Digests

AstraZeneca AB v. Apotex Inc.

T-2311-01

2004 FC 313, O'Keefe J.

2/3/04

37 pp.

Application by AstraZeneca AB, AstraZeneca Canada Inc. (AstraZeneca) for order prohibiting Minister of Health from issuing notice of compliance (NOC) to Apotex Inc. in respect of Apo-Omeprazole capsules containing omeprazole in 20 mg strength for oral administration, until after expiration of Canadian Patent No. 2133762 (762 Patent)--762 Patent discloses certain antibiotic compounds affecting Helicobacter pylori degraded into non-antibacterial metabolites in presence of gastric acid, which drastically reduces antibacterial efficacy --AstraZeneca submitted Apotex's notice of allegation (NOA) fatally flawed because failing to allege non-infringement by patients, to address uses referred to in several of 762 Patent claims--Apotex submitted AstraZeneca failed to discharge burden of establishing Apotex's allegation of non- infringement unjustified, therefore, application must be dismissed--AstraZeneca's principal attack on credibility of Dr. Sherman based on evidence Apo-Omeprazole product monograph would not refer to co-administration with antibiotic (concomitant use) but in fact product monograph did contain such statements--In conclusion on this point, Dr. Sherman found credible based on comparison of cross- examination to statements contained in product monograph, knowledge of Apotex literature--As to sufficiency of Apotex's NOA, AstraZeneca listed four reasons why Apotex's NOA fatally flawed--Second person's (Apotex's) allegation of non-infringement must let first person patentee (AstraZeneca) know grounds for stating issuance of NOC would not lead to infringement--AstraZeneca knew grounds of Apotex's allegations in sufficiently complete manner so as to enable them to decide whether to oppose issuance of NOC by Minister--AstraZeneca led evidence through licensed pharmacist, AstraZeneca executive, regarding third-party infringement--With respect to addressing all uses claimed in some of claims (composition versus combinations), AstraZeneca raised issue, alleged even with that aside and using proper construction, Apotex's Apo-Omeprazole still infringed 762 Patent--NOA not fatally deficient, NOA sufficient--Finally, whether Apotex's allegation of non- infringement justified on specific legal, factual basis set out in NOA involves issue of whether Apotex intends to make use of Apo-Omeprazole for use covered by AstraZeneca's 762 Patent--Product monograph consisting of various sections including "Actions and Clinical Pharmacology", "Indications and Clinical Use", "Information for the Patient", "Pharmacology"--None of statements impugned by AstraZeneca contained in "Indications and Clinical Use" section of Apo-Omeprazole product monograph--Obvious from Apotex's expert witness's cross-examination approved uses of product contained in "Indications and Clinical Uses" section of product monograph and uses contained therein only uses that can lawfully be promoted--Only uses that would be approved uses indicated in "Indications and Clinical Use" section--This appears logical as "Indications and Clinical Use" section particular section of monograph dealing with indications proposed for drug--AstraZeneca can only succeed on facts of case, if references to concomitant use, increases in bioavailability, other impugned product monograph references establish Apotex seeking approval to make use of Apo- Omeprazole concomitantly with antibiotic substances to increase bioavailability, that is to use Apo-Omeprazole with antibiotic such as clarithromycin to achieve better treatment-- After consideration of matter, AstraZeneca did not discharge burden--Uses sought to be approved by Apotex limited to those contained in "Indications and Uses" section of product monograph--References to concomitant use, increases in bioavailability in "Actions and Clinical Pharma-cology", "Pharmacology", "Information for the Patient" sections not indicating Apotex seeking approval for these uses --Application dismissed.