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 ingredient only. Prothonotary Milczynski issued orders in the Teva and Apotex proceedings that the ‘753 patent could not be listed against regulatory submissions for the medicinal ingredient or formulation for KIVEXA or TRIZIVIR.²

The Ruling on Appeal

Justice Hughes upheld the orders of Prothonotary Milczynski, holding that the ‘753 patent was not listable against the regulatory submissions for KIVEXA or TRIZIVIR. In doing so, he relied on prior jurisprudence, which established a requirement for "product specificity" between the patent to be listed and the regulatory submission against which the listing was sought.

The "product specificity" jurisprudence

Justice Hughes canvassed earlier decisions by the Federal Court and Federal Court of Appeal, and summarized the jurisprudence relating to listing of patents on the Patent Register as follows:

• the product specificity requirements are the same across the listing categories under section 4(2) of the PM(NOC) Regulations (i.e., medicinal ingredient, formulation, dosage form and use);
   
• there must be "precise and specific matching between what the patent claims and the product/use/dosage forms for which the NOC has been granted" in order for the Minister to properly list the patent on the Patent Register;
   
• a claim for a formulation means a claim that includes both medicinal and non-medicinal ingredients, therefore a claim directed to medicinal ingredients only does not qualify for listing against a formulation under section 4(2)(b) of the PM(NOC) Regulations; and
   
• where a patent claims only one medicinal ingredient, it cannot be listed against a NOC obtained for two or more medicinal ingredients.³

The ‘753 patent is not listable

As to the first relevant claim in the ‘753 patent, Justice Hughes ruled that a patent claiming a single compound may not be listed against a combination product under section 4(2)(a) of the PM(NOC) Regulations. Such a patent did not claim the "medicinal ingredients." Justice Hughes held that each of the medicinal ingredients must be named in the claim in order for the patent to be listed. Justice Hughes also declined to allow listing on policy grounds, stating such policy considerations were better left for higher courts.

Justice Hughes also ruled that a "formulation" claim of one medicinal ingredient in combination with another selected from a class could not be listed against the formulation of a combination drug product, even if the second ingredient is listed as a class member in the patent description. Further, in order to be a proper "formulation" claim, the jurisprudence had established that the patent claim must include both medicinal and non-medicinal ingredients, and at minimum each medicinal ingredient must be named in the claim in order for the patent to be listed.

Conclusion

There is now a significant divergence between the rulings of the courts and the practices of the Minister of Health. Both of the ViiV decisions to date are explicitly contrary to both the PM(NOC) Guidance Document published by Health Canada and the practices of the Office of Patented Medicines and Liaison (OPML), the Health Canada office tasked with administration of the Patent Register. OPML’s current practice, as set out in guidance documents published by Health Canada, is to allow listing of patents claiming a single medicinal ingredient against combination products. Further, the Minister of Health represented that its current practice is to consider listing a patent claiming a combination of medicinal ingredients as a "formulation" listing, regardless of whether the patent claim includes non-medicinal ingredients. The Minister of Health made written and oral arguments in favour of patent listing in this case, to no effect on the Court’s decision.

Justice Hughes’ decision is under appeal. For the time being, it seems that the courts will strictly enforce the "product specificity" listing requirements for both "medicinal ingredient" and "formulation" patent listings.

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¹ Viiv Healthcare ULC v Teva Canada Limited, 2014 FC 893.

² Teva was the first to initiate PM(NOC) proceedings, and was the first to have a motion heard and decided, see Viiv Healthcare ULC v Teva Canada Limited, 2014 FC 328. With the consent of ViiV and the Minister of Health, Apotex subsequently made similar motions in two additional PM(NOC) proceedings before Prothonotary Milczynski, proceeding on identical evidence as in the Teva motion and resulting in identical orders. ViiV appealed each order made by Prothonotary Milczynski, and the appeals were consolidated in a single hearing before Justice Hughes on consent of all parties.

³ The summary was based on Abbott Laboratories Ltd v Canada (Attorney General), 2008 FCA 244; GD Searle & Co v Canada (Minister of Health), 2009 FCA 35; Bayer Inc v Canada (Minister of Health), 2009 FC 1171, aff’d 2010 FCA 161; Purdue Pharma Canada v Canada (Attorney General), 2011 FCA 132; and Gilead Sciences Canada Inc v Canada (Minister of Health), 2012 FCA 254.

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