Merck & Co. et al. v. Apotex Inc., 2006 FCA 323

• Judge: Linden, Sexton and Malone, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: October 10, 2006
• Jurisdiction: Canada (Federal)
• Citations: 2006 FCA 323;(2006), 354 N.R. 51 (FCA);276 DLR (4th) 686;354 NR 51;55 CPR (4th) 1;[2006] FCJ No 1490 (QL);152 ACWS (3d) 142

Merck & Co. v. Apotex Inc. (2006), 354 N.R. 51 (FCA)

MLB headnote and full text

Temp. Cite: [2006] N.R. TBEd. OC.026

Apotex Inc. (appellant) v. Merck & Co., Inc., Merck Frosst Canada & Co., Merck Frosst Canada Ltd., Syngenta Limited, AstraZeneca UK Limited and AstraZeneca Canada Inc. (respondents)

(A-232-06; 2006 FCA 323)

Indexed As: Merck & Co. et al. v. Apotex Inc.

Federal Court of Appeal

Linden, Sexton and Malone, JJ.A.

October 10, 2006.

Summary:

The plaintiffs (collectively Merck) included the owner of and licensees under Canadian Patent 1,275,350 ('350 patent), respecting lisinopril, a compound useful in treating hypertension. Merck sold drugs in Canada in­corporating lisinopril as an active ingredi­ent. A generic drug manufacturer (Apotex) chose to produce and sell a generic version of some of Merck's lisinopril drugs. Merck commenced an action against Apotex alleg­ing patent infringement (claims 1, 2 and 5). Apotex counterclaimed alleging invalidity of the patent. By the time of trial, Apotex admitted that, if the claims in issue of the patent were valid, then it had infringed those claims subject to certain exemptions as to some quantities of lisinopril obtained from an allegedly licensed source, and certain quan­tities used for other exempted purposes. Merck argued that Apotex was in fact pre­cluded from attacking the validity of the '350 patent because of former proceedings respecting a related patent pertaining to a compound known as enalapril which came from the same parent patent as lisinopril.

The Federal Court, in a decision reported 282 F.T.R. 161, allowed Merck's action and granted remedies ac­cordingly. The court found that Apotex in­fringed each of claims 1, 2 and 5 of the '350 patent, subject to certain exemptions, that Apotex was precluded from challenging the va­lidity of those claims and, in any event, those challenges failed. Apotex appealed and Merck cross-appealed.

The Federal Court of Appeal allowed the Apo­tex appeal in part on issues relating to the limitation period for exemptions and es­toppel. Merck's cross-appeal was allowed in part on the issues of stockpiling and monies held in trust.

Damages - Topic 1318

Exemplary or punitive damages - Patent in­fringement - [See Patents of Invention -Topic 3821 ].

Damages - Topic 1330

Exemplary or punitive damages - Pleading - [See Patents of Invention - Topic 3821 ].

Estoppel - Topic 381.1

Estoppel by record (res judicata) - Res judicata as a bar to subsequent proceedings - In intellectual property proceedings - Patent infringement proceedings - [See Estoppel - Topic 387 ].

Estoppel - Topic 387

Estoppel by record (res judicata) - Res ju­di­cata as a bar to subsequent proceedings -Matters or claims available in prior pro­ceed­ings - On December 6, 1979, Merck filed a Canadian patent application (patent '340) describing a new class of com­pounds, which included lisinopril, enalapril and enalaprilat - From the '340 patent, Merck had several applications divided out as divisional applications, including one for lisinopril (patent '350) and one relating to enalapril (patent '349) - Merck sued Ap­o­tex for patent infringement respecting patent '350 - Apotex counterclaimed chal­lenging the validity of patent '350 on a number of grounds including delay, double patenting and improper divisional - Merck ar­gued that Apotex was estopped from chal­lenging the validity of the '350 patent having regard to prior litigation respecting the '349 patent - The trial judge deter­mined that enalapril ('349) was patentably different from lisinopril ('350) (i.e., the subject matter of the litigation was differ­ent); however, the same questions as to de­lay, double patenting and improper divi­sional could have been raised in the prior proceedings since patent '349 arose from the same parent application ('340) - Ap­otex was therefore precluded from raising these attacks on the validity of the '350 patent - Apotex appealed - The Fed­eral Court of Appeal agreed that the trial judge erred when he determined that a valid es­toppel existed in this case - See para­graphs 60 to 66.

