Date: 20031112
Docket: T-2112-02
Citation: 2003 FC 1333
BETWEEN:
H. LUNDBECK A/S
and
LUNDBECK CANADA INC.
Applicants
and
THE MINISTER OF HEALTH CANADA
and
PHARMASCIENCE INC.
Respondents
REASONS FOR ORDER
RICHARD MORNEAU, PROTHONOTARY:
[1] This is a motion by the respondent Pharmascience Inc. under subsection 6(5) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, March 12, 1993, as amended (the Regulations), for the purposes of obtaining the dismissal of the application for judicial review filed by the applicants under subsection 6(1) of the Regulations (the Lundbeck application).
Context
[2] The essential context to keep in mind for analytical purposes appears to be fairly simple. Furthermore, the provisions of the Regulations at issue in this proceeding are known to the parties and those affected by decisions such as this and these provisions will therefore not be reproduced here in extenso, other than by exception.
[3] Lundbeck is the owner of patent no. 2,049,368 (the Patent) that is intended to protect citalopram hydrobromide (hereinafter citalopram) in the treatment of dementia. The patent application was filed in August 1991 and the Patent expires on August 16, 2011.
[4] In February 1999, Lundbeck obtained from the Minister of Health a notice of compliance (hereinafter, expression referred to under its English acronym "NOC") for citalopram as an antidepressant, that is, in regard to its use in treating depression. Lundbeck markets the citalopram under the name Celexa.
[5] It is therefore recognized at this stage that Lundbeck's NOC covers citalopram in regard to depression but that this use for depression is not the use protected by the Patent, which protects the use of this drug in regard to dementia. In fact, as expressed by Pharmascience's notice of allegation (hereinafter, expression referred to under its English acronym "NOA"), to which we will return later, the use of citalopram in the treatment of depression is not protected in Canada by any patent still in force.
[6] Under section 4 of the Regulations, however, Lundbeck, in the context of its NOC application, included the Patent in its list of patents in regard to citalopram. Under section 3 of the Regulations, the Patent is therefore included in the Register.
[7] However, Pharmascience wants to market citalopram for the treatment of depression.
[8] Since the Patent is listed in relation to Lundbeck's NOC dealing with depression, Pharmascience had to send Lundbeck an NOA if it, Pharmascience, wanted to obtain an NOC some day for the use of citalopram for depression.
[9] On November 12, 2002, therefore, Pharmascience sent Lundbeck the NOA under section 5 of the Regulations. To summarize, this NOA tells Lundbeck that Pharmascience's marketing of citalopram as an antidepressant will not infringe the Patent since the latter protects citalopram in the treatment of dementia. Pharmascience also states in its NOA that the only use that will be listed in the monograph will be the one affecting depression. Here, for that matter, is the full text of Pharmascience's NOA:
Pursuant to section 5 of the Patented Medicines (Notice of Compliance) Regulations ('NOC Regulations'), Pharmascience Inc., ('PMS') hereby serves a detailed statement of the legal and factual basis for its allegation according to section 5(1)(b) of the NOC Regulations.
PMS has filed an Abbreviated New Drug Submissions ('ANDS') in respect of Citalopram Hydrobromide tablets 20 mg and 40 mg for oral administration as an antidepressant. The ANDS was filed on October 31, 2002 and makes reference to the NOC received in respect of Celexa 20 mg and 40 mg tablets for use as an antidepressant.
With respect to the claims of Canadian patent number 2049368, we allege that no holding may be made that the claims for the medicine itself and the claims for the use of the medicine (namely, claims 1 to 21) would be infringed by our making, constructing, using or selling of the aforesaid tablets.
The legal and factual basis for this allegation is as follows:
[omitted]
B) The Canadian patent number 2049368, has been listed against Celexa (Citalopram Hydrobromide) tablets 20 mg and 40 mg for which a Notice of Compliance, dated February 5, 1999, (copy attached) identifies citalopram hydrobromide as an antidepressant medicine only.
