Merck & Co. et al. v. Apotex Inc. et al., (2010) 381 F.T.R. 162 (FC)

• Judge: Snider, J.
• Court: Federal Court (Canada)
• Case Date: December 22, 2010
• Jurisdiction: Canada (Federal)
• Citations: (2010), 381 F.T.R. 162 (FC);2010 FC 1265

Merck & Co. v. Apotex Inc. (2010), 381 F.T.R. 162 (FC)

MLB headnote and full text

Temp. Cite: [2011] F.T.R. TBEd. JA.003

Merck & Co. Inc. and Merck Frosst Canada Ltd. (plaintiffs/defendants by counterclaim) v. Apotex Inc. and Apotex Fermentation Inc. (defendants/plaintiffs by counterclaim)

(T-1272-97; 2010 FC 1265)

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

Federal Court

Snider, J.

December 22, 2010.

Summary:

Merck Frosst Canada Ltd. sold the drug lovastatin in Canada under the trade name MEVACOR (used to treat elevated blood cholesterol), under licence from Merck & Co. MEVACOR was the subject of Canadian Patent No. 1,161,380, which expired on January 31, 2001. The patent was a product-by-process patent to lovastatin when made with a micro-organism known as Aspergillus terreus. In 1997, Apotex Inc. began selling its brand of lovastatin tablets. The active pharmaceutical ingredient (API) in dispute was made either by Apotex Fermentation Inc. (AFI) in Winnipeg, or by Qingyuan Blue Treasure Pharmaceuticals Co. Ltd., in China. Merck claimed that Apotex Inc. and AFI (the defendants) infringed the patent. The defendants claimed that there had been no infringement and that, in any event, the patent was invalid. Further, they argued that Merck & Co. had no standing to bring the action, having assigned all of its interest in the patent to an affiliate. The litigation was subject to a bifurcation order.

The Federal Court concluded that Merck & Co. had standing to bring the action; the patent was infringed; and the patent was valid. Related to the issue of damages, the evidence established that certain volumes of lovastatin produced by the defendants were used for regulatory and experimental purposes and should be exempt from a finding of infringement. Damages and the extent of infringement were to be determined by way of a reference pursuant to rule 153 of the Federal Courts Rules and the bifurcation order.

Contracts - Topic 7401

Interpretation - General principles - Intention of parties (incl. reasonable expectations) - [See third Patents of Invention - Topic 3606 ].

Contracts - Topic 7407

Interpretation - General principles - Whole contract to be considered - [See first and second Patents of Invention - Topic 3606 ].

Contracts - Topic 7409

Interpretation - General principles - Subsequent conduct of parties - [See third Patents of Invention - Topic 3606 ].

Contracts - Topic 7468

Interpretation - Interpretation of words - Whole of contract to be considered - [See first and second Patents of Invention - Topic 3606 ].

Contracts - Topic 7490

Interpretation - Intrinsic aids - Recitals - [See second Patents of Invention - Topic 3606 ].

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - The application leading to the subject patent was filed in Canada on June 11, 1980 - According to ss. 78.1-78.2 of the current Patent Act, patent applications filed before October 1, 1989, were to be dealt with under the provisions of the Patent Act as they read immediately before that date - The Federal Court set out the overarching principles of claims construction, including that it was important to recognize that purposive construction should be directed at the points in dispute - Also, as the subject patent was issued under the "old" Patent Act, all claims at issue were to be construed as of the date the patent was granted and issued - For the subject patent, that date was January 31, 1984 - See paragraphs 57 to 62.

