Merck & Co. et al. v. Apotex Inc., (2006) 282 F.T.R. 161 (FC)

• Judge: Hughes, J.
• Court: Federal Court (Canada)
• Case Date: April 26, 2006
• Jurisdiction: Canada (Federal)
• Citations: (2006), 282 F.T.R. 161 (FC);2006 FC 524

Merck & Co. v. Apotex Inc. (2006), 282 F.T.R. 161 (FC)

MLB headnote and full text

Temp. Cite: [2006] F.T.R. TBEd. MY.021

Merck & Co. Inc., Merck Frosst Canada & Co., Merck Frosst Canada Ltd., Syngenta Limited, AstraZeneca UK Limited and AstraZeneca Canada Inc. (plaintiffs/defendants by counterclaim) v. Apotex Inc. (defendant/plaintiff by counterclaim)

(T-2792-96; 2006 FC 524)

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

Federal Court

Hughes, J.

April 26, 2006.

Summary:

The plaintiffs (collectively Merck) included the owner of and licensees under Canadian Patent 1,275,350 ('350 patent) for lisinopril, a chemical 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 they 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 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.

Damages - Topic 1318

Exemplary or punitive damages - Patent infringement - The Federal Court declined to award punitive damages in a patent infringement action where such damages were not pleaded - See paragraphs 235 to 239.

Damages - Topic 1330

Exemplary or punitive damages - Pleading - [See Damages - Topic 1318 ].

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 and second Patents of Invention - Topic 2941 ].

Estoppel - Topic 386

Estoppel by record (res judicata) - Res judicata as a bar to subsequent proceedings - Issues decided in prior proceedings - [See second Patents of Invention - Topic 2941 ].

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 the 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 in the trial and appeal division of the Federal Court respecting the '349 patent - The Federal Court 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 - The court nevertheless dealt with Apotex's arguments in case it was wrong on the estoppel issue - See paragraphs 175 to 189.

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 vast number of new compounds having a common backbone, which included lisinopril, enalapril and enalaprilat - Subsequently, Merck divided out an application for 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 Federal Court held that were it not constrained jurisprudentially, it would have readily found that the '340 application was directed to but one invention, a class of compounds, of which individual compounds such as lisinopril were but illustrative - However, jurisprudential constraints obliged the court to find otherwise, on the "slender" basis that there was in the '340 application not only examples but also specific claims to the individual compounds enalapril, enalaprilat and lisinopril, each of which, on the theory of prior binding case law, was a different invention from the class - The court (Hughes, J.) stated that "a higher court may be persuaded otherwise however, for jurisprudential integrity in this court, I must find that the '340 application discloses separate inventions to each of the class, to lisinopril, to enalapril and to enalaprilat" - See paragraphs 63 to 116.

Patents of Invention - Topic 1002

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

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - On December 6, 1979, Merck filed a Canadian patent application 341,340 ('340) in the Canadian patent office describing a new class of compounds, which included lisinopril, enalapril and enalaprilat - From the '340 patent, Merck, on its own initiative, had several applications divided out as divisional applications, including lisinopril (patent '350) - Merck pursued patent infringement proceedings respecting patent '350 against Apotex, a generic drug manufacturer, thus requiring the court to consider the construction of that patent - The Federal Court stated that construction was to be made without regard to infringement or validity - Construction was to be considered as of the date the patent was issued and granted, October 16, 1990 - The court was to put itself in the position of the ordinary person skilled in the art to which the patent pertained and read the claims in the context of the description made in the patent as a whole thus, giving a purposive construction to the claims - The court construed the claims accordingly - See paragraphs 122 to 125.

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 Federal Court did not find it necessary to consider this extrinsic evidence for the purpose of construction of the '340 patent - See paragraphs 117 to 121.

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 Federal Court rejected this argument - The court 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 - See paragraphs 198 to 204.

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 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, on its own initiative, had several applications divided out as divisional applications, including lisinopril (patent '350) - Patent '350 was divided out in 1989 and issued in 1990 - Merck pursued patent infringement proceedings against Apotex, a generic drug manufacturer - Apotex counterclaimed challenging the validity of the patent on the basis that Merck had delayed the prosecution for the '350 patent - The Federal Court rejected this argument where there was no evidence that Merck wilfully delayed the issuance of the '350 patent - The court noted that there was no Canadian jurisprudence on the subject of the consequences of delay in prosecuting a patent application - The court declined to look to law outside of Canada on this subject where there was an insufficient factual background in the evidence in this case against which to consider the matter - See paragraphs 215 to 222.

