Wyeth-Ayerst Canada Inc. et al. v. Faulding (Canada) Inc. et al., (2002) 223 F.T.R. 189 (TD)

• Judge: Layden-Stevenson, J.
• Court: Federal Court (Canada)
• Case Date: May 08, 2002
• Jurisdiction: Canada (Federal)
• Citations: (2002), 223 F.T.R. 189 (TD)

Wyeth-Ayerst Can. v. Faulding Inc. (2002), 223 F.T.R. 189 (TD)

MLB headnote and full text

Temp. Cite: [2002] F.T.R. TBEd. OC.014

Wyeth-Ayerst Canada Inc. and American Cyanamid Company (applicants) v. Faulding (Canada) Inc. and the Minister of Health (respondents)

(T-234-01; 2002 FCT 969)

Indexed As: Wyeth-Ayerst Canada Inc. et al. v. Faulding (Canada) Inc. et al.

Federal Court of Canada

Trial Division

Layden-Stevenson, J.

September 13, 2002.

Summary:

Faulding (Canada) Inc. filed a Notice of Allegation (NOA) alleging that its proposed pipercillan sodium product would not infringe Canadian Patent 1209477 (the '477 patent). The applicants sought an order prohibiting the Minister of Health from issuing a Notice of Compliance to Faulding with respect to its pipercillan sodium product until the expiration of the '477 patent. At issue was the extent to which the applicants could rely on the presumption of infringement in s. 6(6) of the Patented Medicines (Notice of Compliance) Regulations.

The Federal Court of Canada, Trial Division, dismissed the application for an order of prohibition.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Prohibition order - [See Food and Drug Control - Topic 1111.1 ].

Food and Drug Control - Topic 1111.1

Drugs - New drugs - Notice of compliance - Practice - Faulding filed a Notice of Allegation (NOA) alleging that its proposed pipercillan sodium product would not infringe Canadian Patent 1209477 (the '477 patent) - The NOA was accompanied by the requisite detailed statement of the legal and factual basis for the NOA - The applicants sought an order prohibiting the Minister of Health from issuing a Notice of Compliance to Faulding until the expiration of the '477 patent - The applicants argued that pursuant to s. 6(6) of the Patented Medicines (Notice of Compliance) Regulations, in the absence of evidence to the contrary, Faulding's product was presumed to be prepared or produced by the processes described and claimed in the '477 patent and the onus was on Faulding to prove that the '477 patent was not infringed - The Federal Court of Canada, Trial Division, concluded that for the purposes of s. 6(6), the NOA and detailed statement constituted proof to the contrary where it was clear from the NOA and detailed statement that Faulding proposed to manufacture a medicine by a process not covered by the claims of the '477 patent.

Cases Noticed:

Bayer Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (2000), 258 N.R. 238; 6 C.P.R.(4th) 285 (F.C.A.), refd to. [para. 13].

Merck Frosst Canada Inc. et al. v. Canada (Minister of National Health and Welfare) et al. (1995), 169 N.R. 342; 55 C.P.R.(3d) 302 (F.C.A.), refd to. [para. 16].

Hoffmann-La Roche Ltd. et al. v. Canada (Minister of National Health and Welfare) et al. (1996), 205 N.R. 331; 70 C.P.R.(3d) 206 (F.C.A.), refd to. [para. 19].

Apotex Inc. v. Canada (Minister of National Health and Welfare) et al. (1997), 219 N.R. 151; 76 C.P.R.(3d) 1 (F.C.A.), refd to. [para. 24].

AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 256 N.R. 172; 7 C.P.R.(4th) 272 (F.C.A.), refd to. [para. 24].

Novartis Pharmaceuticals Canada Inc. et al. v. Abbott Laboratories Ltd. et al. (2000), 258 N.R. 105; 7 C.P.R.(4th) 264 (F.C.A.), refd to. [para. 24].

ICN Pharmaceuticals Inc. et al. v. Patented Medicines Prices Review Board et al. (1996), 200 N.R. 376; 68 C.P.R.(3d) 417 (F.C.A.), refd to. [para. 25].

Bayer AG and Miles Canada Inc. v. Canada (Minister of Health and Welfare) and Apotex Inc. (1993), 163 N.R. 183; 51 C.P.R.(3d) 329 (F.C.A.), refd to. [para. 25].

Bull (David) Laboratories (Canada) Inc. v. Pharmacia Inc. et al. (1994), 176 N.R. 48; 58 C.P.R.(3d) 209 (F.C.A.), refd to. [para. 25].

Pharmacia Inc. et al. v. Canada (Minister of National Health and Welfare) - see Bull (David) Laboratories (Canada) Inc. v. Pharmacia Inc. et al.

Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General) et al. (2001), 266 N.R. 141; 11 C.P.R.(4th) 539 (F.C.A.), refd to. [para. 25].

SmithKline Beecham Pharma Inc. et al. v. Apotex Inc. et al. (2000), 179 F.T.R. 109; 3 C.P.R.(4th) 22 (T.D.), refd to. [para. 28].

Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) et al. (1999), 164 F.T.R. 22; 87 C.P.R.(3d) 251 (T.D.), refd to. [para. 28].

Whirlpool Corp. et al. v. Camco Inc. et al., [2000] 2 S.C.R. 67; 263 N.R. 88; 9 C.P.R.(4th) 129, refd to. [para. 30].

Free World Trust v. Electro Santé Inc. et al., [2000] 2 S.C.R. 1024; 263 N.R. 150; 9 C.P.R.(4th) 168, refd to. [para. 31].

SmithKline Beecham Inc. et al. v. Apotex Inc. et al. (1998), 166 F.T.R. 67; 1 C.P.R.(4th) 99 (T.D.), affd. (2001), 267 N.R. 101; 10 C.P.R.(4th) 338 (F.C.A.), refd to. [para. 37].

AB Hassle et al. v. Apotex et al. (2001), 204 F.T.R. 248; 12 C.P.R.(4th) 289 (T.D.), refd to. [para. 40].

Glaxo Group Ltd. et al. v. Canada (Minister of National Health and Welfare) et al. (2000), 188 F.T.R. 1; 6 C.P.R.(4th) 73 (T.D.), affd. (2001), 273 N.R. 166; 11 C.P.R.(4th) 417 (F.C.A.), refd to. [para. 40].

Rizzo & Rizzo Shoes Ltd. (Bankrupt), Re, [1998] 1 S.C.R. 27; 221 N.R. 241; 106 O.A.C. 1; 154 D.L.R.(4th) 193; 50 C.B.R.(3d) 163; 33 C.C.E.L.(2d) 173; 98 C.L.L.C. 210-006, refd to. [para. 43].

Statutes Noticed:

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 6(6) [para. 27].

Patented Medicines (Notice of Compliance) Regulations - see Patent Act Regulations (Can.).

Counsel:

Gunars A. Gaikis and J. Sheldon Hamilton, for the applicants;

Susan D. Beaubien, for the respondents.

Solicitors of Record:

Smart & Biggar, Toronto, Ontario, for the applicants;

Borden Ladner Gervais LLP, Ottawa, Ontario, for the respondents.

This application was heard on May 8, 2002, at Toronto, Ontario, before Layden-Stevenson, J., of the Federal Court of Canada, Trial Division, who delivered the following decision on September 13, 2002.