AstraZeneca Canada Inc. et al. v. Apotex Inc. et al., (2014) 457 F.T.R. 227 (FC)

• Judge: Rennie, J.
• Court: Federal Court (Canada)
• Case Date: September 04, 2013
• Jurisdiction: Canada (Federal)
• Citations: (2014), 457 F.T.R. 227 (FC);2014 FC 638

AstraZeneca Can. Inc. v. Apotex Inc. (2014), 457 F.T.R. 227 (FC)

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[French language version follows English language version]

[La version française vient à la suite de la version anglaise]

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Temp. Cite: [2014] F.T.R. TBEd. JL.003

AstraZeneca Canada Inc., AstraZeneca Aktiebolag and AstraZeneca UK Limited (plaintiffs/defendants by counterclaim) v. Apotex Inc. and Apotex Pharmachem Inc. (defendants/plaintiffs by counterclaim)

(T-1668-10; 2014 FC 638; 2014 CF 638)

Indexed As: AstraZeneca Canada Inc. et al. v. Apotex Inc. et al.

Federal Court

Rennie, J.

July 2, 2014.

Summary:

Apotex Inc. sought to sell a generic version of esomeprazole. AstraZeneca Canada Inc. and AstraZeneca Aktiebolag applied under the Patented Medicines (Notice of Compliance) Regulations, for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex, for 20 and 40 mg. esomeprazole magnesium tablets (Nexium) until after the expiry of Canadian Patent No. 2,139,653 (the '653 patent). The overriding issue was whether the allegations made by Apotex in its Notice of Allegation that claim 8 of the '653 patent was invalid were justified within the meaning of s. 6(2) of the Regulations.

The Federal Court, in a decision reported 376 F.T.R. 17, dismissed the application for the prohibition order. The court found that the allegations that claim 8 was invalid for lack of sound prediction as to utility and for obviousness, were justified. The allegation as to anticipation was not justified. Thereafter Apotex commenced to sell its generic version of esomeprazole. AstraZeneca Canada Inc., AstraZeneca Aktiebolag, and AstraZeneca UK Ltd. commenced a patent infringement action against Apotex and Apotex counterclaimed for a declaration of invalidity.

The Federal Court dismissed AstraZeneca's action for infringement and granted Apotex's counterclaim for a declaration of invalidity respecting the '653 patent. The court found that the '653 patent was invalid because of inutility. However, for completeness of the record, the court also considered the other alleged grounds of invalidity.

Courts - Topic 2015

Jurisdiction - General principles - Controlling abuse of its process - [See third Patents of Invention - Topic 2946 ].

Estoppel - Topic 377

Estoppel by record (res judicata) - Res judicata as a bar to subsequent proceedings - When applicable - [See first Patents of Invention - Topic 2946 ].

Estoppel - Topic 381.1

Estoppel by record (res judicata) - Res judicata as a bar to subsequent proceedings - In intellectual property proceedings - [See first Patents of Invention - Topic 2946 ].

Estoppel - Topic 386

Estoppel by record (res judicata) - Res judicata as a bar to subsequent proceedings - Issues decided in prior proceedings - [See first and second Patents of Invention - Topic 2946 ].

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - General - The Federal Court stated that "In essence, a two-step approach to constructing claims can be employed: (1) Are the claims, when read in a principled manner, and in the context of the entire specification, clear and unambiguous? If they are, then the disclosure should not be consulted for the purpose of qualifying the scope of clear and unambiguous claims. However, if the claims are ambiguous, then a further question must be asked: (2) do the claims and disclosure complement or contradict each other? If they complement each other, then they can be read harmoniously (i.e. the claims may be qualified by the disclosure). If they contradict each other, then the disclosure cannot be used to resolve the ambiguity because the consequence would be to inappropriately re-write the claims" - See paragraph 68.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - Apotex Inc. sold a generic version of Nexium (esomeprazole), following a determination in Notice of Compliance proceedings that claim 8 of the AstraZeneca patent for esomeprazole (the '653 patent) was invalid - AstraZeneca sued Apotex for patent infringement - The Federal Court interpreted the patent for purposes of the infringement action, including identifying the person skilled in the art, identifying the skilled person's common knowledge and construing the terms of the patent from the perspective of that skilled person - See paragraphs 49 to 82.