Estoppel - Topic 475

Practice - Pleading - Necessity for - [See Patents of Invention - Topic 2941 ].

Injunctions - Topic 6312

Particular matters - Injury to trade - Patent infringement - [See Patents of Invention -Topic 3103 ].

Interest - Topic 5009

Interest as damages (prejudgment interest) - General principles - Prejudgment interest - Calculation of (incl. rate) - [See Patents of Invention - Topic 3834 ].

Interest - Topic 5010

Interest as damages (prejudgment interest) - General principles - Calculation of inter­est - Simple or compound - [See Patents of Invention - Topic 3834 ].

Patents of Invention - Topic 8

General - Invention defined - Merck filed a Canadian patent application ('340) de­scribing a class of new compounds having a common backbone, which included lisi­nopril, enalapril and enalaprilat - Sub­se­quently Merck divided out an appli­cation for the lisinopril (patent '350) - Apotex, a generic drug manufacturer, argued that the '340 application included only one inven­tion such that the divisional application for patent '350 was improper - The trial judge rejected Apotex's argument holding that he was constrained jurisprudentially to find that the '340 application disclosed separate inventions - Apotex appealed - The Federal Court of Appeal held that the trial judge's ultimate conclusion was correct, that the divisional of the `350 patent was not im­proper - The court stated that in fact, s. 36 of the Patent Act called for a divisional in the circum­stances of this case and thus Merck was simply complying with the Act - See para­graphs 23 to 39.

Patents of Invention - Topic 1002

The specification and claims - Scope of - [See Patents of Invention - Topic 8 ].

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - [See Pa­tents of Invention - Topic 8 ].

Patents of Invention - Topic 1034

The specification and claims - Construction of a patent - Evidence (including extrinsic evidence) - Merck filed a Canadian patent application ('340) describing a vast number of new compounds having a common back­bone, which included lisinopril, enal­april and enalaprilat - Merck sued Apotex, a generic drug manufacturer, for patent infringement - Apotex argued that in con­struing patent '340, the court should con­sider extrinsic evidence, including the United States prosecution history of the priority application or papers and internal memoranda written by inventors - The trial judge refused to consider the extrinsic evi­dence primarily on the basis that the gen­eral rule was that extrinsic evidence was inadmissible for the purpose of con­struing a patent specification - The Federal Court of Appeal agreed that the documents in ques­tion should have no bearing on the court's decision - See paragraphs 51 to 53.

Patents of Invention - Topic 1508

Grounds of invalidity - General - Re divi­sional applications - [See Estoppel - Topic 387 and Patents of Invention - Topic 8 ].

Patents of Invention - Topic 1508

Grounds of invalidity - General - Re divi­sional applications - On December 6, 1979, Merck filed a Canadian patent application (patent '340) describing a new class of com­pounds, which included lisinopril, enalapril and enalaprilat - From the '340 patent, Merck had several applications di­vided out as divisional applications, includ­ing one for lisinopril (patent '350) and one relating to enalapril (patent '349) - Merck sued Apotex for patent infringe­ment re­specting patent '350 - Apotex counter­claimed challenging the validity of the patent, arguing that there had been an im­proper division of the patent application rendering the patent void - The trial judge rejected this argument - The judge stated that division of a patent application was essentially a procedural matter - If several patents claiming the same invention were granted, a sufficient remedy as to validity existed under the principles of double patenting - The Federal Court of Appeal agreed with the trial judge's ruling that an improper divisional did not, in the absence of double patenting, result in a loss of patent rights - See paragraphs 40 to 50.

