NIH PROCEDURES FOR HANDLING NON-ELECTION OF TITLE TO PATENTABLEBIOLOGICAL MATERIALS

 

NIH GUIDE, Volume 25, Number 16, May 17, 1996

 

P.T. 36



Keywords:

  Biomed. Research Resources, Other 

  Grants Administration/Policy+ 

 

National Institutes of Health

 

A.  Purpose

 

This notice sets forth the National Institutes of Health (NIH) policy

for allowing contractors and grantees (hereafter "Contractor") to

license biological materials on which the contractor elects not to

file a patent application and which are submitted to the NIH for

review and possible election of government title under the Bayh-Dole

Act.

 

B.  Background

 

The NIH Office of Technology Transfer (OTT) has been delegated the

authority to elect title to extramural inventions on behalf of the

NIH.  Under the Bayh-Dole Act, the NIH Contractor may elect title to

inventions developed with NIH funding, but must file a patent

application within one year of such election.  Where the Contractor

elects not to file a patent application, the Government may request

title.  Typically, the Contractor's election not to file a patent

application on an invention is an indication that the Contractor is

not interested in retaining domain over the invention.

 

However, this is not necessarily the case with regard to patentable

biological materials, which may frequently be licensed for commercial

use without patent protection.  The policy and procedures established

by this notice are intended to simplify: (1) the reporting by

Contractors of their intention to not file a patent application on

the invention but to license the tangible biological material; and

(2) the non-election of title to these inventions by the Federal

Government where certain terms and conditions are met.

 

C.  Policy

 

It is the policy of the United States Public Health Service (PHS) to

make available to the public the results and accomplishments of the

activities it funds.  Restricted availability of unique research

resources, upon which further studies are dependent, can impede the

advancement of research and delivery of medical care.  A notice in

the NIH Guide for Grants and Contracts (Vol. 23, No. 26, July 15,

1994) and the PHS Grants Policy Statement explain in full PHS policy

with regard to the distribution of research resources developed with

PHS funds.

 

The NIH Guide notice referenced above and the PHS Grants Policy

Statement also set forth PHS policy encouraging the commercialization

of the products of research developed with PHS funding, and allow

institutions to make materials available to others for commercial

purposes with appropriate restrictions and licensing terms.  To

ensure consistency with its public availability goals, the NIH Guide

notice (referenced above) and the PHS Grants Policy Statement require

that where the product of research developed with federal funding is

a patentable, but unpatented, research product, the terms of a

license must be no more restrictive than they would have been if the

product had been patented.

 

Accordingly, where the Contractor agrees with the conditions set

forth below, which ensure the availability of unique research

resources, NIH will not request title to the subject invention and

will grant a Contractor's request to distribute the unpatented,

tangible material through licensing.

 

D.  Procedures

 

A contractor electing title to patentable biological materials and

requesting to distribute them through licensing as unpatented

tangible research materials must agree to the following conditions:

 

1.  The Contractor must make a written request to the Division of

Extramural Inventions and Technology Resources, National Institutes

of Health, 6701 Rockledge Drive, MSC 7750, Bethesda, MD 20814-7750

 

2.  Information describing the invention must be made publicly

available either through publication in the scientific literature or

by other appropriate means;

 

3.  The licensing strategy must ensure that the research resource

will be made available to the nonprofit research community.

Generally, this can be accomplished through nonexclusive licensing,

or exclusive licensing for distribution or sale of the materials.  If

an exclusive license is negotiated for internal use by a for-profit

entity, the license must address continuing availability of the

material to the nonprofit research community.  Any exclusive license

must provide for conversion to nonexclusive status or termination of

licensee's rights upon failure to comply with the terms addressing

continuing availability;

 

4.  If an exclusive license is executed, provision must be made for

independent maintenance of the material, such as at a national

repository, or the originating grantee laboratory;

 

5.  The government shall have a worldwide, irrevocable, unlimited

royalty free, paid-up license in the material to make, use or

distribute, or to have it made, used, or distributed for the

Government.  Upon request, sufficient quantities of the biological

material shall be provided to the Government with such documentation

as the Government is needed to preserve, use, and replicate the

material to meet PHS needs; and

 

6.  If the Contractor fails to fulfill the conditions of paragraphs

1-4 above, NIH shall automatically have the right to: (1) distribute

the material, or (2) require the Contractor to comply with the Unique

Research Resource requirements of its grant.

 

F.  Effective Date

 

The policies and procedures set forth in this notice are effective

immediately.

 

INQUIRIES

 

For additional information on this notice, contact:

 

Ms. Sue Ohata

Division of Extramural Inventions and Technology Resources

National Institutes of Health

6701 Rockledge Drive MSC 7750

Bethesda, MD  20892-7750

Telephone:  (301) 435-1986

FAX:  (301) 480-0272

Email: Sue_Ohata@nih.gov

 

.

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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