Many more observations and conclusions than presented below can be made about particular technologies/uses and technology transfers by federal agencies/labs from the data presented here and in the Directory. For example, analyses of numbers and ratios of applications/patents and total invention licenses/exclusive licenses, technology transfers by date and agency/lab, and others can be readily prepared. The Directory database (to be available this fall) includes controlled descriptors for technologies/uses and subjects, agency/lab codes, dates and other information, and users will be able to perform detailed analyses themselves. A more detailed analysis of one area, viral/antiviral technology transfer, is presented in a section below.
The federal government has a portfolio of about 2,100 biomedical/biotech inventions from 1980-1993. PHS (with 60%; 1,254 inventions) and its NIH component (49%; 1,029) are by far the leaders among federal agencies/labs, followed by the USDA, Army and DOE with about 6% each. PHS also leads in invention licenses (with 84%) and CRADAs (with 49%). Note, the ratio of applications to patents is generally related to an agency's reporting of pending applications and an agency's recent level of biomedical/biotech R&D.
There is a trend toward more federal and PHS/NIH biologics/biotechnology inventions and fewer drugs/chemical and apparatus/devices inventions. In 1980, 59% (44) of patents involved drugs/chemical technology, 16% (12) involved biologics/biotechnology and 49% (37) involved apparatus/devices. In 1993, 46% (214) of patents involved drugs/chemical technology, 60% (276) involved biologics/biotechnology and 23% (103) involved apparatus/devices. ["Drugs/chemical," involves drugs (as defined by FDA), chemical substances, materials, or chemical technologies; "Biologics/biotech," involves biologics (as defined by FDA), biotechnology, biological molecules or materials, organisms or their components; and/or "Apparatus/devices," involves hardware, machines, computers (including software) and other technologies. All entries were indexed with one or more of these terms. Note, clinical trials stage refers to products/technologies that have been, are or will shortly be tested in humans (in trials not necessarily conducted by a federal agency/lab)].
Federal biomedical/biotech patents have been increasing rather steadily since about 1986 (the year of passage of the Federal Technology Transfer Act), increasing from a level of about 50-60 patents/year in the early 1980s to 158 granted in 1993. Note, a significant number of patent applications, e.g., from 1993 and the second half of 1992, for which foreign patent applications have not yet been published have been disclosed by federal agencies/labs and included in the Directory.
"Organization" in the figure above refers to the PHS institute, center or division (ICD) designation. The National Cancer Institute (NCI), the largest of PHS components, is by far the leading PHS component in terms of inventions, licenses and CRADAs; followed by the National Inst. of Allergy and Infectious Diseases (NIAID); the National Inst. of Diabetes and Digestive and Kidney Disorders (NIDDK); and the Centers for Disease Control and Prevention (CDC). NCI, NIAID and CDC each have mandates and programs that include considerable disease and other directed research and development of needed treatments and diagnostics.
PHS and NIH are the leaders in most technology/use areas, as expected since they receive the most funding and conduct most of the federal laboratory research in these areas. Biologics/biotech (vs. drugs/chemical or apparatus/devices) technologies/uses dominate PHS and NIH inventions, licenses and CRADAs. Cancer and infectious diseases, particularly viral/antiviral and HIV-related, are the main disease areas in terms of inventions, licenses and CRADAs.
The number of inventions, licenses and CRADAs for agencies/labs and technologies/uses is generally related to its research funding, resources, mandates and technology transfer efforts. For example, NIH with $1.2 billion intramural research funding, mandates to improve public health, large directed development efforts in some areas (e.g., cancer, HIV) and an increasingly active technology transfer program not surprisingly has about 41% of federal biomedical/biotech patents, 59% of patent applications, 72% of all licenses, 57% of exclusive licenses granted and 34% of CRADAs. There appear to be no drastic deficiencies in federal bio-technology transfer (in terms of major research efforts and mandates lacking associated inventions, licenses and CRADAs).