Patents of Invention - Topic 1030

The specification and claims - Construction of a patent - "Person skilled in the art" - What constitutes - The patent at issue in this infringement case was a product-by-process patent to lovastatin when made with a micro-organism known as Aspergillus terreus - Lovastatin, sold under the trade name MEVACOR, was the first commercialized "statin" and was used to treat elevated blood cholesterol - The Federal Court defined what attributes would be held by a hypothetical skilled person - Given the nature of the patent, experience and knowledge related to fungal micro-organisms was fundamental - That expertise would include both academic qualifications and technical experience - Since the invention consisted of processes for preparing compounds that were targeted to lower serum cholesterol, the skilled person would have sufficient knowledge of medical and organic chemistry to be able to understand cholesterol biosynthesis - See paragraphs 63 to 67.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - The subject patent in this infringement action was a "product-by-process patent" - Claim 1 spoke to a process for producing four compounds "which comprises fermenting a nutrient medium with a micro-organism of the genus Aspergillus terreus" - The defendants argued that a skilled person would read the words "genus Aspergillus terreus" as referring to all micro-organisms in the genus Aspergillus - The Federal Court preferred the interpretation of the plaintiffs, namely,"the inventors were claiming only those compounds made with micro-organisms of the species Aspergillus terreus, and inadvertently used the term 'genus' in place of 'species'" - "[T]he words of claim 1 make it very clear that the patentee is not claiming compounds made with any of the 250 species of Aspergillus; rather, the boundary of the invention, as claimed, includes the four identified compounds when made with a single species - Aspergillus terreus. The use of the word 'genus' before 'Aspergillus terreus' may have been a simple inconsequential error by the drafters or the patentee may have intended the word 'genus' to modify only the word 'Aspergillus' and not the entire phrase 'Aspergillus terreus'. Regardless, given the specificity of the term 'Aspergillus terreus', the use of the word 'genus' would not change the meaning ascribed to the phrase by the skilled addressee" - See paragraph 99.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - The subject patent in this infringement action was a "product-by-process patent" - Claim 1 spoke to a process for producing four compounds "which comprises fermenting a nutrient medium with a micro-organism of the genus Aspergillus terreus" - A construction issue concerned that part of claim 1 which stated that the process of producing the compounds "comprises fermenting a nutrient medium with a micro-organism of the genus Aspergillus terreus and isolating the products" - The Federal Court reviewed the specification to determine what meaning was reasonably intended by the inventors, and concluded that the inventors meant the term "isolating" to simply refer to separating the compounds from the fermentation broth - On a proper claims construction, "isolating the products" did not require that the relevant compounds be separated from each other, purified or crystallized prior to testing - The interpretation was also supported by the reading of claim 1 in the context of the other claims - See paragraphs 100 to 109.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - The subject patent in this infringement action was a "product-by-process patent" - Claim 1 spoke to a process for producing four compounds "which comprises fermenting a nutrient medium with a micro-organism of the genus Aspergillus terreus" - The defendants asserted that the patent promised that all strains of aspergillus terreus would be capable of producing the four compounds of the invention - The plaintiffs, on the other hand, asserted that the person skilled in the art would know, and eliminate from coverage of the patent, any strain or fungus that could not produce the claimed compounds - The Federal Court was persuaded that the opinions of the plaintiffs' experts were to be preferred - "An implicit requirement that non-producing strains are excluded from the coverage of claim 1 is 'being neither benevolent nor harsh but rather seeking a construction which is reasonable and fair to both patentee and public'" - See paragraph 121.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - The subject patent in this infringement action was a "product-by-process patent" - Claim 1 spoke to a process for producing four compounds "which comprises fermenting a nutrient medium with a micro-organism of the genus Aspergillus terreus" - As a construction issue, the defendants submitted that the patent made the explicit promise that the four compounds were "highly useful as anti-hypercholesteremic agents for the treatment of atherosclerosis, hyperlipemia and like diseases in humans" - The Federal Court found that, based on the words of the specification and supported by the expert testimony, the skilled person would read the patent as promising that the compounds produced from strains of aspergillus terreus, by the fermentation process identified in the patent, were "useful as antihypercholesteremic agents for the treatment of atherosclerosis, hyperlipemia and like diseases in humans" - See paragraphs 122 to 126.

Patents of Invention - Topic 1653

Grounds of invalidity - Anticipation by prior patent - What constitutes anticipation - The patent in issue in this infringement action was a product-by-process patent to lovastatin when made with a micro-organism known as Aspergillus terreus - The defendants submitted that the claims of the patent were invalid pursuant to the principles of "anticipation by prior use"; specifically, that the compound lovastatin was known and used in the form of traditional Red Yeast Rice long before the priority date of the patent or any earlier date of invention - Red Yeast Rice had been used, produced and consumed in Asian countries for hundreds of years - The Federal Court was not persuaded that the evidence demonstrated that lovastatin was contained in Red Yeast Rice prior to the priority date - There were significant differences in the traditional methods of producing Red Yeast Rice and those that would produce lovastatin - The evidence was strong that the production of lovastatin was very dependent on the temperature of fermentation - It followed that the defendants had not satisfied its burden of demonstrating that Red Yeast Rice anticipated lovastatin - In any event, the court was not persuaded that lovastatin was disclosed to the public by the Red Yeast Rice - The court disagreed with the assertion that the existence of lovastatin in even one sample of Red Yeast Rice was sufficient to demonstrate disclosure - "Anticipation must be more than an accidental presence of a compound" - Red Yeast Rice only satisfied the disclosure requirement if it could be said to necessarily produce lovastatin - That was not the case here - See paragraphs 563 to 609.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - The claimed invention in this patent infringement action was lovastatin created through the process of fermenting the organism Aspergillus terreus - The plaintiffs claimed the product lovastatin and three other compounds when the compounds were made by the processes described in the patent - The defendants submitted that the impugned claims lacked actual utility - The Federal Court rejected that submission - As required by the jurisprudence, the patent disclosed the factual basis and line of reasoning for its promise - The prediction was made sound by the information disclosed - The disclosure of other information within the knowledge of the inventors was not essential to the prediction - The evidence did not support the defendants' assertion that inventive experimentation would be required to find producing strains of Aspergillus terreus - See paragraphs 489 to 532.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - [See Patents of Invention - Topic 1723 ].

