Alcon Canada Inc. et al. v. Cobalt Pharmaceuticals Co. et al., (2014) 448 F.T.R. 96 (FC)

• Judge: Gleason, J.
• Court: Federal Court (Canada)
• Case Date: Friday February 14, 2014
• Jurisdiction: Canada (Federal)
• Citations: (2014), 448 F.T.R. 96 (FC);2014 FC 149

Alcon Can. v. Cobalt Pharmaceuticals (2014), 448 F.T.R. 96 (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. FE.031

Alcon Canada Inc., Alcon Research Ltd., Alcon Pharmaceuticals Ltd., and Kyowa Hakko Kirin Co. Ltd. (applicants) v. Cobalt Pharmaceuticals Company and The Minister of Health (respondents)

(T-504-12; 2014 FC 149; 2014 CF 149)

Indexed As: Alcon Canada Inc. et al. v. Cobalt Pharmaceuticals Co. et al.

Federal Court

Gleason, J.

February 14, 2014.

Summary:

The applicants (collectively Alcon) were owners or licensees of Canadian Patent '924 respecting eye drops in which the active pharmaceutical ingredient was a 0.2% concentration of olopatadine (PATADAY). Cobalt Pharmaceuticals Co. sought approval to sell its generic version of a 0.2% olopatadine eye drop under the Patented Medicines (Notice of Compliance) Regulations and served Alcon with Notices of Allegation contesting the validity of the '924 patent. Alcon applied to prohibit the Minister of Health from issuing the Notice of Compliance to Cobalt.

The Federal Court held that the '924 patent, for the purposes of the Notice of Compliance proceeding, was invalid for lack of demonstrated or soundly predicted utility and for overbreadth. Accordingly, the Alcon application to prohibit the Minister of Health from issuing a Notice of Compliance to Cobalt for its 0.2% olopatadine ophthalmic product was dismissed.

Food and Drug Control - Topic 1104

Drugs - New and innovative drugs - Notice of compliance - General - The Federal Court reviewed how the system under the Patented Medicines (Notice of Compliance) Regulations operated - See paragraphs 13 to 17.

Patents of Invention - Topic 1032

The specification and claims - Construction of a patent - Particular patents - Alcon et al. were owners or licensees of Canadian Patent '924 respecting eye drops in which the active pharmaceutical ingredient was a 0.2% concentration of olopatadine (PATADAY) - The '924 Patent was directed towards particular combinations of olopatadine and polyvinylpyrrolidone (PVP), a known excipient (or ingredient) often present in pharmaceutical formulations - The '924 patent claimed an invention centred on the alleged ability of PVP to stabilize a solution containing olopatadine - Cobalt Pharmaceuticals applied under the Patented Medicines (Notice of Compliance) Regulations to have its generic version of a 0.2% olopatadine eye drop approved and served Alcon with Notices of Allegation contesting the validity of the '924 patent - Alcon applied to prohibit the Minister of Health from issuing a Notice of Compliance to Cobalt - The Federal Court, in this context, construed the patent claims and discussed the inventive concept and promise of the patent - See paragraphs 18 to 63.

Patents of Invention - Topic 1128

The specification and claims - The description - Sufficiency of disclosure - The Federal Court reviewed the law on ambiguity and insufficiency - The court stated that these were related but distinct grounds of invalidity - See paragraphs 230 to 236.

Patents of Invention - Topic 1128.2

The specification and claims - The description - Ambiguity - [See Patents of Invention - Topic 1128].

