Apotex Inc. v. AstraZeneca Canada Inc., (2012) 410 F.T.R. 168 (FC)

JudgeHughes, J.
CourtFederal Court (Canada)
Case DateMay 01, 2012
JurisdictionCanada (Federal)
Citations(2012), 410 F.T.R. 168 (FC);2012 FC 559

Apotex Inc. v. AstraZeneca Can. (2012), 410 F.T.R. 168 (FC)

MLB headnote and full text

[French language version follows English language version]

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

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Temp. Cite: [2012] F.T.R. TBEd. JN.009

Apotex Inc. (plaintiff) v. AstraZeneca Canada Inc. (defendant)

(T-2300-05; 2012 FC 559; 2012 CF 559)

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

Federal Court

Hughes, J.

May 11, 2012.

Summary:

Apotex Inc., a generic drug company, sought recovery of loss under s. 8 of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations). Apotex alleged that there were delays in bringing its generic version of omeprazole to the market because of unsuccessful prohibition proceedings by Astrazeneca Canada Inc., an innovator, which sold omeprazole under the brand name LOSEC (i.e., T-2311-01). A reference was ordered; however, certain issues were to be addressed first.

The Federal Court dealt with the issues accordingly. In the result, the court held that s. 8 was valid legislation. Apotex was a "second person" within the NOC Regulations and was entitled to be compensated under s. 8(1) for the loss suffered by it by reason of the proceedings taken by AstraZeneca in T-2311-01 for the period from January 3, 2002, until December 30, 2003. The court concluded that there was no basis for an exercise of judicial discretion under s. 8(5) of the NOC Regulations to reduce or refuse an award of such compensation. The court ruled that the reference proceed.

Equity - Topic 4621

Election - When applicable - General - [See twelfth Food and Drug Control - Topic 1108.2 ].

Food and Drug Control - Topic 1102

Drugs - New and innovative drugs - Legislation re (incl. international treaty obligations) - The Federal Court (Hughes, J.) stated that "On many occasions, members of this Court have written that the NOC Regulations [Patented Medicines (Notice of Compliance) Regulations] are poorly drafted and difficult to interpret and implement. I will once more lend my voice to that complaint and pass on." - See paragraph 55.

Food and Drug Control - Topic 1102

Drugs - New and innovative drugs - Legislation re (incl. international treaty obligations) - The Federal Court summarized the purpose of the Patented Medicines (Notice of Compliance) Regulations - See paragraph 56.

Food and Drug Control - Topic 1102

Drugs - New and innovative drugs - Legislation re (incl. international treaty obligations) - [See ninth, tenth and eleventh Food and Drug Control - Topic 1108.2 ].

Food and Drug Control - Topic 1104

Drugs - New and innovative drugs - Notice of compliance - General - [See first and second Food and Drug Control - Topic 1102 ].

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Notice of allegation (NOA) - [See sixteenth Food and Drug Control - Topic 1108.2 ].

Food and Drug Control - Topic 1108.2

Drugs - New and innovative drugs - Notice of compliance - Prohibition order - Compensation by first person - Apotex Inc., a generic drug company, sought recovery of loss under s. 8 of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations) - Apotex alleged that there were delays in bringing its generic version of omeprazole (20 mg capsule) to the market because of unsuccessful prohibition proceedings by Astrazeneca Canada Inc., an innovator, which sold omeprazole under the brand name LOSEC (i.e., T-2311-01) - The Federal Court held that Apotex was a "second person" within the NOC Regulations and was entitled to be compensated under s. 8(1) for the loss suffered by it by reason of the proceedings taken by AstraZeneca in T-2311-01 - The period of liability ran from January 3, 2002 (the date certified by the Minister under s. 8(1) of the NOC Regulations as the date on which a NOC would have been granted to Apotex in the absence of the NOC Regulations if AstraZeneca had not started the prohibition application), until December 30, 2003 (the date when AstraZeneca's prohibition application was dismissed) - See paragraphs 24 to 185.

Food and Drug Control - Topic 1108.2

Drugs - New and innovative drugs - Notice of compliance - Prohibition order - Compensation by first person - Section 8 of the Patented Medicines (Notice of Compliance) Regulations allowed a generic drug company (second person) to bring an action against an innovator (first person) for compensation for the period it was kept off the market (period of liability) because of the innovator's unsuccessful prohibition application - The Federal Court referred to the elements of a claim for loss under that section: "... (1) an application for prohibition be dismissed; (2) that a second person has suffered loss from a date certified by the Minister or another date found by the Court to be appropriate, and ending on the date of dismissal. The Court may determine in its discretion whether, and to what extent, a second person's claim for compensation should be reduced or eliminated" - See paragraph 30.

