Digests

H. Lundbeck A/S v. Canada (Minister of Health)

T-122-02

2003 FC 1145, Blais J.

3/10/03

32 pp.

Application by H. Lundbeck A/S and Lundbeck Canada Inc. (applicants) pursuant to Patented Medicines (Notice of Compliance) Regulations (PM Regulations), s. 6(1) for order prohibiting Minister of Health from issuing a Notice of Compliance (NOC) to Genpharm Inc. (Genpharm) in respect of citalopram hydrobromide (citalopram) in each of 10 mg, 20 mg and 40 mg strengths until after expiration of Canadian Patent no. 2049368 (368 patent)--Patent 368 entitled Treatment of Cerebro-Vascular Disorders--Chemical composition of drug involves novel intermediate step, object of patent no. 1237147--Novelty element in patent 368 use of citalopram to treat dementia and cerebro-vascular diseases (CVD)--Citalopram already well-known as anti-depressant, as patent itself states--368 patent contains description of drug, and list of 21 claims--Claims protected by inclusion of drug on patent list are those claims related to use of medicine --Citalopram part of class of pharmaceutical drugs called Selective Serotonin Reuptake Inhibitors (SSRI), type of drug which has shown itself very useful in treatment of depression and depressive illness--Whether Genpharm justified in alleging that by manufacturing and selling drug citalopram it will not infringe 368 patent--In Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.), aff (1994), 53 C.P.R. (3d) 368 (F.C.T.D.), Hugessen, J.A., defined burden of proof in case under PM Regulations--Applicants must discharge burden of proving Genpharm's allegations of non-infringement without merit--Must prove use that Genpharm's drug would be put to would infringe use protected by virtue of fact patent 368 listed on Register-- Applicants must establish Genpharm tablets will be used for protected use (as listed on Register) as opposed to unprotected use, as enunciated in NOC--In case at bar, Genpharm's allegation simple: citalopram it would produce would not be used to treat any of diseases enumerated in patent claims-- Evidence presented by Genpharm two-fold: depression not dementia or CVD, and thus treating former not treating latter; and little likelihood citalopram would be prescribed for uses which patent protects--This evidence serves to support allegation of non-infringement--Matter of inefficacy not aimed at validity of patent, but rather, at probability generic citalopram would be used or prescribed in way infringing patent claims--Infringement can be direct or indirect--In case at bar, applicants have not established, on balance of probabilities, that Genpharm intends to make, use or sell generic form of citalopram for any other purpose save old, approved use--Nor have applicants demonstrated citalopram would be used or prescribed by third parties for uses other than approved use--No evidence of citalopram being recognized by medical profession as promising medication for any of patented uses claimed in patent list--In case at bar, new use for dementia, CVD or Alzheimer's-- Depression not new use, and trying to include it in treatment of those diseases does not make it new use--Claim for use relates to treatment of dementia, CVD, Alzheimer's or ischemia--Use of citalopram for depression old use, and not claimed by patent--Use that NOC has been issued for in case of applicant's drug Celexa depression, not any of diseases for which there is patent claim listed--Patent makes no claim as to depression, since use well-established and thus cannot be patented--If use cannot be patented, it cannot be infringed-- Applicants have not convincingly established Genpharm's citalopram would be prescribed for anything else but depression--No convincing evidence presented citalopram would be of any use to treat CVD, dementia or Alzheimer's as such--Research as to treatment of behavioural problems still very sketchy--Fact is that citalopram offers effective remedy against depression, and that use not protected--All other uses of citalopram have so far been in isolated experiments which have not shown much promise of generating more research-- Applicants have not established issuing NOC to respondent for manufacturing and marketing of citalopram would result in infringement of patent 368--Accordingly, judicial review dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133.