Alcon Canada Inc. et al. v. Apotex Inc. et al., (2014) 459 F.T.R. 255 (FC)

• Judge: Kane, J.
• Court: Federal Court (Canada)
• Case Date: August 08, 2014
• Jurisdiction: Canada (Federal)
• Citations: (2014), 459 F.T.R. 255 (FC);2014 FC 699

Alcon Can. Inc. v. Apotex Inc. (2014), 459 F.T.R. 255 (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. AU.026

Alcon Canada Inc. and Alcon Research, Ltd. (applicants) v. Apotex Inc. and The Minister of Health (respondents)

(T-1666-12; 2014 FC 699; 2014 CF 699)

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

Federal Court

Kane, J.

August 8, 2014.

Summary:

Alcon owned a patent for a glaucoma drug (the '287 patent), containing travoprost as the active ingredient. Apotex sought to market a generic version of the drug. Alcon applied under the Patented Medicines (Notice of Compliance) Regulations to prohibit the Minister of Health from issuing a Notice of Compliance to Apotex in respect of its generic product until the expiry of the '287 patent on August 3, 2014. Apotex alleged that it did not infringe the claims of the '287 patent because the claims were invalid on the grounds of anticipation and obviousness and, alternatively, lack of utility.

The Federal Court dismissed Alcon's application for a prohibition order. The court found that the allegations with respect to the invalidity of the claims at issue for anticipation and obviousness were justified and the allegations with respect to invalidity for lack of utility were not justified.

Food and Drug Control - Topic 1111.4

Drugs - New drugs - Notice of compliance - Evidence and proof (incl. burden of proof) - The Federal Court discussed who bears the burden of proof when the validity of a patent was in issue in Notice of Compliance proceedings - See paragraphs 55 to 62.

Patents of Invention - Topic 17

Patents of invention - General - Selection patents (incl. what constitutes) - The Federal Court reviewed the jurisprudence and principles relating to selection patents - See paragraphs 134 to 145.

Patents of Invention - Topic 17

Patents of invention - General - Selection patents (incl. what constitutes) - Alcon owned a patent for a glaucoma drug (the '287 patent), containing travoprost as the active ingredient - A generic drug manufacturer, Apotex, challenged the validity of the patent in the context of notice of compliance proceedings on the grounds of anticipation and obviousness and, alternatively, lack of utility - Apotex claimed that '287 patent was a selection patent from the genus of a European Patent Application (the '417 application) - The Federal Court held that the allegations of anticipation and obviousness were justified, while the allegation of lack of utility was not - The court found that the patent was not a selection patent, but rather a species patent - The court stated, however that had the '287 patent been found to be a selection patent from the '417 application, the determination of the allegations of lack of utility, anticipation and obviousness would have been the same - See paragraphs 146 to 153.

Patents of Invention - Topic 1026

The specification and claims - Construction of a patent - The Federal Court reviewed the jurisprudence and principles governing the construction of a patent and its claims - See paragraphs 119 to 133.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - Alcon owned a patent respecting a glaucoma drug (the '287 patent), containing travoprost as the active ingredient - A generic drug manufacturer, Apotex, challenged the validity of the patent in the context of notice of compliance proceedings on the grounds of anticipation and obviousness and, alternatively, lack of utility - In this context, the Federal Court discussed the inventive concept of the patent - The court concluded that the inventive concept was a therapeutically effective amount of travoprost or an ophthalmic composition containing a therapeutically effective amount of travoprost for the treatment of glaucoma with an acceptable side effect profile - See paragraphs 154 to 167.

Patents of Invention - Topic 1581

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - General - The Federal Court discussed the jurisprudence and principles respecting obviousness - See paragraphs 378 to 384.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - Alcon owned a patent respecting a glaucoma drug (the '287 patent), containing travoprost as the active ingredient - A generic drug manufacturer, Apotex, challenged the validity of the patent in the context of notice of compliance proceedings on the ground of obviousness - The Federal Court held that the '287 patent was obvious; therefore, the allegations of obviousness were justified - See paragraphs 373 to 483.

Patents of Invention - Topic 1601

Grounds of invalidity - Anticipation - General - The Federal Court reviewed the jurisprudence and principles on anticipation (incl. the test for anticipation) - See paragraphs 254 to 263.

Patents of Invention - Topic 1602

Grounds of invalidity - Anticipation - Test for - [See Patents of Invention - Topic 1601 ].

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - Alcon owned a patent respecting a glaucoma drug (the '287 patent), containing travoprost as the active ingredient - A generic drug manufacturer, Apotex, challenged the validity of the patent in the context of notice of compliance proceedings on the ground of anticipation by prior art (i.e., European Patent Application (the '417 application), which disclosed a large genus of compounds)) - The Federal Court held that the invention in the '287 patent was anticipated by the '417 application - The '417 application disclosed travoprost, although it was not specifically named - The subject matter was disclosed for the same purpose as the invention of the '287 patent - Enablement was not in issue - The allegation of anticipation was justified - See paragraphs 251 to 372.

Patents of Invention - Topic 1653

Grounds of invalidity - Anticipation by prior patent - What constitutes anticipation - [See Patents of Invention - Topic 1605 ].

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General - The Federal Court stated that "If a promise is made, the patentee must live up to the promise. Where a patentee describes the invention as possessing a particular level of utility, he is bound by that promise. Otherwise, a mere scintilla of utility is sufficient" - See paragraph 168.

