The Therapeutic Products Directorate recently issued its report on the administration of the Patented Medicines (Notice of Compliance) Regulations for 2009.

With respect to the Patent Register, the report shows an increase in the number of patent lists added to the Patent Register as well in the number of patents not previously listed, which went up from 68 in 2008 to 89 in 2009. The report further indicates that the vast majority of products (by DIN and by medicinal ingredient) have only 1 or 2 patents listed on the Patent Register against them.

With respect to enforcement proceedings under the Regulations, the report shows that although the number of submissions received has increased from previous years, the number of Notices of Allegation received has decreased. Of the Prohibitions Applications commenced in 2009, 24 were discontinued, 1 was granted, 1 was dismissed, and 38 are pending resolution. Of the Prohibitions Applications commended in 2008, 36 were discontinued, 7 were granted, 3 were dismissed and 27 are resolution. The data for Prohibition Applications commenced in 2007 (which has no applications pending resolution) shows that the average resolution time was 19.1 months.

With respect to the Register of Innovative Drugs, the report indicates that a total of 21 such drugs (for use in humans) were added to the Register in 2009.

The full report can be viewed at: