Pharmacapsules @ Gowlings: November 24, 2010

Edited by Jennifer Wilkie and Isabel Raasch

Contents

Health Canada Releases 2009 Statistical Report On The Administration Of The Patented Medicines (Notice Of Compliance) Regulations Canada's Venture Capital Market: An Update Results of International Report On Access to Medicines Released U.S. Government Now Anti-Gene Patents? Recent Cases Upcoming Trials and Appeals of Interest Recent Resources of Interest on the Gowlings Website: Health Canada Releases 2009 Statistical Report On The Administration Of The Patented Medicines (Notice Of Compliance) Regulations By Isabel Raasch

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: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/docs/patmedbrev/patmrep_mbrevrap_2009-eng.php

Canada's Venture Capital Market: An Update By Michael Herman

The global venture capital (VC) market has been in turmoil since 2008's financial crisis. When capital markets seized up, investment activity dropped significantly and only recently has shown meaningful signs of recovery. Fundraising is challenging as limited partners have reduced or eliminated their commitments to VC. Many knowledgeable observers believe that the global venture capital market is undergoing a fundamental structural change involving a major consolidation in the number of funds and an increase in focus on investments in Asia and other emerging markets.

In Canada, the VC market was in big trouble before the financial crisis and was devastated by 2008's events. VC investment had been dropping for a number of years prior to the economic downturn; the market had never fully recovered from the technology bust in 2001, funds had difficulty attracting institutional investment, retail investment through labour sponsored funds was being phased out in many provinces, including Ontario, and returns to investors were tepid at best. By 2008, investment had fallen to levels not seen in 15 years.

Against this backdrop, venture capital market activity has shown improvement over the past 12 months. The U.S. market has stabilized, with biotechnology a major focus of investment activity. According to Mark Hessen, President of the National Venture Capital Association, "the established software and life sciences sectors continue to benefit from a steady commitment of venture capital dollars being put to work within meaningful pockets of innovation" (emphasis added) (National Venture Capital Association, October 15, 2010 press release).

The Canadian market has recently exhibited a slight, but nonetheless positive, increase in activity. In the third quarter of 2010, investment increased 20% compared to the same period in 2009...