SmithKline Beecham Inc. et al. v. Apotex Inc. et al., (1999) 166 F.T.R. 67 (TD)

• Judge: McGillis, J.
• Court: Federal Court (Canada)
• Case Date: March 22, 1999
• Jurisdiction: Canada (Federal)
• Citations: (1999), 166 F.T.R. 67 (TD)

SmithKline Beecham Inc. v. Apotex Inc. (1999), 166 F.T.R. 67 (TD)

MLB headnote and full text

Temp. Cite: [1999] F.T.R. TBEd. MY.026

SmithKline Beecham Inc. and Beecham Group p.l.c. (applicants) v. Apotex Inc. and the Minister of Health (respondents)

(T-2660-96)

Indexed As: SmithKline Beecham Inc. et al. v. Apotex Inc. et al.

Federal Court of Canada

Trial Division

McGillis, J.

April 20, 1999.

Summary:

SmithKline Beecham Pharma Inc. et al. ("the companies") applied to prohibit the Mini­ster of Health from issuing a notice of com­pliance to Apotex Inc. for their parox­etine hydrochloride tablets until the expiry of their Canadian Letters Patent.

The Federal Court of Canada, Trial Divi­sion, dismissed the application.

Food and Drug Control - Topic 1105

Drugs - New drugs - Notice of compliance - Intervention on application for (incl. notice of allegation) - SmithKline Beecham Pharma Inc. et al. ("the companies") applied to prohibit the Minister of Health from issu­ing a notice of compliance to Apotex Inc. for their paroxetine hydro­chloride tablets until the expiry of their patent - The companies asserted that Apotex's notice of allegation was ambigu­ous and contained insufficient facts to justify its allegation of non-infring­ement - The Fed­eral Court of Canada, Trial Divi­sion, dis­missed the application - The notice of allegation did not infringe the patent and was not insuffi­cient because it consti­tuted a specific factual allegation of non-infring­ement - The companies did not establish on a balance of probabilities that Apotex's allegation of non-infringement was not justified.

Food and Drug Control - Topic 1106

Drugs - New drugs - Notice of compliance - Issuance of - [See Food and Drug Con­trol - Topic 1105 ].

Food and Drug Control - Topic 1302

Drugs - Evidence and proof - Burden of proof - [See Food and Drug Control - Topic 1105 ].

Cases Noticed:

Glaxo Group Ltd. v. Canada (Minister of National Health and Welfare) (1998), 80 C.P.R.(3d) 424 (F.C.T.D.), refd to. [para. 33].

Merck Frosst Canada Inc. v. Canada (Min­ister of National Health and Welfare) (1994), 169 N.R. 342; 55 C.P.R.(3d) 302 (F.C.A.), refd to. [para. 39].

Hoffman-LaRoche Ltd. et al. v. Canada (Minister of National Health and Wel­fare) (1996), 205 N.R. 331; 70 C.P.R.(3d) 206 (F.C.A.), refd to. [para. 40].

Zeneca Pharma Inc. v. Canada (Minister of National Health and Welfare) et al. (1996), 206 N.R. 1; 69 C.P.R.(3d) 451 (F.C.A.), refd to. [para. 40].

Counsel:

A.G. Creber and Helene D'Iorio, for the applicant;

Harry Radomski, Andrew Brodkin and Ivor Hughes for the respondent.

Solicitors of Record:

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

Goodman, Phillips & Vineberg, Ottawa, Ontario, for the respondent.

This application was heard at Ottawa, Ontario, on March 22, 1999, by McGillis, J., of the Federal Court of Canada, Trial Divi­sion, who delivered the following decision on April 20, 1999.