Food and Drug Control - Topic 1108.2

Drugs - New and innovative drugs - Notice of compliance - Prohibition order - Compensation by first person - Section 8 of the Patented Medicines (Notice of Compliance) Regulations allowed a generic drug company (second person) to bring an action against an innovator (first person) for compensation for the period it was kept off the market (period of liability) because of the innovator's unsuccessful prohibition application - The Federal Court discussed the burden or proof under s. 8 - See paragraphs 30 to 35.

Food and Drug Control - Topic 1108.2

Drugs - New and innovative drugs - Notice of compliance - Prohibition order - Compensation by first person - Section 8 of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations) allowed a generic drug company (second person) to bring an action against an innovator (first person) for compensation for the period it was kept off the market (period of liability) because of the innovator's unsuccessful prohibition application - The Federal Court referred to binding authority (Apotex Inc. v. Merck & Co. et al., 2009 FCA 187), wherein it was determined that "... section 8 of the NOC Regulations comes within the general grant of authority set out in subsection 55.2(4) of the Patent Act, R.S.C. 1985, c P-4 and was thus validly promulgated" - See paragraph 67.

Food and Drug Control - Topic 1108.2

Drugs - New and innovative drugs - Notice of compliance - Prohibition order - Compensation by first person - Section 8 of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations) allowed a generic drug company (second person) to bring an action against an innovator (first person) for compensation for the period it was kept off the market (period of liability) because of the innovator's unsuccessful prohibition application and statutory stay - A first person/innovator (AstraZeneca) claimed that s. 8 was unconstitutional for vagueness and ambiguity - The Federal Court rejected AstraZeneca's arguments - See paragraphs 77 to 86.

Food and Drug Control - Topic 1108.2

Drugs - New and innovative drugs - Notice of compliance - Prohibition order - Compensation by first person - Section 8 of the Patented Medicines (Notice of Compliance) Regulations allowed a generic drug company (second person) to bring an action against an innovator (first person) for compensation for the period it was kept off the market (period of liability) because of the innovator's unsuccessful prohibition application and statutory stay - A first person/innovator (AstraZeneca) claimed that s. 8 was invalid because it was draconian, harsh or punitive - The Federal Court stated that "In the absence of a Charter argument, there simply is no basis for striking down or reading down legislation or regulations simply because it is draconian, harsh or punitive. There is no Charter argument in this case. If a regulation falls within the enabling statutory provisions, then, simply because a party may view the effect of the regulation as being harsh in its particular circumstances, does not mean that the regulation is invalid" - See paragraphs 87 and 88.

Food and Drug Control - Topic 1108.2

Drugs - New and innovative drugs - Notice of compliance - Prohibition order - Compensation by first person - Section 8 of the Patented Medicines (Notice of Compliance) Regulations allowed a generic drug company (second person) to bring an action against an innovator (first person) for compensation for the period it was kept off the market (period of liability) because of the innovator's unsuccessful prohibition application and statutory stay - A first person/innovator (AstraZeneca) claimed that s. 8 was invalid because it fell outside the scope of the enabling provisions of the Patent Act or was invalid delegated legislation - The Federal Court noted that the Federal Court of Appeal, in Apotex Inc. v. Merck & Co., 2009 FCA 187 (Alendronate), had already determined that s. 8 was intra vires the Patent Act - The court rejected an argument by AstraZeneca that perhaps certain arguments which were not put to the Court of Appeal might have persuaded it to made a different determination - See paragraphs 87 to 90.

Food and Drug Control - Topic 1108.2

Drugs - New and innovative drugs - Notice of compliance - Prohibition order - Compensation by first person - Section 8 of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations) provided that an innovator (first person) would have to compensate a generic drug company (second person) for the period it was kept off the market because of the innovator's unsuccessful prohibition application and statutory stay - A first person/innovator (AstraZeneca) claimed that s. 8 was invalid because it failed to achieve an appropriate "balance" between the protection of patentee's rights and the desire to reduce health care costs - The Federal Court stated that AstraZeneca's "balance" argument was wrongly based on an assumption that the NOC Regulations had to be interpreted so as to achieve a perfect harmony, and that, AstraZeneca should never be disproportionately disadvantaged - The court held that a "balance" in the legal context was not a perfect equilibrium - It was for Parliament to provide for the appropriate weighing or balancing of interests in enacting the Patent Act, and for the Governor-in-Council to do likewise in promulgating Regulations - There was no independent ground for arguing that s. 8 was invalid simply because it was not "balanced" in the view of one of the parties - Even if "balancing" was a separate ground for invalidity, the Court of Appeal had already determined that s. 8 was appropriately balanced - See paragraphs 92 to 101.

