Janssen-Ortho Inc. et al. v. Apotex Inc. et al., (2011) 417 N.R. 240 (FCA)

• Judge: Sexton, Layden-Stevenson and Stratas, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: February 14, 2011
• Jurisdiction: Canada (Federal)
• Citations: (2011), 417 N.R. 240 (FCA);2011 FCA 57

Janssen-Ortho Inc. v. Apotex Inc. (2011), 417 N.R. 240 (FCA)

MLB headnote and full text

Temp. Cite: [2011] N.R. TBEd. FE.049

Apotex Inc. (appellant) v. The Minister of Health (respondent) and Janssen-Ortho Inc. and Daiichi Sankyo Company, Limited (respondent)

(A-258-10; 2011 FCA 57)

Indexed As: Janssen-Ortho Inc. et al. v. Apotex Inc. et al.

Federal Court of Appeal

Sexton, Layden-Stevenson and Stratas, JJ.A.

February 14, 2011.

Summary:

The respondents applied under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex for its Apo-levofloxacin tablets until after the expiration of the respondents' patent. The application was allowed (see (2008), 332 F.T.R. 1). Apotex's appeal was allowed (see (2009), 392 N.R. 71). The court ordered the matter to be redetermined. The patent expired on the day after that order was made. Apotex was granted a notice of compliance. Apotex then moved for dismissal of the respondents' application of prohibition.

The Federal Court, in a decision reported at [2010] F.T.R. Uned. 754, held that the application for prohibition was moot. Rather than dismissing the application, the court "terminated" the proceeding. Apotex appealed, asserting that the order used the word "terminate" in order to prevent Apotex from bringing a later action seeking compensation under s. 8 of the Regulations, which allowed such an action where an application for prohibition under s. 6(1) was "dismissed". The respondents brought a cross-appeal.

The Federal Court of Appeal allowed the appeal. The court set aside the order "terminating" the application for prohibition and, instead, dismissed the application. The cross-appeal was dismissed.

Courts - Topic 2286

Jurisdiction - Bars - Academic matters or moot issues - The respondents applied under s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex for its Apo-levofloxacin tablets until after the expiration of the respondents' patent - The application was allowed - Apotex's appeal was allowed - The court ordered the matter to be redetermined - The patent expired on the day after that order was made - Apotex was granted a notice of compliance - Apotex then moved for dismissal of the respondents' application of prohibition - Hughes, J., held that the application for prohibition was moot - Rather than dismissing the application, Hughes, J., "terminated" the proceeding - Apotex appealed, asserting that the order used the word "terminate" in order to prevent Apotex from bringing a later action seeking compensation under s. 8 of the Regulations, which allowed such an action where an application for prohibition under s. 6(1) was "dismissed" - The Federal Court of Appeal allowed the appeal - The motion to dismiss for mootness raised only narrow issues - In going beyond the limited scope of that motion, the court's investigation of the availability of a s. 8 action was unfair to Apotex - Apotex could not reasonably have expected that its narrow motion for dismissal on account of mootness would extend to the s. 8 issue - The availability of a s. 8 action was only to be considered if a s. 8 action was brought - The court set aside the order "terminating" the application for prohibition and, instead, dismissed the application - See paragraphs 10 to 18.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order (incl. compensation by first person) - [See Courts - Topic 2286 ].

Counsel:

Harry Radomski and David Lederman, for the appellant, Apotex Inc.;

Neil Belmore and Greg Beach, for the respondent, Janssen-Ortho Inc.;

Michael Charles, for the respondent, Daiichi Sankyo Company, Limited;

No one appearing, for the respondent, Minister of Health.

Solicitors of Record:

Goodmans LLP, for the appellant, Apotex Inc.;

Belmore McIntosh Neidrauer LLP, for the respondent, Janssen-Ortho Inc.;

Bereskin & Parr LLP, for the respondent, Daiichi Sankyo Company, Limited;

Myles J. Kirvan, Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent, Minister of Health.

This appeal and this cross-appeal were heard at Toronto, Ontario, on February 14, 2011, by Sexton, Layden-Stevenson and Stratas, JJ.A., of the Federal Court of Appeal. On the same date, Stratas, J.A., delivered the following judgment of the court orally from the bench.