As we previously reported, Viiv's application against Teva for a prohibition Order regarding a combination product containing abacavir and lamivudine, Viiv's KIVEXA, was dismissed by a prothonotary 2014 FC 328, which decision was upheld on appeal 2014 FC 893. The patent explicitly claimed only abacavir, and contained no claim for the combination of abacavir and lamivudine. Citing the Federal Court of Appeal's decision in Gilead Sciences Canada v Minister of Health, 2012 FCA 254 ("Gilead"), the Prothonotary held that "the medicinal ingredient or formulation approved in the NOC [notice of compliance] must 'match up' and be claimed in the patent sought to be listed." As the patent claimed only one of the active ingredients, she held it was not eligible for listing. Viiv's further appeal to the Federal Court of Appeal was dismissed on April 15, 2015: ViiV Healthcare ULC v Teva Canada Limited, 2015 FCA 93, finding the Federal Court correctly concluded that Gilead applies to the facts of the case.
In short order, on May 2, 2015, proposed Regulations Amending the Patented Medicines (Notice of Compliance) Regulations (Bilingual PDF) were published to clarify the intent of the Governor in Council. The deadline for comments is June 1, 2015.
The Regulatory Impact Analysis Statement (RIAS) indicates that the two recent decisions [Gilead and Viiv] have "reinterpreted" the eligibility requirements in a manner that conflicts with the intent of the Governor in Council, such that "numerous drugs are at risk of losing patent protection under the Regulations." The purpose of the amendments is therefore to "provide rules for the interpretation of the eligibility requirements for listing patents on the patent register in respect of combination drugs in a manner that is consistent with the purpose of the PM(NOC) Regulations and the authority under which they are made."
The proposed amendments, the text of which is set out in the paragraphs following, would indicate there need not be strict matching between patent claims and the approved drug/indication as follows:
- "claim for the medicinal ingredient" - additional medicinal ingredients in approved drug permissible;
- "claim for the formulation" (need not specify non-medicinal ingredients) - additional non-medicinal ingredients in approved drug permissible; and
- "claim for the use of the medicinal ingredient" – additional medicinal ingredients, additional uses, use in combination with another drug, permissible.
The specific language of the proposed amendments would have the following rules apply when determining eligibility under s. 4(2) (listing against a new drug submission):
"claim for the medicinal ingredient" (s. 4(2.1)(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;"
"claim for the formulation" (s. 4(2)(b), 2(1), 2(2))
"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;"
Additionally, the definition section would amend "claim for the formulation" to "means 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 add:
"For the purposes of the definition "claim for the formulation" in subsection (1), the claim for the formulation need not specify the non-medicinal ingredients contained in the drug".
"claim for the use of the medicinal ingredient" (s. 4(2)(d))
"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
- the submission includes additional medicinal ingredients,
- the submission includes other additional uses of the medicinal ingredient, or
- the use that is included in the submission requires the use of the medicinal ingredient in combination with another drug."
Patents deleted; patents refused listing – 30 day resubmission deadline (s. 3.2)
If the Minister deleted a patent from the Register or refused to add a patent to the Register between October 18, 2014 and the day the amendments come into force on the basis of Viiv Health Care ULC v Teva Canada Limited, 2014 FC 893, the first person may resubmit the patent list for addition to the Register within 30 days after the date on which the amendments come into force. However, the RIAS indicates "the frozen register rule ... will apply, so a second person filing a submission for an NOC ... will not be required to address a patent added to the register in accordance with [this section] after the filing date of the second person's submission for an NOC."
Patents subject of pending proceedings subject to amendments (s. 5 of Amending Regulations)
The Court shall consider any ongoing application under the Regulations or any ongoing motion under s. 6(5)(a) (summary dismissal on the basis of ineligibility) of the Regulations initiated between May 2, 2015 and the day the amendments come into force having regard to amended sections 2 and 4.
Coming into force
The amendments will come into force on the date on which they are registered, which date is currently unknown. Prior clarifying amendments pre-published on April 26, 2008 came into force on June 12, 2008 (SOR/2008-211). As noted above, relevant patent lists must be re-submitted within 30 days after registration of the amendments.
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