Text from the fall 1994 press
release/study. Originally released 8/22/94; revised 9/8/94 including new data for 43 NIH CRADAs.
Federal Labs and NIH are Number One in Bio-Technology Transfer
The first comprehensive study clearly shows that federal (U.S. government)
laboratories are by far the leaders in technology transfer in the biomedical,
biotechnology and pharmaceutical areas. In these areas, the federal
laboratories and the Public Health Service (PHS) and its main component, the
National Institutes of Health (NIH), are number one in:
The federal labs, PHS and NIH are:
- inventions available for licensing;
- patents received and patent applications pending;
- inventions that have been licensed out; and
- therapeutics in active development (even compared to the largest
pharmaceutical companies), both in terms of those licensed out and those being
- the U.S. biotechnology and pharmaceutical industries' leading sources for
new technologies, both new products and broadly enabling technologies;
- the leaders in collaborative research and development with the
biotechnology and pharmaceutical industries, including therapeutics in
development and clinical trials; and
- the source for many products and technologies in the marketplace.
However, federal technology transfer is relatively new, and many (hundreds)
more technologies and products are currently in development, both licensed
inventions and those being developed collaboratively through CRADAs with
industry. This includes well over 100 therapeutics having reached clinical
Mr. Ronald A. Rader, President, Biotechnology Information Institute, Rockville,
MD, has presented data from the Federal Bio-Technology Transfer Directory, a
recently published reference book he authored describing all federal
biomedical, biotechnology and pharmaceutical U.S. patents, patent applications,
licenses granted and Collaborative Research and Development Agreements (CRADAs)
from 1980-1993. This is the largest directory of biotechnology and
pharmaceutical inventions available for licensing. The Directory describes
2,100 federal inventions (1,200 patents; 900 applications); nearly 1,000
licenses (including 270 exclusive and 640 nonexclusive patent licenses); and
over 500 CRADAs; along with information about the commercial potential of
inventions and the status of products/technologies in development and the
marketplace. Much of this information has never before been published,
particularly patent licenses and CRADAs. The 678-page book has over 400 pages
of text/abstracts and 250 pages of indexes, including a 37,000 entry subject
index. he Federal Bio-Technology Transfer Directory database will be
available this fall.
The Federal Bio-Technology Transfer Directory shows that:
- Federal agencies and labs have 2,100 U.S. patents granted or pending in
the biomedical, biotechnology and pharmaceutical ("biomedical/biotech") areas
from 1980-1993. PHS (with 60%) and NIH (with 49%) are by far the leaders among
- Biotechnology is involved in the majority of federal bio-technology
transfer. This includes over 50% of inventions; about 70% or more of patent
licenses granted; and up to 70% of CRADAs. Biotechnology involvement is
highest and has been increasing in recent years.
- The numbers of inventions, licenses and CRADAs are related to R&D
funding, mandates and technology transfer efforts. The federal labs'
biomedical/biotech R&D budget is about $2.5 billion/year. The NIH
intramural R&D budget ($1.3 billion) is comparable to that of the largest
pharmaceutical companies and over 40% of total U.S. biotechnology industry
- Most federal bio-technology transfer is recent and continues to increase
steadily. Over 60% of inventions are from 1990-1993; 75% of CRADAs were active
in 1993; and well over 1,000 federal biomedical/biotech patent applications
are currently pending.
- The federal labs and PHS and NIH are consistently the leading recipients
of U.S. patents in biotechnology and genetic engineering, including those with
- The federal labs, PHS and NIH are consistently among the leading
recipients of drug and other bio-active agent patents, ranking with many of the
world's largest pharmaceutical companies.
Licensing, particularly exclusive licensing, of federal inventions is an issue
involving much public debate. This is especially true as PHS/NIH is currently
considering dropping or significantly modifying its "reasonable pricing" clause
in exclusive licenses and CRADAs.
The Federal Bio-Technology Transfer Directory shows that:
- About 27% of federal inventions have been licensed one or more times,
including 34% of PHS and 32% of NIH inventions. These are rather high
percentages of invention licensing, since only about 10% or less of inventions
are ever used commercially.
- Nearly 1,000 licenses have been granted to industry, mostly from PHS (84%)
and NIH (75%).
- The majority of invention licenses are nonexclusive (no restrictions on
granting further licenses). PHS and NIH inventions are more likely to be
licensed nonexclusively and to have more licenses/invention (licensed to more
companies). A few inventions, mostly broadly enabling technologies and
screening assays, have been licensed by up to 20 companies.
