Government Funded Inventions

Mark L. Rohrbaugh, Ph.D., J.D.

Acting Director

Office of Technology Transfer

National Institutes of Health

Office of Technology Transfer

Evaluates, Protects, Markets, Licenses and Monitors the Use of Intellectual Property Generated by Intramural Scientists at NIH to Advance the Health of the Public.

Lead Agency for Technology Transfer at US Department of Health and Human Services (DHHS).

The Credo

• Funding for Basic Research

• Publication and Dissemination of Findings

• Access to Research Tools

• Appropriate Patenting

• Strategic Licensing

• Education of Scientists

Government Funded Inventions

• The Bayh-Dole Act governs

• University can retain title

• Government has residual rights

Goals of the Bayh-Dole Act

• Utilization

• Commercialization – economic activity

• Free competition and enterprise

• Public availability

• Prevent nonuse or unreasonable use

If University Elects Title

• University can patent and license

• University retains royalties

• Prohibition on assignment

If University Declines Title --Inventor Can Seek It

• University requests on behalf of inventor

• NIH grants/denies request

• If granted, inventor can patent, license, and

retain royalties

• Government has residual interests

What Are the Government’s Residual Rights?

• Utilization Reporting

• U.S. Manufacturing Requirement

• Government Use License

• March-in

Research Tools: A Special Category

Properties of Research Tools

• Useful lifecycle is generally short

• Does not require significant R&D

• Generally does not require IP incentive

to make/use

• Desire broad access and availability

Examples of Research Tools

• Animal Models

• Cell Lines

• Bulk DNA Sequences

• Drug Targets

• Clones/Cloning Tools

• Libraries

• Software

• Databases

• Lab Techniques

• Antibody Reagents

NIH Director’s Working Group on Research Tools

• Convened (1997)

• Members from academia, industry, not-for-profit

• Inquired into access problems encountered by

NIH-funded scientists

• Issued four recommendations (1998)

• Guidelines for NIH funding recipients

Principles and Guidelines

• Adopted after Public Comment

• Applicable to Funding Recipients

• Internal Practices will be Consistent

• Call for Other Institutions to Adopt

Principles for Recipients of NIH Funds

• Academic Freedom and Publication

• Appropriate Implementation of Bayh-Dole

• Dissemination of NIH-Funded Tools

• Minimize Impediments to the Research Enterprise

Guidelines for Implementing the Principles

• Importing tools into NIH-funded research

• Disseminating tools developed with NIH funds

• Uniform one-page MTA proposed

• Strategic licensing to achieve balance

Guidelines for Implementing the Principles

Importing Tools Into NIH-Funded Research

-- preserve distribution of future tools

-- ensure agreements with third parties are consistent

Guidelines for Implementing the Principles

Disseminating Tools Developed with NIH Funds

Avoid reach-through

Avoid exclusive internal use

Guidelines for Implementing the Principles

Disseminating Tools Developed With NIH Funds

-- simple letter agreement

-- non-exclusive internal use

-- license to distributor

-- repository

Guidelines for Implementing the Principles

Simple Letter Agreement

• uniform one-page MTA• can be modified

• not for 100% of the transactions

• scientists will ask for it

Guidelines for Implementing the Principles

Use Strategic Licensing to Achieve Balance

NIH License Policy

• Non-exclusive where possible

• Exclusive when necessary

• Ensure appropriate scope

• Ensure expeditious development

• Ensure continuing availability of tools

The Toll-Road Analogy• Prefer Freeways to promote Research Tool (RT) use• Willing to Accept Occasional Tolls

• Avoid Tollbooth Gridlock with patents on RTs

Status of the Principles/Guidelines

• Period of Implementation

• Intramural and Extramural Implementation

• Term of Award for grants and contracts

• Request for Comments on implementation of Principles and Guidelines (September 2000)

FFI

http://ott.od.nih.gov/ Office of Technology Transfer

http://www.bioinfo.com/ Biotech. Information Institute

http://www.wipo.org/ WIPO

http://www.uspto.gov/ USPTO

http://www.autm.net/index_ie.html AUTM