Patents of Invention - Topic 1803

Grounds of invalidity - Prior knowledge and use - Particular patents - The defendants in this patent infringement action submitted that the plaintiff inventors were not the first inventors of the compound lovastatin as claimed in the patent in issue and that, therefore, the patent should be invalidated on the basis that the "invention" was known or used as of the date of filing the patent application - The patent application that resulted in the issuance of the patent was filed on June 11, 1980 (Monaghan application) - The defendants submitted that the Monaghan application disclosed the invention of lovastatin and ought to have been placed into conflict with the Endo application which was filed on February 19, 1980 and which ultimately resulted in the issuance of a patent which claimed a process for preparing lovastatin - The Federal Court was satisfied that there was no requirement to direct conflict proceedings between the Endo application and the Monaghan application - There was no missed conflict and the defendants were precluded, by s. 61(1)(b) of the Patent Act from challenging the validity of the patent on the grounds of prior inventorship - Even if there was a missed conflict, the invention of the patent was not the same as that of the Endo application or patent - See paragraphs 533 to 562.

Patents of Invention - Topic 2888

Infringement of patent - Acts constituting an infringement - Of particular patents - [See both Patents of Invention - Topic 3781 ].

Patents of Invention - Topic 2926

Infringement of patent - Acts not constituting an infringement - Of particular patents - The claimed invention in this patent infringement action was the compound lovastatin created through the process of fermenting the organism Aspergillus terreus - The defendant relied on s. 55.2(1) of the Patent Act (post October 1, 1989) to submit that it should not be held liable for any infringement relating to its experimental and regulatory uses of lovastatin - The Federal Court agreed - The defendant was carrying out research for the purposes of improving its Aspergillus terreus process to ensure that the process could be used on a commercial scale - That was the type of activity that the Supreme Court of Canada held was exempt from infringement (Micro Chemicals, 1972) - See paragraphs 625 to 637.

Patents of Invention - Topic 2944

Infringement of patent - Chemical products and substances intended for food and medicine - New substances - The claimed invention was lovastatin created through the process of fermenting the organism Aspergillus terreus (product-by-process patent) - The parties disputed the meaning of "new substance" in s. 39(2) of the Patent Act which stated that: "In an action for infringement of a patent where the invention relates to the production of a new substance, any substance of the same chemical composition and constitution shall, in the absence of proof to the contrary, be deemed to have been produced by the patented process" - The Federal Court turned to the "modern" principles of statutory interpretation - Further, the court highlighted the presumption of consistent expression and the presumption of coherence - In applying those principles, the question was as follows: to displace the application of s. 39(2), did the plaintiffs have to prove that the substance of the product-by-process claim in the patent was novel, or simply that it was not known before - In the end result, the court interpreted the word "new" to simply mean a substance that was not previously known or used, rather than novel - See paragraphs 138 to 167.

Patents of Invention - Topic 3606

Infringement actions - Parties - Persons entitled to commence action (incl. standing) - The patent at issue was granted to Merck & Co. - The defendant submitted that Merck & Co. had no standing to bring this infringement action, having assigned its interest in the patent to Merck and Co., Inc. (MACI) pursuant to an agreement entitled "License Agreement"; that MACI had the "full and unrestricted benefit" of the patent, and that, as a result, the right to damages under s. 55(1) of the Patent Act - The Federal Court looked at the issue in the context of the law of contracts - "The express language of the parties to a contract is the core of their contractual obligations. Where the words of a contract are clear and unambiguous, a court need not look beyond those clear words to determine its intent and effect" - The court agreed that the title of the License Agreement would not be determinative if there was clear and persuasive evidence that Merck & Co. intended to convey all of its rights in the patent - Whether that was so or not depended on an examination of the words of the agreement and the facts and circumstances surrounding the agreement - In the end result, the court was satisfied that the agreement did not operate as a conveyance of the entire right, title and interest of Merck & Co., and that it had standing to bring the action - See paragraphs 47 and 48.

