Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC et al., (2015) 473 F.T.R. 1 (FC)

Judgede Montigny, J.
CourtFederal Court (Canada)
Case DateJanuary 07, 2015
JurisdictionCanada (Federal)
Citations(2015), 473 F.T.R. 1 (FC);2015 FC 17

Eli Lilly Can. v. Mylan Pharmaceuticals (2015), 473 F.T.R. 1 (FC)

MLB headnote and full text

Temp. Cite: [2015] F.T.R. TBEd. JA.027

Eli Lilly Canada Inc. (applicant) v. Mylan Pharmaceuticals ULC and The Minister of Health (respondents) and ICOS Corporation (respondent patentee)

(T-296-13; 2015 FC 17)

Indexed As: Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC et al.

Federal Court

de Montigny, J.

January 7, 2015.

Summary:

Eli Lilly Canada Inc. (Lilly) applied for an order under s. 55.2(4) of the Patent Act and s. 6 of the Patented Medicines (Notice of Compliance) Regulations to prohibit the issuance of a Notice of Compliance (NOC) to Mylan Pharmaceuticals ULC (Mylan) for a generic version of tadalafil, sold by Lilly under the brand name CIALIS, until after the expiration of Canadian Patent 2,226,784 (the '784 Patent). Mylan argued that Lilly's application should be dismissed because the '784 Patent was invalid for lack of utility and for obviousness-type double patenting.

The Federal Court concluded that Lilly met its burden of proof on the balance of probabilities to establish that the '784 Patent was valid, and that an order prohibiting the Minister of Health from issuing an NOC should issue.

Evidence - Topic 3350

Documentary evidence - Judicial proceedings - General principles - [See Food and Drug Control - Topic 1111.4 ].

Evidence - Topic 3757

Documentary evidence - Public documents - General - Foreign documents - [See Food and Drug Control - Topic 1111.4 ].

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for - Notice of allegation - [See first Patents of Invention - Topic 1721 ].

Food and Drug Control - Topic 1111

Drugs - New drugs - Notice of compliance - Affidavits, detailed statements, etc. - [See Food and Drug Control - Topic 1111.4 ].

Food and Drug Control - Topic 1111.4

Drugs - New drugs - Notice of compliance - Evidence and proof - Eli Lilly Canada Inc. (Lilly) applied for an order to prohibit the issuance of a Notice of Compliance to Mylan Pharmaceuticals ULC (Mylan) for a generic version of tadalafil, sold by Lilly under the brand name CIALIS, until after the expiration of Canadian Patent 2,226,784 (the '784 Patent) - Mylan argued that the '784 Patent was invalid for lack of utility and obviousness-type double patenting - Lilly moved to strike certain paragraphs and exhibits from the affidavit of Mylan's law clerk and portions of Mylan's Memorandum of Fact and Law, all of which related to documents alleged to have been filed by Lilly in a European opposition proceeding to a patent relating to VIAGRA sildenafil - Lilly said these documents had been improperly introduced into evidence, were not relevant to any issue in this proceeding, and constituted hearsay - The Federal Court dismissed the motion to strike - Lilly's argument that Mylan could have introduced the impugned documents pursuant to s. 23 of the Canada Evidence Act had no merit - No argument had been presented in support of the proposition that the European Patent Office was a court of record of a foreign country - In any event, s. 23 of the Canada Evidence Act was not the only procedure by which foreign evidence could be proven, and Lilly had not successfully impugned the authenticity of the material to which it now objected - The evidence offered by Mylan was not relied upon to establish a point of law, but only to show that Lilly's previous statements with respect to the state of the common general knowledge regarding erectile dysfunction and its treatment in the early 1990s were inconsistent with the position it was now taking - Mylan was referring to those statements not for the truth of their content, but for the fact that they were made - To that extent, they were not inadmissible as hearsay evidence and they were relevant to Mylan's allegation of obviousness-type double patenting - The documents sought to be struck by Lilly would remain part of the evidence, but would be given the weight commensurate to the circumstances and the legal context in which they were drafted - See paragraphs 59 to 69.

