Amgen Canada Inc. et al. v. Apotex Inc. et al., 2016 FCA 196

• Judge: Noël, C.J., Stratas and Rennie, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: July 15, 2016
• Jurisdiction: Canada (Federal)
• Citations: 2016 FCA 196;(2016), 487 N.R. 202 (FCA)

Amgen Can. Inc. v. Apotex Inc. (2016), 487 N.R. 202 (FCA)

MLB headnote and full text

Temp. Cite: [2016] N.R. TBEd. JL.016

Amgen Canada Inc. and Amgen Inc. (appellants) v. Apotex Inc. and The Minister of Health (respondents)

(A-501-15; 2016 FCA 196)

Indexed As: Amgen Canada Inc. et al. v. Apotex Inc. et al.

Federal Court of Appeal

Noël, C.J., Stratas and Rennie, JJ.A.

July 15, 2016.

Summary:

Amgen Inc. was the owner of Canadian Letters Patent No. 1,341,537 ('537 patent). Amgen Canada Inc. listed the '537 patent under the provisions of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations). Amgen Canada (first person) secured a Notice of Compliance from the Minister in respect of a product it called Neupogen which was a sterile solution containing a drug known as filgrastim in 300 g/mL and 600 g/mL strength for subcutaneous or intravenous administration. Apotex Inc., a Canadian, generic drug manufacturer (second person), applied to the Minister for a Notice of Compliance to sell a generic version of the Amgen Neupogen product under the name, Grastofil. Apotex served a Notice of Allegation on Amgen, alleging that it would not infringe that patent and, in any event, that the patent was invalid on the grounds of novelty, obviousness and inutility. Amgen applied to prohibit the Minister from issuing a NOC to Apotex.

The Federal Court, in a decision reported [2015] F.T.R. TBEd. NO.066, dismissed the application for the prohibition order. Amgen satisfied the court that Apotex's allegations respecting novelty and utility were not justified but did not establish that Apotex's allegations concerning lack of invention (obviousness) were not justified. Thereafter, the Minister issued the NOC to Apotex. Amgen appealed against the dismissal of its application for a prohibition order. Apotex moved for an order dismissing the appeal as moot.

The Federal Court of Appeal allowed the application, granted Apotex's motion and dismissed the appeal as moot.

Courts - Topic 2286

Jurisdiction - Bars - Academic matters or moot issues - [See Courts - Topic 4087 ].

Courts - Topic 4087

Federal Court of Canada - Jurisdiction - Federal Court of Appeal - "Academic" or moot matters - Amgen applied under the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a notice of compliance to a generic drug manufacturer, Apotex, for its Grastofil pharmaceutical product - The Federal Court dismissed Amgen's application for the prohibition order - The Minister issued the NOC to Apotex - Amgen appealed the Federal Court's decision refusing the prohibition order - Apotex moved for an order dismissing the appeal as moot - The Federal Court of Appeal ruled that it would not advance judicial economy to deal with the motion at the interlocutory stage - The court agreed that the appeal was moot - There was no longer a live controversy - An order prohibiting the Minister from issuing the NOC would serve no purpose as the NOC was already issued - The court declined to exercise its jurisdiction to allow the appeal to proceed notwithstanding its mootness - See paragraphs 7 to 25.

Food and Drug Control - Topic 1108.2

Drugs - New drugs - Notice of compliance - Prohibition order - [See Courts - Topic 4087 ].

Counsel:

Andrew Shaughnessy, Andrew Bernstein, Yael Bienenstock and Nicole Mantini, for the appellants;

Andrew Brodkin, for the respondent, Apotex Inc.

Solicitors of Record:

Torys LLP, Toronto, Ontario, for the appellants;

Goodmans LLP, Toronto, Ontario, for the respondent, Apotex Inc.;

William F. Pentney, Deputy Attorney General of Canada, Ottawa, Ontario, for the respondent, The Minister of Health.

This motion was dealt with in writing without appearance of the parties by Noël, C.J., Stratas and Rennie, JJ.A., of the Federal Court of Appeal. The following decision was delivered for the court by Stratas, J.A., on July 15, 2016.