Patents of Invention - Topic 3606

Infringement actions - Parties - Persons entitled to commence action (incl. standing) - The patent at issue was granted to Merck & Co. - The defendant (Apotex) submitted that Merck & Co. had no standing to bring this infringement action, having assigned all of its interest in the patent to Merck and Co., Inc. (MACI) pursuant to an agreement entitled "License Agreement" - Apotex asserted that MACI had the "full and unrestricted benefit" of the patent and, as a result, the right to damages under s. 55(1) of the Patent Act - In support of its position, Apotex pointed to a recital to the agreement - The Federal Court concluded that the words of the agreement established the creation of a licence and not a conveyance of all rights in the patent - The use of the word "remaining" in the recital did not "triumph over" the words of the agreement - The express language of clause 2 used the word "license" - On its face, the agreement only granted a "license" - Also the language of certain clauses referred to rights retained by Merck & Co. - Retention of those rights was inconsistent with an intention to transfer all rights under the patent - Provisions in the body of the agreement spoke to the intent of the agreement and the scope of the "transfer" - "The use of a recital or preamble as an interpretative aid must always be approached with caution" - In the end result, the court was satisfied that the agreement did not operate as a conveyance of the entire right, title and interest of Merck & Co., and that it had standing to bring the action - See paragraphs 49 to 54.

Patents of Invention - Topic 3606

Infringement actions - Parties - Persons entitled to commence action (incl. standing) - The patent at issue was granted to Merck & Co. - The defendant submitted that Merck & Co. had no standing to bring this infringement action, having assigned all of its interest in the patent to Merck and Co., Inc. (MACI) pursuant to an agreement entitled "License Agreement" - Apotex asserted that MACI had the "full and unrestricted benefit" of the patent and, as a result, the right to damages under s. 55(1) of the Patent Act - The Federal Court was satisfied that, even if it accepted that the agreement was not clear on its face, the parties to the agreement did not intend to convey the entire right, title and interest in the patent - One indication of the intent of the parties was their behaviour after the execution of the agreement - The behaviour of Merck & Co. was not consistent with a company who had given up its entire right, title, estate and interest in the patent - It commenced and pursued this litigation for 13 years in its own name, and it remained as the named patentee on the patent - In the end result, the court held that Merck & Co. had standing to bring the action - See paragraph 55.

Patents of Invention - Topic 3781

Infringement actions - Evidence - General - The patent claimed by the plaintiff (Merck) was a product-by-process patent to lovastatin when made with a micro-organism known as Aspergillus terreus - The defendant (Apotex) began selling its brand of lovastatin tablets - Merck claimed that the lovastatin manufactured by "Blue Treasure" in China and sold to Apotex was produced using a process that infringed the patent - A compound (P2000) was an essential ingredient in the non-infringing process - Apotex put forward photocopies of alleged batch records for 364 fermentation batches of lovastatin made at Blue Treasure - The Federal Court deducted from the mostly circumstantial evidence that there was infringement - The batch records were not reliable - They were not the original working records which had been destroyed six years into this litigation - They did not qualify as business records, as they were not made contemporaneously with the fermentations to which they ostensibly related - The testimony with respect to the batch records lacked credibility - Blue Treasure did not have sufficient quantities of P2000 to run the non-infringing process, and it had the motivation, the means and the opportunity to produce lovastatin with the infringing process - See paragraphs 189 to 342.

Patents of Invention - Topic 3781

Infringement actions - Evidence - General - The patent claimed by the plaintiff (Merck) was a product-by-process patent to lovastatin when made with a micro-organism known as Aspergillus terreus - The defendant (Apotex) began selling its brand of lovastatin tablets - Merck claimed that one batch of lovastatin (CR0157) produced by Apotex contained lovastatin that was made using the process protected by the patent - In essence, it argued that CR0157 was a combined batch of non-infringing and infringing lovastatin - The Federal Court found infringement - Since CR0157 was never tested by Apotex, the court had no direct evidence that the batch was not Aspergillus terreus lovastatin - However, the court did have direct evidence that tablets from the batch were made from infringing lovastatin, based on the DNA testing results - The court concluded that the DNA testing results were reliable and credible evidence, and rejected the contamination theory of Apotex - See paragraphs 343 to 465.

