The Federal Court of Appeal has affirmed the stringent product specificity requirements for listing a patent against a drug for purposes of the PM(NOC) Regulations in its recent decision in ViiV Healthcare ULC et al. v. Teva Canada Limited et al., 2015 FCA 93.

In this proceeding, Teva and Apotex brought motions under the PM(NOC) Regulations arguing that a patent listed against ViiV’s KIVEXA drug was not eligible for purposes of paragraph 4(2)(a) of the Regulations. KIVEXA is a combination drug that contains two medicinal ingredients. The patent at issue explicitly claims one of these ingredients.

Prothonotary Milczynski allowed both motions, holding that the patent did not have the degree of product specificity required to be listed against KIVEXA. The Federal Court dismissed the subsequent appeal, holding 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.”

The Federal Court of Appeal affirmed the lower court’s judgment, observing that:

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.

In dismissing the appeal, the Court also noted that although the Minister has indicated that she may amend the Regulations to address the stringent listing requirements imposed by the Courts, the possibility of amendment does not serve as a basis upon which the present case can be distinguished from the jurisprudence.