Patents of Invention - Topic 1005

The specification and claims - General - Alternative claims - Eli Lilly Canada Inc. (Lilly) applied for an order to prohibit the issuance of a Notice of Compliance to Mylan Pharmaceuticals ULC (Mylan) for a generic version of tadalafil, sold by Lilly under the brand name CIALIS, until after the expiration of Canadian Patent 2,226,784 (the '784 Patent) - Mylan argued that the '784 Patent was invalid for lack of utility - To the extent that the court accepted Lilly's submission that all the asserted claims had to be interpreted as alternative claims, Mylan relied on s. 27(5) of the Patent Act to argue that they should all fail since one of the alternatives was invalid - The Federal Court found that the asserted claims were not alternative claims - The court stated that "... Claim 2 claims a pharmaceutical composition for the treatment of ED in male animals 'comprising a compound selected from the group consisting' of two compounds, tadalafil and 3-methyl tadalafil. Similarly, claim 12 claims the use of a compound 'selected from the group consisting of' tadalafil and 3-methyl tadalafil. This does not strike me as the language of alternatives. Quite to the contrary, these claims define a generic expression or genus covering a group of two different compounds, any one of which will work in the combination claimed" - The asserted claims were "Markush" claims and not alternative claims - They were clearly claims to the two compounds, rather than claims to each of the compounds in the alternative - In other words, each of the compounds could be used interchangeably, and any one of the two compounds could be used to obtain the desired result - For that reason, s. 27(5) of the Patent Act was of no use as it applied only "where a claim defines the subject-matter of an invention in the alternative" - See paragraphs 116 to 120.

Patents of Invention - Topic 1006

The specification and claims - Interpretation of - Eli Lilly Canada Inc. (Lilly) applied for an order to prohibit the issuance of a Notice of Compliance to Mylan Pharmaceuticals ULC (Mylan) for a generic version of tadalafil, sold by Lilly under the brand name CIALIS, until after the expiration of Canadian Patent 2,226,784 (the '784 Patent) - Mylan argued that the '784 Patent was invalid for obviousness-type double patenting - Mylan submitted that Canadian Patent 2,181,377 (the '377 Patent) claimed the same compounds as the '784 Patent, and it disclosed that those compounds were potent and selective inhibitors of PDE V and might therefore be used to treat conditions where inhibition of PDE V was thought to be beneficial - Therefore, the '784 Patent disclosed nothing new, as it was already known that other PDE V inhibitors could be used to treat erectile dysfunction - The parties disagreed as to whether the claims of the '377 Patent should be read literally or in the context of the specification as a whole - The Federal Court stated, inter alia, that "It is no doubt true that the claims are the starting point in construing a patent. Yet, the words of the claims must be interpreted in the context of the specification as a whole to ascertain the true nature of the invention ... In some cases, the wording of a claim will be sufficient to define distinctly what the claimed monopoly is; but in other instances, the person skilled in the art and, ultimately the Court, may have to take the context into account and look at the disclosure to construe the claim and ascertain the true nature of the invention" - See paragraphs 125 to 128.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - [See Patents of Invention - Topic 1591 ].

Patents of Invention - Topic 1591

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Time to determine obviousness (incl. date of invention) - Eli Lilly Canada Inc. (Lilly) applied for an order to prohibit the issuance of a Notice of Compliance to Mylan Pharmaceuticals ULC (Mylan) for a generic version of tadalafil, sold by Lilly under the brand name CIALIS, until after the expiration of Canadian Patent 2,226,784 (the '784 Patent) - Mylan argued that the '784 Patent was invalid for obviousness-type double patenting - Mylan submitted that Canadian Patent 2,181,377 (the '377 Patent) claimed the same compounds as the '784 Patent, and it disclosed that those compounds were potent and selective inhibitors of PDE V and might therefore be used to treat conditions where inhibition of PDE V was thought to be beneficial - Therefore, the '784 Patent disclosed nothing new, as it was already known that other PDE V inhibitors could be used to treat erectile dysfunction (ED) - The Federal Court found that the allegation of obviousness-type double patenting was not justified - The claims in the two patents were patentably distinct - Although both were claims for the same chemical compound, tadalafil, they were claims for different uses of that compound - The '377 Patent did not contemplate the use of tadalafil to treat ED; rather, this was precisely the monopoly claimed in the '784 Patent - The priority date of the '784 Patent (July 14, 1995) was not the relevant date for a double patenting analysis - If January 1994 (the priority date of the '377 Patent) was the relevant date for assessing obviousness-type double patenting, it was clear that the use of tadalafil to treat ED (especially by way of oral administration) would not have been obvious for a person skilled in the art - The court concluded that the use of tadalafil to treat ED, especially by way of oral administration, would not have been obvious for the person skilled in the art in January 1994 and could not have been included in the '377 Patent - It could not be said that the '784 Patent was an evergreening of the '377 Patent when it claimed a new use of tadalafil by any route of administration, or at the very least a new use of tadalafil by way of oral administration - See paragraphs 122 to 150.

Patents of Invention - Topic 1674

Grounds of invalidity - Lack of novelty - Prior invention (incl. double patenting) - [See Patents of Invention - Topic 1591 ].

