ViiV Healthcare ULC et al. v. Teva Canada Ltd. et al., (2015) 474 N.R. 235 (FCA)

• Judge: Ryer, Near and Rennie, JJ.A.
• Court: Federal Court of Appeal (Canada)
• Case Date: April 13, 2015
• Jurisdiction: Canada (Federal)
• Citations: (2015), 474 N.R. 235 (FCA);2015 FCA 93

ViiV Healthcare ULC v. Teva Can. (2015), 474 N.R. 235 (FCA)

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Temp. Cite: [2015] N.R. TBEd. AP.014

ViiV Healthcare ULC, ViiV Healthcare UK Ltd. and Glaxo Group Limited (appellants) v. Teva Canada Limited and The Minister of Health (respondents)

(A-452-14)

ViiV Healthcare ULC, ViiV Healthcare UK Ltd. and Glaxo Group Limited (appellants) v. Apotex Inc. and The Minister of Health (respondents)

(A-453-14; 2015 FCA 93; 2015 CAF 93)

Indexed As: ViiV Healthcare ULC et al. v. Teva Canada Ltd. et al.

Federal Court of Appeal

Ryer, Near and Rennie, JJ.A.

April 15, 2015.

Summary:

A Prothonotary of the Federal Court, in a decision reported at 452 F.T.R. 173, found that Canadian Patent No. 2,289,753 (the '753 Patent) was not eligible for listing against KIVEXA, a drug marketed by ViiV Healthcare ULC, ViiV Healthcare UK Ltd., and Glaxo Group Ltd. (collectively the appellants). The Prothonotary issued orders to that effect in separate proceedings involving the respondent Teva Canada Ltd. and the respondent Apotex Inc. The appellants appealed.

The Federal Court, in a decision reported at (2014), 464 F.T.R. 66, dismissed the appeals. The appellants appealed.

The Federal Court of Appeal dismissed the appeals. Both the Prothonotary and the Federal Court judge correctly concluded that Gilead Sciences Canada Inc. v. Canada (2012 FCA) applied to the facts of this case. In Gilead, the court found that s. 4(2)(a) of the Patented Medicines (Notice of Compliance) Regulations set an exacting threshold of specificity between what was claimed in the patent and what had been approved in the Notice of Compliance (NOC). A patent that did not explicitly claim all of the medicinal ingredients contained in the drug for which the NOC was issued could not be listed against that drug.

Food and Drug Control - Topic 1109.1

Drugs - New drugs - Notice of compliance - Patent list - General - [See Food and Drug Control - Topic 1114 ].

Food and Drug Control - Topic 1114

Drugs - New drugs - Delisting of patent - A Prothonotary of the Federal Court found that Canadian Patent No. 2,289,753 (the '753 Patent) was not eligible for listing against KIVEXA, a drug marketed by the appellants - The Prothonotary issued orders to that effect in separate proceedings involving the respondent Teva Canada Ltd. and the respondent Apotex Inc. - The Federal Court upheld the orders - The appellants appealed - The Federal Court of Appeal dismissed the appeals - The question at issue, the eligibility for listing on the register of a claim to a single medicinal ingredient against an FDC drug containing more than one medicinal ingredient, was a question of law - Thus, it was reviewable on the standard of correctness - Both the Prothonotary and the Federal Court judge correctly concluded that Gilead Sciences Canada Inc. v. Canada (2012 FCA) applied to the facts of this case - In Gilead, the court found that s. 4(2)(a) of the Patented Medicines (Notice of Compliance) Regulations set an exacting threshold of specificity between what was claimed in the patent and what had been approved in the Notice of Compliance (NOC) - A patent that did not explicitly claim all of the medicinal ingredients contained in the drug for which the NOC was issued could not be listed against that drug.

Cases Noticed:

Gilead Sciences Canada Inc. v. Canada (Minister of Health) et al. (2012), 435 N.R. 188; 2012 FCA 254, appld. [para. 8].

Housen v. Nikolaisen et al., [2002] 2 S.C.R. 235; 286 N.R. 1; 219 Sask.R. 1; 272 W.A.C. 1; 2002 SCC 33, refd to. [para. 11].

Bayer Inc. v. Canada (Minister of Health) et al. (2009), 358 F.T.R. 20; 2009 FC 1171, refd to. [para. 12].

Bristol-Myers Squibb Co. et al. v. Canada (Attorney General) et al., [2005] 1 S.C.R. 533; 334 N.R. 55; 2005 SCC 26, refd to. [para. 12].

Miller v. Canada (Attorney General) (2002), 293 N.R. 391; 2002 FCA 370, refd to. [para. 18].

Statutes Noticed:

Patent Act Regulations (Can.), Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, sect. 4(2)(a) [para. 2].

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

Counsel:

Patrick Kierans, Louisa Pontrelli, Christopher A. Guerreiro and Daniel Daniele, for the appellants;

David W. Aitken and Scott A. Beeser, for the respondent in A-452-14, Teva Canada Limited;

Ben Hackett and Jaro Mazzola, for the respondent in A-453-14, Apotex Inc.;

Eric Peterson, for the respondent, the Minister of Health.

Solicitors of Record:

Norton Rose Fulbright Canada LLP, Toronto, Ontario, for the appellant;

Aitken Klee LLP, Toronto, Ontario, for the respondent in A-452-14, Teva Canada Limited;

Goodmans LLP, Toronto, Ontario, for the respondent in A-453-14, Apotex Inc.;

William F. Pentney, Department of Justice, Toronto, Ontario, for the respondent, the Minister of Health.

These appeals were heard on April 13, 2015, at Toronto, Ontario, before Ryer, Near and Rennie, JJ.A., of the Federal Court of Appeal. The following judgment of the Court of Appeal was delivered orally by Near, J.A., on April 15, 2015.