Patents of Invention - Topic 1512

Grounds of invalidity - General - Delay in prosecution of patent application - On De­cember 6, 1979, Merck filed a Canadian patent application ('340) in the Canadian patent office describing a new class of com­pounds, which included lisinopril, enalapril and enalaprilat - From the '340 patent, Merck had several applications di­vided out as divisional applications, includ­ing lisinopril (patent '350) which was is­sued in 1990 - Merck sued Apotex, a ge­neric drug manufacturer, for patent in­fringement - Apotex counterclaimed chal­lenging the validity of the '350 patent on the basis that Merck had delayed the prose­cution for the '350 patent - The trial judge rejected this argument where there was no evi­dence of wilful delay - Apotex appealed - The Federal Court of Appeal declined to interfere with the trial judge's reasons on this issue and his analysis of the evidence -Further, the court noted that prosecution de­lay was an American con­cept and where there was no underlying delay shown in this case, this was not an appropriate case in which to consider whether this concept should be adopted in Canada - See para­graphs 57 to 59.

Patents of Invention - Topic 2941

Infringement of patent - Chemical products and substances intended for food and medi­cine - General - Merck was granted a patent respecting lisinopril in 1990 - In the early 1990s Delmar manufactured batches of lisinopril under a compulsory licence (i.e., before Patent Act compulsory li­cences were statutorily extinguished) - During the licence period, title to these batches of lisinopril passed to a third party - Well after all compulsory licences were statutorily extinguished, Apotex acquired the lisinopril manufactured by Delmar and used it to formulate tablets - Merck sued Apotex for patent infringement - Apotex claimed an exemption relying on Delmar's licence - The trial judge held that Apotex could not claim the benefit of Delmar's licence - The judge stated, however, that were it not for binding authority of the Federal Court of Appeal, he would have held that Apotex could rely on Delmar's licence (i.e., that the licence ran with the goods made before the licence was extin­guished) - In any event, Apotex was es­topped from litigating the issue of the li­cence because of prior proceedings invol­ving a related patent - Apotex appealed on the licence issue - The Federal Court of Appeal dismissed this ground of appeal - The court held that the trial judge erred in raising and deciding the estoppel issue be­cause estoppel was not pleaded - The judge correctly determined that Apotex could not rely on Delmar's licence and was wrong in his opinion that the licence, even if ex­tinguished, ran with the goods made before the licence was extinguished - See para­graphs 83 to 91.

Patents of Invention - Topic 3010

Infringement of patent - Defences - Pur­chase, construction or acquisition prior to issue of patent - On October 20, 1990, Merck was granted a patent (the '350 patent) for lisinopril - Merck sued Apotex, a generic drug manufacturer, for patent in­fringement - Apotex admitted that if the patent was shown to be valid, then it had infringed the claims subject to certain ex­emptions, including s. 56 of the Patent Act (i.e., the provision respecting pur­chases before the patent was granted) - In particu­lar, Apotex claimed an exemption under s. 56 for three lots of lisinopril claimed to have been "purchased, con­structed or acquired" by Apotex before the patent was issued and therefore Apotex had the right to use and sell this lisinopril - The trial judge held that the benefit of s. 56 could not be given to the three lots in issue as the lots could not be said to have been "pur­chased, constructed or acquired" as of the critical date - The lots in issue were not completed products in usable form (i.e., they were not ready to be shipped to a customer) - Apotex appealed arguing that it was entitled to rely on s. 56 respecting these lots - The Federal Court of Appeal rejected this ground of appeal - See para­graphs 67 to 82.

Patents of Invention - Topic 3012

Infringement of patent - Defences - Acting under terms of licence - [See Patents of In­vention - Topic 2941 ].

