AB Hassle et al. v. Apotex Inc. et al., 2006 FCA 51

• Judge: Décary, Evans and Sharlow, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: November 24, 2005
• Jurisdiction: Canada (Federal)
• Citations: 2006 FCA 51;(2006), 350 N.R. 219 (FCA)

AB Hassle v. Apotex Inc. (2006), 350 N.R. 219 (FCA)

MLB headnote and full text

Temp. Cite: [2006] N.R. TBEd. FE.051

Apotex Inc. (appellant/respondent) v. AB Hassle, AstraZeneca AB and AstraZeneca Canada Inc. (respondents/applicants) and The Minister of Health (respondent/respondent)

(A-124-05; 2006 FCA 51)

Indexed As: AB Hassle et al. v. Apotex Inc. et al.

Federal Court of Appeal

Décary, Evans and Sharlow, JJ.A.

February 10, 2006.

Summary:

AstraZeneca owned a patent (the '693 pat­ent) for an enteric coated dosage form of ome­prazole tablets used for treating gastric and duodenal ulcers. The invention disclosed an acid resistant enteric coating and an inert subcoating covering the core of the tablet, which allowed the tablet to pass through the stomach unaltered and to dissolve in the neu­tral to alkaline environment found in the small intestine. The product was marketed un­der the name LOSEC. Apotex served cor­re­spondence, stating to be a notice of allega­tion (NOA), on AstraZeneca, alleging that the '693 patent was invalid, and, in any event, its generic version of omeprazole, did not infringe the '693 patent because the Apo­tex tablet did not have a subcoating be­tween the core and the enteric coating. Astra­Zeneca applied for a declaration that Apotex's correspondence was not a NOA as contemplated by the Patented Medicines (Notice of Compliance) Regulations, and, alternatively, an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex until after the expiry of the '693 patent.

The Federal Court, in a decision reported 271 F.T.R. 30, held that it would not go so far as to grant the declaration sought but ruled that the NOA was deficient in that Apotex could not add to the contents of its NOA by purporting to establish noninfringe­ment by evidence presented during the pro­ceedings for which there was no basis stated in the NOA. In any event, the court ruled that Apotex was estopped from alleging non­infringement and invalidity in light of prior prohibition proceedings dealing with the same issues or wherein the issues raised in this case could have been dealt with. The court issued the order prohibiting the Min­ister of Health from issuing a notice of com­pliance to Apotex. Apotex appealed.

The Federal Court of Appeal dismissed the appeal. The court saw no basis for differing from the trial judge's conclusion on the non­infringement allegation. The court also agreed that Apotex was barred from raising the invalidity allegations for the first time in this case, but based its conclusion solely on the basis of abuse of process (i.e., the court did not consider the estoppel/res judicata is­sues).

Courts - Topic 2015

Jurisdiction - General principles - Control­ling abuse of its process - AstraZeneca sought an order prohibiting the Minister of Health from issuing a notice of compliance (NOC) to Apotex, a generic drug manufac­turer, for omeprazole tablets used for treat­ing gastric and duodenal ulcers - The Fed­er­al Court issued the prohibition order on the basis that Apotex's noninfringement al­le­gation in this proceeding was identical to a noninfringement allegation it had raised in a prior proceeding that had re­sulted in a prohibition order and although Apotex's al­le­gations of invalidity were not made in the prior proceeding, those allega­tions could not to be considered in this case be­cause of the doctrine of issue es­toppel or, alternatively, the doctrine of abuse of pro­cess - Apotex appealed, argu­ing that its no­tice of allegation and detailed statement should be interpreted as having raised a new point of construction not raised in the prior proceedings - The Fed­eral Court of Ap­peal dismissed the appeal - The court saw no basis for differing from the trial judge's conclusion on the nonin­fringement allegation - The court also agreed that Apotex was barred from raising these in­va­lid­ity allegations for the first time in this case, but based its conclusion solely on the basis of abuse of process.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. no­tice of allegation) - The Federal Court of Appeal discussed when a second or subse­quent notice of allegation filed in relation to a certain patent in respect of the same proposed generic product would constitute an abuse of process - The court stated that "it would be fruitless to attempt an exhaus­tive list of situations in which a second or subsequent notice of allegation would not be an abuse of process. How­ever, by way of example, it may be that there would be no abuse of process if the second notice of al­legation is based on new facts, a newly discovered process, a change in the law, a situation that limits the scope or applica­tion of an existing prohibition order, or a new and definitive decision as to the valid­ity or construction of the pat­ent. Even if it is determined that a second or subsequent no­tice of allegation is an abuse of process, the Federal Court never­theless has the dis­cretion to determine the application for a prohibition order on its merits" - See para­graphs 23 to 25.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order - Dismissal of applica­tion for (incl. compensation by first per­son) - [See Courts - Topic 2015 ].

