Industry Canada recently released its Forward Regulatory Plan 2014-2016, setting out the planned initiatives it expects to bring forward over the next two years. Amongst other initiatives, Industry Canada proposes to amend the patent listing requirements under the Patent Medicines (Notice of Compliance) Regulations for patents that claim single medicinal ingredients found in combination drugs.
By way of background, the PM(NOC) Regulations create a link between the patents that are listed on the Patent Register in relation to an innovative drug and the approval of generic versions of that drug. Innovative drug manufacturers may submit one or more patents for inclusion on the Patent Register in association with an approved drug, provided the patents satisfy the listing requirements set out in the PM(NOC) Regulations. If approval is sought for a generic drug through comparison to an innovative drug for which there are listed patents, the manufacturer seeking approval must accept that the approval will not issue until the listed patent has expired unless the manufacturer can show that the approval should issue immediately (e.g. by demonstrating that the patent would not be infringed or that the patent is invalid).
Health Canada has developed a guidance document for the application of the PM(NOC) Regulations. According to this guidance document, a patent claiming, as a compound, a single medicinal ingredient is eligible for listing with respect to a drug that contains that medicinal ingredient in combination with other medicinal ingredients. Recent decisions of the Federal Court, however, appear to have interpreted these requirements in a manner that is inconsistent with the practices of Health Canada.
In the Forward Regulatory Plan, Industry Canada has acknowledged that a strict interpretation of the recent court decisions would require Health Canada to alter its practice in respect of listing certain patents on the Patent Register. Accordingly, Industry Canada has stated that the purpose of the proposed amendments will be to confirm Health Canada's established practices in relation to the policy intent of the PM(NOC) Regulations and clarify the listing requirements for single medicinal ingredients found in combination drug products. This commentary suggests that the amendments will allow patents to be listed on the Patent Register even where those patents do not claim all of the medicinal ingredients present in a combination drug.
According to the Forward Regulatory Plan, interested stakeholders will be given the opportunity to comment when the proposed amendments are pre-published in the Canada Gazette, Part 1.