Patents of Invention - Topic 1033

The specification and claims - Construction of a patent - By reference to disclosure - [See Patents of Invention - Topic 1032 ].

Patents of Invention - Topic 1128

The specification and claims - The description - Sufficiency of disclosure - [See second and third Patents of Invention - Topic 1724 ].

Patents of Invention - Topic 1581

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - General - The Federal Court stated that "There are two key differences between novelty and obviousness: (1) the body of prior art that they consider and (2) the threshold of ingenuity (in the case of obviousness) or effort (in the case of novelty) that must be met when moving from that prior art to the patent in question" - See paragraph 219.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of inventive ingenuity (obviousness) - Test for obviousness - The Federal Court referred to the four-part test for obviousness as set out in Sanofi-Synthelabo v. Apotex (SCC 2008): "a. Identify the person skilled in the art and the relevant common general knowledge; b. Identify the inventive concept of the claim in question or, if that cannot readily be done, construe it; c. Identify what, if any, differences exist between the matter cited as forming part of the "state of the art" and the inventive concept; and d. Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps that would have been obvious to the skilled person or do they require a degree of invention?" - See paragraph 260.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of inventive ingenuity (obviousness) - Particular patents - AstraZeneca owned a patent (the '653 patent) respecting esomeprazole (Nexium) - Apotex Inc. sold a generic version of Nexium - AstraZeneca sued Apotex for patent infringement - Apotex alleged that the '653 patent was invalid because it was obvious - The Federal Court held that the '653 patent was not obvious, nor were the specific methods ultimately employed to reach its high purity obvious to try - See paragraphs 259 to 367.

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art - The Federal Court noted that one of the differences between novelty and obviousness was the body of prior art that they considered - The court stated that "With respect to the body of prior art considered, novelty considers whether a single prior art reference makes the patent old whereas obviousness considers whether the state of the art (i.e. multiple prior art references) makes the patent obvious. Put differently, novelty asks if the invention was already discovered by a single prior art reference whereas obviousness asks if the invention would have been self-evident to discover given the state of the art ..." - See paragraph 220.

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art - The Federal Court stated that "With respect to the threshold that must be met to move from this prior art to the patent in question, novelty considers a lower threshold relating to effort: whether or not a single prior art reference teaches the patent in question without 'undue burden' ... In contrast, obviousness considers a higher threshold relating to ingenuity: whether or not the state of the art teaches the patent in question without the need for an 'inventive step' or 'degree of invention' ... Requiring an inventive step to get from a single prior art reference to the impugned patent is determinative of the impugned patent being novel with respect to that prior art reference. In other words, inventive steps exceed the threshold of undue burden ..." - See paragraph 221.

Patents of Invention - Topic 1602

Grounds of invalidity - Anticipation - Test for - The Federal Court noted for a patent to be anticipated there had to be, from the perspective of the skilled person: (1) prior disclosure; and (2) enablement from that prior disclosure - The court also used this for novelty - See paragraph 224.

Patents of Invention - Topic 1671

Grounds of invalidity - Lack of novelty - General - [See Patents of Invention - Topic 1581 and Patents of Invention - Topic 1602 ].

Patents of Invention - Topic 1672

Grounds of invalidity - Lack of novelty - State of the art - [See both Patents of Invention - Topic 1593 and Patents of Invention - Topic 1675 ].

Patents of Invention - Topic 1675

Grounds of invalidity - Lack of novelty - Particular patents - AstraZeneca owned a patent (the '653 patent) respecting esomeprazole (Nexium) - Apotex Inc. sold a generic version of Nexium - AstraZeneca sued Apotex for patent infringement - Apotex alleged that the '653 patent was invalid because the patent claims were not new - Apotex claimed that there had been prior disclosure in an abandoned German Patent Application (DE 455) which was filed and published before the '653 patent claim date (i.e., May 28, 1993) - The Federal Court held that the '653 patent was novel - The prior disclosure criteria was not met because DE 455 did not disclose the essential characteristic of a specified degree of high optical purity - Further, the court was not convinced that the skilled person would have been enabled to reach the degree of purity specified in the '653 patent by performing DE 455 - See paragraphs 223 to 258.