Cases Noticed:

Bayer AG and Miles Canada Inc. v. Can­ada (Minister of National Health and Welfare) and Apotex Inc. (1993), 163 N.R. 183; 51 C.P.R.(3d) 329 (F.C.A.), refd to. [para. 4].

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al. (2000), 256 N.R. 172; 7 C.P.R.(4th) 272 (F.C.A.), refd to. [para. 4].

SmithKline Beecham Inc. et al. v. Apotex Inc. et al. (2001), 267 N.R. 101; 10 C.P.R.(4th) 338 (F.C.A.), refd to. [para. 4].

AstraZeneca AB et al. v. Apotex Inc. et al. (2005), 335 N.R. 1 (F.C.A.), refd to. [para. 4].

AB Hassle et al. v. Apotex Inc. et al. (2002), 223 F.T.R. 43; 21 C.P.R.(4th) 173 (T.D.), affd. (2003), 312 N.R. 288; 29 C.P.R.(4th) 23 (F.C.A.), refd to. [para. 5].

Gillette Safety Razor Co. v. Anglo-Ameri­can Trading Co. (1913), 30 R.P.C. 465 (H.L.), refd to. [para. 15].

Housen v. Nikolaisen et al., [2002] 2 S.C.R. 235; 286 N.R. 1; 219 Sask.R. 1; 272 W.A.C. 1, refd to. [para. 17].

Warner-Lambert Canada Inc. et al. v. Canada (Minister of Health) et al., [2003] 2 F.C. 514; 296 N.R. 279 (F.C.A.), refd to. [para. 23].

Parke-Davis Division v. Canada (Minister of Health) - see Warner-Lambert Canada Inc. et al. v. Canada (Minister of Health) et al.

Apotex Inc. v. Canada (Attorney General) et al., [2000] 4 F.C. 264; 255 N.R. 319; 188 D.L.R.(4th) 145; 24 Admin. L.R.(3d) 279; 6 C.P.R.(4th) 165 (F.C.A.), leave to appeal refused [2001] 1 S.C.R. v; 268 N.R. 193, refd to. [para. 24].

Apotex Inc. v. Canada (Minister of Na­tional Health and Welfare) et al. (1997), 219 N.R. 151; 153 D.L.R.(4th) 68; 76 C.P.R.(3d) 1 (F.C.A.), leave to appeal refused [1998] 1 S.C.R. viii; 226 N.R. 400, refd to. [para. 24].

Eli Lilly & Co. v. Apotex Inc. - see Apo­tex Inc. v. Canada (Minister of National Health and Welfare) et al.

Elders Grain Co. et al. v. Ship Ralph Misener et al. (2005), 334 N.R. 1; 2005 FCA 139, refd to. [para. 27].

Apotex Inc. v. Syntex Pharmaceuticals International Ltd. et al. (1999), 166 F.T.R. 161; 1 C.P.R.(4th) 22 (T.D.), refd to. [para. 29].

Hoffmann-La Roche Ltd. et al. v. Canada (Minister of National Health and Wel­fare) et al. (1999), 167 F.T.R. 111 (T.D.), refd to. [para. 29].

Counsel:

H. Radomski and A.R. Brodkin, for the appellant;

G. Gaikis and Ms. Kang, for the respon­dent, AB Hassle.

Solicitors of Record:

Goodmans, LLP, Toronto, Ontario, for the appellant;

Smart & Biggar, Toronto, Ontario, for the respondent, AB Hassle;

John H. Sims, Q.C., Deputy Attorney Gen­er­al of Canada, Ottawa, Ontario, for the re­spondent, Minister of Health.

This appeal was heard at Toronto, Ontario, on November 24, 2005, before Décary, Evans and Sharlow, JJ.A., of the Federal Court of Appeal. Sharlow, J.A., delivered the following judgment for the court at Ottawa, Ontario, on February 10, 2006.