Licensing Early-Stage AcademicLicensing Early-Stage AcademicTechnologies to the Pharmaceutical Industry:Technologies to the Pharmaceutical Industry:

Some Dos and Don’ts to Improve SuccessSome 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, CaliforniaMarch 2, 2002

ScenariosScenarios

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

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Question to IndustryQuestion 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?

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ResponseResponse

• 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”

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Non-Confidential DisclosureNon-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

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Understanding the TechnologyUnderstanding 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

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Misrepresenting the TechnologyMisrepresenting 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

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Understanding PatentsUnderstanding 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!

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Confidentiality AgreementsConfidentiality 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

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Material Transfer AgreementsMaterial 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

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