Food and Drug Control - Topic 1108.2

Drugs - New and innovative drugs - Notice of compliance - Prohibition order - Compensation by first person - The Federal Court discussed arts. 1715(2)(f) and 1716 of the North American Free Trade Agreement (NAFTA) and art. 48(1) and 50 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) - The court noted that these provisions of TRIPS and NAFTA were virtually identical - Arts. 48(1) and 1715(2)(f) required "abuse" on behalf of the party seeking enforcement of its intellectual property rights before compensation was required - Arts. 50 and 1716 provided for compensation when provisional measures were resolved or they lapsed due to any act or omission by the applicant - Both treaties were entered into after the Patented Medicines (Notice of Compliance) Regulations first were established, although, those Regulations had been amended several times since - See paragraphs 103 to 111.

Food and Drug Control - Topic 1108.2

Drugs - New and innovative drugs - Notice of compliance - Prohibition order - Compensation by first person - Section 8 of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations), enacted pursuant to s. 55.2 of the Patent Act, provided that an innovator (first person) would have to compensate a generic drug company (second person) for the period it was kept off the market because of the innovator's unsuccessful prohibition application and statutory stay - A first person/innovator (AstraZeneca) claimed that s. 8 was inconsistent and contrary to the North American Free Trade Agreement (NAFTA) and of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) - The Federal Court held that the Implementation Acts did not give the treaties the force of an Act of Parliament, except that they could be used to assist in interpretation of domestic legislation - The treaties could not override the clear words used in a statute - In any event, the "paramountcy" clause in s. 55.2(5) of the Patent Act resolved any doubt; the wording of the Patent Act and NOC Regulations was paramount - See paragraphs 102 to 112.

Food and Drug Control - Topic 1108.2

Drugs - New and innovative drugs - Notice of compliance - Prohibition order - Compensation by first person - Section 8 of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations), enacted under s. 55.2 of the Patent Act, provided for compensation for a generic drug company (second person) for the period it was kept off the market because of the innovator's (first person's) unsuccessful prohibition application and statutory stay - A first person/innovator (AstraZeneca) claimed that s. 8 was contrary to the North American Free Trade Agreement (NAFTA) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) which allowed for compensation only in cases of "abuse" by the first person - AstraZeneca argued that even though the relevant provisions of TRIPS and NAFTA were not directly implemented into Canadian law, they should inform the interpretation of s. 55.2 of the Patent Act and s. 8 of the NOC Regulations, such that the obligation to pay under s. 8(1) was only triggered if there was an "abuse" by the first person - The Federal Court rejected AstraZeneca's argument - Reference to a treaty should only be made if the legislation was unclear and s. 8(1) was not unclear - See paragraphs 102 to 119.

Food and Drug Control - Topic 1108.2

Drugs - New and innovative drugs - Notice of compliance - Prohibition order - Compensation by first person - Apotex Inc., a generic drug company (second person), claimed compensation from AstraZeneca (innovator/first person) under s. 8 of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations), because AstraZeneca delayed Apotex bringing its generic version of omeprazole to the market by unsuccessful prohibition proceedings and the statutory stay - AstraZeneca argued that Apotex was not a "second person" within the meaning of s. 8 because Apotex did not early work the patented invention and did not have a qualifying submission - The Federal Court rejected the argument that Apotex did not engage the "early working" provisions of the Patent Act because AstraZeneca did not plead that point - Nevertheless, the court considered Apotex's arguments in rebuttal holding that: (1) on the basis of res judicata, AstraZeneca could not raise the argument in this action that Apotex was not a "second person"; and (2) AstraZeneca could not "approbate and reprobate", i.e., it could not take advantage of a 24 month statutory stay on the basis that Apotex was a second person, and then say that it was never a second person (the doctrine of election) - Apotex was a "second" person within the NOC Regulations applicable to this case - See paragraphs 120 to 139.

