Health Canada is considering revising the Patented Medicines (Notice of Compliance) Regulations ("PM(NOC) Regulations") Guidance Document with respect to whether administrative drug submissions submitted by a generic manufacturer pursuant to a licensing agreement will trigger section 5 of the PM(NOC) Regulations requiring the party to address the patents listed on the Patent Register against the innovator drug.
The proposed revisions provide Health Canada's stance on the application of the PM(NOC) Regulations to administrative drug submissions submitted pursuant to a licensing agreement between two generic drug manufacturers. Under Health Canada's drug review process, when a manufacturer of a currently marketed drug licenses another manufacturer to sell an identical drug in Canada under a different name, the licensee is required to file an administrative drug submission and such a submission must be crossreferenced to the licensor's drug submission. Previously, generic drug manufacturers who submitted administrative drug submissions pursuant to a licensing agreement with another generic drug manufacturer triggered the application of section 5 of the PM(NOC) Regulations and were, therefore, required to address the patents listed on the Patent Register against the innovator drug.
Health Canada is now proposing that only the originating generic drug submission (i.e. the licensor's drug submission which originally relies on the innovator drug) trigger the application of section 5 of the PM(NOC) Regulations. According to Health Canada, requiring a licensee, who seeks approval to sell an identical drug in Canada as that of a licensor (which had its drug approved on the basis of a comparison to an innovator drug) under a different name, to re-address patents already addressed by the licensor in its submission creates redundancy and is not specifically required under section 5 of the PM(NOC) Regulations. Therefore, such a licensee cannot, in Health Canada's view, make allegations under paragraph 5(1)(b) of the PM(NOC) Regulations and an NOC will be issuable in respect of its administrative drug submission after the requirement of the Food and Drug Regulations have been met and after the licensor's drug submission receives its NOC.
With respect to the date on which the Patent Register is frozen, the proposed Guidance Document clarifies that the appropriate filing date to consider is the licensor's drug submission filing date. However, licensors and licensees seeking approval of a supplemental drug submission for a change in formulation, a change in dosage form, or a change in use of the medicinal ingredient for which a comparison to an innovator's drug is made (and for which patents are listed on the Patent Register), must address each patent on the Patent Register in respect of the innovator's drug listed prior to the date of filing of the respective supplement, in accordance with subsection 5(2) of the PM(NOC) Regulations.
Health Canada has provided a 60 day commenting period which ends on October 17, 2011.
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