Patents of Invention - Topic 1130

The specification and claims - The description - Claims for more than what was invented - Alcon et al. were owners or licensees of Canadian Patent '924 respecting eye drops in which the active pharmaceutical ingredient was a 0.2% concentration of olopatadine (PATADAY) - The '924 Patent was directed towards particular combinations of olopatadine and polyvinylpyrrolidone (PVP), a known excipient (or ingredient) often present in pharmaceutical formulations - The '924 patent claimed an invention centred on the alleged ability of PVP to stabilize a solution containing olopatadine - Alcon alleged that the ability of PVP to stabilize olopatadine solutions was unknown before it was disclosed in the '924 Patent - Cobalt, a generic drug manufacturer, claimed that the relevant claims in the patent were broader than the invention - The Federal Court held that Cobalt's allegation that the '924 patent was invalid for overbreadth was justified - See paragraphs 223 to 228.

Patents of Invention - Topic 1133

The specification and claims - The description - Particular patents - [See Patents of Invention - Topic 1136].

Patents of Invention - Topic 1136

The specification and claims - The description - Chemicals - Alcon et al. were owners or licensees of Canadian Patent '924 respecting eye drops in which the active pharmaceutical ingredient was a 0.2% concentration of olopatadine (PATADAY) - The '924 Patent was directed towards particular combinations of olopatadine and polyvinylpyrrolidone (PVP), a known excipient (or ingredient) often present in pharmaceutical formulations - The '924 patent claimed an invention centred on the alleged ability of PVP to stabilize a solution containing olopatadine - Alcon alleged that the ability of PVP to stabilize olopatadine solutions was unknown before it was disclosed in the '924 Patent - Cobalt, a generic drug manufacturer, claimed that the '924 patent was ambiguous and that disclosure contained in the patent was insufficient - The Federal Court held that Cobalt's allegations of invalidity due to ambiguity and insufficiency were not justified - See paragraphs 229 to 240.

Patents of Invention - Topic 1581

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - General - The Federal Court reviewed the law applicable to claims of obviousness and anticipation - The court discussed the differences in the two concepts - See paragraphs 72 to 80.

Patents of Invention - Topic 1582

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Test for obviousness - The Federal Court set out the four step approach for obviousness as clarified by the Supreme Court of Canada in Sanofi-Synthelabo Canada Inc. v. Apotex Inc. (2008) - The court also referred to the non-exhaustive list of factors that could be considered in determining whether a matter was "obvious to try" within the fourth step of the obviousness analysis - See paragraphs 77 to 79.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - Alcon et al. were owners or licensees of Canadian Patent '924 respecting eye drops in which the active pharmaceutical ingredient was a 0.2% concentration of olopatadine (PATADAY) - The '924 Patent was directed towards particular combinations of olopatadine and polyvinylpyrrolidone (PVP), a known excipient (or ingredient) often present in pharmaceutical formulations - The '924 patent claimed an invention centred on the alleged ability of PVP to stabilize a solution containing olopatadine - Alcon alleged that the ability of PVP to stabilize olopatadine solutions was unknown before it was disclosed in the '924 Patent - Cobalt, a generic drug manufacturer, alleged that the '924 patent was invalid for obviousness - The Federal Court held that Cobalt's claim of invalidity due to obviousness was not justified - See paragraphs 81 to 120.

Patents of Invention - Topic 1601

Grounds of invalidity - Anticipation - General - [See Patents of Invention - Topic 1581].

Patents of Invention - Topic 1721

Grounds of invalidity - Lack of utility and operability - General - The Federal Court reviewed the principles applicable to evaluating a claim of invalidity based on a lack of utility or sound prediction - See paragraphs 122 to 125.

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 - Alcon et al. were owners or licensees of Canadian Patent '924 respecting eye drops in which the active pharmaceutical ingredient was a 0.2% concentration of olopatadine (PATADAY) - The '924 Patent was directed towards particular combinations of olopatadine and polyvinylpyrrolidone (PVP), a known excipient (or ingredient) often present in pharmaceutical formulations - The '924 patent claimed an invention centred on the alleged ability of PVP to stabilize a solution containing olopatadine - Alcon alleged that the ability of PVP to stabilize olopatadine solutions was unknown before it was disclosed in the '924 Patent - Cobalt, a generic drug manufacturer, alleged that the '924 patent was invalid because the promised utility of the patent was neither demonstrated nor soundly predicted by Alcon by the relevant claims in the patent (i.e., Claims 2 and 7) - The Federal Court held that Cobalt's claim of invalidity due to lack of utility was justified - See paragraphs 121 to 222.