Patents of Invention - Topic 3788

Infringement actions - Evidence - Presumptions - [See Patents of Invention - Topic 3789 ].

Patents of Invention - Topic 3789

Infringement actions - Evidence - Burden of proof - The claimed invention was lovastatin created through the process of fermenting the organism Aspergillus terreus - Section 39(2) of the Patent Act dealt with the claims in a product-by-process patent: "In an action for infringement of a patent where the invention relates to the production of a new substance, any substance of the same chemical composition and constitution shall, in the absence of proof to the contrary, be deemed to have been produced by the patented process" - The Federal Court concluded that s. 39(2) was engaged - The question that followed was: what was the interpretation of "in the absence of proof to the contrary" - The court disagreed with the plaintiffs' argument that s. 39(2) mandated that the persuasive burden of proof remained with the defendants to show non-infringement - Section 39(2) created a presumption of infringement that conferred on the defendants an evidentiary burden to rebut infringement - There was no support for the plaintiffs' argument that s. 39(2) deemed infringement and put the persuasive burden on the defendants - See paragraphs 168 to 176 - Combining principles of the evidentiary burden, the common law presumption of infringement and s. 39(2), the court concluded that the defendants' burden was to show that it used a non-infringing process to create lovastatin, and that the process was disclosed to the plaintiffs - "At this time, the Court should not assess the quality, weight or reliability of the evidence, but merely ask if there is sufficient evidence to put the issue in play" - In the end result, the court found that the defendants had met the evidentiary burden by establishing that a viable alternative existed that did not infringe the patent - The persuasive burden of proof was therefore back with the plaintiffs - See paragraphs 177 to 185.

Patents of Invention - Topic 3821

Infringement actions - Damages - General - The Federal Court stated that "[w]hile both damages and accounting of profits are intended to provide compensation to a wronged plaintiff, the fundamental principles underlying the two remedies and the practical considerations are substantially different" - See paragraphs 613 to 617.

Patents of Invention - Topic 3826

Infringement actions - Damages - Profits - General - [See Patents of Invention - Topic 3821 ].

Patents of Invention - Topic 3827

Infringement actions - Damages - Profits - Accounting - The plaintiffs successfully demonstrated infringement, and elected an accounting of profits - The defendants argued that the court should not exercise its discretion to grant the choice of remedy in this case - The Federal Court agreed with the plaintiffs that it had not committed any inequitable conduct that would disentitle them from the equitable remedy of profits - However, other factors weighed against such a remedy in this case - A factor that caused the court serious concern was the time that this matter took to come to trial (almost 13 years) - Reaching back to assess the defendants' profits would be exceedingly difficult - The difficulty in assessing profits was further exacerbated by the complexities of the commercial arrangements that were involved - In the result, the plaintiffs would be entitled to their damages - See paragraphs 618 to 624.

Statutes - Topic 2265

Interpretation - Presumptions and rules in aid - Against change in terminological usage (consistent expression) - [See Patents of Invention - Topic 2944 ].

Statutes - Topic 2603

Interpretation - Interpretation of words and phrases - Modern rule (incl. interpretation by context) - Intention from whole of section or statute - [See Patents of Invention - Topic 2944 ].

Statutes - Topic 2617

Interpretation - Interpretation of words and phrases - Modern rule (incl. interpretation by context) - Harmonization of statutes (incl. presumption of coherence) - [See Patents of Invention - Topic 2944 ].

Words and Phrases

New substance - The Federal Court considered the meaning of the words "new substance" in s. 39(2) of the Patent Act, R.S.C. 1985, c. P-4 - See paragraphs 138 to 153.

Cases Noticed:

Merck & Co. v. Smith (Francis R.) (1958), 261 F.2d 162 (3rd Cir.), refd to. [para. 45].

Vaupel Textilmaschinen KG v. Meccanica Euro Italia SPA (1991), 944 F.2d 870 (Fed. Cir.), refd to. [para. 45].

Prima Tek II, L.L.C. v. A-Roo Co. (2000), 222 F.3d 1372 (Fed. Cir.), refd to. [para. 45].

Guyot v. Thompson, [1894] R.P.C. 541 (C.A.), refd to. [para. 45].

