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Compound patent is not listable against fixed dose combination – Federal Court of Appeal

On April 15, 2015, the Federal Court of Appeal dismissed ViiV’s appeal of the Judgment of Justice Hughes that had held that Canadian Patent No. 2,289,753 claiming abacavir hemisulfate per se is not eligible to be listed on the Patent Register against KIVEXA, ViiV’s fixed dose combination of abacavir and lamivudine. For more information on Justice Hughes’ and Prothonotary Milczynski’s reasons below, see our previous posts here and here.

The issue in the appeal was the proper interpretation of paragraph 4(2)(a) of the PM(NOC) Regulations, which provides:

4. (2) A patent on a patent list in relation to a new drug submission is eligible to be added to the register if the patent contains

(a) a claim for the medicinal ingredient and the medicinal ingredient has been approved through the issuance of a notice of compliance in respect of the submission;

The Court of Appeal held that there was no reason to depart from the interpretation of paragraph 4(2)(a) set out in its previous decision in Gilead (see our previous post here). The Court of Appeal held that product specificity sets an exacting standard and that a patent must explicitly claim all of the medicinal ingredients contained in the approved drug in order to be eligible to be listed:

[15] In our view, both the Prothonotary and the Federal Court judge correctly concluded that Gilead applies to the facts of this case. In Gilead, this Court found that paragraph 4(2)(a) of the Regulations sets an exacting threshold of specificity between what is claimed in the patent and what has been approved in the NOC – 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.

The impact of this decision on the broader pharmaceutical industry remains to be seen as Industry Canada has disclosed its intention to amend the PM(NOC) Regulations to clarify the listing requirements as they relate to single medicinal ingredients found in combination drugs (see our previous post here). While the proposed amendments are expected to be pre-published in Part I of the Canada Gazette for stakeholder comments sometime in 2015, the text of the proposed amendments has yet to be made public.

A copy of the Court of Appeal’s Reasons for Judgment may be found here.

Teva was represented by Aitken Klee LLP.