and listed in the Register. Genpharm therefore requested that the Therapeutic Products Directorate (TPD) remove the patent from the Register. TPD refused to do so on the basis that the patent did contain a claim to the use of citalopram for the treatment of depression, as a claim for the treatment of dementia and cerebrovascular disorders included the treatment of depression. This was an application for judicial review of that decision, for a declaration that the patent was improperly listed, and for an order requiring the Minister to remove the patent from the Register. The issues were whether a patent with a claim for the use of a medicine can be listed in the Patent Register if that use has not been approved by the NOC, and what would be the appropriate relief if the Court decided that the patent should be delisted.

Held, the application should be dismissed.

It would seem that, reading the PM(NOC) Regulations as a whole, the information in the Register should correspond to the information supplied for the NOC, which would include the use. Logic would seem to dictate that such would be the case. However, a majority of the Federal Court of Appeal held, in Eli Lilly Canada Inc. v. Canada (Minister of Health), [2003] 3 F.C. 140, on a strict interpretation of the PM(NOC) Regulations, that there was no necessary link between the NOC and the patent list, beyond the requirements of section 4 of the PM(NOC) Regulations. And that case is binding. On a strict interpretation of subsections 3(3), 4(1), (2) and (7) of the PM(NOC) Regulations, reading them in isolation, their requirements have been met herein. It should be noted that this interpretation in effect accepts that the sole purpose of the PM(NOC) Regulations is to prevent patent infringement, and gives no weight to the statement in the 1998 Regulatory Impact Analysis Statement that the Regulations were intended to provide effective enforcement of patent rights, while at the same time ensuring that generic drugs can enter the market as soon as possible. No doubt clearer language in the PM(NOC) Regulations would go a long way to dispel the ambient fog, and prevent the abundant litigation which is sure to continue as long as the ambiguity remains.

Lundbeck argued that the depression covered by the new use was somehow different from the depression covered by the NOC, which could give rise to infringement. 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 section 5 of the PM(NOC) Regulations, or non-infringement is alleged in regard to the claims in the patent list. The proper forum is the allegation of non-infringement. First, the direction given by the Federal Court of Appeal in Eli Lilly makes delisting problematic. Second, as argued by the Crown respondent and supported by the decision of the Federal Court of Appeal in Apotex Inc. v. Canada (Minister of National Health and Welfare) (2000), 181 D.L.R. (4th) 404 (F.C.A.) the PM(NOC) Regulations offer a full and complete remedy to the problem.

Clear guidance as to the appropriate remedy can be found in Apotex: "There being no mandatory duty on the Minister to refuse to add or 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." As to mandamus, that remedy was not available because, as Gibson J. found in the Federal Court Trial Division decision in Apotex Inc. v. Canada (Minister of National Health and Welfare) (1998), 82 C.P.R. (3d) 68 (F.C.T.D.), there were adequate alternative remedies.

Even though the TPD told the applicant that it would reconsider the decision of not deleting the patent once the opinion of the Canadian Intellectual Property Office was received, the failure to act on this promise was not a denial of procedural fairness. The Minister "may consult with officers or employees of the Patent Office"; he was under no obligation to do so. The Minister was not obliged to act in any haste, especially since other remedies were available. Even if the patent was ineligible for listing in the Patent Register, the "alternative remedies" referred to by Gibson J. in Apotex would be sufficient to resolve the case at bar.

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: dismissing the application where the Court is satisfied that the patents at issue are not eligible for inclusion on the Register; making an order as to costs taking that fact into account; and awarding damages or profits for losses because of a subsection 6(1) application.

The issue of remedies for ineligibility of the patent was moot, since it appeared that the patent was eligible. However, although the patent is eligible for the list, it cannot protect against the use for which the NOC has been applied for by Genpharm.

statutes and regulations judicially

considered

Federal Court Act, R.S.C., 1985, c. F-7, s. 18.1 (as enacted by S.C. 1990, c. 8, s. 5).

Federal Court Rules, 1998, SOR/98-106, r. 152(3).

Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 2 (as am. by SOR/98-166, s. 1; 99-379, s. 1), 3 (as am. by SOR/98-166, s. 2), 4 (as am. idem, s. 3), 5 (as am. idem, s. 4; 99-379, s. 2), 6(1) (as am. by SOR/98-166, s. 5), (5)(a) (as am. idem), (10)(b) (as am. idem), 8 (as am. idem, s. 7).

cases judicially considered

followed:

Eli Lilly Canada Inc. v. Canada (Minister of Health), [2003] 3 F.C. 140; (2003), 23 C.P.R. (4th) 289; 300 N.R. 76 (C.A.).

overruled:

Warner-Lambert Canada Inc. v. Canada (Minister of Health) (2001), 12 C.P.R. (4th) 129; 206 F.T.R. 177 (F.C.T.D.).

applied:

Apotex Inc. v. Canada (Minister of National Health and Welfare) (2000), 181 D.L.R. (4th) 404; 3 C.P.R. (4th) 1; 252 N.R. 72 (F.C.A.); Apotex Inc. v. Canada (Minister of National Health and Welfare) (1998), 82 C.P.R. (3d) 68 (F.C.T.D.).

distinguished:

Baker v. Canada (Minister of Citizenship and Immigration), [1999] 2 S.C.R. 817; (1999), 174 D.L.R. (4th) 193; 14 Admin. L.R. (3d) 173; 1 Imm. L.R. (3d) 1; 243 N.R. 22; Conille v. Canada (Minister of Citizenship and Immigration), [1999] 2 F.C. 33; (1998), 15 Admin. L.R. (3d) 157; 159 F.T.R. 215 (T.D.).

referred to:

H. Lundbeck A/S v. Canada (Minister of Health), 2003 FC 1145; [2003] F.C.J. No. 1481 (T.D.) (QL); RJR-- MacDonald Inc. v. Canada (Attorney General), [1994] 1 S.C.R. 311; (1994), 111 D.L.R. (4th) 385; 54 C.P.R. (3d) 114; 164 N.R. 1; 60 Q.A.C. 241; Friesen v. Canada, [1995] 3 S.C.R. 103; (1995), 127 D.L.R. (4th) 193; [1995] 2 C.T.C. 369; 95 DTC 5551; 186 N.R. 243; Bayer Inc. v. Canada (Attorney General) (1999), 87 C.P.R. (3d) 293; 243 N.R. 70 (F.C.A.); Deprenyl Research Ltd. v. Apotex Inc. (1995), 60 C.P.R. (3d) 501; 180 N.R. 323 (F.C.A.).

APPLICATION for judicial review of Minister of Health's refusal to remove a Canadian patent from the Patent Register even though the use listed did not correspond to the use for which the patent had been approved and for which it had received a notice of compliance. Application dismissed.

appearances:

Timothy H. Gilbert for applicant.

Marie Lafleur for respondent Lundbeck Canada Inc. (Company X).

Marie A. Crowley for respondents Minister of Health and Attorney General of Canada.

solicitors of record:

Gilbert's, Toronto, for applicant.

Fasken, Martineau, DuMoulin LLP, Toronto, for respondent Lundbeck Canada Inc. (Company X).

Deputy Attorney General of Canada, for respondents Minister of Health and Attorney General of Canada.

The following are the reasons for order rendered in English by

[1]Blais J.: This is an application for judicial review pursuant to section 18.1 [as enacted by S.C. 1990, c. 8, s. 5] of the Federal Court Act, R.S.C., 1985, c. F-7, in respect of the Minister of Health's (the Minister) refusal to remove Canadian Patent No. 2049368 (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) und ertaking 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 subsection 18.1(2) of the Federal Court Act. This subsection reads as follows:

18.1 . . . .

(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.

[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, 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, 30 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 th e 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 [SOR/98-106], 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 368 patent 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 10 mg, 20 mg and 40 mg 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 an 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 No. 1237147 (the 147 patent), and the other relating to the use of citalopram, patent No. 2049368 (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 wa s 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 résumés 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 (A.R., Vol. 1, tab 2c, at p. 78):

. . . `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.

[22]Dr. Sadavoy, also reacting to the opinion of Mr. Freed (A.R., Vol. I, tab 3c, p. 123):

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.

[23]Lundbeck submitted the evidence of Dr. Gauthier (also an expert witness in proceedings T-122-02 [H. Lundbeck A/S v. Canada (Minister of Health), 2003 FC 1145; [2003] F.C.J. No. 1481 (T.D. (QL)).

[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 (Dr. Gauthier's affidavit, doc. 39, Court File):

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.

[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]"Biologica l 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 f irst 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 m atter 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 (Richard Pike's affidavit, at p. 4):

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.

[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 Guidelines"; 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:

·     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 a 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 for indication 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 (Louise Gariépy's affidavit, at page 2, doc. 30):

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.

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 f or 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 [as am. by SOR/98-166, s. 2] and 4 [as am. idem, s. 3] of the PM(NOC) Regulations; 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 (subsection 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 (subsection 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 (paragraph 4(2)(b));

- the patent must be relevant to the dosage form, strength and route of administration of the drug (paragraph 4(7)(b)).

