[2013] 3 F.C.R. D-7
Patents
Infringement
Application for order prohibiting Minister of Health from issuing, pursuant to Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 notice of compliance to respondent regarding quietiapine fumarate extended release tablets until expiry of Canadian Patent No. 2251944 ('944 patent)—Drug at issue used to treat various psychiatric disorders—Respondent’s notices of allegation to applicants claiming, inter alia, invalidity of '944 patent for reasons of obviousness, ambiguity—Whether '944 patent invalid on basis of obviousness, ambiguity—Respondent bearing burden of giving allegations of invalidity air of reality; if succeeding, presumption of patent’s validity rebutted—Invention claimed by '944 patent constituting sustained release formulation of quetiapine hemifumarate made with hydroxypropyl methylcellulose (HPMC) as gelling agent with view to decreasing occurrence of dose dumping, reducing dosing frequency—Having to determine whether self-evident that if skilled person combining quetiapine with known sustained release formulation, result would be sustained release formulation of quetiapine—“Obvious to try” test applied herein—Patent may be found obvious if more or less self-evident to try to obtain invention—Motivation constituting key factor in present case—“Fair expectation of success” constituting correct standard against which to assess obviousness—In present case, prior art disclosing motive to create sustained release formulation of quetiapine—Based on evidence, self-evident that fair expectation existing that sustained release formulation of quetiapine using HPMC would be successful—Respondent giving allegations of invalidity air of reality since more or less self-evident to try to obtain sustained release formulation of quetiapine using HPMC—Applicant failing to establish that respondent’s allegations of invalidity unjustified—Given conclusions regarding obviousness, issue regarding ambiguity not examined—Application dismissed.
AstraZeneca Canada Inc. v. Teva Canada Limited (T-1259-11, 2013 FC 245, Near J., judgment dated March 7, 2013, 31 pp.)