Technology Transfer University of Colorado Denver Rick Silva, Ph.D., M.B.A. -- Director Senior Licensing Managers David Poticha, M.S., J.D. Paul Tabor, M.S., M.B.A. Matt Pink, Ph.D. Anschutz Medical Campus

Tech Transfer- Policy Possibly the most inspired piece of legislation to be enacted in America over the past half-century was the Bayh-Dole act of Together with amendments in 1984 and augmentation in 1986, this unlocked all the inventions and discoveries that had been made in laboratories throughout the United States with the help of taxpayers’ money. More than anything, this single policy measure helped to reverse America’s precipitous slide into industrial irrelevance. -The Economist, Dec 2002

Tech Transfer- Raison d'être Bayh-Dole signed into law in 1980 Federal research spending was not translating into benefits for the general public Established a property right for universities in inventions made through the use of federal grants Property rights made technology “ownable” thus opening the doors for private investment in technology- critical to the advent of biotech drugs But not every project, program or piece of research has commercial potential. Very few programs do.

4 INTELLECTUAL property is more than just a great thought and less than a completed product.

5 WHY IS I.P. IMPORTANT? Protects important assets from theft, exploitation or abuse, especially early assets developed at Universities Identifies contributions by the inventor to the field Secures monetary compensation for the University and the inventor Sometimes all a company has to leverage is it’s IP

Myths  All projects create IP  All research has patentable outcomes  All patents are commercially viable  Research results can be owned or leveraged for financial gain  The University must own IP from all research done at the U  Discoveries are patentable and inherently valuable  Filing IP = commercialization

Realities  Few projects create IP (less than 10% of all at CU)  Fewer projects have patentable outcomes (less than 10% that result in an invention disclosure)  Even fewer projects are commercially viable (less than 20% of patents are licensed)  Research results can be owned or leveraged for financial gain (less than 1% of all licenses create over $250,000 in royalty income)  Owning IP in a commerically uninteresting space is like owning land on the moon.  It is one to two decades from the discovery of a new disease mechanism to FDA approval of a drug leveraging that knowledge;  20 years for Zostavax, 16 years for Botox, 15 years for Kineret, 20 years and counting for Tarmogens  Filing a patent by itself will most certainly not result in a windfall or scientific fame.

8 CU Policy on IP “ Discoveries in which the University has an interest ” Assigns ownership of IP from inventors to the University “ Substantial Use of University Resources ” Addresses start-ups, consulting, distribution of revenues

Take Home Points Not all projects have intellectual property potential There is a scientific basis for making these determinations TTO is trained to identify all forms of intellectual property and can work with investigators and sponsors to quickly determine the possibility of commercializable intellectual property TTO is here as a service to the University at large and the offices within that deal with documents addressing intellectual property or research discovery related issues TTO has successfully collaborated with the University to commercialize a number of discoveries 9

Chicken Pox Vaccine

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13 Conduct a prior art search. Is the invention patentable? Yes No Is the invention commercially viable? Do we want to release rights? Yes No Prepare a Patent Justification and submit to director Conduct market research. Follow procedure to release rights. Yes Get cost estimate from patent attorney to file a provisional application. Patent administrator prepares engagement letter. Approved?

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