[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
