and
Beverley Moore
Other Industry News
Health Canada has published proposed revisions to the Guidance Document: Patented Medicines (Notice
of Compliance) Regulations. According to the proposed
revisions, "only the originating NDS or originating ANDS (i.e.
the licensor's drug submission) which directly or indirectly
compares the drug with, or makes reference to, another drug
marketed in Canada under an NOC issued to a first person, triggers
the application of section 5 of the PM(NOC) Regulations
and as such, the licensor must address any patents listed on the
Patent Register in respect of the innovative product. However,
subsequently filed administrative drug submissions that
cross-reference the licensor's drug submission pursuant to a
licensing agreement will not re-trigger section 5 of the
PM(NOC) Regulations." Comments are to be provided to
Health Canada within 60 days from the date of the notice, August
17, 2011.
The Therapeutic Products Directorate published its Moving Forward Strategic Plan 2010-2014.
The Supreme Court will publish the results of three applications
for leave to appeal relating to proceedings under the PM(NOC)
Regulations (Cobalt v. Lundbeck [34066], Apotex v. Lundbeck
[34067] , and Mylan v. Lundbeck [34068]). The Federal Court of Appeal upheld Prohibition
Orders granted by the Trial Judge; considering issues relating to
selection patents, anticipation, obviousness, sound prediction,
sufficiency and procedural fairness. Our summary of the FCA
decision is found here.
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