Federal Court Considers Patent Listing For Combination Drug Products

The Federal Court recently upheld two rulings of a prothonotary, both regarding listing of patents on the Patent Register under the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) against drug products with multiple medicinal ingredients.1 In his ruling, Justice Hughes applied the "product specificity" test for listing patents under the PM(NOC) Regulations. This ruling runs contrary to the current practice and guidance issued by Health Canada. This Federal Court decision is being appealed to the Federal Court of Appeal.

Background

Two generic pharmaceutical manufacturers, Teva Canada Limited (Teva) and Apotex Inc. (Apotex), were involved in PM(NOC) proceedings against ViiV Healthcare ULC (ViiV) relating to two ViiV products: KIVEXA and TRIZIVIR.

The two ViiV products at issue in the appeals are fixed-dose combination products for the treatment of HIV/AIDS. KIVEXA is a co-formulated tablet with two active ingredients, abacavir hemisulfate and lamivudine, while TRIZIVIR is a co-formulated tablet with three active ingredients, abacavir hemisulfate, lamivudine, and zidovudine. ViiV had listed Canadian patent 2,289,753 (the '753 patent) on the Patent Register against both KIVEXA and TRIZIVIR.

The '753 patent contained two claims that were important in the appeal. First, the '753 patent claimed abacavir hemisulfate, in what ViiV characterized as a classic "compound" claim. Second, the '753 patent claimed a combination of abacavir hemisulfate together with one or more medicinal ingredients taken from a class. The patent description named both lamivudine and zidovudine as class members. There was no claim in the '753 patent specifically directed to the two- or three-ingredient combination contained in KIVEXA and TRIZIVIR.

Under section 4(2) of the PM(NOC) Regulations, a patent may be listed for a drug product if it contains a claim to either (a) the medicinal ingredient, (b) the formulation, (c) the dosage form, or (d) the use of a medicinal ingredient, as found in an approved regulatory submission related to that drug product. (In Canada, a regulatory submission is approved by means of a "notice of compliance" or NOC.) ViiV submitted that the '753 patent could be listed against the regulatory submission directed to both the medicinal ingredient and the formulation for KIVEXA and TRIZIVIR, whereas the Minister of Health submitted that the '753 patent could be listed against the regulatory submission for the medicinal...