PATENTS |
Infringement |
Wyeth-Ayerst Canada Inc. v. Faulding (Canada) Inc.
T-234-01
2002 FCT 969, Layden-Stevenson J.
13/9/02
28 pp.
Applicant seeking order prohibiting Minister of Health from issuing Notice of Compliance (NOC) to respondent until expiration of patent pursuant to Patented Medicines (Notice of Compliance) Regulations--Respondent claiming no infringement because process used outside scope of patent-- Unique element of patent being original concentration of formula, and processes following from it--Applicant claiming statutory presumption of infringement, Regulations s. 6(6), displacing burden of proof: Bayer Inc. v. Canada (Minister of National Health and Welfare) (2000), 6 C.P.R. (4th) 285 (F.C.A.), therefore applicant does not need to raise evidence--Respondent properly filed Notice of Allegation of non-infringement (NOA) with requisite legal, factual support--Applicant sought discovery of detailed process information which was not produced, brought application to this Court--Not addressing challenging respondent's NOA-- Threshold requirement of s. 6(6) that presumption only applies in absence of proof to contrary--NOA presumed to be true and constitutes proof: Merck Frosst Canada Inc. v. Canada (Minister of Health and Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.) and Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1996), 70 C.P.R. (3d) 206 (F.C.A.)--If NOA does not prima facie constitute infringement applicant must make positive case that respondent may nonetheless infringe patent--Applicant did not do so--Regulations, s. 6 proceedings confined to administrative purposes only (issue of notice of compliance)--If full trial of validity of infringement issues required, can still commence action--Applicants could have sought court challenge but chose not to do so--Applicant's entire case rests on s. 6(6) presumption--Respondents' NOA indicates activities outside patent monopoly, falls within prior art--Applicant cannot win by saying NOA not sufficiently detailed or allegation not justified--Presumption not altering result--Application dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6(6) (as enacted by SOR/98-166, s. 5; 99-397, s. 3).