Eli Lilly Canada Inc. v. Apotex Inc. et al., 2015 FC 875

• Judge: Gleason, J.
• Court: Federal Court (Canada)
• Case Date: July 20, 2015
• Jurisdiction: Canada (Federal)
• Citations: 2015 FC 875;[2015] F.T.R. TBEd. JL.045

Eli Lilly Can. Inc. v. Apotex Inc., [2015] F.T.R. TBEd. JL.045

MLB being edited

Currently being edited for F.T.R. - judgment temporarily in rough form.

Temp. Cite: [2015] F.T.R. TBEd. JL.045

Eli Lilly Canada Inc. (applicant) v. Apotex Inc. and The Minister of Health (respondents) and ICOS Corporation (respondent/patentee)

(T-1598-13; 2015 FC 875)

Indexed As: Eli Lilly Canada Inc. v. Apotex Inc. et al.

Federal Court

Gleason, J.

July 20, 2015.

Summary:

Eli Lilly Canada Inc. applied for an order under s. 6 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) to prohibit the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex Inc. for approval to sell its generic version of tadalafil until after the expiry of Canadian Patent 2,226,784 (784 Patent). Apotex challenged the validity of the 784 Patent on the grounds that it was an impermissible double patenting of the invention claimed in the earlier 2,181,377 Canadian Patent that Eli Lilly was similarly licensed to use and which likewise pertained to tadalafil; and the 784 Patent was invalid for insufficiency because it failed to provide guidance on how to produce hydrate forms of the compounds claimed in the 784 Patent. Apotex also asserted that Eli Lilly lacked standing under the PMNOC Regulations to bring the application, as it had failed to show that there was a proper chain of title to the 784 Patent in its favour.

The Federal Court rejected Apotex's allegations of invalidity and its argument regarding Eli Lilly's standing. Accordingly, the court allowed Eli Lilly's application for an order prohibiting the Minister from issuing an NOC to Apotex for its tadalafil product.

Courts - Topic 82

Stare decisis - Authority of judicial decisions - Prior decisions of same court - Federal Court (incl. judicial comity) - Eli Lilly Canada Inc. applied for an order under s. 6 of the Patented Medicines (Notice of Compliance) (PMNOC ) Regulations to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for approval to sell its generic version of tadalafil until after the expiry of Canadian Patent 2,226,784 (784 Patent) - Apotex challenged the validity of the 784 Patent on the grounds that it was an impermissible double patenting of the invention claimed in the earlier 2,181,377 Canadian Patent (377 Patent) that Eli Lilly was similarly licensed to use and which likewise pertained to tadalafil; and the 784 Patent was invalid for insufficiency because it failed to provide guidance on how to produce hydrate forms of the compounds claimed in the 784 Patent - The Federal Court stated that "This is the second PMNOC case involving the 784 Patent. On January 7, 2015, my colleague, Justice Yves de Montigny, issued reasons in Eli Lilly Canada v Mylan Pharmaceuticals ULC ... [Mylan Tadalafil] in which he dismissed Mylan's prohibition application because he found Mylan's allegations of invalidity to be unjustified. ... I have reached the same conclusion as Justice de Montigny and have determined that Apotex' allegations of invalidity are unjustified. ... The doctrine of judicial comity applies to the legal, as opposed to the factual, findings made by Justice de Montigny in Mylan Tadalafil. This doctrine provides that a judge of a concurrent court should follow previous legal determinations unless the subsequent judge concludes that a departure is necessary and that there are cogent reasons for the departure. Generally, such reasons involve more than a simple disagreement with the previous judge's legal finding and would instead arise where the subsequent judge concludes the former judge gave insufficient consideration to binding authority, new contrary intervening authority has arisen since the date of the first judge's determination, the determination was unconsidered or the subsequent judge determines that a significant injustice would flow if the previous ruling were to be applied. ... The doctrine of comity rests on the principle that there can only be one correct answer to a legal question. The doctrine also effects the important policy objective of ensuring jurisprudential consistency." - The court agreed with the parties "that Justice de Montigny's construction of the 377 and 784 Patents are legal determinations as is his finding on the appropriate date for undertaking the obviousness-type double patenting analysis [and] ... his assessment of the prior art and conclusions regarding the lack of obviousness at either January 21, 1994 or July 14, 1995 are factual determinations or findings of mixed fact and law to which the doctrine of comity is inapplicable." - See paragraphs 7, 8, 88, 92 and 94.

Evidence - Topic 1527

Hearsay rule - Hearsay rule exceptions and exclusions - General - Where admission of hearsay necessary and evidence reliable - [See Food and Drug Control - Topic 1108.2 ].