Patents of Invention - Topic 3013

Infringement of patent - Defences - Use of patented product related to development and submission of information to govern­ment authorities (regulatory use exemption) - Merck owned the patent for lisinopril (the '350 patent) - Merck sued Apotex, a generic drug manufacturer, for patent in­fringement - Apotex admitted that if the patent was indeed valid, then it had in­fringed the claims subject to certain ex­emptions, including s. 55.2(1) of the Patent Act (i.e., that Apotex could use some lisinopril for regulatory purposes) - The trial judge agreed that certain lots of lisino­pril held by Apotex were exempt under this provision - Merck appealed, arguing that s. 55.2(1) exempted only uses of the patented product prior to when a generic, such as Apotex, obtained a notice of com­pliance, that s. 55.2(1) should be strictly construed and that because none of the samples taken by Apotex were actually sub­mitted to any regulatory body, Apotex was not entitled to rely on s. 55.2(1) - The Federal Court of Appeal rejected Merck's ar­guments, holding that the trial judge did not err in his conclusion that s. 55.2(1) applied to exempt Apotex from infringe­ment with respect to incoming raw m­ater­ial and finished products stored by Apotex in the event they were required for future reference in accordance with regula­tory gov­ernmental requirements - See para­graphs 98 to 104.

Patents of Invention - Topic 3014

Infringement of patent - Defences - Fair dealing - On October 20, 1990, Merck owned a patent for lisinopril (the '350 patent) - Merck sued Apotex, a generic drug manufacturer, for patent infringement - Apotex admitted that if the patent was indeed valid, then it had infringed the claims subject to the common law defence of fair dealing - The trial judge held that the evidence showed that there had been a use of lisinopril that should be considered in the circumstance of "fair dealing", that being the use of lisinopril in ongoing re­search and development of alternate formu­lae, alternate techniques for tablet making, and the like - The judge stated that as to this research and development material, it clearly fell within the "fair dealing" ex­emption provided by the Supreme Court of Canada in Smith Kline v. Micro Chemicals (1972) - Merck appealed respecting the fair dealing issue - The Federal Court of Ap­peal found no reason to interfere with the trial judge's decision on this issue - See paragraphs 105 to 113.

Patents of Invention - Topic 3102

Infringement of patent - Remedies - Dam­ages or accounting of profits - Merck sued Apotex, a generic drug manufacturer, al­leg­ing infringement of its lisinopril patent ('350 patent) - The trial judge allowed Merck's action - The judge held that Merck was entitled to damages, but was not entitled to elect an award of profits because it had made no effort to compete with Apotex, but rather essentially "threw in the towel and left this action to proceed in a leisurely fashion" taking 10 years to get to trial - Merck appealed, arguing that the trial judge erred in refusing to allow it to elect an accounting of profits - Merck argued that the trial judge in reaching this decision relied on two irrelevant factors, the pace of litigation and Merck's failure to compete with Apotex - Merck argued fur­ther, that even if these factors were relevant, Merck was not responsible for the slow pace of litigation and that they did in fact compete with Apotex - The Federal Court of Appeal rejected Merck's argu­ment - See paragraphs 127 to 137.

Patents of Invention - Topic 3103

Infringement of patent - Remedies - In­junc­tive relief - Merck sued Apotex, a generic drug manufacturer, alleging infrin­gement of its lisinopril patent ('350 patent) - The trial judge allowed Merck's action and as a remedy, inter alia, enjoined Ap­otex from continuing the business of mak­ing, using and selling lisinopril containing products until expiry of the '350 patent - Apotex appealed, arguing that the trial judge erred in law by awarding an injunc­tion automatically without proper consider­ation of relevant factors - The Federal Court of Appeal rejected this ground of appeal, stating that the decision to award an injunction was a discretionary one en­titled to considerable deference - See para­graphs 67 to 70.

Patents of Invention - Topic 3109

Infringement of patent - Remedies - Order for delivery up or destruction - Merck sued Apotex, a generic drug manufacturer, al­leg­ing infringement of its lisinopril patent ('350 patent) - The trial judge allowed Merck's action - As to remedies, the judge held that Merck was entitled to damages and enjoined Apotex from continuing the busi­ness of making, using and selling lisinopril containing products until expiry of the '350 patent in 2007 - Apotex was also ordered to either deliver up any infrin­ging material or retain it to be used or sold only upon expiry of the '350 patent - Merck appealed, arguing that by giving Apotex the option of retaining lisinopril products the judge had created a de facto stockpiling exception, allowing Apotex to immediately resume sales from stockpiled lisinopril once the '350 patent expired - The Federal Court of Appeal directed that Apotex could only keep exempted lisino­pril product and any other lisinopril in its possession would have to be delivered up or destroyed - See paragraphs 114 to 124.