Food and Drug Control - Topic 1108.2

Drugs - New and innovative drugs - Notice of compliance - Prohibition order - Compensation by first person - Section 8 of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations), enacted pursuant to s. 55.2 of the Patent Act, provided that an innovator (first person) would have to compensate a generic drug company (second person) for the period it was kept off the market because of the innovator's unsuccessful prohibition application and statutory stay - An issue arose as to whether infringement of a patent by a generic could provide a viable defence to a claim for compensation by that generic under s. 8(5) of the NOC Regulations - The Federal Court noted the Federal Court of Appeal had recently considered this issue, deciding that a finding of infringement did not preclude a claim for compensation; however, there might exist a basis for reducing compensation arising out of any ex turpi causa consideration - However, in this case, the ex turpi causa rule was not engaged, the future possibility of a finding of infringement was insufficient to engage that rule - See paragraphs 142 to 149.

Food and Drug Control - Topic 1108.2

Drugs - New and innovative drugs - Notice of compliance - Prohibition order - Compensation by first person - Apotex Inc., a generic drug company (second person), claimed compensation from AstraZeneca (innovator/first person) under s. 8 of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations), because AstraZeneca delayed Apotex bringing its generic version of omeprazole to the market by unsuccessful prohibition proceedings and the statutory stay - AstraZeneca argued that Apotex was not in a position to market Apo-Omeprazole in the period January 3, 2002 to January 27, 2004, raising an issue as to the impact of Apotex's alleged lack of approvability to manufacture for sale at a commercial manufacturing site - The Federal Court rejected AstraZeneca's argument, holding that Apotex was in a position to market commercially as of January 3, 2002, at one of its sites, or both - See paragraphs 151 to 160.

Food and Drug Control - Topic 1108.2

Drugs - New and innovative drugs - Notice of compliance - Prohibition order - Compensation by first person - Apotex Inc., a generic drug company (second person), claimed compensation from AstraZeneca (innovator/first person) under s. 8 of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations), because AstraZeneca delayed Apotex bringing its generic version of omeprazole to the market by unsuccessful prohibition proceedings and the statutory stay - AstraZeneca argued that the start date for any liability should be forward dated because Apotex's alleged delay in serving a Notice of Allegation and/or Apotex's alleged lack of approvability to manufacture for sale at a commercial manufacturing site - The Federal Court rejected AstraZeneca's arguments, finding no basis to move the start date from January 3, 2002 (i.e., the date certified by the Minister under s. 8(1) of the NOC Regulations as the date on which a NOC would have been granted to Apotex in the absence of the NOC Regulations if AstraZeneca had not started the prohibition application) - See paragraphs 161 to 168.

Food and Drug Control - Topic 1108.2

Drugs - New and innovative drugs - Notice of compliance - Prohibition order - Compensation by first person - Apotex Inc., a generic drug company (second person), claimed compensation from AstraZeneca (innovator/first person) under s. 8 of the Patented Medicines (Notice of Compliance) Regulations because AstraZeneca delayed Apotex bringing its generic version of omeprazole to the market by unsuccessful prohibition proceedings and the statutory stay - AstraZeneca argued that Apotex was under a duty to mitigate its damages by serving the Notice of Allegation at the earliest opportunity and that it failed to do so by delaying service - The Federal Court noted that there was no obligation to serve a Notice of Allegation by some imposed deadline (i.e., no duty to mitigate) - In any event, Apotex did not delay in serving its Notice of Allegation - Therefore, as a factual matter, AstraZeneca failed to establish any basis for alleging the failure to mitigate - See paragraphs 170 to 174.

Food and Drug Control - Topic 1108.2

Drugs - New and innovative drugs - Notice of compliance - Prohibition order - Compensation by first person - Apotex Inc., a generic drug company (second person), claimed compensation from AstraZeneca (innovator/first person) under s. 8 of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations), because AstraZeneca delayed Apotex bringing its generic version of omeprazole to the market by unsuccessful prohibition proceedings and the statutory stay - AstraZeneca argued that, even if the court found against it, some of the issues raised by AstraZeneca still were relevant factors in the assessment of compensation under s. 8(3) - The Federal Court (Hughes, J.) stated that "While s. 8(5) of the NOC Regulations may not be restricted only to actions which contribute to the delay in proceedings, it is not so broad as to encompass any factor that a party or a judge chooses to raise. Here the factors raised by AstraZeneca in respect of Issues #5, #6, #7 and #9 have all been determined against it. Discretion does not afford some sort of consolation prize for having lost or for having given the matter a good try. Having lost on those issues, I will not permit AstraZeneca to have them considered as a matter of judicial discretion" - See paragraphs 175 to 181.