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General (incl. "promise of the patent") - The Federal Court stated that "... In essence, an alleged patent satisfies the requirement of utility if, from the perspective of the skilled person as of the filing date ... its utility is demonstrated, or in the alternative, if its utility is soundly predicted ..." - See paragraph 83.

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General (incl. "promise of the patent") - The Federal Court discussed the legal principles regarding the promise of the patent - The stated, inter alia, that "The utility analysis is intimately connected to the determination of the promise of the patent. Indeed, the promise of the patent is 'fundamental to the utility analysis' ... Conceptually, the promise of the patent is the yardstick against which utility is measured ... Thus, if a patent makes a promise, it will have utility only if that promise is fulfilled" - See paragraphs 85 and 86.

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General (incl. "promise of the patent") - The Federal Court discussed the legal principles regarding the promise of the patent - The court stated, inter alia, that "Identifying the promise of the patent requires a consideration of 'the patent as a whole' ... The perspective adopted in ascertaining the promise of the patent is that of 'the [skilled person] in relation to the science and information available at the time of filing' ... However, while adopting such a perspective to ascertain the promise of the patent may be assisted by expert evidence, it remains a question of law in the exclusive province of the courts ..." - See paragraphs 87 to 89.

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General (incl. "promise of the patent") - The Federal Court discussed the legal principles regarding the promise of the patent - The court stated, inter alia, that "... if the patent does not promise a specific result, a 'mere scintilla' of utility will suffice. However, if the patent does promise a specific result, utility is measured against that explicit promise. In essence, '[t]he question is whether the invention does what the patent promises it will do' ..." - See paragraph 90.

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General (incl. "promise of the patent") - The Federal Court stated that "There is a difference between the goals that a patent hopes to address, and the outcomes that a patent promises will occur ... 'not all statements of advantage in a patent rise to the level of a promise. A goal is not necessarily a promise' ... Differentiating goals and promises is a question of characterization ... Goals merely describe 'a hoped-for advantage of the invention' ... In sum, promises are explicit and define guaranteed or anticipated results from the patent (depending on whether the promise is demonstrated or soundly predicted), whereas goals merely relate to potential uses for the patent" - See paragraphs 115 to 117.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - [See third, fourth, fifth and sixth Patents of Invention - Topic 1724 ]