Patents of Invention - Topic 3510

Infringement actions - General - Limitation of actions - On October 20, 1990, Merck was granted a patent (the '350 patent) for lisinopril - In an action commenced in 1996, Merck sued Apotex, a generic drug manufacturer, for patent infringement - Apotex admitted that if the patent was indeed valid, then it had infringed the claims subject to certain exemptions - The trial judge held that Apotex was entitled to an exemption under s. 55.2(1) of the Pat­ent Act and under the common law as to "fair dealing" - The judge held however that since Apotex did not plead these ex­emptions until January 26, 2006, in amend­ed pleadings, the exemptions were subject to the six year limitation period in s. 55.01 of the Patent Act - Therefore, the exemp­tions would only apply to activity which took place on or after January 26, 2000, i.e., six years before Apotex's plead­ing was amended so as to include a plea as to such exemptions - Apotex appealed - The Fed­eral Court of Appeal held that the trial judge erred in limiting Apotex's exe­mption from infringement to the six years prior to when Apotex amended its plead­ings - Ra­ther, no limitation period applied to any lawful exemptions claimed by Apotex - See paragraphs 92 to 97.

Patents of Invention - Topic 3821

Infringement actions - Damages - General - Merck, and its licensee Astra, sued Apo­tex, a generic drug manufacturer, alleging patent infringement of a patent for lisino­pril (patent '350) - The trial judge allowed the action, but refused a claim by Astra that it was entitled to punitive damages because the matter was not expressly pleaded - Astra appealed - The Federal Court of Ap­peal found no basis to con­clude that the trial judge erred in failing to award puni­tive damages in circumstances of this case - See paragraphs 148 to 152.

Patents of Invention - Topic 3827

Infringement actions - Damages - Profits - Accounting - [See Patents of Invention - Topic 3102 ].

Patents of Invention - Topic 3834

Infringement actions - Damages - Interest -Prejudgment - On October 20, 1990, Merck was granted a patent (the '350 patent) for lisinopril, a compound which could be used in drugs for treating hyper­tension - Since the mid 1990s, a generic drug manufacturer (Apotex) sold a generic version of some of Merck's lisinopril drugs - In an action commenced in 1996, Merck sued Apotex for patent infringement - The trial judge allowed the action and crafted a remedy accordingly, including an award of prejudgment interest (not compounded) at the rate established by the Bank of Canada - Merck appealed, arguing that the rate of prejudgment interest set by the trial judge was too low to properly account for com­mercial reality and it should be set at five per cent per annum, the minimum rate set out in s. 3 of the Interest Act (Can.), and that compound interest should be ordered -The Federal Court of Appeal held that s. 3 of the Interest Act did not apply in this case and the trial judge correctly fixed the interest rate, nor did he err in refusing to award compound interest - See paragraphs 137 to 145.

Patents of Invention - Topic 5629

New substances licences (incl. compulsory licences) - Licences - Transfer or sharing of rights (incl. sublicensing) - [See Patents of Invention - Topic 2941 ].

Practice - Topic 1458

Pleadings - Statement of claim - Necessity of claiming damages or relief - [See Pat­ents of Invention - Topic 3821 ].

Words and Phrases

Purchased, constructed or acquired - The Federal Court of Appeal discussed the meaning of this phrase as it was used in s. 56 of the Patent Act, R.S.C. 1985, c. P-4 -See paragraph 75.

Cases Noticed:

Housen v. Nikolaisen et al., [2002] 2 S.C.R. 235; 286 N.R. 1; 219 Sask.R. 1; 272 W.A.C. 1; 211 D.L.R.(4th) 577; 2002 SCC 33, refd to. [para. 21].

Reza v. Minister of Employment and Imm­igration, [1994] 2 S.C.R. 394; 167 N.R. 282; 72 O.A.C. 348, refd to. [para. 22].

