Novartis Pharmaceuticals Canada Inc. v. Cobalt Pharmaceuticals Co. et al., (2013) 440 F.T.R. 1 (FC)

• Judge: Hughes, J.
• Court: Federal Court (Canada)
• Case Date: September 10, 2013
• Jurisdiction: Canada (Federal)
• Citations: (2013), 440 F.T.R. 1 (FC);2013 FC 985

Novartis v. Cobalt Pharmaceuticals (2013), 440 F.T.R. 1 (FC)

MLB headnote and full text

Temp. Cite: [2013] F.T.R. TBEd. OC.007

Novartis Pharmaceuticals Canada Inc. (applicant) v. Cobalt Pharmaceuticals Company and The Minister of Health (respondents) and Novartis AG and Roche Diagnostics GmbH (respondent patentees)

(T-724-12; 2013 FC 985; 2013 CF 985)

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

Federal Court

Hughes, J.

September 25, 2013.

Summary:

Novartis Pharmaceuticals Canada Inc. applied under the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Cobalt Pharmaceuticals Co. in respect of a drug containing zoledronic acid to be administered in once-yearly doses for the treatment of osteoporosis in humans until the expiry of Canadian Patent 2,410,201.

The Federal Court dismissed the application.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - Novartis Pharmaceuticals Canada Inc. applied under the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Cobalt Pharmaceuticals Co. in respect of a drug containing zoledronic acid to be administered in once-yearly doses for the treatment of osteoporosis in humans until the expiry of Canadian Patent 2,410,201 ('201 patent) - Cobalt asserted that the '201 patent did not qualify for listing under the Regulations applicable at the time of listing - Cobalt argued that the '201 patent did not contain a "claim for the use of a medicinal ingredient", thus the patent should never had been listed, thus this application should be dismissed - The Federal Court rejected the assertion - The argument had no merit - Further, Novartis had not followed proper procedure - It was clear that a person could not challenge a listing in the absence of proceedings taken by the person listing the patent under the Regulations - See paragraphs 102 to 110.

Patents of Invention - Topic 1532

Grounds of invalidity - Want of subject matter - Method of medical treatment - Novartis Pharmaceuticals Canada Inc. applied under the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Cobalt Pharmaceuticals Co. in respect of a drug containing zoledronic acid to be administered in once-yearly doses for the treatment of osteoporosis in humans until the expiry of Canadian Patent 2,410,201 ('201 patent) - Cobalt asserted that the '201 patent was invalid because the subject matter was ineligible for patent protection, i.e., it was a method of medical treatment - The Federal Court dismissed the application - Each claim of the '201 patent, directly or by incorporation by reference, included treatment by intermittent dosages with some claims specifying a dosage range and others specifying specific dosages; and some claims claiming more frequent intervals of dosing and others less - Accordingly, the claims included that which lied within the skill of the medical practitioner and were invalid - See paragraphs 70 to 101.

Patents of Invention - Topic 1589

Grounds of invalidity - Lack of "inventive ingenuity" (obviousness) - Particular patents - Novartis Pharmaceuticals Canada Inc. applied under the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Cobalt Pharmaceuticals Co. in respect of a drug containing zoledronic acid to be administered in once-yearly doses for the treatment of osteoporosis in humans until the expiry of Canadian Patent 2,410,201 ('201 patent) - Cobalt asserted that the '201 patent was invalid on the basis of obviousness - The Federal Court rejected the assertion - The inventive concept lied in the dosage regime: namely, the approximately once-a-year intermittent dosing of zoledronate to treat post-menoposal osteoporosis - No previous researchers had pushed those tests into the unknown territory of administration at less than six month intervals and there was no expectation as to what the results might be - The course of conduct in achieving a once-a-year bisphosphonate was explained by one of the named inventors - He dared to go beyond what a person of ordinary skill in the art would have done at the time - He unexpectedly achieved a good result - The invention as claimed in the '201 patent was not obvious - See paragraphs 60 to 69.

Cases Noticed:

Procter & Gamble Pharmaceuticals Canada Inc. et al. v. Canada (Minister of Health) et al. (2004), 247 F.T.R. 21; 2004 FC 204, refd to. [para. 26].

Novartis Pharmaceuticals Canada Inc. v. Teva Canada Ltd. et al. (2013), 429 F.T.R. 158; 2013 FC 283, refd to. [para. 27].

Merck & Co. et al. v. Pharmascience Inc. et al. (2010), 368 F.T.R. 1; 2010 FC 510, refd to. [para. 31].

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. 62].

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. 63].

Apotex Inc. v. Sanofi-Aventis (2013), 447 N.R. 313; 2013 FCA 186, refd to. [para. 64].

Tennessee Eastman Co. et al. v. Commissioner of Patents, [1974] S.C.R. 111, refd to. [para. 73].

Imperial Chemical Industries Ltd. v. Commissioner of Patents (1986), 67 N.R. 121; 9 C.P.R.(3d) 289 (F.C.A.), refd to. [para. 73].

Shell Oil Co. v. Commissioner of Patents, [1982] 2 S.C.R. 536; 44 N.R. 541, dist. [para. 74].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130, refd to. [para. 76].

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. 80].

Axcan Pharma Inc. v. Pharmascience Inc. et al. (2006), 291 F.T.R. 160; 50 C.P.R.(4th) 321; 2006 FC 527, refd to. [para. 82].

Allergan, Inc. Patent Application No. 2,300,723, Re (2009), 79 C.P.R.(4th) 161, refd to. [para. 84].

Janssen Inc. et al. v. Mylan Pharmaceuticals ULC et al. (2010), 376 F.T.R. 311; 2010 FC 1123, refd to. [para. 88].

Actavis UK Ltd. v. Merck & Co. Inc., [2008] E.W.C.A. Civ. 444 (C.A.), refd to. [para. 100].

Bristol Myers Squibb v. Baker Norton, [2001] R.P.C. 1 (BMS), refd to. [para. 100].

Genentech/method of administration of IFC-1, [2006] E.P.O.R. 9 (Legal Bd. App., Eur. Pat. Off.), refd to. [para. 100].

Wyeth Canada et al. v. ratiopharm Inc. et al. (2007), 370 N.R. 89; 2007 FC 340, refd to. [para. 107].

Abbott Laboratories et al. v. Canada (Minister of Health) et al. (2007), 370 N.R. 109; 2007 FCA 187, refd to. [para. 108].

Authors and Works Noticed:

Moy, R. Carl, Moy's Walker on Patents, generally [para. 61].

Counsel:

Anthony G. Creber and Livia Aumand, for the applicant;

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

Solicitors of Record:

Gowling Lafleur Hendersen LLP, Toronto, Ontario, for the applicant;

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

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

Gowling Lafleur Hendersen LLP, Toronto, Ontario, for the respondent patentees.

This application was heard at Toronto, Ontario, on September 10, 2013, by Hughes, J., of the Federal Court, who delivered the following reasons for judgment on September 25, 2013.