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - The Federal Court stated that "Demonstrated utility is based on whether, as of the filing date, there was proof that the patent worked as it promised ... 'what amounts to demonstrated utility would be evidence that establishes that the embodiment at issue does in fact work in a manner that gives rise to the advantages stated in the patent' ... By contrast, soundly predicted utility is based on the three part test set out by the Supreme Court of Canada in Apotex Inc. v. Wellcome Foundation Ltd. 2002 SCC ...: (1) there must be a factual basis for the prediction, (2) the inventor must have at the date of the patent application an articulable and sound line of reasoning from which the desired result can be inferred from the factual basis, and (3) there must be proper disclosure" - See paragraphs 137 and 138.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - The Federal Court discussed the issue of disclosure in the context of utility and sound prediction - The court concluded that "proper disclosure" of utility applied only to "new use" patents, rather than sound prediction cases generally (i.e., there was no enhanced disclosure requirement in all sound prediction cases) - Utility and disclosure were treated separately under the Patent Act, and consequently, should be treated separately in the jurisprudence as well - See paragraphs 139 to 161.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - AstraZeneca owned a patent for esomeprazole (Nexium) (the '653 patent) - AstraZeneca sued Apotex Inc., a generic drug manufacturer, for patent infringement - Apotex asserted that the '653 patent was invalid for want of utility - Astra Zeneca argued that the patent's promises of stability against enzyme-mediated racemization and an improved therapeutic profile (the second and third promises) were soundly predicted because of studies that were internal to AstraZeneca and not disclosed in the '653 patent - Apotex argued that if the patent's validity depended on the sound prediction of the second or third promises, then such a sound prediction was invalid in law because it failed to satisfy the requirement of proper disclosure - The Federal Court held that the patent promised reduced interindividual variation, and that none of the studies, disclosed or otherwise, demonstrated or soundly predicted such utility - AstraZeneca's failure to disclose the studies it relied upon for a sound prediction in this case would be irrelevant because the '653 patent was not a new use patent - See paragraphs 139 to 161.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - AstraZeneca owned a patent for esomeprazole (Nexium) (the '653 patent), which promised use as a proton pump inhibitor (PPI) - In patent infringement/validity proceedings, AstraZeneca argued that this promise was either demonstrated or soundly predicted based on a paper by Erlandsson which taught that the activities of omeprazole enantiomers were the same - The Federal Court stated that the knowledge that omeprazole was itself useful as a PPI, and that its enantiomers had identical activity, supported a sound prediction of utility - The use of the enantiomers as a PPI was, however, not directly demonstrated - Without studies directly on the enantiomers themselves such evidence fell short of demonstration - Rather, such a use was extremely likely given the relationship between the enantiomers and the racemate - There was no issue regarding proper disclosure of this promise - AstraZeneca's expert's opinion, that the use of the claimed compounds as PPI's was soundly predicted, was based on the Erlandsson paper which was expressly referred to in the '653 patent - See paragraphs 162 to 166.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - AstraZeneca owned a patent for esomeprazole (Nexium) (the '653 patent), which promised an improved therapeutic profile such as a lower degree of interindividual variation (promise 2) - In patent infringement/validity proceedings, AstraZeneca argued that the promise was soundly predicted - The Federal Court held that the expert testimony with respect to utility showed that the internal AstraZeneca studies neither demonstrated nor soundly predicted the full promise of an improved therapeutic profile - The '653 patent was therefore invalid because of lack of utility - It promised more that it could provide - See paragraphs 191 to 213.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - AstraZeneca owned a patent for esomeprazole (Nexium) (the '653 patent) - The patent promised, inter alia, stability against racemization - In patent infringement/validity proceedings an issue arose as to whether the promise was demonstrated or soundly predicted - The Federal Court opined that this promise was directed at two types of racemization: stability against chemical-mediated and enzyme-mediated racemization - The promise of stability against chemical-mediated racemization was limited to circumstances of neutral and basic pH - The promise of stability against chemical-mediated racemization and enzyme-mediated racemization was soundly predicted; however, the promise of improved pharmacokinetic and metabolic properties was neither demonstrated or soundly predicted - See paragraphs 106 to 112 and 167 to 190 and 216 and 217.

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - [See first Patents of Invention - Topic 1721 ].

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - AstraZeneca owned a patent for esomeprazole (Nexium) (the '653 patent) - The patent contained three potential promises: use as a proton pump inhibitor (PPI), stability against racemization and improved pharmacokinetic and metabolic properties - AstraZeneca sued Apotex Inc., a generic drug manufacturer, for patent infringement - Apotex asserted that the '653 patent was invalid because it was not useful - Apotex claimed that the promise of stability against racemization was not was not a promise in itself, but rather an integral aspect of another promise (i.e., the promise of improved properties) - The Federal Court agreed with Apotex - There were, therefore, only two promises of utility in the patent (i.e., the use as a PPI and improved properties) - The court however, in case it was wrong, discussed the promise of stability against racemization - See paragraphs 95 to 100 and 133.

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - AstraZeneca owned a patent for esomeprazole (Nexium) (the '653 patent) - The patent provided that "It is desirable to obtain compounds with improved pharmacokinetic and metabolic properties which will give an improved therapeutic profile such as a lower degree of interindividual variation " - AstraZeneca sued Apotex Inc., a generic drug manufacturer, for patent infringement - Apotex argued that the '653 patent was invalid because it was not useful - Apotex claimed that the underlined portion was an explicit promise - AstraZeneca argued that the use of the word "will" in the patent was prospective and therefore indicative of an expectation or goal rather than a promise - The Federal Court disagreed with AstraZeneca - Promises and goals were both inherently prospective - Thus, the use of prospective language such as "will" did not undermine the promissory nature of the passage - The emphasized portion was a promise - See paragraphs 113 to 119.

