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Infringement

GlaxoSmithKline Inc. v. Canada (Minister of Health)

T-1871-01

2002 FC 899, Noël J.

18/7/03

35 pp.

Application for order prohibiting Minister of Health from granting to Pharmascience Inc. (Pharmascience) notice of compliance (NOC) in respect of medicine carvedilol tablets (used for treatment of congestive heart failure (CHF), reducing mortality) until after expiration of applicants' patent No. 2212548 (548 patent)--GlaxoSmithKline bears legal burden to demonstrate, on balance of probabilities, that Pharmascience's allegations in notice of allegation (NOA) not justified--Issue whether Pharmascience's allegations of invalidity of 548 patent for reasons of anticipation and/or obviousness in light of prior art justified--Application dismissed--548 patent invention as directed to novel use of known compound (association of use of carvedilol for treatment of CHF with benefit of reducing mortality)-- Application of test for obviousness as articulated in Beloit Can. Ltd. v. Valmet Oy (1986), 8 C.P.R. (3d) 289 (F.C.A.): would technician skilled in art but having no scintilla of inventiveness or imagination, in light of state of art and common general knowledge as at claimed date of invention, have come directly and without difficulty to solution taught by patent?--Next step to evaluate prior art relating to use of carvedilol and, based on it, determine whether solution claimed by GlaxoSmithKline one which would have occurred to everyone of ordinary intelligence and acquaintance with carvedilol who applied his mind to problem--Prior art, individually or taken together, would have led unimaginative skilled technician (cardiologist) to invention, specifically, to consider use of carvedilol as treatment of CHF, particularly to prolong survival, without undue experimentation, whole thing subject to results of trials expected in 1994--548 patent rendered obvious by prior art in existence at date of invention--As to anticipation, GlaxoSmithKline has establi-shed that allegation of invalidity on ground of anticipation not justified.

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