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General (incl. "promise of the patent") - Eli Lilly Canada Inc. (Lilly) applied for an order to prohibit the issuance of a Notice of Compliance to Mylan Pharmaceuticals ULC (Mylan) for a generic version of tadalafil, sold by Lilly under the brand name CIALIS, until after the expiration of Canadian Patent 2,226,784 (the '784 Patent) - Mylan argued that the '784 Patent was invalid for lack of utility - Lilly argued that the proper construction of the promise for the '784 Patent was the promise of treatment of erectile dysfunction by the use of tadalafil or 3-methyl tadalafil - Mylan said that the promise also required that the compounds be effective on oral administration, and not have side effects so severe as to make them unusable in treatment - Lilly argued that Mylan's version of the promise as expressed in its NOA was silent as to the mode of administration, and that the NOA was therefore improper - The Federal Court stated that "Mylan's NOA squarely raised the allegation of inutility, including lack of sound prediction. It is true that Mylan did not refer to the mode of administration in construing the promise of the '784 Patent. It cannot be said, however, that the NOA is inadequate for that reason or that Mylan changed its construction of the promise. First of all, the promise of a patent is an issue of construction, and such an issue is a question of law. Of course, the allegation that the invention was not soundly predicted is dependent to some extent on the construction of the promise underlying the patent. There is no evidence, however, that Lilly had difficulty understanding the grounds for the allegation of inutility or that it was misled by the absence of any reference to oral administration in the NOA. Moreover, no affidavit was filed by Lilly stating that they were prejudiced to any extent in this regard: ... Lilly also argued that Mylan changed its construction of the promise to match what was asserted by its experts in evidence. This is not problematic, as promise construction should indeed be based on expert evidence. As pointed out by Mylan, its experts were reacting to Lilly's own experts discussing oral administration in their affidavits. As a result, Mylan cannot be faulted for narrowing down the promise to take into account its interpretation of the expert evidence" - See paragraphs 76 to 81.

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General (incl. "promise of the patent") - [See Patents of Invention - Topic 1724 ].

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - [See Patents of Invention - Topic 1724 ].

Patents of Invention - Topic 1724

Grounds of invalidity - Lack of utility and operability - Doctrine of sound prediction - Eli Lilly Canada Inc. (Lilly) applied for an order to prohibit the issuance of a Notice of Compliance to Mylan Pharmaceuticals ULC (Mylan) for a generic version of tadalafil, sold by Lilly under the brand name CIALIS, until after the expiration of Canadian Patent 2,226,784 (the '784 Patent) - Mylan argued that the '784 Patent was invalid for lack of utility - Lilly argued that the proper construction of the promise for the '784 Patent was the promise of treatment of erectile dysfunction (ED) by the use of tadalafil or 3-methyl tadalafil - Mylan said that the promise also required that the compounds be effective on oral administration, and not have side effects so severe as to make them unusable in treatment - The Federal Court found that the promise did not include oral administration or reduced side effects - The court concluded that "Mylan's own experts have conceded that a person skilled in the art could have soundly predicted that tadalafil and 3-methyl tadalafil could be used to treat ED as promised in the specification. Since the promise does not specify a mode of administration, all that is necessary for the promise to be fulfilled is that tadalafil and 3-methyl tadalafil could be used to treat ED. This would be sufficient to dismiss Mylan's argument that the asserted claims of the '784 Patent are invalid for lack of utility. Even if I were to find that the promise includes oral administration, however, I would still be of the view that the promise was soundly predicted at the Canadian filing date. Despite the absence of any in vivo clinical data or some evidence of efficacy in valid animal models, I believe that the '377 Patent and the state of the art in 1996 were sufficient to establish a sound line of reasoning that tadalafil could treat ED through oral administration" - The promise of the '784 Patent, whether construed as excluding or including oral administration, had been soundly predicted - See paragraphs 76 to 121.

Cases Noticed:

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 366 N.R. 347; 2007 FCA 209, refd to. [para. 29].

AstraZeneca Canada Inc. et al. v. Pharmascience Inc. et al. (2014), 460 N.R. 343; 2014 FCA 133, refd to. [para. 29].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 319 F.T.R. 48; 2007 FC 971, affd. (2009), 385 N.R. 148; 2009 FCA 8, refd to. [para. 29].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2009), 346 F.T.R. 78; 2009 FC 320, refd to. [para. 29].

Armstrong v. Canada (Attorney General), [2005] F.T.R. Uned. 613; 2005 FC 1013, refd to. [para. 62].

Inhesion Industrial Co. v. Anglo Canadian Mercantile Co., [2000] F.T.R. Uned. 354; 6 C.P.R.(4th) 362 (T.D.), refd to. [para. 63].

