Digests

Biovail Corp. v. Canada (Minister of Health)

T-472-02

2004 FC 257, Gauthier J.

20/2/04

19 pp.

Applicants seeking order prohibiting Minister of National Health and Welfare from issuing notice of compliance (NOC) to RhoxalPharma (Rhoxal) for diltiazem hydrochloride capsules of strengths from 120mg to 360mg until after expiration of Canadian Patent No. 2111085 (085 patent)--As to adequacy of Notice of Allegation (NOA) detailed statement in Rhoxal's NOA, with respect to allegation of non- infringement of claims 34 to 37 in NOA, meets requirement of Patented Medicines (Notice of Compliance) Regulations, s. 5(3)(a)--Far from situation where second person makes bald statement of non-infringement unsupported by factual assertions--NOA contains sufficient information to make Biovail Corporation fully aware of grounds on which Rhoxal seeks NOC--As to claims 35 to 37 (dependent claims), sufficient for Rhoxal to state because it would not infringe independent claim 34, it would not infringe claims 35 to 37--No need for Rhoxal to address other element of claims unless variant on which it relies to support allegation of non- infringement relates to element specific to those claims--This was not the case since variant referred to in NOA absence of effective amount of wetting agent to maintain solubility of diltiazem in gastrointestinal tract, allegedly essential element of independent claim 34--Biovail also alleging NOA defective because not stating how Rhoxal maintains solubility of diltiazem in its beads if it does not use wetting agent-- Argument based on misunderstanding of present proceeding-- Rhoxal only needs to allege grounds supporting allegation of non-infringement--In conclusion, NOA complete, not ambiguous--As to scope of evidence filed by Rhoxal, no need to deal with Biovail's argument Dr. Weiner's evidence went beyond content of NOA because dealing with such argument irrelevant--As to allegation of non-infringement, Court bound to assume factual statements supporting allegation of non-infringement true--Biovail needed to establish that (i) even if those statements true, they would not in law give rise to conclusion patent would not be infringed by Rhoxal's capsule because variant not involving essential element of claims at issue, or (ii) all or most of statements wrong-- Biovail appeared to concede presence of wetting agent essential element of claim 34--Unless Biovail establishes Rhoxal's factual assertions in NOA wrong, application will fail--Mrs. Khairo's affidavit only evidence produced by Biovail to contradict factual assertions made by Rhoxal to support position capsule will not contain essential element of claim 34--Biovail confirmed during Mrs. Khairo's cross-examination she was not put forth as expert, could not be asked questions of opinion--No weight given to this evidence, statements in NOA unchallenged--Biovail asserting Dr. Weiner, in cross-examination, confirmed theoretically possible for water to make way through Rhoxal's beads from outside to sugar in core without having to dissolve diltiazem first--Even if proposition accepted, it would have little impact on Biovail's case for it leaves intact most important factual assertions supporting Rhoxal's allegation of non- infringement--Biovail arguing Court should give little weight to Dr. Weiner's opinion, Rhoxal's allegation of non- infringement unjustified as implying one read words "in admixture" into claim 34--Words present in claims 1 to 33 but not included in claims 34 to 37--Thus, claim 34 should be given distinct meaning because of change in language-- According to Dr. Weiner, words "an effective amount of wetting agent to maintain solubility of the diltiazem in gastrointestinal tract" necessarily imply use of dry sugar in admixture with diltiazem--No evidence dry sugar effective wetting agent even when not mixed with drug having solubility problem--No evidence sugar in solution effective wetting agent that could maintain solubility of diltiazem in gastrointestinal tract--No evidence dry sugar in core of Rhoxal's beads acts as effective wetting agent maintaining solubility of diltiazem in gastrointestinal tract--In absence of such evidence, Court could not simply disregard factual assertions assumed to be true--Biovail has not met burden of establishing Rhoxal's allegation of non-infringement unjustified--Application dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 5(3)(a) (as am. by SOR/99-379, s. 2).