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PMNOC Regulations amendments re: listing claim for single medicinal ingredient against fixed-dose combination now registered
by Nancy Pei
As we previously reported, on May 2, 2015, proposed Regulations Amending the Patented Medicines (Notice of Compliance) Regulations (Bilingual PDF) were published for comment. The final amendments were registered on June 19, 2015 and therefore came into force on that date. They will be published on July 1, 2015, together with a Regulatory Impact Analysis Statement.
The amendments as registered are identical to those proposed, with the minor exception that "the day on which this section is published in the Canada Gazette, Part I" in section 5 was replaced with the actual pre-publication date, "May 2, 2015." Please therefore refer to our previous article for a summary of the amendments, including that the amendments clarify that there need not be strict matching between patent claims and the approved drug/indication as follows:
- "claim for the medicinal ingredient" — additional medicinal ingredients in approved drug permissible;
- "claim for the formulation" (need not specify non-medicinal ingredients) — additional non-medicinal ingredients in approved drug permissible; and
- "claim for the use of the medicinal ingredient" — additional medicinal ingredients, additional uses, use in combination with another drug, permissible.
Importantly, if the Minister deleted a patent from the Register or refused to add a patent to the Register between October 18, 2014 and June 19, 2015 on the basis of Viiv Health Care ULC v Teva Canada Limited, 2014 FC 893, the first person may resubmit the patent list for addition to the Register within 30 days after the date on which the amendments come into force, i.e. by July 19, 2015. The Regulations only provide this one opportunity to resubmit.
If you have any questions regarding the foregoing, please contact a member of our Life Sciences — Regulatory and Compliance group.
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