Health Canada recently released proposed revisions to its
Patented Medicines (Notice of Compliance) Regulations
guidance document that, if implemented, will exclude certain
administrative drug submissions (e.g., where a licensee
cross-references a licensor's drug submission) from the scope
of section 5 of the PM(NOC) Regulations. Section 5 of the
Regulations sets out requirements that a second person
(typically a generic manufacturer) must comply with in submissions
seeking a NOC for a drug that references another drug marketed in
Canada by a first person (typically an innovator) and in respect of
which patents have been listed on the Patent Register.
Presently, drug manufacturers who submit administrative drug
submissions pursuant to a licensing agreement trigger section 5 of
the Regulations such that the licensee must address any
applicable listed patents upon filing its administrative drug
submission. Under the proposed revisions, only the originating NDS
or ANDS (i.e., the licensor's drug submission) will trigger
section 5 of the Regulations. Thus, while an
administrative drug submission that cross-references the
licensor's drug submission pursuant to a licensing agreement
will not re-trigger section 5 of the Regulations, a NOC
will not issue to the licensee until the licensor's drug
submission receives its NOC. If, however, a licensor or licensee
files a supplement to its respective submission (e.g., seeking a
NOC for a change in formulation, dosage form, or use of the
medicinal ingredient) that references a first person's drug,
the proposed amendment would require that any patents on the Patent
Register in respect of the first person's drug listed prior to
the date of filing of the supplement be addressed.
The exclusion of administrative drug submissions from the scope
of section 5 of the Regulations should decrease
administrative burden on licensees, as the need to re-address
patents already considered by the licensor in its submission is
likely redundant. In this regard, companies that develop private
label drug products based on licensed products may particularly
benefit from the proposed revisions.
Stakeholders have until October 17, 2011 to provide their
comments to Health Canada on the proposed changes.
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