C) The only use that will be included in our Product Monograph will be the use of citalopram hydrobromide as an antidepressant, i.e. for the treatment of depression.
D) The use of citalopram hydrobromide as an antidepressant is a prior art use.
E) The disclosure of Canadian patent number 2049368 in fact acknowledges such use, as a prior art use (see attached copies of pages 1 and 2). The prior art includes the prior art as discussed during prosecution of the application for Canadian patent number 2049368, such as, in the response dated March 29, 2001 filed by the applicant (copy attached); as well as the prior art mentioned during the prosecution of the counterpart U.S. and European applications (i.e. U.S. patent number 5296507 and EP - 474580).
F) For example, Canadian patent number 1094087 which issued January 20, 1981 (now expired), identifies citalopram hydrobromide as an antidepressant medicine; the corresponding U.S. patent number 4,136,193, which issued January 23, 1979, is acknowledged as prior art on page 1 of the disclosure of Canadian patent number 2049368.
G) Canadian patent number 2049368 was filed on August 16, 1991 based on a priority date of September 6, 1990 and issued October 23, 2001.
H) The claims of Canadian patent number 2049368 relate only to the specific use of citalopram hydrobromide for the manufacture of a medicine for the treatment of cognitive disorders or amnesia associated with dementia and of cerebrovascular disorders (claims 1 to 7), to a composition for the specific treatment of dementia and cerebrovascular disorders (claims 8 to 14) and to a method to make compositions for the specific treatment of dementia and cerebrovascular disorders (claims 15 to 21).
I) Our product, including its manufacture, by admixing Citalopram Hydrobromide with a pharmaceutically acceptable carrier or diluent, will not infringe any of the claims of Canadian patent number 2049368 since, as noted above, the only use that will be included in our Product Monograph will be the prior art use of citalopram hydrobromide as an antidepressant.
J) In the event that any or all of the claims of Canadian patent number 2049368 are interpreted to include the use of citalopram hydrobromide as an antidepressant, all such claims are invalid in view of the prior art. As indicated above, the use of citalopram hydrobromide as an antidepressant was known and was, in fact, the object of an expired Canadian Patent, prior to the priority date of Canadian patent number 2049368. In other words, any so interpreted claims of Canadian patent number 2049368 are anticipated in view of the prior art, and in particular in view of Canadian patent number 1094087.
K) Furthermore, as indicated above, Canadian patent number 2049368 does not relate to an antidepressant drug and as such is not relevant to the antidepressant drug mentioned in the Notice of Compliance, dated February 5, 1999 (referred to above). Since the Canadian patent number 2049368 is thus ineligible for inclusion in the register, there can be no holding of infringement, for the purposes of the Patented Medicines (Notice of Compliance) regulations, with respect to Canadian patent number 2049368.
(Emphasis added.)
[10] However, in December 2002, Lundbeck filed pursuant to section 6 of the Regulations its application by which it asks this Court to prohibit the responsible minister under the Regulations from issuing an NOC before the expiration of the Patent essentially, for our purposes, on the ground that Pharmascience's allegation of non-infringement of the Patent is not justified.
Analysis
[11] Pharmascience's motion to dismiss is made, as I indicated earlier in paragraph [1], under subsection 6(5) of the Regulations. This subsection stipulates that this Court may dismiss an application, such as Lundbeck's, either under paragraph 6(5)(a), because the Court is satisfied that the Patent is not eligible for inclusion on the Register, or, under paragraph 6(5)(b), because the Court finds that the application is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process.
[12] Pharmascience's motion to dismiss asks the Court to consider the dismissal under both paragraphs of subsection 6(5) of the Regulations.
[13] In regard to the burden of proof that Pharmascience must meet on this motion, it is essentially similar to the one that a defendant must meet when it seeks to have a statement of claim struck out under rule 221 of the Federal Court Rules, 1998.
[14] Pharmascience must therefore persuade this Court that it is clear and obvious that Lundbeck, in the context of its application, will be unable to persuade the Court, by a preponderance of evidence, that Pharmascience's allegation of non-infringement of the Patent is not justified (hereinafter referred to occasionally as the applicable test).