Patents of Invention - Topic 1724

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

Patents of Invention - Topic 1725

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

Cases Noticed:

Wyeth Canada et al. v. ratiopharm Inc. et al. (2007), 370 N.R. 89; 60 C.P.R.(4th) 375; 2007 FCA 264, refd to. [para. 13].

AB Hassle et al. v. Canada (Minister of National Health and Welfare) et al. (2000), 256 N.R. 172; 7 C.P.R.(4th) 272 (F.C.A.), refd to. [para. 14].

Procter & Gamble Pharmaceuticals Canada Inc. et al. v. Canada (Minister of Health) et al. (2002), 291 N.R. 339; 20 C.P.R.(4th) 1; 2002 FCA 290, refd to. [para. 14].

Bayer Inc. et al. v. Cobalt Pharmaceuticals Co. et al. (2013), 441 F.T.R. 72; 2013 FC 1061, refd to. [para. 14].

Lundbeck Canada Inc. et al. v. ratiopharm Inc. et al. (2009), 357 F.T.R. 75; 79 C.P.R.(4th) 243; 2009 FC 1102, refd to. [para. 17].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 361 N.R. 308; 59 C.P.R.(4th) 243; 2007 FCA 153, refd to. [para. 17].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2007), 366 N.R. 347; 60 C.P.R.(4th) 81; 2007 FCA 209, refd to. [para. 17].

Allergan Inc. et al. v. Canada (Minister of Health) et al. (2012), 414 F.T.R. 56; 103 C.P.R.(4th) 155; 2012 FC 767, refd to. [para. 17].

Pfizer Canada Inc. et al. v. Pharmascience Inc. et al. (2013), 427 F.T.R. 6; 111 C.P.R.(4th) 88; 2013 FC 120, refd to. [para. 17].

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. 18].

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. 18].

Dimplex North America Ltd. v. CFM Corp. (2006), 292 F.T.R. 38; 54 C.P.R.(4th) 435; 2006 FC 586, refd to. [para. 20].

Pfizer Canada Inc. et al. v. Canada (Minister of Health) et al. (2005), 285 F.T.R. 1; 46 C.P.R.(4th) 244; 2005 FC 1725, refd to. [para. 20].

Halford et al. v. Seed Hawk Inc. et al. (2004), 246 F.T.R. 1; 31 C.P.R.(4th) 434; 2004 FC 88, refd to. [para. 39].

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. 48].

Allergan Inc. et al. v. Canada (Minister of Health) et al. (2011), 400 F.T.R. 164; 97 C.P.R.(4th) 331; 2011 FC 1316, refd to. [para. 48].

Fournier Pharma Inc. et al. v. Canada (Minister of Health) et al. (2012), 413 F.T.R. 277; 107 C.P.R.(4th) 32; 2012 FC 741, refd to. [para. 48].

Apotex Inc. v. Sanofi-Aventis (2013), 447 N.R. 313; 2013 FCA 186, refd to. [para. 53].

Eli Lilly Canada Inc. et al. v. Novopharm Ltd. (2010), 405 N.R. 1; 85 C.P.R.(4th) 413; 2010 FCA 197, refd to. [para. 72].

Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2009), 385 N.R. 148; 72 C.P.R.(4th) 141; 2009 FCA 8, refd to. [para. 72].

Novartis Pharmaceuticals Canada Inc. v. Cobalt Pharmaceuticals Co. et al. (2013), 440 F.T.R. 1; 234 A.C.W.S.(3d) 728; 2013 FC 985, refd to. [para. 72].

