Eli Lilly & Co. et al. v. Novopharm Ltd. et al., (1997) 137 F.T.R. 32 (TD)

• Judge: Dubé, J.
• Court: Federal Court (Canada)
• Case Date: September 25, 1997
• Jurisdiction: Canada (Federal)
• Citations: (1997), 137 F.T.R. 32 (TD)

Eli Lilly & Co. v. Novopharm Ltd. (1997), 137 F.T.R. 32 (TD)

MLB headnote and full text

Temp. Cite: [1997] F.T.R. TBEd. NO.002

In The Matter of an application for an Order pursuant to Section 55.2(4) of the Patent Act and Section 6 of the Patented Medicines (Notice of Compliance) Regulations

Eli Lilly and Company, Eli Lilly Canada Inc. and Shionogi & Co. Ltd. (applicants) v. Novopharm Limited, and The Minister of National Health and Welfare (respondents)

(T-734-96)

Indexed As: Eli Lilly & Co. et al. v. Novopharm Ltd. et al.

Federal Court of Canada

Trial Division

Dubé, J.

October 15, 1997.

Summary:

Novopharm provided a notice of allegation to Eli Lilly relating to Novopharm's new drug submission respecting the drug cefaclor. Eli Lilly applied to prohibit the Minister of National Health and Welfare from issuing a notice of compliance to Novopharm (the first proceeding). Novopharm applied for leave to amend its notice of allegation to raise the allegation that Eli Lilly's patents did not contain a claim for the medicine itself.

The Federal Court of Canada, Trial Division, in a decision reported 81 F.T.R. 116, dismissed the application. Novopharm's appeal was dismissed for want of prosecution. Novopharm provided a second notice of allegation respecting cefaclor, alleging that Eli Lilly's patent did not contain a claim for the medicine itself. Eli Lilly applied for a second order prohibiting the Minister from issuing a notice of compliance (the second proceeding). Alternatively, Eli Lilly sought a declaration that Novopharm's detailed statement and allegations respecting cefaclor were void and of no effect for noncompliance with the Patented Medicines Notice of Compliance Regulations. Alternatively, Eli Lilly sought permission to withdraw the present proceeding or to permanently stay the proceedings.

The Federal Court of Canada, Trial Division, in a decision not reported in this series of reports, released an order in the first proceeding prohibiting the Minister from issuing a notice of compliance until after the expiration of the Eli Lilly's patents.

The Federal Court of Canada, Trial Division, dismissed Eli Lilly's application in the second proceeding.

Estoppel - Topic 377

Estoppel by record (res judicata) - Res judicata as a bar to subsequent proceedings - When applicable - Novopharm was denied permission to amend its notice of allegation to allege that Eli Lilly's patents respecting the drug cefaclor contained no claims to the medicine itself - Novopharm adduced no evidence respecting noninfringement - Eli Lilly obtained a prohibition order prohibiting the Minister of National Health and Welfare from issuing a notice of compliance to Novopharm - Novopharm provided a second notice of allegation, alleging that Eli Lilly's patents did not contain a claim for the medicine itself - The Federal Court of Canada, Trial Division, held that Novopharm was entitled to file the second notice of allegation - The court denied Eli Lilly's request for a second prohibition order, where its patents were either expired or only process patents - Res judicata was inapplicable, because a notice of allegation was merely a statement of evidence.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for - Notice of allegation - [See Estoppel - Topic 377 ].

Food and Drug Control - Topic 1106

Drugs - New drugs - Notice of compliance - Issuance of - [See Estoppel - Topic 377 ].

Food and Drug Control - Topic 1111.1

Drugs - New drugs - Notice of compliance - Practice - [See Estoppel - Topic 377 ].

Cases Noticed:

Merck Frosst Canada Inc. et al. v. Apotex Inc. (1997), 208 N.R. 388; 72 C.P.R.(3d) 170 (F.C.A.), refd to. [para. 16, footnote 1].