International Law - Topic 5

General - Incorporation into domestic law - [See Treaties - Topic 1606 ].

Practice - Topic 4506

Discovery - Use of examination in court - Original and amended discovery answers - Apotex Inc., a generic drug company, claimed compensation from AstraZeneca (innovator/first person) under s. 8 of the Patented Medicines (Notice of Compliance) Regulations - Two weeks before trial, Apotex corrected an answer it had given almost a year earlier on discovery - AstraZeneca claimed that Apotex was wrongfully attempting to withdraw an admission upon which AstraZeneca was relying - The Federal Court referred to case law which distinguished between answers given on discovery and "formal" admissions - According to that authority, discovery answers could be corrected, leaving the impact of the correction to be determined by the trial judge - The court stated that in the present case, Apotex "corrected" an earlier answer in respect of a critical fact - AstraZeneca had further discovery - Two Apotex witnesses testified on the point at trial and were cross-examined - AstraZeneca led no evidence of its own in respect of this fact - The court accepted the corrected answer into evidence and would weigh it along with the evidence of the other witnesses - See paragraphs 14 to 23.

Statutes - Topic 1414

Interpretation - Construction where meaning is not plain - General principles - Ambiguity - General - The Federal Court stated that "It is difficult to find, outside of Charter cases, any situation where a Court has struck down legislation simply because it was vague or ambiguous. For instance, in Canada v JTI-Macdonald Corp, [2007], 2 SCR 610 at paragraphs 62 to 66, per McLachlin, C.J., the Court has held that where a reasonable interpretation can be afforded to legislation, the Court should not strike it down for vagueness" - See paragraph 79.

Statutes - Topic 4541

Operation and effect - Validity - General - The Federal Court stated that "In the absence of a Charter argument, there simply is no basis for striking down or reading down legislation or regulations simply because it is draconian, harsh or punitive ... If a regulation falls within the enabling statutory provisions, then, simply because a party may view the effect of the regulation as being harsh in its particular circumstances, does not mean that the regulation is invalid" - See paragraph 87.

Statutes - Topic 4552

Operation and effect - Validity - Vagueness - [See Statutes - Topic 1414 ].

Statutes - Topic 5362

Operation and effect - Delegated legislation - Regulations - Validity of - General principles - [See Statutes - Topic 4541 ].

Statutes - Topic 5369

Operation and effect - Delegated legislation - Regulations - Validity of - Vagueness or lack of particularity - [See fifth Food and Drug Control - Topic 1108.2 ].

Treaties - Topic 1606

Operation and effect - Domestic or internal consequences - The Federal Court stated that with respect to the North American Free Trade Agreement (NAFTA) and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the Implementation Acts themselves did not give those treaties the force of an Act of Parliament, except that they could be used to assist in the interpretation of domestic legislation - The treaty could not override the clear words used in a statute - See paragraph 111.

Cases Noticed:

Archambault v. Ministre du Revenu national (1998), 189 F.T.R. 37 (F.C.T.D.), affd. (2000), 264 N.R. 171 (F.C.A.), refd to. [para. 20].

Apotex Inc. et al. v. Wellcome Foundation Ltd. (2009), 343 F.T.R. 41; 2009 FC 117, refd to. [para. 21].

Marchand v. Public General Hospital Society of Chatham et al. (2000), 138 O.A.C. 201; 51 O.R.(3d) 97 (C.A.), refd to. [para. 22].

Apotex Inc. v. Merck & Co. et al. (2011), 430 N.R. 74; 2011 FCA 364, refd to. [para. 30].

Rainbow Industrial Caterers Ltd. et al. v. Canadian National Railway Co. et al., [1991] 3 S.C.R. 3; 126 N.R. 354; 3 B.C.A.C. 1; 7 W.A.C. 1, refd to. [para. 32].

Thamotharem v. Canada (Minister of Citizenship and Immigration) (2007), 366 N.R. 301; 2007 FCA 198, refd to. [para. 45].

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Welfare) et al., [1998] 2 S.C.R. 193; 227 N.R. 299; 80 C.P.R.(3d) 368, refd to. [para. 56].

Apotex Inc. v. Merck & Co. et al. (2008), 335 F.T.R. 255; 2008 FC 1185, refd to. [para. 58].

