ViiV Healthcare ULC v Teva Canada Limited, 2015 FCA 93
The FCA confirmed that paragraph 4(2)(a) of the Patented Medicines (Notice of Compliance Regulations) requires that a patent listed on the register requires an “exacting threshold of specificity” between what is claimed in the patent and what has been approved in the Notice of Compliance (NOC). This decision affirms the previous ruling in Gilead Sciences Canada Inc v Canada (Health), 2012 FCA 254 [Gilead], where the FCA first made the controversial determination. As a result, in this case, ViiV Healthcare’s Canadian Patent No. 2,289,753, which claims only one of the two medicinal ingredients for which KIVEXA was approved in its NOC, [4-5] could not be listed against KIVEXA.  However, proposed amendments to the PM(NOC) Regulations would reverse this holding. A summary of the proposed amendments can be read here.
For reference, paragraph 4(2)(a) is reproduced below:
(2) A patent on a patent list in relation to a new drug submission is eligible to be added to the register if the patent contains
(a) a claim for the medicinal ingredient and the medicinal ingredient has been approved through the issuance of a notice of compliance in respect of the submission; … [PM(NOC) Regulations]
The Gilead decision was controversial because it ran contrary to established Health Canada practices. As a result of Gilead and the lower court’s decision in this case (2014 FC 893) Industry Canada announced in December 2014 that it would amend the PM(NOC) Regulations to confirm Health Canada’s practices.
On May 2, 2015, the proposed amendments were published in the Canada Gazette. The proposed amendments would dispose of the exact matching requirement by adding subsection 4(2.1) immediately following subjection 4(2):
(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.
Notably, the Minister of Health was also a party to this appeal and argued (unsuccessfully) alongside the appellants that Gilead was either distinguishable or wrongly decided.