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Government publishes proposed amendments to patent listing requirements for combination drug products

On May 2, 2015, the federal government published proposed amendments to the Patented Medicines (Notice of Compliance) Regulations. As we previously blogged about here, the proposed amendments are in response to judicial interpretations involving the drugs COMPLERA (see our previous post here) and KIVEXA (see our previous post here) that have required a perfect match between the medicinal ingredients claimed in the patent and approved in the drug submission.

According to the Regulatory Impact Analysis Statement accompanying the proposed amendments, the COMPLERA and KIVEXA Courts’ interpretation of the patent listing requirement is inconsistent with the policy intent of the Regulations of allowing the listing of patents that claim one or more, but not all, of the medicinal ingredients contained in an approved combination drug. The proposed amendments introduce section 4(2.1) which provides the following rules for determining listing eligibility of patents against drugs containing more than one medicinal ingredient:

(2.1) The following rules apply when determining the eligibility of a patent to be added to the register under subsection (2):

(a) for the purposes of paragraph (2)(a), a patent that contains a claim for the medicinal ingredient is eligible even if the submission includes, in addition to the medicinal ingredient claimed in the patent, other medicinal ingredients;

(b) for the purposes of paragraph (2)(b), a patent that contains a claim for the formulation is eligible if the submission includes the non-medicinal ingredients specified in the claim, if any are specified, even if the submission contains any additional nonmedicinal ingredients; and

(c) for the purposes of paragraph (2)(d), a patent that contains a claim for the use of the medicinal ingredient is eligible if the submission includes the use claimed in the patent, even if

(i) the submission includes additional medicinal ingredients,

(ii) the submission includes other additional uses of the medicinal ingredient, or

(iii) the use that is included in the submission requires the use of the medicinal ingredient in combination with another drug.

The proposed amendments also provide an opportunity to list or relist patents that are ineligible under current jurisprudence. Any patent that the Minister of Health either refused to add or deleted from Patent Register between October 30, 2014 and the date the proposed amendments come into force on the basis of the Federal Court’s decision in KIVEXA may be added to the Register by  resubmitting a patent list for that patent within the 30 days following the registration of the amendments.

Interested persons have 30 days to provide representations in respect of the proposed amendments.

A copy of the proposed amendments and the accompanying RIAS  from the Canada Gazette  Part 1, published May 2, 2015, may be found here.

Aitken Klee LLP successfully represented Teva Canada Limited in the KIVEXA matter.