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1. Introduction  
2. Setting up Office and Research Space
2.1 What should I do before I get to UCSF?
2.2 What should I do once I arrive at UCSF?
2.3 What Research Support Services are available?
3. Obtaining Regulatory Committee Approvals
3.1 Making Sense of Regulations
3.2 What is Research Online
3.3 Working with Biologicals
3.4 Working with Chemicals
3.5 Working with Radioactive Materials
3.6 Working with Radioactive Materials in Humans
3.7 Working with Controlled Substances
3.8 Working with Animals
3.9 Involving Human Subjects in Research
3.10 Serving on Committees
3.11 Working with Affiliates
4. Finding, Obtaining, and Managing Money
4.1 Fiscal Responsibility
4.2 Pre-award: How do I find and ask for funds?
4.3 Post-award: How do I manage funding awards?
4.4 Working with Industry
4.5 Minimizing Financial Conflicts of Interest
4.6 Intellectual Property
5. Being Responsible
5.1 Ethical Conduct of Research
5.2 Authorship and Publication
5.3 Confidentiality and Privacy
5.4 Data Management: Research Records
5.5 Training in Responsible Conduct of Research
5.6 Guidelines for Lab Notebooks
6. Leaving or Transferring Funds/Specimens Out of UCSF
 
Appendices
I. UCSF Acronyms
II. UCSF Research Links
III. Whistleblower Policies & Procedures
 
School of Medicine Clinical and Translational Research

THE OFFICE OF RESEARCH

RESEARCH INVESTIGATOR HANDBOOK

4. FINDING, OBTAINING, AND MANAGING MONEY

4.6 Intellectual Property

• What is intellectual property?
• Whom do I contact?
• When should I disclose an invention to the OTM?
• What is a MTA (Material Transfer Agreement)?
• What MTA should I use and where do I submit it?
• What resources are available?
• Top Tips to Prevent Problems
• Relevant policies and procedures


What is intellectual property?

Intellectual property can be any one of the following:

•  An invention that is useful, novel, and non-obvious for which a patent might be sought,
•  An original work of authorship fixed in a medium for expression (including software),
•  A tangible material such as an organism, antibody or a computer disk with embedded data, or
•  Specific useful know-how.

Technologies that are conceived or first reduced to practice by UCSF employees are considered to be the property of The Regents of the University of California and thus assets of the State of California, which are managed by the Office of Technology Management (OTM). Employees who develop intellectual property in their capacity as UC employees, on their own time using their own resources, or as consultants to non-UC organizations must disclose this intellectual property to the OTM in a timely manner. The OTM is the means by which campus intellectual property, whether or not patentable, gets licensed to commercial developers for public use and benefit and new companies get founded based on those technologies.

Whom do I contact?

Contact the Office of Technology Management (OTM) and either phone or email any of the licensing staff. This office will work with you to determine the licensing opportunity your technology might afford and, as appropriate, to license the associated patent rights, copyrights, trademark rights, property rights in tangible materials, or know-how. The OTM's Director will review your technology and assign your technology to a Licensing Officer to manage the evaluation, marketing and licensing process. Should the OTM license the intellectual property rights to one or more third parties, any net license income is shared with the inventor(s) as personal income under the system wide UC Patent Policy. The OTM distributes license income once in the Fall for net income received during the prior fiscal year.

How do I start the process?

In all cases, the process begins when you develop technology that might have commercial value and you disclose your technology to the OTM for evaluation in fulfillment of your obligations as an employee under UC’s Patent Acknowledgement.

The OTM will review the merit of the invention from the standpoint of the business opportunity it affords UCSF and the competitive advantage it affords a prospective licensee. If the OTM determines the invention to be licensable, the OTM will obtain the appropriate type of intellectual property protection necessary to support its commercialization strategy. (See Working with OTM guidelines)

Inventions can be disclosed to the OTM on forms available from the OTM web page or by first contacting the OTM’s licensing staff.

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When should I contact the OTM?

Develop a relationship early in your career with the OTM and disclose inventions as soon as you have them in hand. Do not wait until you start writing a manuscript or start planning a public presentation!

If you disclose an invention to the OTM after it has been publicly disclosed, it will no longer be possible to obtain patent protection in most industrialized foreign countries which, depending on the nature of the invention, can diminish its value or make it unlicensable.

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What is an MTA?

Material Transfer Agreements (MTA) are the contractual instruments by which the university shares its proprietary research materials with other organizations for research purposes. The MTA serves the following purposes:

•  Identifies the specific material to be shipped,
•  Establishes the terms and conditions under which the materials can be used,
•  Protects the university’s rights in the materials, and
•  Protects the university from legal claims.

As a PI, you should ensure that your entire research team knows the importance of putting an MTA in place when sending research materials developed at UCSF. In addition to intellectual property benefits, the MTA can also help you to document that you have met the public disclosure conditions necessary to receive Federal funds.

For more information see: Material Transfer Agreements Quick Guide

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What MTA should I use and where do I submit it?


You will need to process the MTA in different ways depending on the type of proprietary material, whether it is being transferred out of UCSF or into UCSF, and the type of organization that is involved.

The Office of Technology Management (OTM) is responsible for outgoing transfers of all UCSF proprietary materials other than human clinical specimens. Investigators who want to send material to another university, government lab or research institute can use the Non-profit MTA letter agreement template found on the OTM's website. Investigators who want to send materials to a company should contact the OTM. The OTM will negotiate the MTA based on its For-Profit MTA template.

The Office of Sponsored Research (OSR) is responsible for all transfers of human clinical specimens both outgoing and incoming to UCSF. The OSR is also responsible for negotiating incoming MTAs for all other types of proprietary research materials from other organizations for use by UCSF investigators.

If you are using human biological specimens, you will be required to show documentation that you have the appropriate Committee on Human Research approval.

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What resources are available?

The primary resource available to you is the expertise of the Licensing Officers in the OTM. The OTM is your business partner for commercializing your technologies or helping to start your company. The OTM exists to promote the transfer of UCSF's life science and medical technologies for public use and benefit, while generating income to support campus research and education. To this end, the OTM:

•  Evaluates campus inventions as commercial assets and licensing opportunities
•  Develops and executes invention management strategies
•  Negotiates confidential disclosure agreements for campus intellectual property
•  Negotiates outgoing transfers of all UCSF proprietary research materials except human clinical specimens
•  Secures intellectual property protection for inventions as it deems appropriate
•  Markets inventions to commercial developers and investors
•  Negotiates and writes license agreements to facilitate the commercial development of campus technologies
•  Manages license agreements over their lifetime to insure licensee compliance
•  Forms new life science companies
• 
Strives to educate investigators about intellectual property management, technology transfer, partnering with industry, and company formation

Additional important resources are:

•  How to Keep a Laboratory Notebook for Patent Purposes
• 
OTM Guide to Intellectual Property Management

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Tips to Prevent Problems:

•  Contact the OTM as soon as you think you have an invention that might have commercial value.
•  Do not write a manuscript or apply to give a presentation before conferring with the OTM.

Use an MTA when transferring any of your materials to colleagues outside UCSF.

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Relevant policies and procedures:

•  OTM Frequently Asked Questions (FAQ)
•  About the OTM (Policies, Procedures, and Information)
•  UC Policies on Patents and Copyrights
• 
UC Office of Technology Transfer (excellent guidelines polices for faculty, industry)