May & Baker Ltd. v. Boots Pure Drug Co. (1950), 67 R.P.C. 23 (H.L.), refd to. [para. 25].

C.H. Boehringer Sohn v. Bell-Craig Ltd., [1962] Ex. C.R. 201, affd. [1963] S.C.R. 410, refd to. [para. 26].

Hoechst Pharmaceuticals of Canada Ltd. v. Gilbert & Co., [1965] 1 Ex. C.R. 710, affd. [1966] S.C.R. 189, refd to. [para. 26].

Ciba-Geigy AG v. Commissioner of Pat­ents (1982), 42 N.R. 587; 65 C.P.R.(2d) 73 (F.C.A.), refd to. [para. 32].

Fada Radio Ltd. v. Canadian General Electric Co., [1927] S.C.R. 520, refd to. [para. 47].

Aventis Pharma Inc. v. Apotex Inc. et al. (2005), 278 F.T.R. 1; 2005 FC 1283, affd. (2006), 349 N.R. 183; 2006 FCA 64, leave to appeal denied [2006] S.C.C.A. No. 136, refd to. [para. 47].

Procter & Gamble Co. v. Beecham Can­ada Ltd. and Calgon Interamerican Corp. (1982), 40 N.R. 313; 61 C.P.R.(2d) 1 (F.C.A.), refd to. [para. 47].

GlaxoSmithKline Inc. et al. v. Apotex Inc. et al. (2003), 234 F.T.R. 251; 2003 FCT 687, refd to. [para. 48].

Nekoosa Packaging Corp. et al. v. AMCA International Ltd. et al. (1994), 172 N.R. 387; 56 C.P.R.(3d) 470 (F.C.A.), refd to. [para. 53].

P.L.G. Research Ltd. et al. v. Jannock Steel Fabricating Co. et al. (1991), 46 F.T.R. 27; 35 C.P.R.(3d) 346 (T.D.), affd. (1992), 142 N.R. 203; 41 C.P.R.(3d) 492 (F.C.A.), refd to. [para. 53].

Refrigerating Equipment Ltd. v. Drum­mond, [1930] Ex. C.R. 154, refd to. [para. 55].

Canadian Marconi Co. et al. v. Vera Pri­nzen Enterprises Ltd. et al. (1964), 46 C.P.R. 97 (Ex. Ct.), refd to. [para. 55].

Angle v. Minister of National Revenue, [1975] 2 S.C.R. 248; 2 N.R. 397; 47 D.L.R.(3d) 544, refd to. [para. 62].

Danyluk v. Ainsworth Technologies Inc. et al., [2001] 2 S.C.R. 460; 272 N.R. 1; 149 O.A.C. 1, refd to. [para. 62].

Teledyne Industries Inc. and Teledyne In­dustries Canada Ltd. v. Lido Industries Products Ltd. (1981), 39 N.R. 561; 57 C.P.R.(2d) 29 (F.C.A.), refd to. [para. 75].

Libbey-Owens-Ford Glass Co. v. Ford Motor Co. of Canada Ltd., [1969] 1 Ex. C.R. 529; 57 C.P.R. 155, affd. [1970] S.C.R. 833; 62 C.P.R. 223, refd to. [para. 77].

Cooper et al. v. Molson's Bank (1896), 26 S.C.R. 611, refd to. [para. 87].

Apotex Inc. v. Merck & Co. et al., [2003] 1 F.C. 242; 291 N.R. 96; 19 C.P.R.(4th) 163 (F.C.A.), refd to. [para. 89].

Eli Lilly & Co. et al. v. Novopharm Ltd. et al., [1998] 2 S.C.R. 129; 227 N.R. 201, refd to. [para. 89].

Bristol-Myers Squibb Co. et al. v. Canada (Attorney General) et al., [2005] 1 S.C.R. 533; 334 N.R. 55; 2005 SCC 26, refd to. [para. 100].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130; 2002 SCC 77, refd to. [para. 101].

