Amendments to the PM(NOC) Regulations relating to the listing of patents against combination drugs have been made. The amending regulations, substantially in the form published in May, were registered last week and will be formally published on July 1st in the Canada Gazette.
The regulations (see PDF) include the addition of a new section 4(2.1) to the Regulations as reproduced below, changes to the definition of “claim for the formulation”, a new section 2(2), a new section 3.2 and transitional provisions.
As noted in my blog post from May, the amendments address the recent decisions of Gilead Sciences Canada Inc. v. The Minister of Health and The Attorney General of Canada 2012 FCA 254 and ViiV Healthcare ULC v. Teva Canada Limited, 2015 FCA 93 which denied the listing of certain patents on the basis that the patents “lack strict product specificity with regards to the three medicinal ingredients listed in the NDS”.
One of the new sections to be added to the Regulations states:
(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 non-medicinal 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.