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention (incl. double patenting) - On December 6, 1979, Merck filed a Canadian patent application 341,340 ('340) in the Canadian patent office describing a new class of compounds, which included lisinopril, enalapril and enalaprilat - From the '340 patent, Merck, on its own initiative, had several applications divided out as divisional applications, including enalapril (patent '349), enalaprilat (patent 1,300,313), enalapril plus a diuretic (patent '684) and lisinopril (patent '350) - A generic drug manufacturer (Apotex) sold a generic version of some of Merck's lisinopril drugs - Merck sued Apotex for patent infringement - Apotex challenged the validity of the patent on the ground of double patenting having regard to patent ('684) which had been divided out of the same parent application ('340) as the '350 patent - The Federal Court reviewed the "judge-made concept" of double patenting and held that the '350 patent was not invalid for double patenting over the '684 patent - The court stated that it had "already found that lisinopril and enalapril are separate inventions. A fortiori lisinopril and enalapril plus a diuretic are separate inventions, they are 'patentably distinct' they are not 'identical or coterminous'. Being different inventions, one is not 'obvious' in view of the other in the sense of Bayer or Hoechst, supra, where the same compound was simply diluted or formulated" - See paragraphs 205 to 214.

Patents of Invention - Topic 1748

Grounds of invalidity - Public dedication of patent - Effect of - On December 6, 1979, Merck filed a Canadian patent application (patent '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 an application relating to lisinopril plus a diuretic and to uses of lisinopril alone (patent '559) and patent '350 directed to lisinopril alone - In 2004 the claims in the '559 patent directed to uses of lisinopril alone were dedicated to the public by Merck without prejudice to any rights in other claims in that patent or any other patent or application - An issue arose as to whether the dedication of the '559 patent claims to the public gave Apotex, a generic drug manufacturer, a defence to an infringement action based on patent '350 - The Federal Court held that the dedication of some of the claims of the '559 patent did not affect the enforceability or validity of claims 1, 2 and 5 of the '350 patent - The court stated that even if the claims in the '559 patent were invalid, that did not make the claims in the earlier '350 patent invalid nor did the dedication of claims in the '559 patent impair, or permit infringement of the '350 patent - See paragraphs 164 to 169.

Patents of Invention - Topic 2888

Infringement of patent - Acts constituting an infringement - Of particular patents - Merck sued Apotex, a generic drug manufacturer, alleging infringement of its lisinopril patent ('350 patent) - Apotex counterclaimed alleging invalidity - Merck argued that Apotex was in fact estopped from attacking the validity of the '350 patent because of former proceedings respecting a related patent - The Federal Court allowed Merck's action - 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 - The court 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 - The court enjoined Apotex from continuing the business of making, using and selling lisinopril containing products until expiry of the '350 patent - 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 - See paragraphs 224 to 243 .

Patents of Invention - Topic 2941

Infringement of patent - Chemical products and substances intended for food and medicine - General - [See Patents of Invention - Topic 2888 ].

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 the compulsory licence scheme provided by the Patent Act before that scheme was repealed - During the licence period, title to these batches of lisinopril passed to a third party - Well after the license period expired Apotex acquired both title and possession to the lisinopril manufactured by Delmar and used it to formulate tablets - Merck sued Apotex for patent infringement - Apotex claimed that it was exempt from an infringement claim respecting certain lots made with the lisinopril obtained from Delmar because of Delmar's license - The Federal Court held that Apotex could not claim the benefit of Delmar's licence - The court stated that were it not for binding authority of the Federal Court of Appeal, the court would have held that Apotex could rely on Delmar's licence (i.e., the court would have concluded that the goods were licensed and that the licence ran with the goods made before the licence was extinguished) - Further, since the compulsory licence issue had already been litigated in a patent dispute between the same parties involving a patent which arose from the same parent patent as the patent here in issue, Apotex was estopped from litigating the issue of the licence - See paragraphs 139 to 152.

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, a compound which could be used in drugs for treating hypertension - A generic drug manufacturer (Apotex) sold a generic version of some of Merck's lisinopril drugs - Merck sued Apotex for patent infringement - Apotex admitted, that if the patent was indeed 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 Federal Court 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, nor was the product ready to be shipped to a customer - See paragraphs 131 to 138.

Patents of Invention - Topic 3012

Infringement of patent - Defences - Acting under terms of licence - [See second 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) - 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 - A generic drug manufacturer (Apotex) sold a generic version of some of Merck's lisinopril drugs - Merck sued Apotex 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 - Section 55.2(1) provided that it was not patent infringement for any person, such as Apotex, to make, construct, use or sell the patented invention solely for uses reasonably related to the development and submission of information required under any law of Canada, a province, or any other country that regulated the manufacture, construction, use or sale of any product - The Federal Court held that certain lots of lisinopril held by Apotex were exempt under this provision - See paragraphs 153 to 158.

