Digests

AstraZeneca AB v. Apotex Inc.

T-148-02

2004 FC 44, Russell J.

14/1/04

47 pp.

Application for order prohibiting Minister of Health (Minister) from issuing Notice of Compliance (NOC) to Apotex Inc. (Apotex) in respect of Apo-Omeprazole tablets for oral administration in 10 mg, 20 mg and 40 mg strength until after expiration of Canadian Patent No. 2166794 (794 Patent) and for declaration Apotex's letter dated December 12, 2001 not notice of allegation (NOA) as contemplated in Patented Medicines (Notice of Compliance) Regulations (Regulations) --794 patent claiming magnesium omeprazole having degree of crystallinity of not less than 70%, and tablet formulation containing magnesium omeprazole having degree of crystallinity higher than 70%--Apotex alleging non-infringement in detailed statements as patent claims relating only to magnesium omeprazole having degree of crystallinity higher than 70% and as their tablets will contain only amorphous magnesium omeprazole--AstraZeneca says this statement insufficient to justify conclusion of non-infringement as not addressing crystallinity of magnesium omeprazole used to make tablets--When read together, two paragraphs of detailed statement clear enough that there will be no infringement of process, composition or use claims because only amorphous magnesium omeprazole will be involved--As held in SmithKline Beecham Inc. v. Apotex Inc. (2001), 10 C.P.R. (4th) 338 (F.C.A.), sufficiency and ambiguity cannot be assessed by merely considering wording of statement itself without reference to context--Whether NOA truly ambiguous in absence of specific statement in NOA that tablets will not be made using crystalline magnesium omeprazole with crystallinity greater than 70%, depends upon total context in which detailed statement made, including teachings in 794 patent and what AstraZeneca actually knows, or legally obliged to ascertain, about whether amorphous magnesium omeprazole tablets can be made from greater than 70% crystalline material--Only evidence from AstraZeneca addressing point at issue contained in affidavit of expert in x-ray powder diffraction analysis--No teaching in 794 patent that material with degree of crystallinity higher than 70% could be used to make amorphous tablet and AstraZeneca made no attempt to substantiate expert's brief suggestion crystallinity of magnesium omeprazole used during processing steps could have degree of crystallinity higher than 70%--Also no record of AstraZeneca attempting to obtain relevant information on crystallinity of Apotex's raw material or to compel its production--In absence of explanation for such claim, it remains in realm of speculation and "raises no more than a possibility of infringement by Apotex" (SmithKline Beecham)--AstraZeneca's approach to issue suggesting principal concern to float vague theoretical doubt that could be used to attack sufficiency of NOA, rather than voice real concern, with factual base, that 794 patent could be infringed by Apotex in this case--Expert could quite easily have explained matters further, but chose not to do so-- Nothing suggesting AstraZeneca had any real concerns about grounds on which Apotex claimed 794 patent would not be infringed--No convincing evidence AstraZeneca perceived true deficiency in detailed statement preventing it from deciding whether or not to resist issuance of NOC--NOA sufficient to justify conclusion of non-infringement of 794 patent--Whether allegation in NOA tablets will contain amorphous magnesium omeprazole deficient--AstraZeneca alleging Apotex's tablets can be analysed to determine crystallinity of magnesium omeprazole --If testing of AstraZeneca's position that samples will be determinative of issue of non-infringement, failure of generic to provide such samples as part of NOA means NOA deficient--This is tantamount to allegation of fraud--Notion Apotex would obtain NOC by reference to specified process and circumvent Regulations by thereafter going to market with product produced by another process not substantiated--This type of allegation must be proven and cannot rest on mere insinuation --No foundation for suggestion advanced by counsel for AstraZeneca in this regard--Detailed statement sufficiently complete for AstraZeneca to respond to NOA--NOA not deficient and no acceptable evidence that assertions in allegation incorrect--Facts in allegation presumed to be true and AstraZeneca produced no convincing evidence to contrary or to show either NOA, or statement of fact supporting it, fraudulent--No abuse of process--AstraZeneca submitting NOA abuse of process as not separate, distinct from Apotex's prior allegation in which asserted no infringement as Apotex would use material whose crystallinity would be less than 70%--Use of crystalline material clearly contemplated--In NOA, Apotex moving away from crystalline material entirely and basing claim of non-infringement on use of amorphous material--This allegation not "encompassed" by earlier allegation because earlier allegation contemplated crystalline material and did not contemplate amorphous material-- Further, review of "factual underpinning" for Apotex's withdrawal of earlier allegation reveals real and convincing difficulties in complying with health and safety requirements --Consequently, no "factual underpinning" for finding of abuse of process--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133.