PATENTS |
Apotex Inc. v. Canada (Minister of Health)
T-812-02
2004 FC 650, O'Keefe J.
30/4/04
34 pp.
Registration--Apotex Inc. (Apotex), generic drug manufacturer, attempting since 2001 to obtain regulatory approval from respondent Minister of Health (Minister) to sell 20 mg Apo-Omeprazole capsules, generic version of 20 mg "Losec" capsules produced by respondent, AstraZeneca Canada Inc. (AstraZeneca)--Application for order prohibiting Minister from issuing Notice of Compliance (NOC) to Apotex in respect of 20 mg Apo-Omeprazole capsules until after expiration of AstraZeneca's patent (762 Patent), dismissed-- Apotex now seeking declarations: (1) if eligible for listing on patent register pursuant to Patented Medicines (Notice of Compliance) Regulations (NOC Regulations), 762 patent eligible for listing only in respect of Supplemental New Drug Submission (SNDS) Control No. 059881, which resulted in issuance of Notice of Compliance (NOC) to AstraZeneca on June 4, 1999, and not in respect of any other submission for NOC; and (2) Apotex not required to address 762 patent pursuant to NOC Regulations, in respect of NDS for NOC for Apo-Omeprazole 20 mg capsules, and Apotex has, in respect of 762 patent, satisfied requirements of NOC Regulations-- Apotex arguing: (1) 762 patent ineligible for listing because not meeting strict timing requirements of NOC Regulations as AstraZeneca's SNDS filings not triggering opportunity for patent list to be filed; (2) since subject-matter of 762 patent not relevant to AstraZeneca's 1993 SNDS filings, 762 patent not eligible under Regulations s. 5(1) for listing on register against NOCs issued for those filings; (3) s. 5(1) requirements not triggered because Apotex not making comparison to "Losec" capsules marketed pursuant to NOC for new uses of 762 patent; and (4) s. 5(1) requirements not triggered because patented product never "marketed in Canada"--In Apotex Inc. v. Canada (Minister of National Health and Welfare) (2000), 3. C.P.R. (4th) 1, Federal Court of Appeal refusing to interfere with Minister's discretion to refuse to delete patents from patent list register, due to scheme of NOC Regulations-- Ruling NOC Regulations provided comprehensive scheme for dealing with ineligible patents included on register and for dealing with damage, loss and costs suffered by generic manufacturers as result of ineligible patents being included on register--Here, Apotex filed Notice of Allegation (NOA) stating with respect to 762 patent, no claim for use of medicine or no claim for medicine itself would be infringed by Apotex's Apo-Omeprazole capsules--AstraZeneca then applied to Court for order prohibiting Minister from issuing NOC to Apotex--As result of filing of patent lists, 762 patent added to patent register--Issues raised by Apotex should have been dealt with as part of prohibition proceedings pursuant to NOC Regulations, s. 6(5)(a), which provide complete scheme for dealing with whether patent should be on patent register so as to have required Apotex to file NOA--Court of Appeal clearly indicating this is manner in which such questions to be dealt with--Alternatively, Court addressing timing and comparison arguments raised by Apotex in case not covered by procedure outlined by NOC Regulations, s. 6(5)(a)--As to timing, Apotex and Minister each proposing different interpretation of NOC Regulations, s. 5(1)--Court not needing to decide which interpretation correct because with either interpretation, s. 5(1) will apply and require Apotex to address 762 patent--As AstraZeneca not ceasing marketing of "Losec" in Canada until 1996, did market "Losec" in Canada pursuant to NOCs associated with patent list, namely, NOCs issued June 30, 1993 and July 15, 1994--S. 5(1) triggered, obliging Apotex to address 762 patent in NOA--As to comparison, Apotex submitting s. 5(1) not applicable because drug to which comparison made not drug with respect to which 762 patent issued--S. 5(1) simply referring to drug, not dealing with uses of drug--Drug in question "Losec" 20 mg capsules, to which Apotex compared 20 mg Apo-Omeprazole capsules--Accordingly, s. 5(1) applicable to Apotex, declarations requested by Apotex refused--Application dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 5(1) (as am. by SOR/99-379, s. 2), 6(5)(a) (as enacted by SOR/98-166, s. 5).