Following a pair of decisions in the Federal Court and Federal Court of Appeal, namely Gilead Sciences Canada v Minister of Health, 2012 FCA 254, and ViiV Healthcare ULC v Teva Canada Limited, 2014 FC 893, aff’d 2015 FCA 93, Industry Canada announced in December of 2014 that it would make amendments to the PM(NOC) Regulations to clarify the patent listing requirements as they relate to single medicinal ingredients found in combination drugs. On May 2, 2015, the proposed amendments were published in the Canada Gazette.
The amendments propose adding a new subsection to clarify the provisions that were at issue in Gilead and ViiV, particularly paragraphs 4(2)(a) and 4(2)(b) of the Regulations. The publication in the Canada Gazette states that these two decisions reinterpreted the PM(NOC) Regulations regarding the eligibility for listing on the patent register of patents claiming one or more medicinal ingredients “in a manner that conflicts with the intent of the Governor in Council in making the Regulations” and is contrary to long-standing practices of Health Canada.
The problematic holding in Gilead, which was subsequently followed in ViiV, was that “[a] patent claim for only one medicinal ingredient cannot support a listing under the NOC Regulations where the underlying NOC is for a combination (synergistic or otherwise) of two or more medicinal ingredients.” [89, ViiV] In particular, in Gilead, “the relevant claims in the ‘475 Patent do not meet the requirements of paragraphs 4(2)(a) as they lack strict product specificity with regards to the three medicinal ingredients listed in the NDS.” [3, Gilead]
Paragraphs 4(2)(a) and 4(2)(b), which were interpreted in Gilead to include a strict product specificity requirement, read:
(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;
(b) a claim for the formulation that contains the medicinal ingredient and the formulation has been approved through the issuance of a notice of compliance in respect of the submission;
The proposed amendments seek to dispose of the strict product specificity requirement and reinforce Health Canada practices by adding subsection 4(2.1) immediately following subjection 4(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.
The amendments would also change the definition of “claim for the formulation” (relevant to paragraph 4(2)(b) to mean “a claim for a mixture that is composed of medicinal and non-medicinal ingredients, that is contained in a drug and that is administered to a patient in a particular dosage form”, and would specify that the claim for the formulation need not specify the non-medicinal ingredients contained in the drug.
The proposed changes also allow for any patent which was deleted from the register or refused listing on the register after October 18, 2014, on the basis of the decision in ViiV, to be resubmitted within 30 days of the proposed amendments coming into force. An example of a case which may fall into this category, and which revisits the issues discussed here in the context of paragraph 4(2)(b) of the Regulations, is Eli Lilly Canada v Canada (Attorney General), 2014 FC 152, summarized here.
For new proceedings commended under section 6 of the Regulations, the Court will be required to consider the provisions as amended.