[15] This test is derived, in the first place, from what has been said about the burden of proof that an applicant must meet in an application on the merits under subsection 6(1) of the Regulations. In Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.), Mr. Justice Hugessen, as he then was, stated on behalf of the Federal Court of Appeal, at page 319:
Furthermore, since the regulations clearly allow the Minister, absent a timely application under s. 6, to issue a notice of compliance on the basis of the allegations in the notice of allegation, it would seem that on the hearing of such an application, at least where the notice has alleged non-infringement, the court should start from the proposition that the allegations of fact in the notice of allegation are true except to the extent that the contrary has been shown by the applicant. In determining whether or not the allegations are "justified" (s. 6(2)), the court must then decide whether, on the basis of such facts as have been assumed or proven, the allegations would give rise in law to the conclusion that the patent would not be infringed by the respondent.
(Emphasis added.)
[16] Secondly, in AB Hassle v. Canada (Minister of National Health and Welfare (2000), 9 C.P.R. (4th) 79, Mr. Justice McKeown of the Federal Court Trial Division stated at page 85, in regard to the burden under paragraph 6(5)(b) of the Regulations:
The burden of proof and standard is very high on a motion to dismiss pursuant to paragraph 6(5)(b) of the Regulations. In considering such a motion, any doubt must be left for resolution by the trial judge. A proceeding should not be summarily dismissed unless it is without doubt or obvious that the application is so clearly futile that there is not the slightest chance of succeeding.
[17] Now let us look at how the Pharmascience motion stands up to the applicable test under each of the paragraphs in subsection 6(5) of the Regulations.
[18] In regard to paragraph 6(5)(a), the Pharmascience motion must be dismissed since in a recent decision dated October 3, 2003, in the context of an application for judicial review on the merits in which another generic company, Genpharm, was asking, for essentially the same reasons as those raised in this proceeding by Pharmascience, that the Patent be withdrawn from the Register, Mr. Justice Blais of this Court held that he was bound by the cases to acknowledge that the Patent could remain on the Register. If Blais J. was bound by precedent, it will be understood that I, as a prothonotary of this Court, am bound even further by precedent, including the decision of Blais J. In that judgment, Genpharm Inc. v. Minister of Health, Attorney General of Canada and Company X, 2003 F.C. 1148, October 3, 2003,Blais J. states at paragraphs [76] and [77]:
[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.
[19] I adopt this conclusion of Blais J., although technically it can be viewed as obiter dicta, since Blais J. holds that the withdrawal of a patent from the Register is obtained through a motion for dismissal under subsection 6(5) of the Regulations and not through an application for judicial review on the merits.
[20] In regard to paragraph 6(5)(b) of the Regulations, Pharmascience's motion does, in my opinion, for the reasons that follow, meet the applicable test (see paragraph [14], supra), and Lundbeck's application must consequently be dismissed.
[21] Lundbeck's position in its application and on this motion essentially comes down to a fairly simple equation.
[22] It argues that its evidence establishes that there is a segment of the population that suffers from both depression and dementia. This is not disputed by Pharmascience, apparently.
[23] Lundbeck argues, accordingly, that even if Pharmascience's allegations in its NOA are taken as proved, i.e. that Pharmascience will market citalopram only for depression, because depression and dementia coexist in a portion of the population the citalopram will necessarily be used for the purposes protected by the Patent, namely, the manufacture and use of citalopram in the treatment of dementia.
[24] At the hearing on this motion, the parties, referring to the affidavit evidence filed by Lundbeck and the cross-examinations on those affidavits, debated whether on the facts it could be expected that the citalopram would be used effectively to fight dementia. Without discussing this, I will take this point for granted, in Lundbeck's favour, because even on that assumption - a conclusion that is necessarily incorporated in Lundbeck's basic equation - that equation can be answered here.
[25] Lundbeck expresses itself more precisely as follows, at paragraphs 20 to 25 of its application:
20. The factual basis relied upon by Pharmascience, even if assumed to be true, does not justify the allegation of non-infringement.