Nelson Burns & Co. et al. v. Gratham Industries Ltd. et al. (1987), 25 O.A.C. 89 (C.A.), refd to. [para. 59].

McNeil v. Board of Censors (N.S.) and Nova Scotia (Attorney General), [1978] 2 S.C.R. 662; 19 N.R. 570; 25 N.S.R.(2d) 128; 36 A.P.R. 128, refd to. [para. 65].

Apotex Inc. v. Merck & Co. et al. (2009), 391 N.R. 336; 2009 FCA 187, leave to appeal denied (2010), 404 N.R. 396 (S.C.C.), refd to. [para. 66].

Merck Frosst Canada Ltd. v. Apotex Inc. - see Apotex Inc. v. Merck & Co. et al.

Kitkatla Indian Band et al. v. British Columbia (Minister of Small Business, Tourism and Culture) et al., [2002] 2 S.C.R. 146; 286 N.R. 131; 165 B.C.A.C. 1; 270 W.A.C. 1; 2002 SCC 31, refd to. [para. 68].

Abou-Elmaati et al. v. Canada (Attorney General) et al. (2011), 276 O.A.C. 130; 2011 ONCA 95, refd to. [para. 33].

Phillips v. Nova Scotia (Commission of Inquiry into the Westray Mine Tragedy) - see Philips et al. v. Richard, J.

Phillips et al. v. Richard, J., [1995] 2 S.C.R. 97; 180 N.R. 1; 141 N.S.R.(2d) 1; 403 A.P.R. 1, refd to. [para. 70].

Bekker v. Minister of National Revenue (2004), 323 N.R. 195; 2004 FCA 186, refd to. [para. 74].

Ontario v. Canadian Pacific Ltd., [1995] 2 S.C.R. 1031; 183 N.R. 325; 82 O.A.C. 243, refd to. [para. 77].

JTI-Macdonald Corp. et al. v. Canada (Attorney General), [2007] 2 S.C.R. 610; 364 N.R. 89; 2007 SCC 30, refd to. [para. 79].

Sanofi-Aventis Canada Inc. et al. v. Teva Canada Ltd. (2012), 410 F.T.R. 1; 2012 FC 552, refd to. [para. 84].

R. v. Bell (1977), 15 O.R.(2d) 425 (C.A.), revd. [1979] 2 S.C.R. 212; 26 N.R. 457, refd to. [para. 89].

R. v. Big M Drug Mart Ltd., [1985] 1 S.C.R. 295; 58 N.R. 81; 60 A.R. 161, refd to. [para. 93].

Bristol-Myers Squibb Co. et al. v. Canada (Attorney General) et al., [2005] 1 S.C.R. 533; 334 N.R. 55; 2005 SCC 26, refd to. [para. 94].

AstraZeneca Canada Inc. v. Canada (Minister of Health) et al., [2006] 2 S.C.R. 560; 354 N.R. 88; 2006 SCC 49, refd to. [para. 95].

Baker Petrolite Corp. et al. v. Canwell Enviro-Industries Ltd. et al. (2002), 288 N.R. 201; 2002 FCA 158, refd to. [para. 111].

National Corn Growers' Association et al. v. Canadian Import Tribunal, [1990] 2 S.C.R. 1324; 114 N.R. 81, refd to. [para. 113].

Fraser v. Janes Family Foods Ltd. et al. (2012), 430 N.R. 378; 2012 FCA 99, refd to. [para. 117].

Angle v. Minister of National Revenue, [1975] 2 S.C.R. 248; 2 N.R. 397; 47 D.L.R.(3d) 544, refd to. [para. 130].

Danyluk v. Ainsworth Technologies Inc. et al., [2001] 2 S.C.R. 460; 272 N.R. 1; 149 O.A.C. 1; 2001 SCC 44, refd to. [para. 131].

Johnson v Agnew, [1980] A.C. 367 (H.L.), refd to. [para. 137].

Apotex Inc. v. Merck & Co. et al. (2011), 430 N.R. 74; 2011 FCA 364, refd to. [para. 142].

Merck & Co. et al. v. Apotex Inc. et al. (2010), 381 F.T.R. 162; 2010 FC 1265, affd. (2011), 430 N.R. 66; 2011 FCA 363, refd to. [para. 142].

Les Laboratoires Servier v Apotex Inc, [2011] EWHC 730 (U.K. H.C.J.(Ch.)), revsd. [2012] E.W.C.A. Civ. 593, refd to. [para. 143].

