PATENTS |
Pfizer Canada Inc. v. Apotex Inc.
T-2096-00
2002 FCT 1138, Dawson J.
5/11/02
54 pp.
Applicants seeking order pursuant to s. 6(1) of Patented Medicines (Notice of Compliance) Regulations prohibiting respondent Minister of Health from issuing a notice of compliance (NOC) to respondent Apotex Inc. in connection with version of drug sertraline until after expiration of Canadian Letters Patent No. 2029065 (065 patent)--Pfizer Inc., owner of 065 patent, sells sertraline in Canada under trade-mark "Zoloft"--Apotex Inc. Canadian manufacturer of generic products--On August 31, 1982, Canadian Letters Patent No. 1130815 (815 patent) issued to Pfizer in relation to use of sertraline for treatment of depression--065 patent discloses and claims new uses for sertraline for disorders distinct from depression--Upon expiration of 815 patent Apotex received NOC for apo-sertraline for treatment of depression only--Whether 065 invalid on grounds of obviousness, anticipation, insufficient specification or double patenting, ambiguity--Apotex served notice of allegation (NOA) to obtain NOC to enable it to see apo-sertraline with additional uses in connection with obsessive-compulsive disorder (OC) and panic disorder (PD)--Apotex alleged 065 patent invalid because not containing inventive subject-matter and not complying with Patent Act--Regarding burden of proof under Regulations, principle set out in SmithKline Beecham Pharma Inc. v. Apotex Inc., [2001] 4 F.C. 518 (T.D.) --Burden on Pfizer only to disprove allegations in notice of allegation, not to justify declarations of validity and infringement or conversely to negative claims for declarations of invalidity and non-infringement--Apotex not obliged to put in issue validity of claims contained in 065 Patent irrelevant to authorized use of sertraline to treat PD and OCD-- Obligation of generic manufacturer seeking NOC and comparing drug to another to establish bioequivalence set out in s. 5(1) of Regulations--S. 5(1) providing generic's obligation triggered by filing submission for NOC in circumstances where comparison between generic's drug and another drug already marketed in Canada pursuant to NOC --Interpretation of legislation having regard to purpose of legislation, intention of Parliament--Purpose of Regulations to prevent infringement--Purpose not served by requiring generic manufacturer in proceedings under Regulations to invalidate patent claims that are irrelevant to proposed use by generic and irrelevant to comparison triggering application of s. 5 of Regulations--Under purposive interpretation of Regulations, if innovator unable to disprove allegation use claim invalid, purpose of Regulations served by issuance of NOC in connection with that use in question--Here relevant allegation in substance relates to use of sertraline for PD and OCD, together with broader related claims, and does not relate to uses of sertraline not authorized in Canada-- Regarding allegation of invalidity on ground of obviousness, test for obviousness whether alleged invention required exercise of inventive ingenuity--No inventiveness in following obvious, well-charted route using known techniques and processes involving known compositions unless inventor encounters difficulties not reasonably expected by person versed in art or overcome by application of ordinary skill--Patent directed to skilled psychiatrist or someone knowledgeable in treatment of anxiety-related disorders--No inventive step or undue experimentation required in circumstances for notional skilled psychiatrist to prescribe sertraline for PD and OCD--On totality of evidence Pfizer failed to meet burden to establish on balance of probabilities allegation of obviousness not justified--Regarding argument of invalidity of 065 patent on ground of anticipation, legal test for anticipation set out in Free World Trust v. Électro Santé Inc., [2000] 2 S.C.R. 1024: whether specific piece of prior art contains sufficient information to enable person of ordinary skill and knowledge in field to understand nature of invention and carry it into practical use without aid of inventive genius but purely by mechanical skill, without access to patent--Pfizer not discharging burden to establish allegation of invalidity of claims not justified on ground of anticipation--Application for order of prohibition dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, rr. 5 (as am. by SOR/98-166, s. 5; 99-379, s. 2), 6 (as am. by SOR/98-166, s. 5; 99-379, s. 3)--Patent Act, R.S.C., 1985, c. P-4, s. 43(2) (as am. by S.C. 1993, c. 15, s. 42).