PATENTS |
Infringement |
H. Lundbeck A/S v. Canada (Minister of Health)
T-135-02
2003 FC 1334, Martineau J.
12/11/03
17 pp.
Applicants H Lundbeck A/S and Lundbeck Canada Inc. (Lundbeck) seeking order under Patented Medicines (Notice of Compliance) Regulations (PMR), s. 6 prohibiting Minister of Health (Minister) from issuing notice of compliance (NOC) to respondent Apotex Inc. (Apotex) in respect of 20 mg and 40 mg tablets of citalopram hydrobromide (citalopram) until after expiration of Canadian Patent No. 2,049,368 (368 Patent)-- 368 Patent containing specific description of drug, and list of 21 claims--Novelty element in 368 Patent use of citalopram to treat dementia and cerebro-vascular disorders (CVD) (claimed uses)--Citalopram already known as anti-depressant, as patent itself states--In case at bar, undisputed Apotex intends to manufacture and sell drug containing citalopram-- Application must fail for three reasons--First, claim 1 of 368 Patent claiming manufacture of drug product containing citalopram for claimed uses--Accordingly, if Apotex does not manufacture citalopram tablets for claimed uses, but rather, manufactures citalopram tablets solely for unclaimed use, no possible direct infringement of claim 1--Claim 8 for use of citalopram for treatment of dementia or CVD, where citalopram "effective" for such uses--Therefore, for Apotex's tablets to infringe claim 8, applicants must establish both "purpose" of tablets to be used for treatment of dementia or CVD, and tablet "effective" for such uses--Neither of foregoing has been alleged, much less proven by Lundbeck-- In conclusion, no direct infringement of claims 1 and 8 either by Apotex or by independent third parties, namely, patients-- Second, no conclusive evidence sustaining Lundbeck's allegation of direct infringement--Third, case law not supporting Lundbeck's assertion of direct infringement-- Decisions relied upon by Lundbeck distinguishable on basis citalopram has already been used to treat depressive illness (unclaimed use)-- Moreover, overlap of patients affected with both depression and dementia or CVD not sufficient per se to establish direct infringement--Finally, Lundbeck's assertion 368 Patent directly infringed inconsistent with purposes of PMR and also raising serious policy issues--In case at bar, Lundbeck's allegations of infringement purely speculative and not supported by evidence--Manifestly, Lundbeck has not proved, on balance of probabilities, if NOC issued to Apotex and it were to manufacture, market, or sell aforesaid tablets, claims 1 and 8 of 368 Patent would be infringed-- Application dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6 (as am. by SOR/98-166, s. 5; 99-379, s. 3).