Digests

GlaxoSmithKline Inc. v. Genpharm Inc.

T-1755-01

2003 FC 1248, Heneghan J.

24/10/03

56 pp.

Applicants (GSK) seeking order under Patented Medicines (Notice of Compliance) Regulations, s. 6(1) prohibiting Minister of Health from issuing notice of compliance (NOC) to Genpharm Inc. (respondent) until after expiry of Canadian letters patent 1287060 (060 patent) relating to crystalline paroxetine hydrochloride hemihydrate, processes for preparation, use as therapeutic agent in pharmaceutically acceptable form--Applicants taking issue only with claim 10 of patent--Application seeking to prohibit issuance of NOC to respondent for product containing crystalline paroxetine hydrochloride anyhydrate--NOC Regulations prohibiting Minister of Health from issuing NOC until all relevant product, use patents in earlier approved medicine have expired--Second person must either wait until patent expiry before receiving NOC or may submit notice of allegation (NOA) to Minister with new drug submission--Burden of proving on balance of probabilities, Genpharm's allegations not justified, on GSK--Court must determine whether Genpharm's allegations of invalidity, non-infringement justified or not--NOA sufficiently setting out factual, legal basis for respondent's allegations--Detailed statement filed by respondent raising allegations of invalidity on grounds of anticipation, novelty, in relation to claim 10--Detailed statement also raising issue of non-infringement--NOA, including detailed statement, met test for sufficiency as described in relevant case law--Current case law requiring Court to take purposive approach, having regard to entirety of patent, including disclosure--Respondent arguing patent invalid on two grounds: obviousness, anticipation-- Test for obviousness requiring capable but non-imaginative skilled person to look at common knowledge in art at date of invention and immediately, without inventive ingenuity, reach described invention--Cited art here not meeting test--Test for anticipation defined by Federal Court of Appeal in Beloit Canada Ltd. et al. v. Valmet Oy (1986), 8 C.P.R. (3d) 289--Anticipation, or lack of novelty, asserts that invention made known to public prior to relevant time--Respondent's argument claim 10 anticipated because of Patent Act, s. 27(1)(a), that is invention "known or used" by another person before priority date, failing as such knowledge, use must have been "available to the public" under Act, s. 61(1)(a)--As to infringement, burden on applicants to show respondent's product infringing claim 10 of patent--Applicants relying on testing of bulk material, certain tablets--However, doubt has been cast on reliability of testing--Applicants failed to establish infringement by respondent--Application for order of prohibition relating to 060 patent dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6(1)--Patent Act, R.S.C., 1985, c. P-4, ss. 27 (as am. by R.S.C., 1985 (3rd Supp.), c. 33, s. 8; S.C. 1993, c. 15, s. 31; c. 44, s. 192), 61 (as repealed by R.S.C., 1985 (3rd Supp.), c. 33, s. 23).