Licensing Early-Stage Academic Technologies to the Pharmaceutical Industry: Some Dos and Don’ts to Improve Success Gerald J. Siuta, Ph.D. President Siuta Consulting, Inc. Workshop Presented at the Annual Meeting of the Association of University Technology Managers San Diego, California March 2, 2002

Scenarios 1. Company seeks to learn more about a specific technology or the research of a particular scientist 2. Company makes a general inquiry seeking to learn about any technologies or research programs within certain therapeutic areas Siuta Consulting, Inc.

Question to Industry Based on these two scenarios, what are some of the problems that you have encountered in your dealings with academic technology transfer offices? Siuta Consulting, Inc.

Response Be sure to respond – And respond promptly And most importantly, respond properly – Don’t just send technology lists – Don’t refer me to your web site – Don’t just send publications – Provide answers to questions on a technology Don’t just “let me speak to the inventor” Siuta Consulting, Inc.

Non-Confidential Disclosure What exactly do you have to license? What is the technology? – What does it do? – What disease will it treat? – What does it help to discover? What is the patent situation? – What is claimed and where has it been filed? Provide data, data and more data Forget market size Siuta Consulting, Inc.

Understanding the Technology What is the technology? – How will it be used? – What is its potential value to industry? Is there a potential product? – Is there a market for such a product? – What are the competitive products? – Time and cost to develop the product Siuta Consulting, Inc.

Misrepresenting the Technology Misuse of descriptive words and phrases – “Novel therapeutic agent” implies that a new chemical entity has been discovered – Using “new treatment” instead of “new use” A newly discovered use for an old compound or a marketed drug is not a “new treatment” Overstatement of significance Overestimating the value Siuta Consulting, Inc.

Understanding Patents What is specifically claimed? – Know the difference between composition of matter, method of treatment and use claims Has a patent search been done? – Is there evidence that a patent will issue? Can you practice the invention? – Are there any dominating patents? Just because a patent issues, doesn’t mean it is viable! Siuta Consulting, Inc.

Confidentiality Agreements Try to avoid until absolutely necessary – Companies don’t want to sign until after the specific technology is found to be of interest not to determine if it is of interest Add an additional burden – Corporate attorneys must approve for signature – Require monitoring for term of the Agreement – May jeopardize company’s in-house research Siuta Consulting, Inc.

Material Transfer Agreements Receive a summary of all testing results Be able to use results in further licensing efforts Agree not to publish without written approval Be willing to provide samples without disclosing the chemical structures – Confidentiality Agreement not required – Use compound number designations Have all unused material returned to the inventor Siuta Consulting, Inc.