Digests

Novartis Pharmaceuticals Canada Inc. v. RhoxalPharma Inc.

T-462-02

2004 FC 474, Lemieux J.

29/3/04

75 pp.

Applicants seeking order pursuant to Patented Medicines (Notice of Compliance) Regulations, prohibiting Minister of Health from issuing to RhoxalPharma (Rhoxal) Notice of Compliance (NOC) under Food and Drugs Act in connection with 25 mg and 50 mg capsules of drug cyclosporine for oral administra-tion (Rhoxal capsule) until expiry of Canadian patent 1308656 (656 patent)--Novartis AG owner of 656 patent and Novartis Pharmaceuticals Canada Inc. (Novartis) holds NOCs to market cyclosporine drug products--As preliminary point, Rhoxal saying Novartis's application should be dismissed on ground of res judicata and issue estoppel--In previous NOC proceeding, Tremblay-Lamer J. holding Novartis failed to show Rhoxal's 100 mg cyclosporine capsules for oral administration would infringe 656 patent-- Before appeal of that decision heard, Minister issuing NOC to Rhoxal for 100 mg capsules--Appeal dismissed as moot --Rhoxal submitting Novartis attempting to relitigate issue already decided by Tremblay-Lamer J.--Also pointing to US litigation and judgment of US District Court of Delaware in cyclosporine proceedings between Novartis and EON-- US decision not applicable because US patent differently written and clear from preliminary decision trial judge limited scope of US claim to hydrosols formed in different manner-- Res judicata encompassing two forms of estoppel: cause of action estoppel and issue estoppel--Clear from Danyluk v. Ainsworth Technologies Inc., [2001] 2 S.C.R. 460, meeting preconditions for application of cause of action, issue estoppel not sufficient--Court must still determine whether, as matter of discretion, estoppel ought to be applied--In Danyluk, Binnie J. stated estoppel equitable doctrine closely related to abuse of process; doctrine designed as implement of justice and protection against injustice and calls upon exercise of judicial discretion to achieve fairness according to all circumstances in each case--Considering representations made by Rhoxal on appeal of Tremblay-Lamer's judgment when mootness argued as grounds to dismiss appeal, application of either form of estoppel herein would be clearly unjust to Novartis--Rhoxal's capsule, after ingestion, forms hydrosol after contact with water and gastric juices in human stomach--Hydrosol formed of small solid particles of cyclosporine stabilized and suspended in aqueous medium found in human stomach--Evidence for this finding overwhelming--Rhoxal's Notice of Allegation (NOA) would be justified if Rhoxal's capsule, which creates hydrosol meeting specifications for hydrosol in 656 patent, would not infringe that patent--Principles of patent construction reviewed--Construing claim 2(a) of 656 patent in purposive way by considering whole of disclosure and claims and being instructed as to meaning of terms by experts skilled in art of formulation of pharmaceutical preparations reveals hydrosol form in situ within claim as pharmaceutical preparation consisting of hydrosol--Properly interpreted "pharmaceutical preparation" not limited to hydrosol prepared before ingestion and claim 2(a) not limited to parenteral applications--Fact that conclusion different from conclusion reached by Tremblay-Lamer J. justified by substantially different evidence --Novartis demonstrated Rhoxal's NOA unjustified--As to application of doctrine of equivalents, Rhoxal argued doctrine has no application to NOC proceedings which are summary in nature, for limited administrative purposes, and not akin to action of infringement--Decision of Binnie J. in Free World Trust v. Électro Santé Inc., [2000] 2 S.C.R. 1024, settles this point-- Binnie J. integrated doctrine of equivalents into mainstream of inquiry into infringement as apparent from decision, as well as discussion on essential and non-essential elements of invention, factors of their allocation and, in particular, third allocation factor whether obvious at time patent disclosed substituting different variant would make difference in way invention works bringing into play three questions posed by Lord Hoffmann in Improver Corp. v. Remington Consumer Products Ltd., [1990] F.S.R. 181 (Pat. Ct.)--Based on affidavit of Novartis expert, Dr. McGinity who answered those three questions, found equivalency and not cross-examined, hydrosol of cyclosporine particles within specified nanometre range formed in situ equivalent to hydrosol of cyclosporine particles with same specifications formed outside body-- Application allowed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133--Food and Drugs Act, R.S.C., 1985, c. F-27.