Laboratoires Servier et al. v. Apotex Inc. et al. (2008), 332 F.T.R. 193; 2008 FC 825, refd to. [para. 143].

Michaels et al. v. Red Deer College, [1976] 2 S.C.R. 324; 5 N.R. 99, refd to. [para. 171].

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

Statutes Noticed:

Agreement on Trade-Related Aspects of Intellectual Property Rights, art. 1(1) [para. 108]; art. 48.1, art. 50 [para. 104].

Free Trade Agreement Implementation Act, S.C. 1993, c. 44, sect. 3 [para. 109].

N.A.F.T.A. - see North American Free Trade Agreement.

North American Free Trade Agreement, Can. T.S. 1994 No. 2, art. 1715(2)(f), art. 1716(7) [para. 105].

Patent Act, R.S.C. 1985, c. P-4, sect. 55.2 [para. 110]; sect. 55.2(5) [para. 112].

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 5(1), sect. 5(1.1) [para. 122]; sect. 8 [para. 57].

Patented Medicines (Notice of Compliance) Regulations - see Patent Act Regulations (Can.).

T.R.I.P.S. - see Agreement on Trade-Related Aspects of Intellectual Property Rights.

Authors and Works Noticed:

Bingham, Tom (Lord), The Rule of Law (2008), 8(1) J.S.I.J. 121, pp. 127 and 128 [para. 179].

Sopinka, John, Lederman, Sidney N., and Bryant, Alan W., The Law of Evidence in Canada (3rd Ed. 2009), para. 1263 [para. 19].

Counsel:

Andrew Brodkin, Harry Radomski, Ben Hackett, Daniel Cappe, Jerry Topolski and Nando De Luca, for the plaintiff;

Mark Biernacki, Gunars Gaikis, Nancy Pei and Jordan Scopa, for the defendant.

Solicitors of Record:

Goodmans LLP, Toronto, Ontario, for the plaintiff;

Smart & Biggar, Toronto, Ontario, for the defendant.

This matter was heard in Toronto, Ontario, on March 19-22, 26, 28, April 30 and May 1, 2012, before Hughes, J., of the Federal Court, who delivered the following decision on May 11, 2012.

