[Federal Register Volume 59, Number 131 (Monday, July 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16697]


[[Page Unknown]]

[Federal Register: July 11, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

Appeals Procedures Related To Licensing of Patents and Inventions 
Under the Jurisdiction of the Department of Health and Human Services

AGENCY: National Institutes of Health, Public Health Service, HHS

ACTION: Proposed Interim Procedures.

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SUMMARY: The National Institutes of Health is proposing for public 
comment interim appeals procedures under 37 CFR Sec. 404.11 which 
permits appeals from any decision or determination concerning the 
grant, denial, interpretation, modification, or termination of a 
license and specifies the parties who may appeal.

DATES: Written comments on the proposed interim procedure must be 
received by August 10, 1994.

ADDRESSES: Comments regarding the proposed interim procedure may be 
submitted to Mr. Arthur J. Cohn, Esq., Technology Licensing Specialist, 
Office of Technology Transfer, National Institutes of Health, 6011 
Executive Boulevard, Suite 325, Rockville, Maryland 20852.

SUPPLEMENTARY INFORMATION:

Background

    This proposed interim procedure implements 35 U.S.C. 207(a), and 
209, and the Department of Commerce Regulation in 37 CFR Part 404 
dealing with the licensing of federally owned inventions. This interim 
procedure describes the terms, conditions and procedures under which 
specified parties may appeal from a decision of the Director of the 
Office of Technology Transfer, National Institutes of Health, 
concerning the grant, denial, interpretation, modification or 
termination of a license of any patent or invention in the custody of 
the Department of Health and Human Services. Upon promulgation of these 
procedures, following consideration of the comments made in response to 
this notice, the procedures will remain in effect until permanent 
procedures are adopted as a part of comprehensive policies or 
regulations governing the technology transfer activities of the 
National Institutes of Health.

Interim Procedure for Appeals From Licensing Decisions by the 
Department of Health and Human Services

Purpose

    In accordance with 37 CFR Sec. 404.11 this interim procedure 
describes the terms, conditions and procedures under which a party may 
appeal a decision of the Office of Technology Transfer (OTT) concerning 
the grant, denial interpretation, modification or termination of a 
license for any invention in the custody of the Public Health Service 
(PHS), Department of Health and Human Services (HHS).

Definitions

    (a) ``OTT Director'' means the Director of the Office of Technology 
Transfer, National Institutes of Health.
    (b) ``Director,'' means the Director of the National Institutes of 
Health (NIH) or any officer or employee of the NIH to whom the 
authority involved may be delegated.
    (c) ``Person'' means any individual or entity.
    (d) ``Invention'' means any invention or discovery which is or may 
be patentable or otherwise protected under title 35, United States 
Code, or any novel variety of plant which is or may be protectable 
under the Plant Variety Protection Act (7 U.S.C. Sec. 2321 et seq.).
    (e) ``Written Objection'' means a written objection in response to 
a notice of a prospective license published in the Federal Register as 
required by 37 CFR Sec. 404.7(a)(1)(i) or 37 CFR Sec. 404.7(b)(1)(i).
    (f) ``Appellant'' means a person who requests reconsideration or 
appeals a decision of the OTT in accordance with this subpart.

Licensing Authority

    The OTT Director has been delegated authority to make any decision 
or determination concerning the grant, denial, interpretation, 
modification or termination of any license for any invention in the 
custody and control of the PHS. The decision and determination of the 
OTT Director is final and conclusive on behalf of the Department unless 
the procedures for reconsideration and appeal set forth below are 
initiated.

Persons Who May Request Reconsideration and Appeal

    Under 37 CFR Sec. 404.11, the following person(s) may request 
reconsideration by the OTT Director and may subsequently appeal to the 
Director any decision or determination concerning the grant, denial, 
interpretation, modification or termination of a license:
    (a) A person whose application for a license has been denied;
    (b) A licensee whose license has been modified or terminated in 
whole or in part; or
    (c) A person who has timely filed a written objection in response 
to the notice required by 37 CFR Sec. 404.7(a)(1)(i) or 
Sec. 404.7(b)(1)(i) and who can demonstrate to the satisfaction of the 
OTT Director or the Director, as appropriate, that such person may be 
damaged by the determination of the OTT.

Request for Reconsideration

    (a) Prior to appealing a determination by the OTT granting, 
denying, interpreting, terminating, or modifying a license, the 
Appellant must request reconsideration by filing with the OTT Director 
a written request for reconsideration within thirty (30) days after the 
notice of denial, termination or modification or a response to a 
Written Objection is sent by the OTT to the Appellant. The request for 
reconsideration, in concise and brief terms, shall state the grounds 
for reconsideration and include copies of all pertinent documents. The 
OTT Director may require submission of additional information or 
documentation. Upon written request by the Appellant and at the sole 
discretion of the OTT Director this thirty (30) day period may be 
extended for good cause.
    (b) The OTT Director will make a written determination within sixty 
(60) days of receiving all required documentation in support of the 
request for reconsideration. The decision of the OTT Director will be 
based on all information in the administrative record, including all 
information submitted with the request for reconsideration.

Appeal

    (a) An Appellant, who has received an adverse determination from 
the OTT Director following a request for reconsideration, may appeal 
such determination to the Director. The Director may designate another 
individual from within the NIH to review the notice of appeal and 
render a decision thereon. The Appellant shall file a written notice of 
appeal to the Director with two copies to the OTT Director no later 
than thirty (30) days from the receipt of an adverse decision by the 
OTT Director following a request for reconsideration unless the 
Director grants for good cause an extension of time. The notice of 
appeal, in concise and brief terms, shall state the grounds for appeal 
and include copies of all pertinent documents. The notice of appeal 
shall be accompanied by concise arguments as to why the OTT Director's 
decision should be rejected or modified. Upon review of the notice of 
appeal, the Director may require submission of additional information 
or documentation.
    (b) The Director will make a written determination within sixty 
(60) days of receiving all required documentation. The decision of the 
Director will be based on all the information in the administrative 
record, including the information submitted by the Appellant and shall 
constitute a final decision by the agency.

    Dated: July 1, 1994.
Donald P. Christoferson,
Acting Director, Office of Technology Transfer.
[FR Doc. 94-16697 Filed 7-8-94; 8:45 am]
BILLING CODE 4140-01-P