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order (incl. compensation by first person) - Eli Lilly Canada Inc. applied for an order under s. 6 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for approval to sell its generic version of tadalafil until after the expiry of Canadian Patent 2,226,784 (784 Patent) - Apotex challenged the validity of the 784 Patent on the ground, inter alia, that Eli Lilly lacked standing under the PMNOC Regulations to bring the application as it had failed to show a proper chain of title to the 784 Patent in its favour - The Federal Court rejected the argument - Apotex challenged the sufficiency of Eli Lilly's evidence on this issue - It challenged the legitimacy of an assignment from the original patentee to a subsequent putative patent owner (ICOS) - However, the 784 Patent had been registered under the Patent Act and the registration indicated that ICOS owned the 784 Patent - Therefore, Apotex was attacking the validity of the 784 Patent, but had done so indirectly by asserting that it was only challenging Lilly's standing in this application under the PMNOC Regulations - Apotex could not challenge ICOS's ownership of the 784 Patent in this manner - In any event, Lilly had established that there was an assignment to ICOS of ownership of the invention claimed in the 784 Patent - In this regard, the court found a document (the "1997 Amendment") to be admissible even though it was appended to the affidavit of Smith, in-house counsel at Eli Lilly - As Smith did not author the 1997 Amendment, it was prima facie hearsay if introduced through her - However, it was admissible under the principled exception - The evidence was reliable as the 1997 Amendment was appended to the affidavit of a solicitor, who was an officer of the Court, and thus had an ethical obligation to be completely truthful - The document was drawn from Lilly's corporate database of agreements, which ought to contain only accurate versions of agreements, and on its face it was a complete agreement - Moreover, there was no suggestion that the Amendment was anything other than that which it purported to be - The necessity criterion was also met as the manner in which Eli Lilly produced the 1997 Amendment was by far the most practical and preferable way for the evidence to be brought before the court in a prohibition application under the PMNOC Regulations - See paragraphs 177 to 202.

Food and Drug Control - Topic 1301

Drugs - Evidence and proof - General - [See Food and Drug Control - Topic 1108.2 ].

Patents of Invention - Topic 1006

The specification and claim - General - Interpretation of - Eli Lilly Canada Inc. applied for an order under s. 6 of the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for approval to sell its generic version of tadalafil until after the expiry of Canadian Patent 2,226,784 (784 Patent) - Apotex challenged the validity of the 784 Patent on the grounds that it was an impermissible double patenting of the invention claimed in the earlier 2,181,377 Canadian Patent (377 Patent) that Eli Lilly was similarly licensed to use and which likewise pertained to tadalafil; and the 784 Patent was invalid for insufficiency because it failed to provide guidance on how to produce hydrate forms of the compounds claimed in the 784 Patent - The parties disputed the construction of the 377 Patent - Eli Lilly argued that the claims of the 377 Patent were to be read without reference to the ability of tadalafil to inhibit PDE V - The Federal Court stated that the relevant claims in the 377 Patent, relied upon by the parties were Claims 10 and 13 - Eli Lilly was correct in noting that these claims did not mention the fact that tadalafil and 3-methyl tadalafil were PDE V inhibitors - Nor was this fact mentioned in any other of the claims in the 377 Patent - However, the court stated that "While the claims of a patent are the starting point in construction, the case law teaches that, where necessary, they must be read in the context of the specification as a whole to ascertain their import. ... The specification ... speaks at length about the ability of tadalafil to suppress PDE V. ... When one reads Claim 10 in the 377 Patent in light of the specification, the importance of the ability of tadalafil to inhibit PDE V is apparent; indeed, this is the essence of the invention claimed in the 377 Patent. Thus, I see no error in construing Claim 10 as encompassing tadalafil as a PDE V inhibitor. This construction applies equally to Claim 13, where tadalafil is claimed for a number of uses. Therefore, both Claims 10 and 13 of the 377 Patent are to be construed by incorporating the notion that tadalafil is a PDE V inhibitor." - See paragraphs 97 to 106.

Patents of Invention - Topic 1030.1

The specification and claims - Construction of a patent - "Person skilled in the art" - Common general knowledge - [See second Patents of Invention - Topic 1034 and Patents of Invention - Topic 1593 ].

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - [See Patents of Invention - Topic 1006 ].

Patents of Invention - Topic 1034

The specification and claims - Construction of a patent - Evidence (incl. extrinsic evidence) - [See Patents of Invention - Topic 1593 ].