- About one-quarter of invention licenses are exclusive licenses, and about
40% of licensed inventions have been exclusively licensed. Many of these
involve major commercial products in development. About 75% of federal and 87%
of NIH exclusive licenses involve therapeutics-related inventions (mostly
therapeutic agents). Many of these therapeutics-related licenses involve biopharmaceuticals and drugs in development.
- Over two-thirds of licensed inventions are therapeutics-related and about
one-third of exclusively licensed therapeutics-related inventions have reached
the clinical trials stage of development.
Regarding CRADAs, the Federal Bio-Technology Transfer Directory shows that:
- Collaborative R&D with industry ranges from basic speculative research
through product development and testing, including clinical trials.
- PHS with 51% (279) and NIH with 37% (228) lead all federal agencies/labs
with CRADAs in the biomedical/biotech areas. However, CRADAs remain an
insignificant part of the PHS/NIH total R&D, unlike some other federal
agencies/labs where CRADAs are up to 10% of total R&D.
- About two-thirds of federal, 73% of PHS and 80% of NIH CRADAs involve
therapeutics-related technologies (mostly therapeutic agents). About one-third
of all federal, PHS and NIH therapeutics-related CRADAs involve therapeutics
that have reached the clinical trials stage. Many of these CRADAs involve
ongoing clinical trials, with most conducted by PHS and NIH.
Mr. Rader has also documented that:
- The federal labs, PHS and NIH each rank number one or among the leaders in
the number of drugs and biopharmaceuticals in development (even compared to the
largest pharmaceutical companies), both in terms of those licensed out and
those being developed internally.
- PHS and NIH rank among the top recipients of licensing income among U.S.
universities and nonprofit research organizations--$12.2 million licensing
royalty income in FY1992, with about 80% or more of this from the licensing of
HIV diagnostic patents.
- Federal labs are filing over 450 new patent applications/year (PHS alone over
300), licensing activity is increasing, and CRADAs are growing rapidly (except
- The PHS/NIH "reasonable pricing" exclusive licensing clause has
contributed to many biotechnology and pharmaceutical companies of all sizes
avoiding PHS/NIH CRADAs and licensing.
- Cancer and infectious diseases, particularly viral infections and HIV, are
the main disease areas for federal inventions, licenses and CRADAs (most of
these within PHS/NIH).
- Federal labs, PHS and NIH are each the leading recipients of
antiviral/virus-related patents and have the most antiviral drugs and vaccines
in development, including those licensed out and those being developed
internally. NIH co-discovered HIV, claims co-discovery of the utility of AZT
and exclusively licensed the next two drugs approved for HIV-infection (DDI;
- Federal labs in Maryland (particularly NIH) are the source for over 70% of
federal biomedical/biotech inventions, licenses and CRADAs. These labs (and
NIH alone) make the suburban MD/Montgomery county area the world's leading area
for biomedical, biotechnology and pharmaceutical technology transfer
opportunities. MD and DC organizations have over 70 CRADAs.
Although only a small portion of the nation's total R&D, the federal labs
are a major national resource for inventions and technology transfer. The
federal labs as a whole, and PHS and NIH each have the largest and most
important portfolios of biomedical and biotechnology inventions available for
licensing. Unlike corporate inventions, these are all available for licensing.
Federal labs, PHS and NIH each are the most important sources for the licensing
of new technologies and for collaborative R&D with the U.S. biotechnology
and pharmaceutical industries. The federal and, especially, the PHS and NIH
invention portfolios and technology transfer activities are unsurpassed in many
areas including cancer; HIV, viral and other infectious diseases and vaccines;
gene therapy and sequencing; therapeutics screening; radiopharmaceuticals; and
fundamental aspects of molecular and cellular biology. Federal technology
transfer is relatively new and more federal inventions are in development than
are currently in the marketplace. Hundreds of examples are described in the
Federal Bio-Technology Transfer Directory. Many federal inventions will form
the basis for a significant portion of the U.S. biotechnology and
pharmaceutical industries' future products and technologies. Federal
inventions tend to be the types most needed by industry--fundamental
breakthrough technologies (e.g., gene therapy), broadly enabling technologies
(e.g., therapeutics screening assays) and biopharmaceuticals and drugs for
diseases for which therapeutics are not available.
No technology, market or competitive assessment in the biomedical,
biotechnology or pharmaceutical areas is complete without considering federal
technology transfer. The Federal Bio-Technology Transfer Directory is the only
information resource providing the biotechnology and pharmaceutical industries
and the biomedical and life sciences research communities with access to
federal technology transfer opportunities and activities.
[For further information, contact: Mr. Ronald A. Rader, President,
Biotechnology Information Institute, Phone: 301-424-0255; FAX:
301-424-0257; E-mail: email@example.com].