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
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
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)
Health Canada has provided a 60 day commenting period which ends
on October 17, 2011.
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