21. The question is not whether Pharmascience seeks approval for the treatment of dementia and cerebrovascular disorders, or more particularized forms thereof, but rather whether its product will in fact be used for those purposes. The intention of Pharmascience is immaterial.
22. In this case, there is a portion of the population affected by both depression and dementia or cerebrovascular disorders. Therefore, in those patients, the making or marketing of a product containing citalopram hydrobromide for the avowed purpose of treating depressive illnesses will infringe the patent since the drug will also treat dementia or cerebrovascular disorders.
23. Therefore, the fact that Pharmascience will not indicate any of the uses claimed in the '368 patent in its submission, and that it will not be able to indicate any of these uses should the Minister issue a Notice of Compliance, does not mean that the '368 patent will not be infringed.
24. The factual basis alleged by Pharmascience in its Notice of Allegation does not justify the conclusion of non-infringement and the Notice of Allegation is deficient.
35. The product to be manufactured or marketed by Pharmascience is within the scope of the claims of the '368 patent and any manufacture, use, import or sale of citalopram hydrobromide by Pharmascience in Canada will infringe the said patent.
(Emphasis added.)
[26] Lundbeck argues that we should therefore conclude that the coexistence of a new use protected by patent (in this case, citalopram for dementia) with an old use unprotected by patent (here, citalopram for depression) means that the old use for the profit of a generic company cannot be covered by an NOC.
[27] At the end of the day, such a position, when all is said and done, would allow Lundbeck to get a monopoly on the citalopram. This is an untenable result, and has already been denounced at least twice by the Federal Court of Appeal, even if the factual dynamics leading to this monopoly finding in those judgments differed from ours (i.e. the coexistence of two illnesses or disorders).
[28] In 1989, in Apotex v. Hoffmann-La Roche Ltd. (1989), 24 C.P.R. (3d) 289, the Federal Court of Appeal held, at page 299:
The appellant relied on the decision of the Supreme Court of Canada in Shell Oil Co. Ltd. v. Com'r of Patents (1982), 67 C.P.R. (2d) 1, 142 D.L.R. (3d) 117, [1982] 2 S.C.R. 536">[1982] 2 S.C.R. 536, as authority for the proposition that a new use for an old compound was patentable in Canada. That is no doubt correct. But, in my view, the case is far from being authority for the proposition that the discovery of a new use for an old compound entitles the discoverer to a complete monopoly of the old compound.
(Emphasis added.)
[29] Recently, on November 1, 2002, the Federal Court of Appeal, in AB Hassle v. Apotex Inc. (2002), 22 C.P.R. (4th) 1 (AB Hassle), stated at page 18, paragraphs [57] to [60]:
[57] Thus Apotex cannot be prevented from obtaining a NOC solely on the basis that it will sell omeprazole. If it were otherwise, then serious policy issues would arise. If there was any likelihood that a patient would consume a generic product for a patented use, then the generic product would not be approved. This would prevent new uses from being approved for existing drugs because there is always the possibility that someone somewhere will use the drug for the prohibited, patented purpose. This would result in a real injustice: since a generic company cannot possibly control how everyone in the world uses its product, the prevention of the generic from marketing the product would further fortify and artificially extend the monopoly held by the patent holders. The patent holder would, therefore, effectively control not just the new uses for the old compound, but the compound itself, even though the compound itself is not protected by the patent in the first place. The patent holders, as a result, would obtain a benefit they were not meant to have. In the end, society would be deprived of the benefit of new methods of using existing pharmaceutical medicines at a lower cost.
[58] Nor can Apotex be held liable in patent infringement proceedings under the Patent Act if, contrary to the evidence presented in the NOC proceeding, third party infringements do occur after the issue of a NOC, unless Apotex has implicated itself in the infringements by, for example, inducing or encouraging them. Genpharm has no application to a generic's liability under the Patent Act for any patent infringement by a third party that occurs after a NOC has been issued.
