[Federal Register Volume 60, Number 237 (Monday, December 11, 1995)]
[Notices]
[Pages 63536-63537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30004]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health


National Institute of Allergy and Infectious Diseases: Licensing 
Opportunity and/or Opportunity for a Cooperative Research and 
Development Agreement (CRADA) for the Development of Influenza A PB2 
Gene Technology

AGENCY: National Institutes of Health, Public Health Service, DHHS.

ACTION: Notice.

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SUMMARY: The National Institutes of Health is seeking licensees and/or 
CRADA Collaborators for the joint research, development, evaluation, 
and commercialization of its influenza A polymerase basic 2 (PB2) 
patent portfolio. The inventions claimed in U.S. Patent Application 
Serial No. 08/123,933 (``Method for Generating Influenza A Viruses 
Bearing Attenuating Mutations in Internal Protein Genes,'' filed 
September 20, 1993), and its related patent applications, are available 
for either co-exclusive or non-exclusive licensing (in accordance with 
35 U.S.C. 207 and 37 CFR Part 404) and/or further development under one 
or more CRADAs for important clinical and research applications 
described below in the Supplementary Information section.

DATES: License applications must be received on or before March 11, 
1996. CRADA proposals should be received on or before April 11, 1996 
for priority consideration. However, CRADA proposals submitted 
thereafter will be considered until a suitable CRADA Collaborator is 
selected.

ADDRESSES: CRADA proposals and questions about this opportunity should 
be addressed to: Claire T. Driscoll, Technology Transfer Manager, 
National Institute of Allergy and Infectious Diseases, National 
Institutes of Health, Building 31, Room 3B62, 9000 Rockville Pike, 
Bethesda, MD 20892; Telephone: 301/496-2644; Fax: 301/402-7123; E-mail: 
[email protected].
    Licensing proposals and questions about this opportunity should be 
addressed to: Cindy K. Fuchs, J.D., Technology Licensing Specialist, 
Office of Technology Transfer, National Institutes of Health, 6011 
Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: 
301/496-7735 ext. 232; Fax: 301/402-0220; E-mail: Cindy__F[email protected].
    Information on the patent applications and pertinent information 
not yet publicly disclosed can be obtained under a Confidential 
Disclosure Agreement. Respondees interested in licensing the 
invention(s) will be required to submit an Application for License to 
Public Health Service Inventions. Respondees interested in submitting a 
CRADA proposal should be aware that it may be necessary to secure a 
license to the above patent rights in order to commercialize products 
arising from a CRADA agreement.

SUPPLEMENTARY INFORMATION: This invention involves the use of modern 
molecular virologic techniques to introduce temperature sensitive (ts) 
attentuating mutations into a complementary DNA (cDNA) copy of the 
influenza A polymerase basic 2 (PB2) protein gene and to recover 
viruses bearing the mutant PB2 gene. Viral RNA (vRNA) transcribed in 
vitro from the PB2 DNA is transfected into avian kidney cells in the 
presence of an influenza A helper virus. The PB2 gene of the helper 
virus, which restricts its replication in mammalian cells, is 
substituted by the transfected mutant PB2 gene, which is known to 
function efficiently in mammalian cells. Using this system it has been 
possible to introduce three attenuating temperature sensitive mutations 
into the PB2 gene and to recover an infectious virus bearing this 
triple mutant gene. The virus bearing this mutant gene was highly 
attenuated in animals, was stable genetically even after prolonged 
replication in immunosuppressed rodents, and induced resistance to 
challenge with wild type influenza A virus. This gene can now be 
transferred from a donor virus to new epidemic or pandemic variants of 
influenza A virus as they appear in nature. The end result is a live 
attenuated reassortant influenza A virus vaccine that not only contains 
an attenuating PB2 gene from the attenuated donor but also the 
protective antigens, i.e., the hemagglutinin and neuraminidase 
glycoproteins, from the newly emerged wild type virus. Such a 
reassortant virus can serve as a protective vaccine, when administered 
into the respiratory tract of a vaccine, against disease caused by the 
epidemic influenza A viruses.
    To speed the research, development, and commercialization of these 
agents, the NIH is seeking one or more license agreements and/or CRADAs 
with pharmaceutical or biotechnology companies in accordance with the 
regulations governing the transfer of Government-developed agents. 
Proposals relating to any biomedical area will be considered.
    The CRADA aims will include the rapid publication of research 
results consistent with protection of proprietary information and 
patentable inventions as well as the timely exploitation of commercial 
opportunities. The CRADA Collaborator will enjoy the benefits of first 
negotiation for licensing Government rights to any inventions arising 
under the agreement and will advance funds payable upon signing the 
CRADA to help defray Government expenses for patenting such inventions 
and other CRADA-related costs.
    The role of the National Institute of Allergy and Infectious 
Diseases will be as follows:

[[Page 63537]]

    1. Provide the PB2 technology to the CRADA Collaborator.
    2. Jointly develop a series of donor viruses containing the mutant 
PB2 gene with or without a second non-hemaglutinin (HA), non-
neuraminidase (NA) attenuating gene.
    3. Jointly produce a series of reassortants bearing current H1 or 
H3 hemagglutinins (HAs) for evaluation in clinical trials in humans.
    4. Jointly produce experimental vaccines and evaluate them in 
clinical trials.
    The role of the Collaborator(s) will be to:
    1. Participate in joint activities 2-4 above.
    2. Evaluate a variety of mammalian cell lines for production of 
live attenuated virus vaccines in lieu of production in the allantoic 
cavity of eggs.
    Selection criteria for choosing the CRADA Collaborator(s) will 
include but are not limited to the following:
    1. The ability to collaborate with the NIAID on further research 
and development of this technology. This ability can be demonstrated 
through experience and expertise in this and related areas of 
technology.
    2. The demonstration of adequate resources to perform the research, 
development, and commercialization of this technology (e.g., personnel, 
expertise, and facilities) and accomplish objectives according to an 
appropriate timetable to be outlined in the CRADA Collaborator's 
proposal.
    3. The ability to perform clinical testing or trials, and obtain 
IND, ELA/PLA and FDA approval for a new vaccine or other products based 
on this technology.
    4. The demonstration of expertise in the commercial development, 
production, marketing and sales of products related to this technology.
    5. The level of financial support to CRADA Collaborator will 
provide for CRADA-related Government activities.
    6. The willingness to cooperate with the NIAID in the timely 
publication of research results consistent with the protection of 
proprietary information and patentable inventions that may arise during 
the period of the CRADA.
    7. Agreement to be bound by DHHS rules and regulations involving 
human subjects, patent rights, ethical treatment of animals, and 
randomized clinical trails.
    8. The willingness to accept the language and legal provisions of 
the NIH model CRADA with only minor modifications, if any. These 
provisions govern the equitable distribution of patent rights to any 
inventions developed under the CRADA. Generally, the rights of 
ownership are retained by the organization which is the employer of the 
inventor, with (1) The grant of an irrevocable, non-exclusive, royalty-
free license for research purposes to the Government when the CRADA 
Collaborator's employee(s) is/are the sole inventor(s), or (2) the 
grant of an option to negotiate an exclusive or non-exclusive license 
to the CRADA Collaborator when a Government employee(s) is/are the sole 
inventor(s).

    Dated: November 30, 1995.
Barbara M. McGarey,
Deputy Director, Office of Technology Transfer.
[FR Doc. 95-30004 Filed 12-8-95; 8:45 am]
BILLING CODE 4140-01-M