Combination Drugs: Industry Canada to Amend the PM(NOC) Regulations

Industry Canada has announced that the Patent Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) will be amended; according to the federal government’s Forward Regulatory Plan 2015-2017, the changes will "address the exclusion of certain pharmaceutical patents from Health Canada’s Patent Register following recent Federal Court and Federal Court of Appeal decisions relating to patents claiming single medicinal ingredients found in combination drugs."¹

What You Need To Know

• If you are currently selling combination drug products in Canada (or plan on selling these products), Industry Canada’s proposed changes to the PM(NOC) Regulations will impact your strategy.
• Listing patents that are directed to single medicinal ingredients on Canada’s Orange Book against combination drug products containing the ingredient is no longer certain.
• The outcome of the Federal Court of Appeal decision in ViiV Healthcare ULC v Teva Canada Limited (ViiV) (see below) and Industry Canada’s proposed changes to the PM(NOC) Regulations will be highly relevant to listing patents directed to single medicinal ingredients against combination drug products.
• There will be an opportunity to comment on Industry Canada’s proposed changes to the PM(NOC) Regulations (expected to be published in Canada Gazette, Part I, in the spring of 2015).

The PM(NOC) Regulations link patents to Health Canada’s approval of a generic version of an innovative drug. Patents associated with an approved innovative drug may be listed on Health Canada’s Patent Register, provided they meet certain listing requirements contained in the PM(NOC) Regulations. If a manufacturer compares its generic version to an innovative drug, the manufacturer must address each patent listed on the Patent Register with respect to that innovative drug. The manufacturer must either accept that Health Canada will not issue marketing approval (in the form of a NOC) until the listed patents have expired, or must allege that the patent is not valid or no claim (for the medicinal ingredient, formulation, dosage form or use of the medicinal ingredient) would be infringed by the drug which is the subject of the regulatory submission. The manufacturer of the innovative drug then has an opportunity to apply to a court prohibiting the Minister of Health from issuing the NOC.

Health Canada’s "Guidance Document: Patented Medicines (Notice of Compliance) Regulations" provides Health Canada’s historical position on listing patents relating to single medicinal ingredients found in combination drugs on its Patent Register: "a patent claiming, as a compound, a single medicinal ingredient will be eligible for listing with respect to a drug that contains the said medicinal ingredient in combination with other medicinal ingredients, notwithstanding that the medicinal ingredient on the NOC is the combination of medicinal ingredients" (emphasis added).^{2 3}

The Guidance Document has been recently updated to provide that two Federal Court decisions have impacted the application of section 4 of the PM(NOC) Regulations with respect to combination drugs. These two court decisions are inconsistent with Health Canada’s position as stated in the guidance. In each of ViiV Healthcare ULC v Teva Canada Limited, 2014 FC 893 and Gilead Sciences Canada v Canada (Health), 2012 FCA 254, the Court ruled that in order for a patent to be listed against a combination drug, the PM(NOC) Regulations require that the patent claim the exact combination of medicinal ingredients (i.e., there must be precise and specific matching between the claim language and the product for which the NOC has been granted). An appeal of the ViiV decision will be heard on April 13, 2015.

Industry Canada’s proposed amendments will provide much-needed certainty to drug manufacturers. In the meantime, Health Canada has begun to refuse to list patents directed to single medicinal ingredients found in combination drugs on Health Canada’s Patent Register.

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¹ http://www.ic.gc.ca/eic/site/020.nsf/eng/h_00595.html#sp_5.

² http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/patmedbrev/pmreg3_mbreg3-eng.php.

³ Ibid. at section 3.2.1.