ViiV Healthcare ULC et al. v. Teva Canada limited et al.; ViiV Healthcare ULC et al. v. Apotex Inc. et al., 2015 FCA 93
April 15, 2015
Kierans P., Pontrelli L., Guerreiro C.A., Daniele D. for ViiV Healthcare ULC et al.
Aitken D.W., Beeser S.A. for Teva Canada Limited.
Hackett B., Mazzola J. for Apotex Inc.
Peterson E. for the Minister of Health
This decision is an appeal of 2014 FC 893 (which itself was an appeal of 2014 FC 328), and concerns the eligibility for listing of Canadian patent number 2,289,753 (the “’753 Patent”) against Kivexa, a drug marketed by the ViiV Healthcare ULC et al. (the “Appellants”) under paragraph 4(2)(a) of the PM (NOC) Regulations Regulations.
Kivexa is an anti-retroviral fixed-dose combination drug that contains two medicinal ingredients: abacavir hemisulfate and lamivudine. The ‘753 Patent relates to a novel salt of abacavir and explicitly claimed abacavir hemisulfate in claim 2. The Minister added the ‘753 Patent to the register against Kivexa in February 2007.
In response to prohibition applications brought by the Appellants against Teva and Apotex, both Teva and Apotex brought motions under the PM (NOC) Regulations arguing that the ‘753 Patent was not eligible for listing against Kivexa. The Prothonotary in 2014 FC 328 allowed Teva and Apotex’s motions, reasoning that the ‘753 Patent did not have the requisite degree of product specificity required to be listed against Kivexa (see Gilead Sciences, 2012 FCA 254). The FC Judge in 2014 FC 893 upheld the Prothonotary’s decision, concluding that “[a] patent claim for only one medicinal ingredient cannot support a listing under the NOC Regulations where the underlying NOC is for a combination (synergistic or otherwise) of two or more medicinal ingredients”.
In this decision, the Court of Appeal concluded that both the Prothonotary and the FC Judge were correct in applying the Gilead case to the facts of this case. In essence, a patent that does not explicitly claim all of the medicinal ingredients contained in the drug for which the NOC was issued cannot be listed against that drug.
Both appeals are dismissed with costs fixed in the amount of $5000 to Teva and $2500 to Apotex.
By: Pablo Tseng, Gowling Lafleur Henderson LLP