After Court Rulings, Canada Proposes Changes to Combination Drug Requirements

Canada is looking to amend its Patented Medicines (Notice of Compliance) Regulations after two high-profile court rulings took a strict interpretation of the regulations that would make it more difficult to protect combination drugs under the regulations.

Background

In Canada, a notice of compliance is issued to a drug company when its product has been authorized. The requirements for a notice of compliance to be issued can be found in C.08.004 of the Food and Drugs Regulations.

The intent of the Patented Medicines (Notice of Compliance) Regulations is to list the patents associated with an authorized drug on the Patent Register, which provides protection from generic competition while the patents are active. Under Paragraph 4(2) of the Patented Medicines (Notice of Compliance) Regulations, for a patent to be placed on the Patent Register, it must contain:

(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;

(c) a claim for the dosage form and the dosage form has been approved through the issuance of a notice of compliance in respect of the submission; or

(d) a claim for the use of the medicinal ingredient, and the use has been approved through the issuance of a notice of compliance in respect of the submission.

Initially, authorities in Canada interpreted Paragraph 4(2)(a) broadly, allowing patents claiming one ingredient in a combination drug to be listed. However, two recent court rulings would challenge that practice, and ultimately take a stricter view of the requirements to be listed on the Patent Register.

Gilead Ruling

In the case of Gilead Sciences Canada Inc. v. Canada (Minister of Health), the minister refused to list one of Gilead's patents for its HIV drug Complera, which is a combination of three active ingredients: tenofovir, emtricitabine and rilpirivine.

The patent at the center of this case references tenofovir and emtricitabine, but does not specifically mention the rilpirivine. The patent does, however, state that the two mentioned ingredients should be combined with a third antiviral from one of several classes, including the class containing rilpirivine.

After losing the initial case at Canada's Federal Court, Gilead filed for appeal. In its appeal, Gilead pointed to Health Canada's Guidance Document: Patented Medicines (Notice of Compliance Regulations, which prior to 2015 allowed patents claiming only one active ingredient to be listed for combination drugs. The guidance states:

"However, a patent claiming, as a compound, a single medicinal ingredient will be eligible for listing with respect to a drug that contains the said medicinal ingredient in combination with other medicinal ingredients, notwithstanding that the medicinal ingredient on the NOC is the combination of medicinal ingredients."

Gilead also argued that the use of the phrase "in respect of" of Paragraph 4(2) allows for a broad interpretation of the regulation. However, the judge in Gilead's appeal disagreed, citing a change to the Patented Medicines (Notice of Compliance) Regulations in 2006, which did away with the requirement for patents to meet certain general criteria to be listed, and introduced a "more specific and detailed set of criteria."

The judge dismissed Gilead's argument that Health Canada's guidance document supported its case, as the guidance documents are not legally binding, and in this case are "inconsistent" with the regulations, which take precedence.

Viiv Healthcare Ruling

The second ruling was consolidated for two cases heard by the Federal Court, Viiv Healthcare ULC v. Teva Canada Limited and the Minister of Health and Viiv Healthcare ULC v. Apotex Inc and the Minister of Health. Both cases concern a patent held by Viiv for abacavir hemisulfate, which is one of two active ingredients in Viiv's antiretroviral combination drug Kivexa.

Initially, Viiv's patent was accepted for listing on the Patent Register by the Minister of Health, giving Kivexa protection against generic competition. However, both Teva and Apotex filed Abbreviated New Drug Submissions (ANDS) to market a generic competitor, using Kivexa as a reference product.

Viiv sought to defend its patent protection by commencing prohibition applications against Teva and Apotex; however, the two defendants filed claims that Viiv's patent "was not eligible for listing" under Paragraph 4(2)(a) of the regulations. Citing the Gilead case, the judge ruled against Viiv, upholding the narrow interpretation of Paragraph 4(2)(a).

While the minister of health is named as a defendant in the Viiv cases, the minister argued that the Gilead case "was wrongly decided," and informed the court that the Ministry intended to amend the Patented Medicines (Notice of Compliance) Regulations to circumvent the Gilead ruling.

The Proposed Amendment

Now, the Department of Industry is proposing an amendment to the Patented Medicines (Notice of Compliance) Regulations that would undo the court's strict interpretation of Paragraph 4(2)(a).

While Viiv is in the process of appealing the decision in its case, Health Canada has been forced to follow the court's ruling. This has caused the agency to deny "some patents in reference to drugs with multiple medicinal ingredients, as well as to reconsider the listing of some patents already on the register in reference to such combination drugs."

The proposed amendment would add several clauses following Paragraph 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 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.

Additionally, the proposed amendment provides recourse to companies whose patents were deleted or refused from the Patent Registry as a result of the Viiv ruling by allowing them to resubmit their patent list for consideration by the minister of health.

Canada Gazette