NIH Technology Transfer and Ethics

Pat Lake, Deputy Director

Extramural Technology Transfer

NIDDK, NIH

FLC – Mid Atlantic Regional Meeting, Rocky Gap, Maryland

September 15, 2005

National Institutes of Health• Mission: The National Institutes of Health

is the steward of medical and behavioral research for the Nation.

• 27 Institutes, Centers and Divisions

• 18,000 employees

• Total FY 2004 budget 27 billion dollars

NIH IC Offices of Technology Transfer

• Evaluates new inventions generated by scientists

• Assists in marketing Institute patents/ inventions to industry

• Assists scientists in implementing transactional agreements, i.e. Material Transfer Agreements (MTAs), Confidential Disclosure Agreements (CDAs)

NIH IC Offices of Technology Transfer (Cont’d)

• Assists scientists in setting up collaborations with profit and not for profit entities through CRADAs and Clinical Trial Agreements (CTAs)

• Acts as a resource to our scientists for a wide variety of technology transfer & intellectual property matters

CRADAs & Ethics

NIH CRADA Review Process

• Institute & Collaborator PIs develop Research Plan

• Institute performs actual negotiations with CRADA Collaborator

• NIH Office of Technology Transfer, IC Ethics Office and Office General Counsel review the CRADA

• Internal NIH CRADA Subcommittee reviews and makes the recommendation for approval

Conflict of Interest & Fair Access Review

• COIFA Form

• PIs complete and Ethics Office reviews

• Questions include: Financial or Personal relationships PI has with CRADA Collaborator

• Fair Access Issues-why was this Collaborator chosen

Other Case Studies\Examples

Royalties going directly to a Charity

• Sorry! According to HHS OGC not possible

• Royalties must go directly to inventor

• Inventor can then make arrangements with a charity of choice

Employee Owned Inventions

• New employee hired by NIH from European research institute

• He personally was prosecuting his own patent application

• Wanted to continue research in this area covered in patent

• PI assigned IP rights to NIH who assumed patent prosecution costs

Sponsored Travel

• Sponsored travel is handled differently amongst the NIH institutes.

• Some Institutes don’t allow their scientists to accept sponsored travel from industry without a one year cooling-off period before a collaboration can begin.

• Since sponsored travel is technically a gift to the Institute and not the scientist, it is not a conflict. This is a policy issue for the institutes.

Recap of NIH’s New Ethics Rules

• No consulting in personal capacity

• Scientist are encouraged to consult with industry in their official capacity!!!

• See our ethics website for summary of new rules….

• Http://www.nih.gov/about/ethics/summary_ammendments

Please feel free to contact:

Pat LakeDeputy DirectorExtramural Technology Transfer NIDDK, NIHOffice of Technology Transfer and Development6707 Democracy Plaza, Suite 906B, MSC 5343Bethesda, MD 20892-5343Ph. 301-594-6762Fax: 301-480-7546Email: LakeP@mail.nih.gov