On July 1, 2015, the Federal government published amendments to the Patented Medicines (Notice of Compliance) Regulations. The amendments, effective as of June 19, 2015, are in response to two Court decisions applying a strict product specificity requirement to fixed dose combination products and paragraph 4(2)(a) of the Regulations. In the first, the Federal Court of Appeal held that a patent specifically claiming only two of the three of medicinal ingredients approved in Gileads’ COMPLERA® product was not eligible to be listed (see here). In the second, the Court of Appeal held that a patent claiming only one-of-two medicinal ingredients in ViiV’s KIVEXA® product was ineligible to be listed against this product (see our previous post here).
The registered amendments largely follow those that were pre-published in part I of the Canada Gazette on May 2, 2015 (see our previous post here). Newly added paragraph 4(2.1)(a) sets out that a patent containing a claim for a medicinal ingredient is eligible to be listed even if the approved product contains, in addition to the claimed medicinal ingredient, other medicinal ingredients. Paragraph 4(2.1)(b) provides that a claim to a formulation will be eligible to be listed under paragraph 4(2)(b) if the submission contains non-medicinal ingredients specified in the claim, if any are specified, even if the submission contains other non-medicinal ingredients. New paragraph 4(2.1)(c) provides that a claim for the use of the medicinal ingredient is eligible if the submission includes the use claimed in the patent, even if the submission includes additional medicinal ingredients, additional uses of the medicinal ingredient or the use included in the submission requires the use of the medicinal ingredient in combination with another drug.
The Regulatory Impact Analysis Statement accompanying the amendments briefly summarizes and responds to the stakeholder comments made during the 30 day consultation period following the prepublication of the proposed amendments. While several submissions sought to address other issues with the Regulations generally, the RIAS states:
Other matters relating to the application of the PM(NOC) Regulations may deserve further examination, but are beyond the scope of the amendments made at this time.
The new product specificity requirements will apply to any prohibition application or ongoing 6(5)(a) motion commenced on or after May 2, 2015.
A copy of the amendments, published in the Canada Gazette Part II on July 1, 2015, may be found here.