PATENTS |
Infringement |
GlaxoSmithKline Inc. v. Apotex Inc.
T-1059-01
2003 FCT 687, Kelen J.
30/5/03
52 pp.
Application under Patented Medicines (Notice of Compliance) Regulations, s. 6(1) for order prohibiting Minister of Health from issuing Notice of Compliance (NOC) to respondent Apotex Inc. for drug paroxetine hydrochloride until after expiry of Canadian Letters Patent 2214575 (575 patent)--Application brought in response to Notice of Allegation (NOA) filed by Apotex--Apotex alleging no claim for medicine itself, no claim for use of medicine infringed by plans to manufacture, sell tablets containing paroxetine hydrochloride--Whether allegations set out in Apotex's NOA justified--Application concerning formulation process for tablets of anti-depressant medication paroxetine--First step in reaching determination with respect to Apotex's allegations of non-infringement, invalidity to construe claims made in 575 patent in order to identify what inventor considered to be essential elements of invention--Based on construction of 575 patent, Apotex's allegation of non-infringement justified --By shifting production to anhydrate form, Apotex altered essential element of invention claimed by 575 patent--In order for patent to be valid, invention it claims must not have been disclosed by applicant or person who obtained knowledge from applicant, directly or indirectly, more than one year before filing date--Relevant date for determining anticipation one year prior to filing date by applicant--575 patent having priority date of December 15, 1993 based on filing in United Kingdom--Application for 575 patent filed as divisional application of 637 patent--Act, s. 36 governing filing of divisional applications, issuance of patent based on divisional application--Under s. 36(2), where application for patent describes more than one invention, divisional application may be filed, separate patent issued--Issuance of two patents for single invention traditionally prohibited in Canada--Prohibition against double patenting has two branches--Second branch of prohibition against double patenting referred to as "obviousness" double patenting, relevant to present application--"Sin of double patenting" has not evaporated--Regardless of whether "the sin of double patenting" still exists, patent holder should not be able to receive additional patents for same invention--Apotex rightly submitting 575 patent violation of second branch of prohibition as formulation obvious variant from claims of 637 patent, does not disclose inventive step--Claims of 575 patent display no novelty, ingenuity over claims of 637 patent--Applicants failed to refute Apotex's allegation of double patenting--Apotex's allegations of non-infringement, invalidity justified--Application dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6--Patent Act, R.S.C., 1985, c. P-4, s. 36 (as am. by S.C. 1993, c. 15, s. 39).