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27 practice notes
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    • Canada
    • Canada (Federal) Federal Court of Appeal (Canada)
    • September 30, 2014
    ...Ltd. et al., [2008] 1 F.C.R. 174 ; 364 N.R. 325 ; 2007 FCA 163 , refd to. [para. 39]. Apotex Inc. v. Astrazeneca Canada Inc. (2012), 410 F.T.R. 168; 2012 FC 559 , refd to. [para. Johnson v. Agnew, [1980] A.C. 367 (H.L.), refd to. [para. 39]. Eli Lilly Canada Inc. et al. v. Novopharm L......
  • Teva Canada Ltd. v. Pfizer Canada Inc., 2016 FCA 161
    • Canada
    • Canada (Federal) Federal Court of Appeal (Canada)
    • May 31, 2016
    ...the event a successful applicant for an interlocutory injunction should ultimately fail at trial: Apotex Inc. v. AstraZeneca Canada Inc., 2012 FC 559, 410 F.T.R. 168 at para. 58, aff’d 2013 FCA 77, 444 N.R. 254; Apotex Inc. v. Merck & Co. Inc., 2009 FCA 187, [2010] 2 F.C.R. 389 at para.......
  • Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC, 2020 FC 816
    • Canada
    • Federal Court (Canada)
    • September 10, 2020
    ...diligence in answering discovery questions, and importantly, the Defendants had not established any prejudice (Apotex v Astrazeneca, 2012 FC 559 at paras 22–23, aff’d 2013 FCA 77 ). Despite having been granted the opportunity to do so, the Defendants did not state which witnesses they woul......
  • Teva Canada Ltd. v. Pfizer Canada Inc., (2014) 451 F.T.R. 261 (FC)
    • Canada
    • Canada (Federal) Federal Court (Canada)
    • April 3, 2014
    ...et al., [2012] F.T.R. Uned. 607 ; 105 C.P.R.(4th) 399 ; 2012 FC 1235 , consd. [para. 25]. Apotex Inc. v. Astrazeneca Canada Inc. (2012), 410 F.T.R. 168; 2012 FC 559 , consd. [para. 25]. Apotex Inc. v. AstraZeneca Canada Inc. (2013), 444 N.R. 254 ; 2013 FCA 77 , consd. [para. 25]. Sano......
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20 cases
  • Pfizer Canada Inc. et al. v. Apotex Inc. et al., (2014) 465 N.R. 306 (FCA)
    • Canada
    • Canada (Federal) Federal Court of Appeal (Canada)
    • September 30, 2014
    ...Ltd. et al., [2008] 1 F.C.R. 174 ; 364 N.R. 325 ; 2007 FCA 163 , refd to. [para. 39]. Apotex Inc. v. Astrazeneca Canada Inc. (2012), 410 F.T.R. 168; 2012 FC 559 , refd to. [para. Johnson v. Agnew, [1980] A.C. 367 (H.L.), refd to. [para. 39]. Eli Lilly Canada Inc. et al. v. Novopharm L......
  • Teva Canada Ltd. v. Pfizer Canada Inc., 2016 FCA 161
    • Canada
    • Canada (Federal) Federal Court of Appeal (Canada)
    • May 31, 2016
    ...the event a successful applicant for an interlocutory injunction should ultimately fail at trial: Apotex Inc. v. AstraZeneca Canada Inc., 2012 FC 559, 410 F.T.R. 168 at para. 58, aff’d 2013 FCA 77, 444 N.R. 254; Apotex Inc. v. Merck & Co. Inc., 2009 FCA 187, [2010] 2 F.C.R. 389 at para.......
  • Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC, 2020 FC 816
    • Canada
    • Federal Court (Canada)
    • September 10, 2020
    ...diligence in answering discovery questions, and importantly, the Defendants had not established any prejudice (Apotex v Astrazeneca, 2012 FC 559 at paras 22–23, aff’d 2013 FCA 77 ). Despite having been granted the opportunity to do so, the Defendants did not state which witnesses they woul......
  • Teva Canada Ltd. v. Pfizer Canada Inc., (2014) 451 F.T.R. 261 (FC)
    • Canada
    • Canada (Federal) Federal Court (Canada)
    • April 3, 2014
    ...et al., [2012] F.T.R. Uned. 607 ; 105 C.P.R.(4th) 399 ; 2012 FC 1235 , consd. [para. 25]. Apotex Inc. v. Astrazeneca Canada Inc. (2012), 410 F.T.R. 168; 2012 FC 559 , consd. [para. 25]. Apotex Inc. v. AstraZeneca Canada Inc. (2013), 444 N.R. 254 ; 2013 FCA 77 , consd. [para. 25]. Sano......
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5 firm's commentaries
  • Pharma In Brief - FCA Considers Impact Of Successful Infringement Judgement On Prior Order For S. 8 Damages
    • Canada
    • Mondaq Canada
    • July 15, 2016
    ...Hughes' decision – 2015 FC 799. Court of Appeal decision - 2016 FCA 194. Section 8 action - Apotex Inc. v. AstraZeneca Canada Inc., 2012 FC 559, aff'd 2013 FCA 77 Prohibition proceeding - AstraZeneca AB v. Apotex Inc., 2004 FC 313 About Norton Rose Fulbright Canada LLP Norton Rose Fulbright......
  • AstraZeneca’s LOSEC Patent Valid And Infringed By Apotex
    • Canada
    • Mondaq Canada
    • March 18, 2015
    ...the reference to quantify AstraZeneca's liability, if any, following the finding of s. 8 liability in Apotex Inc v AstraZeneca Canada Inc, 2012 FC 559, aff'd 2013 FCA 77 . One of the issues for determination will be the impact of the infringement finding on any s. 8 AstraZeneca was represe......
  • Pharma in brief - Canada: Federal Court Holds That Apotex Is Entitled To Section 8 Damages In Respect Of Omeprazole [LOSEC®]
    • Canada
    • Mondaq Canada
    • June 11, 2012
    ...as a matter of judicial discretion under subsection 8(5) of the Regulations. Links to decision: Apotex Inc. v. Astrazeneca Canada Inc., 2012 FC 559 Footnotes 1 Sanofi-Aventis v. Teva Canada Limited, 2012 FC 552 ; Apotex Inc. v. Sanofi-Aventis, 2012 FC 2 Apotex Inc. v. Merck & Co, 200......
  • Patents Year In Review 2012
    • Canada
    • Mondaq Canada
    • February 14, 2013
    ...an authorized generic and another generic would have entered the market. In another section 8 case (namely, Apotex v. AstraZeneca Canada, 2012 FC 559), the Court also upheld the validity of section 8. In determining damages, the Court stated that each case must be decided on its own facts: ......
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