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 , Apotex v. Lundbeck  , and Mylan v. Lundbeck ). 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.