PATENTS |
AstraZeneca Canada Inc. v. Apotex Inc.
T-660-02
2004 FC 647, Gauthier J.
29/4/04
37 pp.
AstraZeneca Canada Inc. (AstraZeneca) sought order prohibiting Minister of Health from issuing Notice of Compliance (NOC) to Apotex Inc. (Apotex) for its Apo-Omeprazole tablets until expiration of patent No. 1338377 (377 patent)--Claim 1 covering pharmaceutical composition for inhibition of gastric acid secretion comprised of basic inorganic salt stabilizing agent (potassium, sodium or aluminium salts) and enteric coating--Apotex sent Notice of Allegation (NOA) in respect of Apo-Omeprazole tablets for oral administration in 10, 20 and 40 mg strengths, alleged no claim for medicine itself, no claim for use of medicine in 377 patent, would be infringed by making, constructing, using, selling tablets--AstraZeneca commenced present application, arguing NOA deficient because fails to identify active ingredient in tablets; NOA abuse of process because not separate, distinct from previous NOA's for same product; allegation of non-infringement not justified because product would contain potassium, sodium or aluminium salt--Fact that evidence of Apotex' witness previously found not credible of little assistance in evaluating credibility on specific issues before Court, and argument no weight should be given to witness' testimony because of alleged mistake in respect of entirely unrelated issue in another proceeding, rejected-- However, personal interest of witness in matter, lack of expertise in certain areas addressed in affidavit, can affect, diminish weight of evidence--Patented Medicines (Notice of Compliance) Regulations, s. 5(3)(c)(ii) not requiring second person to identify "active ingredient" or "drug" in NOA-- Court adopting approach to interpretation of Regulations summarized in Parke-Davis Division v. Canada (Minister of Health), [2003] 2 F.C. 514 (C.A.), applied in Eli Lilly Canada Inc. v. Canada (Minister of Health), [2003] 3 F.C. 140 (C.A.) --Desired specificity achieved by reference to dosage form, strength, route of administration--Apotex not failing to meet requirements of s. 5(3)(c)(ii)--As to whether name of active ingredient in tablets required to be disclosed pursuant to s. 5(3)(a), name of active ingredient not relevant to specific allegation put forth by Apotex--NOA read to mean allegation justified by fact tablets would not contain any of "specified stabilizing agents"--This statement sufficient and complete whatever active ingredient used in Apotex' tablets--If this interpretation wrong, NOA deficient because did not include all facts on which Apotex based assertion that sodium salts in tablets not stabilizing agent--Detailed statement required by s. 5(3)(a) must be complete (AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R. (4th) 272 (F.C.A.))--Statement that does not include all prior art relied upon by second person deficient--Concerning abuse of process, after review of evidence (transcripts, affidavits, documentation with respect to studies), Court satisfied Apotex withdrew previous NOAs because of technical difficulties, abuse of process not established--S. 6(1) (NOC) proceeding not action for infringement--Court need only determine whether facts assumed or proven and legal assertions made justify specific allegation of non-infringement--AstraZeneca having burden of convincing Court allegation of non-infringement unjustified by showing: (1) statements assumed true would not in law give rise to conclusion patent would not infringe; (2) all or most of facts relied upon by Apotex to justify allegation wrong--Allegation here founded on absence of listed stabilizing agents in tablets (potassium, sodium, aluminium salts)--Thus to establish allegation of non-infringement not justified, AstraZeneca had only to establish, on balance of probability, that tablets would include potassium, sodium or aluminium salt--AstraZeneca argued cross-examination of Apotex' witness revealing carboxyme-thylcellulose and sodium croscaremellose in Apotex' tablets are sodium salts--Argued failure of Apotex' witness to answer questions in relation to latter ingredient entitled Court to make negative inference substance found in core of tablets is sodium salt--Court not accepting argument because objections of Apotex well-founded: AstraZeneca could not use production of updated version of product monograph to cross-examine witness a second time on issue--Court also refusing to draw negative inference since AstraZeneca knew what ingredients would be used in tablets, and it had means of determining whether carboxyme-thylcellulose or sodium croscaremellose sodium salts--As for sodium croscaremellose, AstraZeneca stated Apotex' witness admitted substance a sodium salt--Court agreeing that no weight should be given to Apotex' witness' statement that tablets would not contain any of stabilizing agents specified in 377 patent--However, because testimony not definite confirmation that substance is sodium salt and that NOA incorrect, and because AstraZeneca presented no expert evidence on matter, Court not satisfied that presumption of truth applicable to factual statements in NOA rebutted-- Application dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 5(3)(a) (as am. by SOR/98-166, s. 4; 99-379, s. 2), (c)(ii) (as am. by SOR/99-379, s. 2, 6(1) (as am. by SOR/98-166, s. 5).