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - AstraZeneca owned a patent for esomeprazole (Nexium) (the '653 patent) - The patent provided that "It is desirable to obtain compounds with improved pharmacokinetic and metabolic properties which will give an improved therapeutic profile such as a lower degree of interindividual variation " - AstraZeneca sued Apotex Inc., a generic drug manufacturer, for patent infringement - Apotex argued that the '653 patent was invalid because it was not useful - Apotex claimed that the underlined portion was an explicit promise -AstraZeneca argued that the skilled person would characterize an improved therapeutic profile as merely a goal because such a promise could not be substantiated in a patent that did not contain clinical studies (i.e., "will" had to, in the absence of clinical studies, mean "may") - The Federal Court disagreed with AstraZeneca, holding that, based on the evidence, and on the plain and ordinary meaning of the language used, the skilled person would not read down the unequivocal language of the patent promising an improved therapeutic profile because of the absence of clinical studies - The emphasized portion was a promise - See paragraphs 113 to 126.

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - AstraZeneca owned a patent for esomeprazole (Nexium) (the '653 patent) - The patent provided that "It is desirable to obtain compounds with improved pharmacokinetic and metabolic properties which will give an improved therapeutic profile such as a lower degree of interindividual variation " - AstraZeneca sued Apotex Inc., a generic drug manufacturer, for patent infringement - Apotex argued that the underlined portion was an explicit promise, not merely a goal - The Federal Court agreed, stating that "the '653 patent promises improved metabolic and pharmacokinetic properties which will give an improved therapeutic profile such as a lower degree of interindividual variation. As a corollary of this promise ... I therefore also find that the '653 patent promises stability against enzyme-mediated racemization - a precondition to such improved pharmacokinetic and metabolic properties" - See paragraphs 113 to 132.

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - [See fifth Patents of Invention - Topic 1724 ].

Patents of Invention - Topic 2946

Infringement of patent - Chemical products and substances intended for food and medicine - Effect of Notice of Compliance (NOC) proceedings in infringement action - Apotex Inc. sold a generic version of Nexium (esomeprazole), following a determination in Notice of Compliance proceedings that a claim in AstraZeneca's esomeprazole patent (the '653 patent) was invalid - AstraZeneca sued Apotex for patent infringement - Apotex raised res judicata - The Federal Court stated that it was settled law that the decisions taken in the NOC proceedings were not binding on infringement actions or to declare a patent invalid - NOC proceedings were never intended to be a surrogate for a trial on infringement - In consequence, Apotex's plea of res judicata was struck - However, the doctrines of issue estoppel and abuse of process remained open for consideration in the discretion of the trial judge - Thus the relitigation of an issue decided against a party in a NOC proceeding was generally not permissible - However, whether issue estoppel or abuse of process applied was informed by the factual context - See paragraphs 7 and 25 to 31.

Patents of Invention - Topic 2946

Infringement of patent - Chemical products and substances intended for food and medicine - Effect of Notice of Compliance (NOC) proceedings in infringement action - Apotex Inc. sold a generic version of Nexium, following a determination in Notice of Compliance proceedings that a claim in AstraZeneca's Nexium patent was invalid because of lack of sound prediction and obviousness - AstraZeneca sued Apotex for patent infringement - Apotex claimed that AstraZeneca was precluded from relitigating the validity of its patent because of the prior NOC proceeding, relying on issue estoppel - The Federal Court noted that applicability of the doctrine of issue estoppel depended, inter alia, on similarity in the substance of the evidence, whether it was contested, and the court's assessment of its weight and credibility - Here, the evidentiary record was not shown to be sufficiently similar and therefore the doctrine did not apply - See paragraphs 32 to 37.

