Genomics Research and Intellectual Property Genome Canada GPS Series April 28, 2011 Presented by: Jamie Mills

According to Honest Abe “The patent system … added the fuel of interest to the fire of genius” Abraham Lincoln

Patents are the Economic Foundation for the Entire Biotechnology Industry the level of national R&D investment has been linked to the strength of a nation’s patent laws biotech firms have massive upfront costs in drug development costs average of $1.2 Billion to bring a biologic to market 70% of products that make it to human trials fail up to 12 years to develop a product public or non-profit entities cannot bear these costs and risks need a mechanism to recoup that investment

Patents Drive Investment in Research small biotech companies need funding to keep researching – especially if no product on market yet need to pitch to investors patents are typically the only assets of significant value patents reassure investors they will earn a reasonable financial return on products that make it to market no data exclusivity to supplement patent rights in diagnostics sharing will not work – no mechanism to recoup investment trade secrets are the only viable alternative this will not advance science

Gene Patents are Not Patents on Humans isolated gene very different from human chromosome has been extracted and changed significantly isolation is not merely purification cannot function in the same way as chromosomes does not exist in nature isolated gene can be used for purposes the human chromosome cannot greatly add to our understanding of hereditary diseases useful as chemical reagents; research tools; diagnostic and biological probes; gene therapy; to manufacture vaccines, proteins and industrial enzymes; to improve food production, and more personalized medicine

Innovation Must be Encouraged by Patent Protection Oct – FDA acknowledged that we must address the growing threats to the strength of the biotechnology industry a strong patent system promotes: research-based advances in agriculture, medicine, diagnostics and therapeutics existing commerce and industry based on current investments and reliance upon issued patents investors mistakenly interpreted a statement by President Clinton and Prime Minister Blair as announcing an intent to restrict gene patents even though statement quickly clarified – biotech companies lost US $50 billion in aggregate shareholder value in 2 weeks NASDAQ had second steepest dive ever Canada cannot afford to fall behind

Thank you Jamie Mills –