NOVARTIS PHARMACEUTICALS CANADA INC. Appellant v. COBALT PHARMACEUTICALS COMPANY and THE MINISTER OF HEALTH, 2014 FCA 17

Date: 20140127 Docket: A-318-13 Citation: 2014 FCA 17 CORAM: SHARLOW J.A. WEBB J.A. NEAR J.A. BETWEEN: NOVARTIS PHARMACEUTICALS CANADA INC. Appellant and COBALT PHARMACEUTICALS COMPANY and THE MINISTER OF HEALTH Respondents and NOVARTIS AG and ROCHE DIAGNOSTICS GmbH Respondents/Patentees Heard at Toronto, Ontario, on January 23, 2014. Judgment delivered at Ottawa, Ontario, on January 27, 2014. REASONS FOR JUDGMENT BY: SHARLOW J.A. CONCURRED IN BY: WEBB J.A. NEAR J.A. Date: 20140127 Docket: A-318-13 Citation: 2014 FCA 17 CORAM: SHARLOW J.A.

WEBB J.A. NEAR J.A. BETWEEN: NOVARTIS PHARMACEUTICALS CANADA INC.

Appellant andCOBALT PHARMACEUTICALS COMPANY AND THE MINISTER OF HEALTH Respondents andNOVARTIS AG AND ROCHE DIAGNOSTICS GMBH Respondents/Patentees REASONS FOR JUDGMENT SHARLOW J.A. [1] This is an appeal of the decision of Justice Hughes (2013 FC 985) dismissing the application of Novartis PharmaceuticalsCanada Inc. under the Patented Medicines (Notice of Compliance) Regulations (SOR/93-133) for an order prohibiting the Minister ofHealth from issuing a notice of compliance to Cobalt Pharmaceuticals Company for a generic version of a drug containing zoledronicacid to be administered in once-yearly doses for the treatment of osteoporosis, until after the expiry of Canadian Patent No. 2,410,201. [2] Cobalt alleged that the 201 patent is invalid for want of patentable subject matter.

Justice Hughes found that allegation to bejustified because the claims essentially are for a method of medical treatment as explained in Tennessee Eastman Co. v. Commissioner ofPatents, (SCC), [1974] SCR 111. Novartis argues that this conclusion is wrong in law. I do not agree. [3] To accept the argument of Novartis it would be necessary to conclude in the face of Tennessee Eastman that a method ofmedical treatment is patentable subject matter, or to conclude that Justice Hughes misconstrued the patent.

Having carefully consideredthe argument of Novartis and the authorities to which the Court was referred, I am unable to reach either conclusion. [4] For that reason, I would dismiss the appeal with costs. “K. Sharlow” J.A. “I agree Wyman W. Webb J.A.” “I agree D. G. Near J.A.” FEDERAL COURT OF APPEAL

NAMES OF COUNSEL AND SOLICITORS OF RECORD Docket: A-318-13 (APPEAL FROM A JUDGMENT OR ORDER OF THE HONOURABLE MR. JUSTICE HUGHES, DATED SEPTEMBER 25, 2013, DOCKET NO. T-724-12) STYLE OF CAUSE: NOVARTIS PHARMACEUTICALS CANADA INC. v. COBALT PHARMACEUTICALS COMPANY and THE MINISTER OF HEALTH and NOVARTIS AG and ROCHE DIAGNOSTICS GmbH PLACE OF HEARING: Toronto, Ontario DATE OF HEARING: January 23, 2014 REASONS FOR JUDGMENT BY: SHARLOW J.A. CONCURRED IN BY: WEBB, NEAR JJ.A. DATED: January 27, 2014 APPEARANCES : Anthony G. Creber Livia Aumand For The Appellant Douglas N.

Deeth Kavita Ramamoorthy For The Respondents SOLICITORS OF RECORD : Gowling Lafleur Henderson LLP Ottawa, Ontario For The Appellant Deeth Williams Wall LLP Toronto, Ontario For The Respondents