Schering Canada Inc. et al. v. Nu-Pharm Inc. et al. (1994), 85 F.T.R. 271; 58 C.P.R.(3d) 14 (T.D.), refd to. [para. 30, footnote 2].

Diamond v. Western Realty Co., [1924] 2 D.L.R. 922 (S.C.C.), refd to. [para. 31, footnote 3].

Rocois Construction Inc. v. Dominion Ready Mix Inc. et al., [1990] 2 S.C.R. 440; 112 N.R. 241; 31 Q.A.C. 241, refd to. [para. 31, footnote 3].

Rocois Construction Inc. v. Quebec Ready Mix - see Rocois Construction Inc. v. Dominion Ready Mix Inc. et al.

Doering v. Grandview (Town), [1976] 2 S.C.R. 621; 7 N.R. 299, refd to. [para. 32, footnote 4].

Vautour v. New Brunswick (1985), 62 N.B.R.(2d) 162; 161 A.P.R. 162 (C.A.), refd to. [para. 32, footnote 4].

General Foods Ltd. v. Struthers Scientific Corp. (1971), 4 C.P.R.(2d) 97 (S.C.C.), refd to. [para. 32, footnote 4].

Midway Manufacturing Co. v. Bernstein et al. (1988), 23 F.T.R. 295; 23 C.P.R.(3d) 272 (T.D.), refd to. [para. 32, footnote 4].

Labrie v. Uniformes Town & Country Inc. (1992), 141 N.R. 159 (F.C.A.), refd to. [para. 32, footnote 4].

Metodieva v. Ministre de l'Emploi et de l'Immigration (1991), 132 N.R. 38 (F.C.A.), refd to. [para. 32, footnote 4].

Saywack v. Minister of Employment and Immigration, [1986] 3 F.C. 189 (F.C.A.), refd to. [para. 32, footnote 4].

Deprenyl Research Ltd. et al. v. Apotex Inc. et al. (1994), 77 F.T.R. 62; 55 C.P.R.(3d) 171 (T.D.), refd to. [para. 36, footnote 5].

Deprenyl Research Ltd. et al. v. Apotex Inc. et al. (1995), 180 N.R. 323; 60 C.P.R.(3d) 501 (F.C.A.), refd to. [para. 37, footnote 6].

Eli Lilly & Co. et al. v. Apotex Inc. et al. (1995), 101 F.T.R. 33; 63 C.P.R.(3d) 245 (T.D.), refd to. [para. 37, footnote 7].

Apotex Inc. v. Canada (Minister of National Health and Welfare) et al., (1997), 129 F.T.R. 300; 72 C.P.R.(3d) 421 (T.D.), refd to. [para. 44, footnote 8].

Apotex Inc. v. Canada (Minister of National Health and Welfare) et al. (1997), 219 N.R. 151 (F.C.A.), refd to. [para. 45, footnote 9].

Pharmacia Inc. v. Bull (David) Laboratories (Canada) Inc. (1994), 175 N.R. 334 (F.C.A.), refd to. [para. 48, footnote 10].

Bayer AG and Miles Canada Inc. v. Canada (Minister of National Health and Welfare) and Apotex Inc. (1995), 179 N.R. 122; 60 C.P.R.(3d) 129 (F.C.A.), refd to. [para. 48, footnote 10].

Counsel:

Anthony G. Creber and Patrick Smith, for the applicants;

Douglas N. Deeth, for the respondent, Novopharm Ltd.

Solicitors of Record:

Gowling, Strathy & Henderson, Ottawa, Ontario, for the applicants;

Deeth Williams Wall, Toronto, Ontario, for the respondent, Novopharm Ltd.;

George Thomson, Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent, The Minister of National Health and Welfare.

This application was heard in Toronto, Ontario, on September 25, 1997, before Dubé, J., of the Federal Court of Canada, Trial Division, who delivered the following judgment on October 15, 1997.