Patents of Invention - Topic 3014

Infringement of patent - Defences - Fair dealing - 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 - A generic drug manufacturer (Apotex) sold a generic version of some of Merck's lisinopril drugs - Merck sued Apotex 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 Federal Court 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 court 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) - See paragraphs 159 to 163.

Patents of Invention - Topic 3102

Infringement of patent - Remedies - Damages or accounting of profits - [See Patents of Invention - Topic 2888 ].

Patents of Invention - Topic 3103

Infringement of patent - Remedies - Injunctive relief - [See Patents of Invention - Topic 2888 ].

Patents of Invention - Topic 3109

Infringement of patent - Remedies - Order for delivery up or destruction - [See Patents of Invention - Topic 2888 ].

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, a compound which could be used in drugs for treating hypertension - 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 - Apotex admitted, that if the patent was indeed valid, then it had infringed the claims subject to certain exemptions - The Federal Court 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 court 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 - See paragraphs 170 to 174.

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 Federal Court allowed the action and crafted a remedy accordingly, including an award of prejudgment interest - The judge awarded prejudgment interest (not compounded) calculated separately for each year since the infringing activity began at the average annual bank rate established by the Bank of Canada as the minimum rate at which the bank made short-term advances to the banks listed in Schedule 1 of the Bank Act - See paragraph 240.

Patents of Invention - Topic 5006

Licencing agreements - Licensee estoppel - 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 - A generic drug manufacturer (Apotex) sold a generic version of some of Merck's lisinopril drugs - Merck sued Apotex for patent infringement - Apotex challenged the validity of the patent, but argued, that in any event it was exempt from infringement with respect to certain quantities of lisinopril it had acquired from Delmar which at the time had a compulsory licence respecting lisinopril - The Federal Court held that since Apotex was estopped for other reasons from challenging the validity of the '350 patent and from raising the licence exemption, Apotex could not, by reason of licensee estoppel only, be said to be estopped from challenging validity of the patent - See paragraphs 190 to 192.

Patents of Invention - Topic 5629

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

Practice - Topic 1458

Pleadings - Statement of claim - Necessity of claiming damages or relief - [See Damages - Topic 1318 ].

Cases Noticed:

Ex parte Markush (1925), 240 US OG 835, refd to. [para. 33].

Bayer Aktiengesellschaft et al. v. Apotex Inc. (1995), 60 C.P.R.(3d) 58 (Ont. Gen. Div.), affd. (1998), 113 O.A.C. 1; 82 C.P.R.(3d) 526 (C.A.), refd to. [para. 5].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88, refd to. [para. 81].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150, refd to. [para. 81].

Burton Parsons Chemicals Inc. et al. v. Hewlett-Packard (Canada) Ltd. et al., [1976] 1 S.C.R. 555; 3 N.R. 553, refd to. [para. 83].

Western Electric Co. v. Baldwin International Radio of Canada, [1934] S.C.R. 570, refd to. [para. 84].

May & Baker Ltd. v. Boots Pure Drug Co. (1950), 67 R.P.C. 23 (H.L.), refd to. [para. 108].

C.H. Boehringer Sohn v. Bell-Craig Ltd. (1962), 39 C.P.R. 201 (Ex. Ct.), affd. (1963), 41 C.P.R. 1 (S.C.C.), refd to. [para. 112].

Hoechst Pharmaceuticals of Canada Ltd. v. Gilbert & Co. (1965), 50 C.P.R. 26, refd to. [para. 114].

Lovell Manufacturing Co. v. Beatty Brothers Ltd. (1962), 41 C.P.R. 18 (Ex. Ct.), refd to. [para. 119].

Laboratoire Pentagone Ltée v. Parke, Davis & Co., [1968] S.C.R. 307, refd to. [para. 119].

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. 120].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88, refd to. [para. 122].

Merck & Co. et al. v. Apotex Inc. (2003), 315 N.R. 175; 30 C.P.R.(4th) 40; 2003 FCA 488, refd to. [para. 124].

Merck & Co. et al. v. Apotex Inc. [1995] 2 F.C. 723; 180 N.R. 373; 60 C.P.R.(3d) 356 (F.C.A.), refd to. [para. 124].

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. 137].

Eli Lilly & Co. et al. v. Novopharm Ltd. et al. (1998), 227 N.R. 201; 80 C.P.R.(3d) 321; 161 D.L.R.(4th) 1 (S.C.C.), refd to. [para. 147].

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. 148].

Merck KG v. Integra Lifesciences Ltd. (2005), 545 US 1, refd to. [para. 154].

Micro Chemicals Ltd. v. Smith, Kline & French Inter-American Corp., [1972] S.C.R. 506, refd to. [para. 159].