Patents of Invention - Topic 1034

The specification and claims - Construction of a patent - Evidence (incl. extrinsic evidence) - Eli Lilly applied for an order under s. 6 of the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex Inc. for approval to sell its generic version of tadalafil until after the expiry of Canadian Patent 2,226,784 (784 Patent) - Apotex challenged the validity of the 784 Patent on the ground, inter alia, that it was an impermissible double patenting of the invention claimed in the earlier 2,181,377 Canadian Patent that Eli Lilly was similarly licensed to use and which likewise pertained to tadalafil - At issue were three documents that Apotex alleged would have formed part of the relevant prior art and would have been within the knowledge base of the skilled person to whom the Patents were directed - The Federal Court rejected Apotex's position that in any case where one party blinded its experts but the other did not, the former's evidence was to be preferred - See paragraphs 163 to 166.

Patents of Invention - Topic 1128

The specification and claims - The description - Sufficiency of disclosure - The Federal Court stated that "... there must be sufficient disclosure in a patent to enable a skilled person to replicate the invention claimed in the patent as sufficiency of disclosure is part of the basic patent bargain: the inventor is granted exclusive rights in their invention in exchange for disclosure of the invention ..." - See paragraph 173.

Patents of Invention - Topic 1591

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Time to determine obviousness (incl. date of invention) - [See second Patents of Invention - Topic 1674 ].

Patents of Invention - Topic 1593

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Prior art (incl. common general knowledge and mosaicing) - Eli Lilly applied for an order under s. 6 of the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex Inc. for approval to sell its generic version of tadalafil until after the expiry of Canadian Patent 2,226,784 (784 Patent) - Apotex challenged the validity of the 784 Patent on the ground, inter alia, that it was an impermissible double patenting of the invention claimed in the earlier 2,181,377 Canadian Patent (377 Patent) that Eli Lilly was similarly licensed to use and which likewise pertained to tadalafil - At issue, inter alia, were three documents that Apotex alleged would have formed part of the relevant prior art and would have been within the knowledge base of the skilled person to whom the Patents were directed, namely a Briefing document and two patent applications (277 and 902 Applications) - The Federal Court stated that there was no evidence that the Briefing Document was ever publicly disclosed - Moreover, the document on its face suggested that it was destined for an internal readership at Pfizer - Therefore, the Briefing document did not form part of the prior art that would have fallen within the common general knowledge of the skilled person to whom the 784 Patent was directed and was accordingly irrelevant to the obviousness-type double patenting analysis - Likewise, whatever might have been said about sildenafil (subject of the 902 patent application) during briefings held by Pfizer prior to July 14, 1995 (priority date of the 784 Patent) could not form part of the common general knowledge because attendees at such briefings (a "handful" of invited elite urologists) were required to sign non-disclosure agreements, which confirmed the private and non-public nature of the information disclosed there - The court found that the 277 and 902 Applications would have been within the common general knowledge of the skilled person to whom the 784 Patent was directed as of July 27, 1995 (publication date of the 377 Patent) because the skilled person included a medicinal chemist and the evidence established that medicinal chemists routinely read patent applications like the 277 and 902 Applications - However, these Applications did not render the use of tadalafil, 3-methyl tadalafil or their salts or solvates to treat erectile dysfunction, as claimed in the 798 Patent, obvious - See paragraphs 97 to 168.

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention (incl. double patenting) - The Federal Court discussed the general principles applicable to double patenting, including the two types of double patenting, namely same invention and obviousness - In summary, the court stated that "in order to assess a claim of double patenting, the court must undertake the following three-step inquiry: First, it must set out what is claimed in each of the patents, construing the claims, if necessary; Second, the court must determine if the claims in the two patents are identical. If they are and the same invention is claimed, the second patent will be void for same invention or coterminous double patenting; and Finally, if the inventions claimed in the two patents are not identical, the court must then go on to determine if the invention claimed in the later patent is inventive or patentably distinct from the invention claimed in the earlier patent. If not, then the second patent will be void for obviousness-type double patenting." - See paragraphs 60 to 68.

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention (incl. double patenting) - Eli Lilly Canada Inc. applied for an order under s. 6 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for approval to sell its generic version of tadalafil until after the expiry of Canadian Patent 2,226,784 (784 Patent) - Apotex challenged the validity of the 784 Patent on the grounds that it was an impermissible double patenting of the invention claimed in the earlier 2,181,377 Canadian Patent (377 Patent) that Eli Lilly was similarly licensed to use and which likewise pertained to tadalafil - This was the second PMNOC case involving the 784 Patent; on January 7, 2015, de Montigny, J., issued reasons in Eli Lilly Canada v. Mylan Pharmaceuticals ULC in which he dismissed Mylan's prohibition application because he found Mylan's allegations of invalidity to be unjustified - The Federal Court stated that "Regarding same invention double patenting, Justice de Montigny held that the inventions in the two patents were not the same. He determined that the 377 Patent claimed the compound tadalafil as a PDE V inhibitor for various uses not including ED [erectile dysfunction], whereas the 784 Patent claimed the use of tadalafil to treat ED. Because they claimed different uses for tadalafil, he found that the two patents did not claim the same invention and thus that the claims were not coterminous. ... The doctrine of comity ... applies to his construction and requires that I follow it unless I am convinced that there are cogent reasons to conclude otherwise. I am not so convinced ..." - See paragraphs 83 and 114 to 117.