Domco Industries Ltd. v. Armstrong Cork Canada Ltd. et al. and Congoleum-Nairn Inc. et al., [1982] 1 S.C.R. 907; 42 N.R. 254; 66 C.P.R.(2d) 46, refd to. [para. 49].

Heap v. Hartley (1889), 42 Ch. D. 461, refd to. [para. 49].

Dukart v. Surrey (District) et al., [1978] 2 S.C.R. 1039; 21 N.R. 471; [1978] 4 W.W.R. 1; 86 D.L.R.(3d) 609, consd. [para. 51].

Lay v. Lay (2000), 131 O.A.C. 47; 47 O.R.(3d) 779; 184 D.L.R.(4th) 652 (C.A.), leave to appeal refused (2000), 264 N.R. 398; 131 O.A.C. 47 (S.C.C.), refd to. [para. 53].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 2000 SCC 67, refd to. [para. 57].

Dimplex North America Ltd. v. CFM Corp. (2006), 292 F.T.R. 38; 2006 FC 586, affd. (2007), 370 N.R. 516; 60 C.P.R.(4th) 277; 2007 FCA 278, refd to. [para. 57].

Aventis Pharma Inc. v. Apotex Inc. et al. (2005), 278 F.T.R. 1; 43 C.P.R.(4th) 161; 2005 FC 1283, refd to. [para. 58].

Apotex Inc. v. Syntex Pharmaceuticals International Ltd. et al. (1999), 166 F.T.R. 161 (T.D.), refd to. [para. 58].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2008), 323 F.T.R. 56; 63 C.P.R.(4th) 406; 2008 FC 142, refd to. [para. 59].

Eli Lilly Canada Inc. v. Novopharm Ltd. et al., [2007] F.T.R. Uned. 828; 58 C.P.R.(4th) 214; 2007 FC 596, refd to. [para. 59].

Shire Biochem Inc. et al. v. Canada (Minister of Health) et al. (2008), 328 F.T.R. 123; 67 C.P.R.(4th) 94; 2008 FC 538, refd to. [para. 59].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2005), 285 F.T.R. 1; 2005 FC 1725, refd to. [para. 61].

Apotex Inc. v. Bristol-Myers Squibb Co. et al., [2007] N.R. Uned. 171; 2007 FCA 379, refd to. [para. 87].

Metalliflex Ltd. v. Wienenberger Aktiengesellschaft, [1961] S.C.R. 117, refd to. [para. 96].

Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390; 122 D.L.R.(3d) 203; 56 C.P.R.(2d) 145, refd to. [para. 121].

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. 135].

Rizzo & Rizzo Shoes Ltd. (Bankrupt), Re, [1998] 1 S.C.R. 27; 221 N.R. 241; 106 O.A.C. 1; 154 D.L.R.(4th) 193, appld. [para. 145].

Bell ExpressVu Limited Partnership v. Rex et al., [2002] 2 S.C.R. 559; 287 N.R. 248; 166 B.C.A.C. 1; 271 W.A.C. 1; 212 D.L.R.(4th) 1; 2002 SCC 42, refd to. [para. 145].

Jabel Image Concepts Inc. et al. v. Minister of National Revenue, [2000] G.S.T.C. 45; 257 N.R. 193 (F.C.A.), refd to. [para. 148].

Peach Hill Management Ltd. v. R. - see Jabel Image Concepts Inc. et al. v. Minister of National Revenue.

Mattabi Mines Ltd. v. Ontario (Minister of Revenue), [1988] 2 S.C.R. 175; 87 N.R. 300; 29 O.A.C. 268; 53 D.L.R.(4th) 656, refd to. [para. 149].

Jevco Insurance Co. v. Pilot Insurance Co., [2000] O.T.C. 446; 49 O.R.(3d) 760 (Sup. Ct.), refd to. [para. 150].

Eli Lilly & Co. v. Nu-Pharm Inc. et al. (1994), 78 F.T.R. 27; 54 C.P.R.(3d) 145 (T.D.), refd to. [para. 162].

Apotex Inc. v. Tanabe Seiyaku & Nordic (1994), 59 C.P.R.(3d) 38 (Ont. Gen. Div.), refd to. [para. 169].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2004), 260 F.T.R. 276; 2004 FC 1349, consd. [para. 173].

Circle Film Enterprises Inc. v. Canadian Broadcasting Corp., [1959] S.C.R. 602; 31 C.P.R. 57, consd. [para. 175].

