Monday, April 13, 2015

Affirmed that Perfect Match Required for Listing on Patent Register for Medicine as Well as Formulation

ViiV Healthcare ULC v Teva Canada Ltd 2015 FCA 93 Near J: Ryer, Rennie JJA aff’g 2014 FC 893 Hughes J (here) aff’g 2014 FC 328 Milczynski J (here)
            abacavir & lamivudine / KIVEXA / 2,289,753

In this decision the FCA affirmed that the “perfect match” requirement for listing of a patent on the Patent Register applies under all branches of the s 4(2)(a) of the NOC Regulations. That is, each medicinal ingredient must be explicitly named in a claim; it is not enough that the generic product would necessarily infringe the claim and it is not enough that all the ingredients are explicitly listed in the description.

This holding is not a surprise. I have argued that the perfect match requirement is not sound as a matter of policy, but, as discussed in my posts on the decisions under appeal (here and here) and as the FCA held [17], the case at hand is not distinguishable from the leading case, Gilead / COMPLERA 2012 FCA 254 (blogged here).

While the Minister argued in favour of the perfected match requirement in the cases in which the requirement was initially established, it argued against the requirement in this case. Industry Canada has recently indicated that the NOC Regulations will be amended to “confirm established Health Canada practices in relation to the policy intent of the NOC Regulations.” It sounds like this will reverse the rule in ViiV v Teva, but I doubt the amendments will be entirely satisfactory. As discussed here, the Minister's position is that a perfect match is required under para 4(2)(b), which applies to "a claim for the formulation that contains the medicinal ingredient," but not under para 4(2)(a), which applies to "a claim for the medicinal ingredient.” But as I explained in that earlier post, the perfect match requirement may result in pointless formalism even when applied solely under para 4(2)(b).

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