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention (incl. double patenting) - Eli Lilly Canada Inc. applied for an order under s. 6 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for approval to sell its generic version of tadalafil until after the expiry of Canadian Patent 2,226,784 (784 Patent) - Apotex challenged the validity of the 784 Patent on the ground, inter alia, that it was an impermissible double patenting of the invention claimed in the earlier 2,181,377 Canadian Patent (377 Patent) that Eli Lilly was similarly licensed to use and which likewise pertained to tadalafil - This was the second PMNOC case involving the 784 Patent; on January 7, 2015, de Montigny, J., issued reasons in Eli Lilly Canada v. Mylan Pharmaceuticals ULC (Mylan Tadalafil) in which he dismissed Mylan's prohibition application because he found Mylan's allegations of invalidity to be unjustified - The Federal Court agreed with the policy reason given by de Montigny, J., in Mylan Tadalafil for rejecting "the Canadian filing or publication dates of the 784 Patent (July 11, 1996 and February 6, 1997, respectively) for the conduct of the obvious-type double patenting analysis as selection of either of these dates would circumvent the temporal limitations in section 28.3 of the Patent Act and expose the patentee to prior art that arises after the claim date of the later patent. This would effectively place an inventor with an earlier unpublished patent at a substantial disadvantage in respect of the date for assessing prior art as compared to any other person who might have made the same invention. ... [S]uch a result should not be countenanced as it would discourage inventors from publicizing their inventions after the claim date while their applications are still pending." - The court held that the issue of the correct date for undertaking the double patenting analysis was moot as the same result obtained if the analysis was undertaken as of the priority date of either the 377 Patent or of the 784 Patent - Given the comity principle and the lack of authority on the point, the court preferred not to make a firm determination on the point as, under either of the two possible dates, the 784 patent was not invalid for obvious-type double patenting - See paragraphs 121 to 135.

Patents of Invention - Topic 1779

Grounds of invalidity - Insufficiency - Particular cases - Eli Lilly applied for an order under s. 6 of the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for approval to sell its generic version of tadalafil until after the expiry of Canadian Patent 2,226,784 (784 Patent) - Apotex challenged the validity of the 784 Patent on the ground, inter alia, that the 784 Patent was invalid for insufficiency because it failed to provide guidance on how to produce hydrate forms of the compounds claimed in the 784 Patent - Many of the relevant claims in the 784 Patent included solvates of tadalafil or 3-methyl tadalafil, and it was common ground between the parties that a solvate included a hydrate - Thus, several of the relevant claims in the 784 Patent extended to hydrates of tadalafil - The Federal Court found that there was "... adequate disclosure in the 784 Patent to enable the production of solvates of tadalafil and 3-methyl tadalafil and that, from there, the skilled person, relying on his or her common general knowledge, would be able to create and if necessary modify reaction conditions so as to favour hydrate formation." - Thus, the allegation of insufficiency was not justified - See paragraphs 169 to 176.

Cases Noticed:

Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC et al., [2015] F.T.R. TBEd. JA.027; 249 A.C.W.S.(3d) 191; 2015 FC 17, refd to. [para. 7].

Teva Canada Ltd. v. Pfizer Canada Inc. - see Pfizer Canada Inc. et al. v. Novopharm Ltd. et al.

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. 35].

Pfizer Canada Inc. et al. v. Novopharm Ltd. et al. (2009), 352 F.T.R. 35; 76 C.P.R.(4th) 83; 2009 FC 638, refd to. [para. 41].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 319 F.T.R. 48; 61 C.P.R.(4th) 305; 2007 FC 971, affd. (2009), 385 N.R. 148; 72 C.P.R.(4th) 141; 2009 FCA 8, refd to. [para. 41].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88; 9 C.P.R.(4th) 129; 2000 SCC 67, consd. [para. 61].

Merck & Co. et al. v. Pharmascience Inc. et al. (2010), 368 F.T.R. 1; 85 C.P.R.(4th) 321; 2010 FC 510, refd to. [para. 63].

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. 63].

