Axcan Pharma Inc. v. Pharmascience Inc. et al., (2006) 291 F.T.R. 160 (FC)

• Judge: Harrington, J.
• Court: Federal Court (Canada)
• Case Date: March 30, 2006
• Jurisdiction: Canada (Federal)
• Citations: (2006), 291 F.T.R. 160 (FC);2006 FC 527

Axcan Pharma v. Pharmascience (2006), 291 F.T.R. 160 (FC)

MLB headnote and full text

Temp. Cite: [2006] F.T.R. TBEd. MY.016

Axcan Pharma Inc. (applicant) v. Pharmascience Inc. and the Minister of Health (respondents)

(T-1005-04; 2006 FC 527)

Indexed As: Axcan Pharma Inc. v. Pharmascience Inc. et al.

Federal Court

Harrington, J.

April 26, 2006.

Summary:

Axcan Pharma Inc. applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Pharmascience Inc.

The Federal Court dismissed the application.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - Axcan Pharma Inc. owned Canadian patent ‘590 for Ursodiol, used to treat primary biliary cirrhosis in a dosage portion of 13 to 15 mg/kg/day - Axcan applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Pharmascience Inc. - Pharmascience argued that Axcan’s patent was invalid - The Federal Court dismissed the application - The patent was invalid - The claimed dosage was an essential element of the patent - However, the number of capsules to prescribe was a matter between the patient and his/her doctor and did not form a monopoly protected by the patent - Therefore, the patent was invalid because it claimed a method of medical treatment - An invention relating to the area of professional skill or methods of medical treatment was not patentable - See paragraphs 42 to 52.

Patents of Invention - Topic 1532

Grounds of invalidity - Want of subject matter - Method of medical treatment - [See Food and Drug Control - Topic 1109.1 ].

Patents of Invention - Topic 1603

Grounds of invalidity - Anticipation - By previously published article or patent - Axcan Pharma Inc. owned Canadian patent ‘590 for Ursodiol, used to treat primary biliary cirrhosis (PBC) in a dosage portion of 13 to 15 mg/kg/day - Axcan applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Pharmascience Inc. - Pharmascience argued that Axcan’s patent was invalid - The Federal Court dismissed the application - The patent was invalid because a claim for the use of Ursodiol in the treatment of PBC was reported in an article by Dr. David which was published more than two years prior to the application for the Canadian patent - See paragraphs 36 to 38 and 52.

Patents of Invention - Topic 1605

Grounds of invalidity - Anticipation - Particular patents - [See Patents of Invention - Topic 1603 ].

Cases Noticed:

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Welfare) et al., [1998] 2 S.C.R. 193; 227 N.R. 299, refd to. [para. 7].

Bristol-Myers Squibb Co. et al. v. Canada (Attorney General) et al., [2005] 1 S.C.R. 533; 334 N.R. 55, refd to. [para. 7].

Biovail Pharmaceuticals Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (2005), 267 F.T.R. 243; 2005 FC 9, refd to. [para. 11].

Fournier Pharma Inc. et al. v. Canada (Minister of Health) et al., [2004] F.T.R. Uned. A56; 2004 FC 1718, refd to. [para. 11].

Free World Trust v. Électro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150, refd to. [para. 13].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 1067; 263 N.R. 88, refd to. [para. 18].

Apotex Inc. and Novopharm Ltd. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153; 296 N.R. 130, refd to. [para. 43].

Tennessee Eastman Co. v. Commissioner of Patents, [1974] S.C.R. 111, refd to. [para. 44].

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

Visx Inc. v. Nidek Co. et al. (1999), 181 F.T.R. 22; 3 C.P.R.(4th) 417 (T.D.), affd. (2001), 273 N.R. 268; 16 C.P.R.(4th) 251 (F.C.A.), refd to. [para. 45].

Merck & Co. et al. v. Apotex Inc. et al. (2005), 274 F.T.R. 113; 41 C.P.R.(4th) 35 (F.C.), refd to. [para. 47].

Imperial Chemical Industries Ltd. v. Commissioner of Patents, [1986] 3 F.C. 40; 67 N.R. 121 (F.C.A.), refd to. [para. 49].

Authors and Works Noticed:

David, R. et al., Die Wirkung von Ursodesoxycholsaure bei chromishchen Lebererkrankungen, Eine Pilotstudie (1985), Z. Gastroenterologie, vol. 23, p. 420 [para. 37].

Fisher and Parradine, Paper on Influence of Ursodeoxycholic Acid (UDCA) on Biochemical Parameters in Cholestic Liver Disease (1986), generally [para. 39].

Counsel:

François Grenier, for the applicant;

Warren Sprigings, for the respondent, Pharmascience Inc.

Solicitors of Record:

Leger Robic Richard, Montreal, Quebec, for the applicant;

Hitchman & Sprigings, Toronto, Ontario, for the respondent, Pharmascience Inc.;

John H. Sims, Q.C., Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent, the Minister of Health.

This application was heard on March 30, 2006, at Montreal, Quebec, by Harrington, J., of the Federal Court, who delivered the following judgment on April 26, 2006.