Patents of Invention - Topic 2946

Infringement of patent - Chemical products and substances intended for food and medicine - Effect of Notice of Compliance (NOC) proceedings in infringement action - Apotex Inc. sold a generic version of Nexium, following a determination in Notice of Compliance proceedings that a claim in AstraZeneca's Nexium patent was invalid because of lack of sound prediction and obviousness - AstraZeneca sued Apotex for patent infringement - Apotex claimed that AstraZeneca's action was an abuse of process because AstraZeneca had adopted positions in the infringement action relating to utility and obviousness which were inconsistent with those adopted in the NOC proceedings - The Federal Court did not consider that AsztraZeneca's new and contradictory views were abusive and worthy of precluding AstraZeneca from advancing its arguments - See paragraphs 38 to 48.

Patents of Invention - Topic 3606

Infringement actions - Parties - Persons entitled to commence action - Section 55(1) of the Patent Act provided that "A person who infringes a patent is liable to the patentee and to all persons claiming under the patentee for all damage sustained by the patentee or by any such person, after the grant of the patent, by reason of the infringement" - The Federal Court discussed the test for what constituted "persons claiming under the patent" within the meaning of s. 55(1) - See paragraphs 19 to 21.

Patents of Invention - Topic 3606

Infringement actions - Parties - Persons entitled to commence action - AstraZeneca Aktiebolag held a patent for esomeprazole magnesium tablets (Nexium) - Apotex Inc. sold a generic version of Nexium, following a determination in Notice of Compliance proceedings that claim 8 of the AstraZeneca patent was invalid - AstraZeneca Aktiebolag and AstraZeneca Canada sued Apotex for patent infringement - Apotex claimed that AstraZeneca Canada lacked standing because it was not a "person claiming under the patentee" (Patent Act, s. 55(1)) - Apotex noted that there was no express licence agreement - The Federal Court held that AstraZeneca Canada had standing - There was an implied license between AstraZeneca Aktiebolag and AstraZeneca Canada regarding the sale of Nexium - See paragraphs 7 to 30.

Cases Noticed:

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2001] 1 F.C. 495; 262 N.R. 137 (F.C.A.), refd to. [para. 11].

Signalisation de Montréal Inc. v. Services de Béton Universels ltée et al., [1993] 1 F.C. 341; 147 N.R. 241; 46 C.P.R.(3d) 199 (F.C.A.), refd to. [para. 20].

JAY-LOR International Inc. et al. v. Penta Farm Systems Ltd. et al. (2007), 313 F.T.R. 1; 59 C.P.R.(4th) 228; 2007 FC 358, refd to. [para. 21].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2001), 266 N.R. 371; 11 C.P.R.(4th) 245 (F.C.A.), refd to. [para. 27].

Apotex Inc. v. Pfizer Ireland Pharmaceuticals (2011), 419 N.R. 189; 93 C.P.R.(4th) 42; 2011 FCA 77, refd to. [para. 28].

Toronto (City) v. Canadian Union of Public Employees, Local 79 et al., [2003] 3 S.C.R. 77; 311 N.R. 201; 179 O.A.C. 291; 2003 SCC 63, refd to. [para. 38].

Merck & Co. et al. v. Pharmascience Inc. et al. (2010), 368 F.T.R. 1; 2010 FC 510, refd to. [para. 51].

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. 65].

Free World Trust v. Électro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 2000 SCC 66, refd to. [para. 65].

Metalliflex Ltd. v. Wienenberger Aktiengesellschaft, [1961] S.C.R. 117; 35 C.P.R. 49, refd to. [para. 67].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 366 N.R. 347; 2007 FCA 209, refd to. [para. 69].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al., [2012] 3 S.C.R. 625; 436 N.R. 299; 2012 SCC 60, refd to. [para. 83].

Eli Lilly Canada Inc. et al. v. Novopharm Ltd. (2010), 405 N.R. 1; 85 C.P.R.(4th) 413; 2010 FCA 197, refd to. [para. 85].

Pfizer Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2011), 394 F.T.R. 1; 93 C.P.R.(4th) 81; 2011 FC 547, refd to. [para. 86].

Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390; 56 C.P.R.(2d) 145, refd to. [para. 86].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2011), 423 N.R. 180; 95 C.P.R.(4th) 193; 2011 FCA 236, refd to. [para. 89].

AstraZeneca Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2011), 396 F.T.R. 162; 2011 FC 1023, refd to. [para. 115].

Apotex Inc. v. Sanofi-Aventis (2013), 447 N.R. 313; 2013 FCA 186, refd to. [para. 115].

Eurocopter v. Bell Helicopter Textron Canada Ltd. et al. (2013), 449 N.R. 111; 2013 FCA 219, refd to [para. 137].

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. 138].

Novopharm Ltd. v. Eli Lilly & Co. (2011), 420 N.R. 188; 2011 FCA 220, refd to. [para. 150].

R. v. Henry (D.B.) et al., [2005] 3 S.C.R. 609; 342 N.R. 259; 376 A.R. 1; 360 W.A.C. 1; 219 B.C.A.C. 1; 361 W.A.C. 1; 2005 SCC 76, refd to. [para. 156].

Rothmans, Benson & Hedges Inc. et al. v. Imperial Tobacco Ltd. (1993), 152 N.R. 292; 47 C.P.R.(3d) 188 (F.C.A.), refd to. [para. 219].

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. 221].

Shire Biochem Inc. et al. v. Canada (Minister of Health) et al. (2008), 328 F.T.R. 123; 2008 FC 538, refd to. [para. 227].

Eli Lilly & Co. et al. v. Apotex Inc. (2009), 351 F.T.R. 1; 2009 FC 991, refd to. [para. 229].

Bristol-Myers Squibb Canada Co. et al. v. Apotex Inc. et al. (2009), 342 F.T.R. 161; 74 C.P.R.(4th) 85; 2009 FC 137, refd to. [para. 245].

AbbVie Corp. et al. v. Janssen Inc., [2014] F.T.R. Uned. 23; 2014 FC 55, refd to. [para. 269].

Janssen-Ortho Inc. et al. v. Novopharm Ltd. (2007), 366 N.R. 290; 59 C.P.R.(4th) 116; 2007 FCA 217, refd to. [para. 291].

AstraZeneca Canada Inc. et al. v. Teva Canada Ltd. et al. (2013), 428 F.T.R. 269; 2013 FC 245, refd to. [para. 324].

Bayer AG et al. v. Apotex Inc. et al. (2007), 366 N.R. 246; 2007 FCA 243, refd to. [para. 343].

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 2, sect. 27(3) [para. 143]; sect. 55(1) [para. 8].

Authors and Works Noticed:

Canadian Consensus Conference, Management of Gastro-oesophageal Reflux Disease in Adults (2005), 19 Canadian Journal of Gastroenterology, No. 1, generally [para. 362].

Erlanssson, P. et al., "Resolution of enantiomers of esomeprazole ...", in Journal of Chromatography (1990), Section 532, pp. 305 to 319 [para. 75].

Gold, Richard, and Shortt, Michael, The Promise of the Patent in Canada and Around the World (2014) 30:1 CIPR 35, generally [para. 87].

Siebrasse, Must the Factual Basis for Sound Prediction be Disclosed in the Patent? (2012) 28:1 CIPR 39, generally [paras. 158, 159].

Counsel:

Gunars Gaikis, Yoon Kang, Urszula Wojtyra, Tracey Stott, Kyle Ferguson, for the plaintiffs/defendants by counterclaim;

Harry Radomski, Richard Naiberg, Sandon Shogilev, David Lederman, Ben Hackett, for the defendants/plaintiffs by counterclaim.

Solicitors of Record:

Smart & Biggar, Toronto, Ontario, for the plaintiffs/defendants by counterclaim;

Goodmans LLP, Toronto, Ontario, for the defendants/plaintiffs by counterclaim.

This matter was heard on several dates between September 4, 2013, and November 20, 2013, before Rennie, J., of the Federal Court, who delivered the following decision on July 2, 2014.