Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Notices 67747

Dated: November 12, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–25647 Filed 11–18–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Best Practices for the Licensing of 

Genomic Inventions

AGENCY: National Institutes of Health, 

Public Health Service, Health and 

Human Services (HHS).

ACTION: Notice of proposed best 

practices for the licensing of genomic 

inventions; request for comments. 

SUMMARY: The Public Health Service’s 

(PHS) primary mission is to acquire new 

knowledge through the conduct and 

support of biomedical research to 

improve the health of the American 

people. PHS seeks to maximize the 

public benefit whenever PHS owned or 

funded technologies are transferred to 

the commercial sector. These best 

practices for the licensing of 

government-funded genomic inventions 

are recommendations to the intramural 

PHS technology transfer community as 

well as to PHS funding recipients.

DATES: Comments must be received no 

later than January 18, 2005.

ADDRESSES: Comments on the proposed 

best practices must be submitted to: Dr. 

Bonny Harbinger, Office of Technology 

Transfer, National Institutes of Health, 

6011 Executive Blvd., Suite 325, 

Rockville, Maryland, 20852; telephone: 

(301) 594–7700; e-mail: 

harbingb@mail.nih.gov.

SUPPLEMENTARY INFORMATION:

Best Practices for the Licensing of 

Genomic Inventions 

Introduction 

The Public Health Service’s (PHS) 

primary mission is to acquire new 

knowledge through the conduct and 

support of biomedical research to 

improve the health of the American 

people. This mission is advanced by the 

intramural research efforts of 

government-owned and -operated 

laboratories and by the extramural 

research efforts funded through grants 

and contracts. PHS seeks to maximize 

the public benefit whenever PHS owned 

or funded technologies are transferred to 

the commercial sector. Motivated by 

this goal, we offer the following best 

practices for the licensing of 

government-funded genomic inventions. 

Genomic inventions include a wide 

array of technologies and materials such 

as cDNAs; expressed sequence tags 

(ESTs); haplotypes; antisense molecules; 

small interfering RNAs (siRNAs); fulllength genes and their expression 

products; as well as methods and 

instrumentation for the sequencing of 

genomes, quantification of nucleic acid 

molecules, detection of single 

nucleotide polymorphisms (SNPs), and 

genetic modifications. Much of the 

value associated with the commercial 

use of these technologies involves 

nucleic acid-based diagnostics, potential 

gene therapy applications, and the 

development of new DNA- and RNAbased therapeutics. 

Background 

Among the benefits derived from 

PHS-conducted and -supported 

biomedical research are effective and 

accessible new healthcare treatments 

and services. Practical realization of 

these benefits depends on the ability 

and willingness of private sector 

partners to develop and commercialize 

new technologies arising from PHS 

conducted and funded research. For 

potential preventive, diagnostic, and 

therapeutic products, the interest of the 

private sector in commercializing new 

technologies often depends on the 

existence of patent protection on the 

technology in the United States and 

foreign countries. 

The Bayh-Dole Act of 1980 allows 

PHS grantees and contractors to seek 

patent protection on subject inventions 

made using Government funds and to 

license those inventions with the goal of 

promoting their utilization, 

commercialization, and public 

availability. Recipients of PHS grants 

and contracts have a role in 

implementing the requirements of the 

Bayh-Dole Act (http://sedison.info.nih.gov/iEdison/

www.iedison.gov). In 1986, Federal 

laboratories, including PHS research 

laboratories at the National Institutes of 

Health (NIH), the Food and Drug 

Administration (FDA), and the Centers 

for Disease Control and Prevention 

(CDC), were given a statutory mandate 

under the Federal Technology Transfer 

Act (Pub. L. 99–502) and Executive 

Order 12591 to ensure that new 

technologies developed in those 

laboratories were transferred to the 

private sector and commercialized.

PHS recognizes that patenting and 

licensing genomic inventions presents 

formidable challenges for academic and 

government technology transfer 

programs because of the complexities in 

bringing these technologies to the 

marketplace in a way that balances the 

expansion of knowledge and direct 

public health benefit with the 

commercial needs of private interests. 

The following represents best 

practices recommendations to the 

intramural PHS technology transfer 

community as well as to universities, 

hospitals and other non-profit PHS 

funding recipients. These 

recommendations are not intended to 

constitute additional regulations, 

guidelines or conditions of award for 

any contract or grant, although they are 

consistent with existing policies set out 

in Sharing Biomedical Research 

Resources (http://ott.od.nih.gov/

NewPages/RTguide_final.html) and 

Developing Sponsored Research 

Agreements (http://ott.od.nih.gov/

NewPages/text-com.htm). 

Patent Protection 

Like other emerging technology areas, 

patents directed to genomic inventions 

tend to issue with claims that are broad 

in scope. Public health-oriented 

technology transfer must balance the 

rewards of broad intellectual property 

protection afforded to founders of 

enabling genomic inventions with the 

benefits of fostering opportunities for 

those striving to improve upon those 

innovations. 

