Industry Canada has announced its intent to propose amendments to the Patented Medicines (Notice of Compliance) Regulations as part of its Forward Regulatory Plan 2014-2016 that would clarify the patent listing requirements as they relate to single medicinal ingredients found in combination drugs. The proposed amendments are said to confirm Health Canada’s established practices which, in light of recent Federal Court and Federal Court of Appeal decisions, may need to change.
The PM(NOC) Regulations provide for a listing of pharmaceutical patents on brand name drugs which must be complied with (or circumvented) by generic companies if they seek approval to market a generic version of the brand name drug. One facet of Health Canada’s established practice, as outlined in a guidance document, is in contention. The guidance document states that “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.” Two recent decisions bring this practice into question.
In ViiV Healthcare ULC v Teva Canada Limited, 2014 FC 893, the Federal Court relied on Gilead Sciences Canada v Minister of Health, 2012 FCA 254, for the proposition 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.” [89, ViiV] This proposition seems to run contrary to Health Canada’s established practice.
Interested stakeholders will have the opportunity to comment when the proposed amendments are pre-published in the Canada Gazette, Part 1. Timing is to be decided.