[59] The Appellants have not proved that, if a NOC were issued to Apotex and it were to sell omeprazole, patients or other third parties would infringe the Appellants' use patent. If a first person cannot prove in prohibition proceedings that future infringements will occur if a NOC is issued, it cannot obtain a prohibition by relying on subparagraph 5(1)(b)(iv), however the required nexus between the generic and the infringement is defined.
Conclusion
[60] This appeal should be dismissed with costs.
(Emphasis added.)
[30] Finally, quite recently, on October 3, 2003, Blais J. issued another decision, H. Lundbeck A/S and Lundbeck Canada Inc. v. Genpharm Inc., 2003 FC 1145, in which he applied AB Hassle in a way that was central to his decision on an application for judicial review brought by Lundbeck on the basis of the Patent pursuant to the issuance of an NOA (by Genpharm) similar to the one by Pharmascience in the case at bar. In the situation before Blais J., only the identity of the respondent and occasionally the content of the evidence were different.
[31] Although Blais J. assesses at some length the evidence concerning the effectiveness or lack thereof of citalopram in the treatment of dementia, this additional analysis, when all is said and done, parallels the assessment he made of the equation submitted by Genpharm, one that is similar to Pharmascience's (see paragraphs [16], [42] and [49] of the decision of Blais J.). He relies heavily on AB Hassle, supra.
[32] In conclusion, he states, at paragraph [65]:
[65] The claim for use relates to the treatment of dementia, CVD, Alzheimer or ischemia. The use of citalopram for depression is an old use, and is not claimed by the patent. The use that the NOC has been issued for in the case of Lundbeck's drug Celexa is depression, not any of the diseases for which there is a patent claim listed. The patent makes no claim as to depression, since that use is well-established and thus cannot be patented. It stands to reason that if the use cannot be patented, it cannot be infringed.
(Emphasis added.)
[33] Furthermore, I fully share the following views of counsel for Pharmascience when they state, in paragraph 36 of their written submissions:
Should any claim of the '368 patent be interpreted in such a way as to cover the manufacture and marketing of citalopram hydrobromide for the treatment of depression and preclude Pharmascience from practicing such use, then any such claim would simply be invalid by reason of anticipation or being obvious by the prior art, notably by the '087 patent and the '193 patent.
[34] For these reasons, an order shall go dismissing Lundbeck's application. As to costs on this motion, notwithstanding Pharmascience's request that they be awarded on a solicitor-client basis, I think it is more reasonable and acceptable that the costs be awarded to Pharmascience but under the maximum in Column IV of Tariff B.
"Richard Morneau"
Prothonotary
Montréal, Quebec
November 12, 2003
Certified true translation
Suzanne Gauthier, C.Tr., LL.L.
FEDERAL COURT
Date: 20031112
Docket: T-2112-02
Between:
H. LUNDBECK A/S
and
LUNDBECK CANADA INC.
Applicants
and
THE MINISTER OF HEALTH CANADA
and
PHARMASCIENCE INC.
Respondents
REASONS FOR ORDER
FEDERAL COURT
SOLICITORS OF RECORD
DOCKET: T-2112-02
STYLE: H. LUNDBECK A/S
and
LUNDBECK CANADA INC.
Applicants
and
THE MINISTER OF HEALTH CANADA
and
PHARMASCIENCE INC.
Respondents
PLACE OF HEARING: Montréal, Quebec
DATE OF HEARING: October 29, 2003
REASONS FOR ORDER OF RICHARD MORNEAU, PROTHONOTARY
DATED: November 12, 2003
APPEARANCES:
Marie Lafleur for the applicants
Martin Sheehan
Bruno Barrette for the respondent Pharmascience Inc.
Pascal Lauzon
SOLICITORS OF RECORD:
Fasken Martineau DuMoulin for the applicants
Montréal, Quebec
Brouillette Charpentier Fortin for the respondent Pharmascience Inc.
Montréal, Quebec
Morris Rosenberg
Deputy Attorney General of Canada
for the respondent, the Minister of Health Canada
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