Therefore, in considering whether to 

seek patent protection on genomic 

inventions, institutional officials should 

consider whether significant further 

research and development by the 

private sector is required to bring the 

invention to practical and commercial 

application. Intellectual property 

protection should be sought when it is 

clear that private sector investment will 

be necessary to develop and make the 

invention widely available. By contrast, 

when significant further research and 

development investment is not required, 

such as with many research material 

and research tool technologies, best 

practices dictate that patent protection 

rarely should be sought. 

Best Licensing Practices 

The optimal strategy to transfer and 

commercialize many genomic 

inventions is not always apparent at 

early stages of technology development. 

As an initial step in these instances, it 

may be prudent to protect the 

intellectual property rights to the 

invention. As definitive commercial 

pathways unfold, those embodiments of 

an invention requiring exclusive 

licensing as an incentive for commercial 

development of products or services can 

be distinguished from those that would 

best be disseminated non-exclusively in 

the marketplace. 

67748 Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Notices 

Whenever possible, non-exclusive 

licensing should be pursued as a best 

practice. A non-exclusive licensing 

approach favors and facilitates making 

broad enabling technologies and 

research uses of inventions widely 

available and accessible to the scientific 

community. When a genomic invention 

represents a component part or 

background to a commercial 

development, non-exclusive freedom-tooperate licensing may provide an 

appropriate and sufficient complement 

to existing exclusive intellectual 

property rights. 

In those cases where exclusive 

licensing is necessary to encourage 

research and development by private 

partners, best practices dictate that 

exclusive licenses should be 

appropriately tailored to ensure 

expeditious development of as many 

aspects of the technology as possible. 

Specific indications, fields of use, and 

territories should be limited to be 

commensurate with the abilities and 

commitment of licensees to bring the 

technology to market expeditiously. 

For example, patent claims to gene 

sequences could be licensed exclusively 

in a limited field of use drawn to 

development of antisense molecules in 

therapeutic protocols. Independent of 

such exclusive consideration, the same 

intellectual property rights could be 

licensed non-exclusively for diagnostic 

testing or as a research probe to study 

gene expression under varying 

physiological conditions. 

License agreements should be written 

with developmental milestones and 

benchmarks to ensure that the 

technology is fully developed by the 

licensee. The timely completion of 

milestones and benchmarks should be 

monitored and enforced. Best practices 

provide for modification or termination 

of licenses when progress toward 

commercialization is inadequate. 

Negotiated sublicensing terms and 

provisions optimally permit fair and 

appropriate participation of additional 

parties in the technology development 

process.

Funding recipients and the intramural 

technology transfer community may 

find these recommendations helpful in 

achieving the universal goal of ensuring 

that public health consequences are 

considered when negotiating licenses 

for genomic technologies. 

PHS encourages licensing policies 

and strategies that maximize access, as 

well as commercial and research 

utilization of the technology to benefit 

the public health. For this reason, PHS 

believes that it is important for funding 

recipients and the intramural 

technology transfer community to 

reserve in their license agreements the 

right to use the licensed technologies for 

their own research and educational 

uses, and to allow other non-profit 

institutions to do the same. 

Conclusion 

PHS recognizes that these 

recommendations generally reflect 

practices that may already be followed 

by most funding recipients and the 

intramural technology transfer 

community with regard to licensing of 

genomic and other technologies. PHS 

also acknowledges the need for 

flexibility in the licensing negotiation 

process as the requirements of 

individual license negotiations may 

vary and may not always be adaptable 

to these best practices.

Dated: November 14, 2004. 

Mark L. Rohrbaugh, 

Director, Office of Technology Transfer, 

National Institutes of Health.

[FR Doc. 04–25671 Filed 11–18–04; 8:45 am] 

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy.

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel, Apoptosis in Liver 

Cells. 

Date: December 14, 2004. 

Time: 3 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Telephone 

Conference Call). 

Contact Person: Lakshmanan Sankaran, 

PhD, Scientific Review Administrator, 

Review Branch, DEA, NIDDK, National 

Institutes of Health, Room 777, 6707 

Democracy Boulevard, Bethesda, MD 20892–

5452, (301) 594–7799, Is38oz@nih.gov.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS)

Dated: November 15, 2004. 

LaVerne Y. Stringfield, 

Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 04–25668 Filed 11–18–04; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Child Health and 

Human Development; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy.

Name of Committee: National Institute of 

Child Health and Human Development 

Special Emphasis Panel, Mortality and 

Fecundity in Two-sided Search for Male. 

Date: December 1, 2004. 

Time: 2 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6100 

Executive Boulevard, Room 5B01, Rockville, 

MD 20852 (Telephone Conference Call). 

Contact Person: Marita R. Hopmann, PhD, 

Scientific Review Administrator, Division of 

Scientific Review, National Institute of Child 

Health and Human Development, 6100 

Building, Room 5B01, Bethesda, MD 20892 

(301) 435–6911, hopmannm@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle.

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and