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:

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 developed internally.

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 trials.

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 federal agencies.

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 R&D funding.

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 pharmaceutical uses.

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 for PHS/NIH).

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; DDC).

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: biotech@bioinfo.com].