Hoffmann-La Roche Ltd. et al. v. Canada (Minister of National Health and Welfare) et al. (1996), 205 N.R. 331; 70 C.P.R.(3d) 206 (F.C.A.), consd. [para. 178].

R. v. Fontaine (J.), [2004] 1 S.C.R. 702; 318 N.R. 371; 2004 SCC 27, refd to. [para. 179].

Pharmacia Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1995), 92 F.T.R. 253; 60 C.P.R.(3d) 328 (T.D.), refd to. [para. 180].

Ares v. Venner, [1970] S.C.R. 608; 12 C.R.N.S. 349, refd to. [para. 220].

R. v. T.E., [2007] O.A.C. Uned. 537; 2007 ONCA 891, consd. [paras. 246, 247].

R. v. T.E., [2004] O.T.C. 42 (Sup. Ct.), consd. [paras. 246, 247].

Levesque v. Comeau, [1970] S.C.R. 1010; 5 N.B.R.(2d) 15; 16 D.L.R.(3d) 425, refd to. [para. 258].

Minister of Employment and Immigration v. Satiacum (1989), 99 N.R. 171 (F.C.A.), refd to. [para. 338].

R. v. Mohan, [1994] 2 S.C.R. 9; 166 N.R. 245; 71 O.A.C. 241; 114 D.L.R.(4th) 419, refd to. [para. 400].

Backman v. Minister of National Revenue (1999), 246 N.R. 309; 178 D.L.R.(4th) 126 (F.C.A.), refd to. [para. 445].

Rorer (William H.) (Canada) Ltd. v. Johnson & Johnson (1980), 48 C.P.R.(2d) 58 (F.C.T.D.), refd to. [para. 445].

Misik (E.) v. Minister of National Revenue, [1993] 1 C.T.C. 2360 (T.C.C.), refd to. [para. 445].

Biovail Pharmaceuticals Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (2005), 267 F.T.R. 243; 37 C.P.R.(4th) 487; 2005 FC 9, consd. [para. 470].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2008), 323 F.T.R. 56; 63 C.P.R.(4th) 406; 2008 FC 142, affd. (2009), 392 N.R. 243; 78 C.P.R.(4th) 388; 2009 FCA 97, leave to appeal refused (2009), 401 N.R. 400 (S.C.C.), consd. [paras. 473, 521].

Merck & Co. et al. v. Apotex Inc. et al. (2005), 274 F.T.R. 113; 41 C.P.R.(4th) 35; 2005 FC 755, refd to. [para. 478].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 306 F.T.R. 254; 2007 FC 26, affd. (2007), 367 N.R. 98; 60 C.P.R.(4th) 177; 2007 FCA 195, leave to appeal refused (2007), 381 N.R. 399 (S.C.C.), refd to. [para. 478].

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. 480].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al., [2009] 1 F.C.R. 253; 377 N.R. 9; 67 C.P.R.(4th) 23; 2008 FCA 108, refd to. [para. 482].

Procter & Gamble Co. v. Bristol-Myers Ltd. (1978), 39 C.P.R.(2d) 145 (F.C.T.D.), refd to. [para. 532].

Mobil Oil Corp. et al. v. Hercules Canada Inc. (1995), 188 N.R. 382; 63 C.P.R.(3d) 473 (F.C.A.), refd to. [para. 532].

Laboratoires Servier et al. v. Apotex Inc. et al. (2008), 332 F.T.R. 193; 67 C.P.R.(4th) 241; 2008 FC 825, refd to. [para. 539].

Sanofi-Synthelabo Canada Inc. et al. v. Apotex Inc. et al., [2008] 3 S.C.R. 265; 381 N.R. 125; 2008 SCC 61, refd to. [para. 565].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2008), 337 F.T.R. 17; 71 C.P.R.(4th) 237; 2008 FC 1359, affd. (2009), 387 N.R. 347; 2009 FCA 94, consd. [para. 568].

Hoffmann-La Roche & Co. v. Commissioner of Patents, [1955] S.C.R. 414; 23 C.P.R. 1, consd. [para. 576].

Hoffman-La Roche & Co. v. Commissioner of Patents, [1954] Ex. C.R. 52; 19 C.P.R. 80, refd to. [para. 577].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 361 N.R. 308; 59 C.P.R.(4th) 30; 2007 FCA 153, refd to. [para. 580].

Bayer AG et al. v. Apotex Inc. et al. (2001), 278 N.R. 178; 14 C.P.R.(4th) 263; 2001 FCA 263, consd. [para. 581].