[41]The respondent 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 of Appeal decision in Apotex Inc. v. Canada (Minister of National Health and Welfare) (2000), 181 D.L.R. (4th) 404 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 subsection 6(1) [as am. by SOR/98-166, s. 5], the generic manufacturer may apply to the Court under paragraph 6(5)(a) [as am. idem] to dismiss the subsection 6(1) application because based on a patent that is ineligible for the Register. Paragraph 6(10)(b) [as am. idem] further provides a remedy as to costs in the case of the inclusion on the certified patent list of a patent that 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, supra.

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;

"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;

"court" means the Federal Court of Canada or any other superior court of competent jurisdiction;

"expire" means, in relation to a patent, expire, lapse or terminate by operation of law;

"first person" means the person referred to in subsection 4(1);

"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;

"Minister" means the Minister of National Health and Welfare;

"notice of compliance" means a notice issued under section C.08.004 of the Food and Drug Regulations;

"patent list" means a list of all patents that is submitted pursuant to section 4;

"register" means the register maintained by the Minister under section 3.

"second person" means the person referred to in subsection 5(1) or (1.1), as the case may be.

    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.

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 subsection 3(3). Yet it is essential to the understanding of the link between the Register and the NOC.

[49]In French, subsection 3(3) reads:

3. . .

(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" i s 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 possi ble 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 (paragraph 4(2)(a) and subsection 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 has 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 subsection 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, paragraph 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 subsection 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 at pages 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), 12 C.P.R. (4th) 129 (F.C.T.D.); and Eli Lilly Canada Inc. v. Canada (Minister of Health), [2003] 3 F.C. 140 (C.A.). 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 an 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 [at paragraphs 17-19]:

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.

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)).

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, supra, 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 , supra, 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 paragraph 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 paragraph 34, after quoting subsections 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 is 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 appr oved 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 i s 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 an 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 section 5 [as am. by SOR/98-166, s. 4; 99-379, s. 2] 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, supra, the PM(NOC) Regulations offer a full and complete remedy to the problem.

[64]Many arguments have been put forth by the applicant as 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, supra, and Eli Lilly, supra, it appears that the applicant's position is based on more than simply its own interpretation of the PM(NOC) Re gulations.

[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 [at paragraphs 19, 21 and 22]:

The Minister, in exercising the authority under subsection 3(1), must consider whether the patent list meets the requirements of subsections 3(3), 4(1), 4(2) and 4(7) of the PM(NOC) Regulations.

    . . .

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. . . .

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".

[66]The decision applies the requirements of subsections 3(3), 4(1), 4(2) and 4(7) of the PM(NOC) Regulations 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 (subsection 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 (subsection 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 (subsection 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 (subsection 4(7)).

[71]In Eli Lilly, supra, the majority concludes thus as to the inclusion of the patent on the Register [at paragraph 29]:

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 (at paragraph 51) "contrary to what my colleague has asserted, . . . the requirements of subsection 3(3) have not been met".

[74]Isaac J.A. disagrees with Sharlow J.A. (at paragraph 52) "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". 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 subsection 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 [at paragraph 33] "can do no more than explain in very general terms the objective of the 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 page 353; Friesen v. Canada, [1995] 3 S.C.R. 103, at page 139; Bayer Inc. v. Canada (Attorney General) (1999), 87 C.P.R. (3d) 293 (F.C.A.), at page 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' ri ghts. Isaac J.A. writes (at paragraph 73):

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.

[76]The Federal Court of Appeal has not yet rendered a decision on the exact issue in this case, whether "a clai m to the use of the medicine" referred to in paragraph 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 supra, 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. v. Canada (Minister of National Health and Welfare) (2000), 181 D.L.R. (4th) 404.

(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 paragraphs 11 and 12:

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.

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), 82 C.P.R. (3d) 68 (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 (at paragraph 34):

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".

(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 (Minister of Citizenship and Immigration), [1999] 2 S.C.R. 817; and Conille v. Canada (Minister of Citizenship and Immigration), [1999] 2 F.C. 33 (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 [F.C.A.], there was a question as to (at paragraph 13) "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."

[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, supra, 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 Min ister 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 368 was ineligible for the Patent Register, the "alternative remedies" Gibson J. refers to in Apotex [F.C.T.D.] would be sufficient to resolve the case at bar.

(iii)     Remedies offered by the PM(NOC) Regulations

[85]In the Apotex (F.C.A.) decision, supra, 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, subsection 6(10) provides that one of the factors which the Court may take into account in making an order as to costs is, at paragraph 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 paragraphs 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 paragraph 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 [as am. by SOR/98-166, s. 1] provides for the possibility of the Court awarding damages or profits for losses incurred because of a subsection 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 [F.C.A. Apotex decision, at paragraphs 27-28]:

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.

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.