Cochlear Corp. v. Cosem Neurostim ltée (1995), 102 F.T.R. 81; 64 C.P.R.(3d) 10 (T.D.), refd to. [para. 159].

Fearson v. Loe (1878), 9 Ch. D. 48 (C.A.), refd to. [para. 160].

Searle (G.D.) & Co. et al. v. Merck & Co. et al. (2002), 219 F.T.R. 64; 20 C.P.R.(4th) 103; 2002 FCT 540, refd to. [para. 168].

Sandvik, A.B. v. Windsor Machine Ltd. and Stihl Chain Saw (Canada) Ltd. (1986), 2 F.T.R. 81; 8 C.P.R.(3d) 433 (T.D.), refd to. [para. 173].

Diversified Products Corp. and Brown Fitzpatrick Lloyd Patent Ltd. v. Tye-Sil Corp. (1991), 125 N.R. 218; 35 C.P.R.(3d) 350 (F.C.A.), refd to. [para. 176].

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. 180].

Maynard v. Maynard, [1951] S.C.R. 346, refd to. [para. 181].

Green v. Weatherill, [1929] 2 Ch. 213, refd to. [para. 181].

AB Hassle et al v. Apotex Inc. et al. (2005), 271 F.T.R. 30; 38 C.P.R.(4th) 216; 2005 FC 234, affd. (2006), 350 N.R. 219; 2006 FCA 51, refd to. [para. 182].

Apotex v. Tanabe Seiyaku & Nordic (1994), 59 C.P.R.(3d) 38 (Ont. Gen. Div.), refd to. [para. 191].

Fada Radio Ltd. v. Canadian General Electric Co., [1927] S.C.R. 520, refd to. [para. 202].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2006), 288 F.T.R. 215; 2006 FC 220, refd to. [para. 209].

Bayer Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1998), 154 F.T.R. 192; 82 C.P.R.(3d) 359 (T.D.), refd to. [para. 210].

Commissioner of Patents v. Farbwerke Hoechst A/G, [1964] S.C.R. 49, refd to. [para. 210].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; refd to. [para. 211].

Voith (J.M.) GmbH v. Beloit Corp. (1993), 61 F.T.R. 161; 47 C.P.R.(3d) 448 (T.D.), affd. (1997), 214 N.R. 85; 73 C.P.R.(3d) 321 (F.C.A.), refd to. [para. 228].

Dableh v. Ontario Hydro (1993), 67 F.T.R. 241; 50 C.P.R.(3d) 290 (T.D.), refd to. [para. 229].

Zeneca Pharma Inc. v. Canada (Minister of National Health and Welfare) et al. (1996), 206 N.R. 1; 69 C.P.R.(3d) 451 (F.C.A.), refd to. [para. 233].

Zeneca Pharma Inc. v. Canada (Minister of National Health and Welfare) et al. (2000), 267 N.R. 6; 10 C.P.R.(4th) 146 (F.C.A.), refd to. [para. 234].

Merck & Co. v. Brantford Chemicals Inc., [2004] N.R. Uned. 101; 2004 FCA 223, refd to. [para. 236].

Whiten v. Pilot Insurance Co. et al. (2002), 283 N.R. 1; 156 O.A.C. 201; 209 D.L.R.(4th) 257 (S.C.C.), refd to. [para. 237].

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 55.2(1) [para. 153]; sect. 56 [para. 131].

Authors and Works Noticed:

Fox, Harold G., The Canadian Law and Practice Relating to Letters Patent for Inventions (4th Ed. 1969), p. 60 [para. 106].

Morton, James C., Limitation of Civil Actions (1988), generally [para. 173].

Wryvatt, Evolution of Angiotensin-Converting Enzyme Inhibitors (1988), generally [para. 43].

Counsel:

J. Nelson Landry, Patrick Kierans, Judith Robinson, Frederique Amrouni and Jordana Sanft, for the plaintiff (Merck & Co.);

James Kokonis, Q.C., Gunars Gaikis, J. Sheldon Hamilton, Nancy P. Pei and Denise Lacombe, for the plaintiffs (AstraZeneca UK Limited et al.);

H.B. Radomski, Ivor Hughes, David Scrimger, Nando Deluca and Miles Hastie, for the defendant.

Solicitors of Record:

Ogilvy Renault, Toronto, Ontario, for the plaintiff (Merck & Co.);

Smart & Biggar, Toronto, Ontario, for the plaintiffs (Syngenta Limited et al.);

Goodmans LLP, Toronto, Ontario, for the defendant.

This case was heard between January and April 2006, in Toronto, Ontario, before Hughes, J., of the Federal Court, who delivered the following reasons for judgment on April 26, 2006.