R. v. Evans (C.D.), [1993] 3 S.C.R. 653; 158 N.R. 278; 145 A.R. 81; 55 W.A.C. 81, refd to. [para. 65].

Eli Lilly Canada Inc. v. Apotex Inc. et al. (2007), 311 F.T.R. 21; 2007 FC 455, affd. (2008), 375 N.R. 381; 2008 FCA 44, refd to. [para. 66].

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. 70].

Eli Lilly Canada Inc. et al. v. Novopharm Ltd. (2010), 405 N.R. 1; 2010 FCA 197, refd to. [para. 70].

Apotex Inc. v. Bristol-Myers Squibb Co. et al., [2007] N.R. Uned. 171; 2007 FCA 379, refd to. [para. 71].

Hoffmann-La Roche Ltd. v. Apotex Inc. et al. (2011), 394 F.T.R. 142; 104 C.P.R.(4th) 233; 2011 FC 875, refd to. [para. 71].

Laboratoires Servier et al. v. Apotex Inc. et al. (2008), 332 F.T.R. 193; 2008 FC 825, affd. (2009), 392 N.R. 96; 2009 FCA 222, refd to. [para. 74].

Bayer Inc. et al. v. Apotex Inc. et al. (2014), 454 F.T.R. 48; 2014 FC 436, refd to. [para. 78].

Novo Nordisk Canada Inc. et al. v. Cobalt Pharmaceuticals Inc. et al. (2010), 376 F.T.R. 104; 2010 FC 746, refd to. [para. 80].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2014), 465 N.R. 306; 2014 FCA 250, refd to. [para. 88].

Fournier Pharma Inc. et al. v. Canada (Minister of Health) et al. (2012), 413 F.T.R. 277; 2012 FC 741, refd to. [para. 89].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2014), 451 F.T.R. 158; 2014 FC 314, affd. (2014), 465 N.R. 306; 2014 FCA 250, refd to. [para. 89].

AstraZeneca Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2011), 396 F.T.R. 162; 2011 FC 1023, affd. (2012), 432 N.R. 292; 2012 FCA 109, refd to. [para. 90].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2011), 423 N.R. 180; 2011 FCA 236, dist. [para. 91].

Eurocopter v. Bell Helicopter Textron Canada Ltd. et al. (2013), 449 N.R. 111; 2013 FCA 219, refd to. [para. 98].

Teva Canada Ltd. v. Novartis AG (2013), 428 F.T.R. 1; 2013 FC 141, refd to. [para. 98].

Alcon Canada Inc. et al. v. Cobalt Pharmaceuticals Co. et al. (2014), 454 F.T.R. 265; 2014 FC 462, refd to. [para. 114].

Pfizer Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2012), 430 N.R. 326; 2012 FCA 103, refd to. [para. 114].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2005), 281 F.T.R. 74; 2005 FC 1332, affd. (2007), 361 N.R. 308; 2007 FCA 153, refd to. [para. 118].

Schering-Plough Canada Inc. et al. v. Pharmascience Inc. et al. (2009), 360 F.T.R. 109; 2009 FC 1128, refd to. [para. 118].

Markush, Ex Parte (1925), 340 USOG 839, refd to. [para. 119].

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. 123].

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. 123].

Aventis Pharma Inc. et al. v. Pharmascience Inc. et al. (2006), 352 N.R. 99; 2006 FCA 229, refd to. [para. 123].

Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, [1964] S.C.R. 49; 41 C.P.R. 9, refd to. [para. 124].

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. 127].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 2000 SCC 66, refd to. [para. 127].

Bayer AG et al. v. Novopharm Ltd. et al. (2006), 289 F.T.R. 263; 2006 FC 379, refd to. [para. 128].

Merck & Co. et al. v. Pharmascience Inc. et al. (2010), 368 F.T.R. 1; 2010 FC 510, refd to. [para. 128].

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. 145].

Statutes Noticed:

Canada Evidence Act, R.S.C. 1985, c. E-5, sect. 23 [para. 65].

Patent Act, R.S.C. 1985, c. P-4, sect. 27(1), sect. 27(5) [para. 117].

Counsel:

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

Tim Gilbert, Sana Halwani and Zarya Cynader, for the respondent, Mylan Pharmaceuticals ULC.

Solicitors of Record:

Borden Ladner Gervais LLP, Ottawa, Ontario, for the applicant and the respondent patentee;

Gilbert's LLP, Toronto, Ontario, for the respondent, Mylan Pharmaceuticals ULC;

William F. Pentney, Deputy Attorney General of Canada, Toronto, Ontario, for the respondent, The Minister of Health.

This application was heard on October 14 to 17, 2014, at Ottawa, Ontario, before de Montigny, J., of the Federal Court, who delivered the following decision on January 7, 2015.

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