Calgon Carbon Corp. v. North Bay City et al. (2008), 375 N.R. 372; 64 C.P.R.(4th) 337; 2008 FCA 81, refd to. [para. 601].

Baker Petrolite Corp. et al. v. Canwell Enviro-Industries Ltd. et al. (2002), 288 N.R. 201; 17 C.P.R.(4th) 478; 2002 FCA 158, refd to. [para. 601].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2006), 350 N.R. 242; 56 C.P.R.(4th) 387; 2006 FCA 187, refd to. [para. 605].

Synthon BV v. Smithkline Beecham plc, [2005] N.R. Uned. 180; [2006] 1 All E.R. 685; [2005] UKHL 59, refd to. [para. 605].

Beloit Canada Ltd. v. Valmet Oy (1994), 78 F.T.R. 86; 55 C.P.R.(3d) 433 (T.D.), varied (1995), 184 N.R. 149; 61 C.P.R.(3d) 271 (F.C.A.), leave to appeal refused (1995), 64 C.P.R.(3d) vi (S.C.C.), refd to. [para. 615].

Beloit Canada Ltd. v. Valmet Oy (1992), 144 N.R. 389; 45 C.P.R.(3d) 116 (F.C.A.), refd to. [para. 616].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2006), 301 F.T.R. 166; 57 C.P.R.(4th) 58; 2006 FC 1234, affd. (2007), 366 N.R. 290; 59 C.P.R.(4th) 116; 2007 FCA 217, leave to appeal refused (2007), 383 N.R. 397 (S.C.C.), refd to. [para. 617].

Merck & Co. et al. v. Apotex Inc. (2006), 282 F.T.R. 161; 53 C.P.R.(4th) 1; 2006 FC 524, revd. (2006), 354 N.R. 51; 55 C.P.R.(4th) 1; 2006 FCA 323, leave to appeal refused (2006), 370 N.R. 400 (S.C.C.), refd to. [para. 627].

Micro Chemicals Ltd. v. Smith, Kline & French Inter-American Corp., [1972] S.C.R. 506; 2 C.P.R.(2d) 193, refd to. [para. 636].

Statutes Noticed:

Canada Evidence Act, R.S.C. 1985, c. C-5, sect. 30(1) [para. 221].

Patent Act, R.S.C. 1985, c. P-4, sect. 27(1) [para. 535]; sect. 39(1) [para. 135]; sect. 39(20) [para. 136]; sect. 43(1) [para. 536]; sect. 43(2) [para. 551]; sect. 43(5) [para. 552]; sect. 55.2(1) [para. 626]; sect. 61(1)(b) [para. 538].

Authors and Works Noticed:

Fox, Harold George, The Canadian Law and Practice Relating to Letters Patent for Inventions (4th Ed. 1969), p. 153 [para. 482].

Hughes, Roger T., and Woodley, John H., Patents (2nd Ed. 2005) (Looseleaf), para. 45 [para. 171].

Sullivan, Ruth, Sullivan on the Construction of Statutes (5th Ed. 2008), pp. 3 [para. 146]; 214 to 223 [para. 147]; 221 [para. 149]; 222 [paras. 149, 150]; 223 [paras. 147, 151]; 224 to 225 [para. 147].

Counsel:

Andrew J. Reddon, Glynnis P. Burt, David Tait, William H. Richardson and Ariel Neuer, for the plaintiffs;

Harry Radomski, Jerry Topolski, Ben Hackett and David Scrimger, for the defendant, Apotex Inc.;

John A. Myers, G. Patrick S. Riley, Nicole D.S. Merrick and Rodrique C. Roy, for the defendant, Apotex Fermentation Inc.;

J. Alan Aucoin, Anthony M. Prenol, Antonio Turco and Athar K. Malik, for the former third party, Biogal Pharmaceutical Works Ltd.

Solicitors of Record:

McCarthy Tétrault LLP, Toronto, Ontario, for the plaintiffs;

Goodmans LLP, Toronto, Ontario, for the defendant, Apotex Inc.;

Taylor McCaffrey LLP, Winnipeg, Manitoba, for the defendant, Apotex Fermentation Inc.;

Blake Cassels & Graydon LLP, Toronto, Ontario, for the former third party, Biogal Pharmaceutical Works Ltd.

This action was heard at Toronto, Ontario, on various dates throughout February, March, April and May, 2010, before Snider, J., of the Federal Court, who delivered the following public reasons for judgment and judgment, dated December 22, 2010.