Abacavir Patent Not Listable Against Fixed Dose Combination Products

On September 18, 2014, Justice Hughes of the Federal Court of Canada dismissed three appeals of Orders of Prothonotary Milczynski that Canadian Patent No. 2,289,753 is ineligible to be listed against ViiV’s KIVEXA and TRIZIVIR fixed dose combination products. For more details on the Prothonotary’s Order in the Teva matter, see our previous post here.

There were three motions before Justice Hughes, one each by Teva and Apotex in respect ViiV’s KIVEXA product containing a fixed dose combination of abacavir sulfate and lamivudine and one by Apotex in respect of ViiV’s TRIZIVIR product, containing abacavir sulfate, lamivudine and zidovudine.

In his reasons, Justice Hughes provides a concise summary of the evolution of patent listing jurisprudence, including the leading decision of the Federal Court of Appeal in Gilead. Justice Hughes rejected ViiV’s policy arguments that the decision below would discourage innovation and that 2006 amendments to the NOC Regulations should not apply to fixed-dose combinations, holding:

[66] In light of the foregoing, I agree with Teva that adopting ViiV’s interpretation of the NOC Regulations would constitute an effective rewriting of those NOC Regulations in order to create what ViiV perceives as a fair and proper balance between the interests of brand and generic manufacturers. As I indicated before, such an act of supplanting the government’s attempt to maintain this balance for a balance preferred by the Court would be a political decision, not a judicial decision and would constitute an unjustified overstepping of this Court’s bounds outside the jurisprudential sphere and into the political sphere of policy-making (Ontario v Criminal Lawyers’ Association of Ontario, 2013 SCC 43 at paras 27-30, [2013] 3 SCR 3).

Justice Hughes also rejected ViiV’s submission that the Federal Court of Appeal’s holding in Gilead that that the same legislative requirement applies to all paragraphs of subsection 4(2) of the NOC Regulations was obiter concluding:

[77] Gilead is amply clear; a high threshold of specificity between what is claimed in the patent and the NOC is required. A patent claiming only one medicinal ingredient cannot be listed in respect of an NOC containing two or more medicinal ingredients.

As the judgment would have terminated the two Apotex prohibition applicatons, Justice Hughes stayed the effect of his judgment for 30 days to permit ViiV to file an appeal. Justice Hughes also awarded Teva $10,000 in costs.

Teva was represented by Aitken Klee LLP.

A copy of the judgment may be found here.