Merck & Co. et al. v. Pharmascience Inc. et al. (2010), 368 F.T.R. 1; 2010 FC 510, refd to. [para. 72].

Schering-Plough Canada Inc. et al. v. Pharmascience Inc. et al. (2009), 360 F.T.R. 109; 81 C.P.R.(4th) 9; 2009 FC 1128, refd to. [para. 72].

Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; 35 N.R. 390, refd to. [para. 73].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2008), 337 F.T.R. 17; 71 C.P.R.(4th) 237; 2008 FC 1359, [para. 75].

ratiopharm inc. v. Pfizer Ltd. (2010), 405 N.R. 209; 87 C.P.R.(4th) 185; 2010 FCA 204, refd to. [para. 79].

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Merck & Co. et al. v. Apotex Inc. et al. (2005), 274 F.T.R. 113; 41 C.P.R.(4th) 35; 2005 FC 755, refd to. [para. 122].

Canales Rodriguez et al. v. Canada (Minister of Citizenship and Immigration), [2011] F.T.R. Uned. 142; 95 C.P.R.(4th) 193; 2011 FCA 236, refd to. [para. 124].

Pfizer Canada Inc. v. Canada (Minister of Health) - see Canales Rodriguez et al. v. Canada (Minister of Citizenship and Immigration).

AstraZeneca Canada Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2011), 396 F.T.R. 162; 96 C.P.R.(4th) 159; 2011 FC 1023, refd to. [para. 127].

Novopharm Ltd. v. Eli Lilly & Co. (2010), 376 F.T.R. 227; 87 C.P.R.(4th) 301; 2010 FC 915, refd to. [para. 194].

Novopharm Ltd. v. Eli Lilly & Co. (2011), 420 N.R. 188; 94 C.P.R.(4th) 95; 2011 FCA 220, leave to appeal refused (2011), 430 N.R. 397 (S.C.C.), refd to. [para. 196].

Minerals Separation North American Corp. v. Noranda Mines Ltd., [1950] S.C.R. 36; 12 C.P.R. 99, refd to. [para. 224].

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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. 230].

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Letourneau et al. v. Clearbrook Iron Works Ltd., [2005] F.T.R. Uned. A85; 44 C.P.R.(4th) 345; 2005 FC 1229, refd to. [para. 232].

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. 233].

Airseal Controls Inc. v. M & I Heat Transfer Products Ltd. (1993), 72 F.T.R. 196; 53 C.P.R.(3d) 259 (T.D.), refd to. [para. 235].

Novartis Pharmaceuticals Canada Inc. v. Teva Canada Ltd. et al. (2013), 429 F.T.R. 158; 110 C.P.R.(4th) 79; 2013 FC 283, refd to. [para. 236].

Merck & Co. et al. v. Apotex Inc. (1994), 88 F.T.R. 260; 59 C.P.R.(3d) 133 (T.D.), refd to. [para. 238].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd. (1998), 145 F.T.R. 161; 79 C.P.R.(3d) 193 (T.D.), refd to. [para. 238].

Statutes Noticed:

Patent Act, R.S.C. 1985, c. P-4, sect. 2 [para. 76]; sect. 27(3) [para. 234]; sect. 28.3 [para. 76].

Patent Act Regulations (Can.), Patent Rules, SOR/96-423, rule 87 [para. 39].

Patent Rules - see Patent Act Regulations (Can.).

Counsel:

Neil Belmore and Ariel Neuer, for the applicants;

Douglas N. Deeth and Kavita Ramamoorthy, for the respondent, Cobalt Pharmaceuticals Company.

Solicitors of Record:

Belmore Neidrauer LLP, Toronto, Ontario, for the applicants;

Deeth Williams Wall LLP, Toronto, Ontario, for the respondent, Cobalt Pharmaceuticals Company;

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

This application was heard in Toronto, Ontario, on December 9, 10 and 11, 2013, before Gleason, J., of the Federal Court, who delivered the following decision on February 14, 2014.