Harvard College v. Commissioner of Pat­ents, [2002] 4 S.C.R. 45; 296 N.R. 1, refd to. [para. 102].

Micro Chemicals Ltd. v. Smith, Kline & French Inter-American Corp., [1972] S.C.R. 506, refd to. [para. 105].

Monsanto Canada Inc. et al. v. Schmeiser et al., [2004] 1 S.C.R. 902; 320 N.R. 201; 2004 SCC 34, refd to. [para. 106].

Madey v. Duke University (2002), 64 U.S.P.Q.2d 1737 (Fed. Cir. C.A.), refd to. [para. 108].

Frearson v. Loe (1878), 9 Ch. D. 48, refd to. [para. 109].

Doucet-Boudreau et al. v. Nova Scotia (Minister of Education) et al., [2003] 3 S.C.R. 3; 312 N.R. 1; 218 N.S.R.(2d) 311; 687 A.P.R. 311, refd to. [para. 114].

Allied Signal Inc. v. Du Pont Canada Inc. and Complax Corp. (1995), 184 N.R. 113; 61 C.P.R.(3d) 417 (F.C.A.), refd to. [para. 127].

Apotex Inc. v. Merck & Co. (1996), 70 C.P.R.(3d) 183 (F.C.A.), refd to. [para. 127].

Voith (J.M.) GmbH v. Beloit Corp. (1997), 214 N.R. 85; 73 C.P.R.(3d) 321 (F.C.A.), refd to. [para. 129].

Lubrizol Corp. et al. v. Imperial Oil Ltd. et al. (1992), 150 N.R. 207; 45 C.P.R.(3d) 449 (F.C.A.), refd to. [para. 130].

Wellcome Foundation Ltd. v. Apotex Inc. (1992), 52 F.T.R. 249; 40 C.P.R.(3d) 361 (T.D.), refd to. [para. 140].

British Pacific Properties Ltd. v. British Columbia, [1980] 2 S.C.R. 283; 33 N.R. 98, refd to. [para. 143].

Whiten v. Pilot Insurance Co. et al., [2002] 1 S.C.R. 595; 283 N.R. 1; 156 O.A.C. 201; 2002 SCC 18, refd to. [para. 149].

Lubrizol Corp. et al. v. Imperial Oil Ltd. et al. (1996), 197 N.R. 241; 67 C.P.R.(3d) 1 (F.C.A.), refd to. [para. 150].

Statutes Noticed:

Federal Courts Act, R.S.C. 1985, c. F-7, sect. 20(2) [para. 122]; sect. 36(4)(b) [para. 144]; sect. 36(5) [para. 139]; sect. 39 [para. 93].

Interest Act, R.S.C. 1985, c. I-15, sect. 3 [para. 141].

Patent Act, R.S.C. 1985, c. P-4, sect. 36 [para. 41]; sect. 42 [para. 106]; sect. 55.01 [para. 94]; sect. 55.2(1) [para. 98]; sect. 56 [para. 71].

Authors and Works Noticed:

Sopinka, John, Lederman, Sidney N., and Bryant, Alan W., The Law of Evidence in Canada (2nd Ed. 1999), generally [para. 87].

Counsel:

H.B. Radomski, David M. Scrimger, Nando de Luca and Miles Hastie, for the appellant;

Judith Robinson, Patrick E. Kierans and Jordana Sanft, for the respondents, Merck Inc. et al.;

Gunars A. Gaikis, J. Sheldon Hamilton and Nancy P. Pei, for the respondents, Astra­Zeneca.

Solicitors of Record:

Goodmans LLP, Toronto, Ontario, for the appellant;

Ogilvy Renault, Montreal, Quebec, for the respondent, Merck Inc.;

Smart & Biggar, Toronto, Ontario, for the respondent, AstraZeneca et al.

This appeal and cross-appeal were heard in Toronto, Ontario, on September 11-14, 2006, before Linden, Sexton and Malone, JJ.A., of the Federal Court of Appeal. Malone J.A., delivered the following judgment for the court in Ottawa, Ontario, on October 10, 2006.