Commissioner of Patents v Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, [1964] S.C.R. 49; 41 C.P.R. 9 , refd to. [para. 65].

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. 66].

Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390; 122 D.L.R.(3d) 203, refd to. [para. 67].

Allergan Inc. et al. v. Canada (Minister of Health) et al. (2012), 440 N.R. 269; 105 C.P.R.(4th) 371; 2012 FCA 308, refd to. [para. 89].

Apotex Inc. v. Pfizer Canada Inc. (2013), 432 F.T.R. 205; 114 C.P.R.(4th) 270; 2013 FC 493, affd. (2014), 461 N.R. 295; 117 C.P.R.(4th) 401; 2014 FCA 54, refd to. [para. 90].

Glaxo Group Ltd. et al. v. Canada (Minister of National Health and Welfare) et al. (1995), 103 F.T.R. 1; 64 C.P.R.(3d) 65 (T.D.), refd to. [para. 91].

Bell v. Cessna Aircraft Co., [1983] 6 W.W.R. 178; 149 D.L.R.(3d) 509; 36 C.P.R. 115 (B.C.C.A.), refd to. [para. 91].

Western Electric Co. v. Baldwin International Radio of Canada, [1934] S.C.R. 570; 4 D.L.R. 129, refd to. [para. 95].

Weatherford Canada Ltd. et al. v. Corlac Inc. et al. (2011), 422 N.R. 49; 95 C.P.R.(4th) 101; 2011 FCA 228, appld. [para. 95].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 9 C.P.R.(4th) 168; 2000 SCC 66, refd to. [para. 105].

Teva Canada Innovation et al. v. Apotex Inc. et al., [2015] F.T.R. TBEd. AP.034; 252 A.C.W.S.(3d) 322; 2014 FC 1070, dist. [para. 163].

AstraZeneca Canada Inc. et al. v. Apotex Inc. et al. (2014), 457 F.T.R. 227; 244 A.C.W.S.(3d) 180; 2014 FC 638, affd. (2015), 474 N.R. 296; 2015 FCA 158, dist. [para. 163].

Abbott and Haliburton Co. Ltd. et al. v. WBLI Chartered Accountants, [2015] 2 S.C.R. 182; 470 N.R. 324; 360 N.S.R.(2d) 1; 1135 A.P.R. 1; 2015 SCC 23, refd to. [para. 165].

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. 173].

Cadbury Schweppes Inc. et al. v. FBI Foods Ltd. et al., [1999] 1 S.C.R. 142; 235 N.R. 30; 117 B.C.A.C. 161; 191 W.A.C. 161; 167 D.L.R.(4th) 577, refd to. [para. 173].

Pioneer Hi-Bred Ltd. v. Commissioner of Patents, [1989] 1 S.C.R. 1623; 97 N.R. 185; 60 D.L.R.(4th) 223, refd to. [para. 174].

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1997), 132 F.T.R. 60; 74 C.P.R.(3d) 131 (T.D.), dist. [para. 187].

Parke-Davis Division, Warner-Lambert Canada Inc. v. Canada (Minister of Health) - see Warner-Lambert Canada Inc. et al. v. Canada (Minister of Health) et al.

Warner-Lambert Canada Inc. et al. v. Canada (Minister of Health) et al. (2002), 296 N.R. 279; 22 C.P.R.(4th) 417; 2002 FCA 454, dist. [para. 187].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2001] 1 F.C. 495; 262 N.R. 137; 10 C.P.R.(4th) 65 (F.C.A.), affd. [2002] 4 S.C.R. 153; 296 N.R. 130; 2002 SCC 77, refd to. [para. 192].

R. v. Smith (A.L.), [1992] 2 S.C.R. 915; 139 N.R. 323; 55 O.A.C. 321; 94 D.L.R.(4th) 590, refd to. [para. 195].

R. v. Khan, [1990] 2 S.C.R. 531; 113 N.R. 53; 41 O.A.C. 353, refd to. [para. 195].

Counsel:

Jamie Mills, Chantal Saunders and Beverley Moore, for the applicant and respondent patentee;

Andrew Brodkin, Jordan Scopa and Sandon Shogilev, for the respondent, Apotex Inc.

Solicitors of Record:

Jamie Mills, Chantal Saunders and Borden Ladner Gervais, LLP, Ottawa, Ontario, for the applicant and respondent patentee;

H.B. Radomski and Andrew Brodkin, Goodmans, LLP, Toronto, Ontario, for the respondent, Apotex Inc.

This application was heard at Ottawa, Ontario, on May 11-13, 2015, by Gleason, J., of the Federal Court, who delivered the following decision on July 20, 2015.