Patents of Invention - Topic 1723

Grounds of invalidity - Lack of utility and operability - Chemical products and substances intended for food and medicine - Alcon owned a patent respecting a glaucoma drug (the '287 patent), containing travoprost as the active ingredient - A generic drug manufacturer, Apotex, challenged the validity of the patent in the context of notice of compliance proceedings on the grounds lack of utility and sound prediction - The Federal Court reviewed the applicable principles and held that the allegations of lack of utility and sound prediction were not justified - See paragraphs 168 to 250.

Patents of Invention - Topic 1724

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

Patents of Invention - Topic 1725

Grounds of invalidity - Lack of utility and operability - Particular patents - [See Patents of Invention - Topic 1723 ].

Cases Noticed:

Lundbeck Canada Inc. et al. v. ratiopharm Inc. et al. (2009), 357 F.T.R. 75; 2009 FC 1102, refd to. [para. 56].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 361 N.R. 308; 2007 FCA 153, refd to. [para. 56].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 366 N.R. 347; 2007 FCA 209, refd to. [para. 56].

Allergan Inc. et al. v. Canada (Minister of Health) et al. (2012), 414 F.T.R. 56; 2012 FC 767, affd. (2012), 440 N.R. 269; 2012 FCA 308, refd to. [para. 56].

Pfizer Canada Inc. et al. v. Pharmascience Inc. et al. (2013), 427 F.T.R. 6; 2013 FC 120, refd to. [para. 56].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2007), 306 F.T.R. 254; 2007 FC 26, affd. (2007), 367 N.R. 98; 2007 FCA 195, leave to appeal refused (2007), 381 N.R. 399 (S.C.C.), refd to. [para. 57].

Hoffman-La Roche Ltd. v. Apotex Inc. et al. (2013), 436 F.T.R. 198; 2013 FC 718, refd to. [para. 63].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2006), 351 N.R. 189; 2006 FCA 214, refd to. [para. 134].

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. 135].

I.G. Farbenindustrie A.G.'s Patents, Re (1930), 47 R.P.C. 289 (Ch. D.), refd to. [para. 136].

Eli Lilly Canada Inc. et al. v. Novopharm Ltd. (2010), 405 N.R. 1; 2010 FCA 197, refd to. [para. 137].

Apotex Inc. v. Sanofi-Aventis (2013), 447 N.R. 313; 2013 FCA 186, refd to. [para. 175].

Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390, refd to. [para. 176].

AstraZeneca Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2012), 432 N.R. 292; 2012 FCA 109, refd to. [para. 178].

Fournier Pharma Inc. et al. v. Canada (Minister of Health) et al. (2012), 413 F.T.R. 277; 2012 FC 741, refd to. [para. 181].

Pfizer Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2014), 446 F.T.R. 274; 2014 FC 38, refd to. [para. 183].

AstraZeneca Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2011), 396 F.T.R. 162; 2011 FC 1023, refd to. [para. 184].

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. 186].

Abbott Laboratories et al. v. Canada (Minister of Health) et al., [2009] 4 F.C.R. 401; 337 F.T.R. 17; 2008 FC 1359, affd. (2009), 387 N.R. 347; 2009 FCA 94, refd to. [para. 254].

Lundbeck Canada Inc. v. Canada (Minister of Health) et al. (2009), 343 F.T.R. 53; 2009 FC 146, refd to. [para. 262].

Eli Lilly Canada Inc. v. Novopharm Ltd. et al. (2009), 346 F.T.R. 42; 2009 FC 301, refd to. [para. 262].

Schering-Plough Canada Inc. et al. v. Pharmascience Inc. et al. (2009), 360 F.T.R. 109; 2009 FC 1128, red to. [para. 262].

AstraZeneca Canada Inc. et al. v. Apotex Inc. et al. (2010), 376 F.T.R. 17; 2010 FC 714, refd to. [para. 262].

Merck & Co. et al. v. Canada (Minister of Health) et al. (2010), 375 F.T.R. 121; 2010 FC 1042, refd to. [para. 262].

Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd., [1985] R.P.C. 59 (C.A.), refd to. [para. 379].

Pozzoli SPA v. BDMO SA, [2007] F.S.R. 37; [2007] EWCA Civ. 588 (C.A.), refd to. [para. 379].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2009), 385 N.R. 148; 2009 FCA 8, refd to. [para. 382].

Alcon Canada Inc. et al. v. Cobalt Pharmaceuticals Co. et al. (2014), 448 F.T.R. 96; 2014 FC 149, refd to. [para. 383].

Counsel:

Gunars Gaikis, Sheldon Hamilton and Tracey Stott, for the applicants, Alcon Canada Inc. et al.;

Andrew Brodkin, Dino Clarizio and Jordan Scopa, for the respondent, Apotex Inc.;

Nil, for the respondent, The Minister of Health.

Solicitors of Record:

Smart & Biggar LLP, Toronto, Ontario, for the applicants, Alcon Canada Inc. et al.;

Goodman's LLP, Toronto, Ontario, for the respondent, Apotex Inc.;

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

This application was heard on Toronto, Ontario, May 12 and 13, 2014, by Kane, J., of the Federal Court, who delivered the following decision in Ottawa, Ontario, on August 8, 2014.