The National Institutes of Health (NIH), an agency of the US Department of Health and Human Services, is widely known as the
largest single resource for biomedical research—its budget in fiscal year 2006 was nearly $29 billion. NIH may not be as well
known as a source of innovative technologies used in biomedical products and services. Yet, almost 200 products that incorporate
NIH-licensed technologies have reached the market. FDA has approved 25 of these products,1
with most of the remainder representing research reagents and tools. NIH licensees report a combined total of almost $5 billion
in sales of these products.
Mark L. Rohrbaugh, PhD
Through its 27 institutes and centers, ranging from mental health and cancer to infectious and chronic diseases, the NIH funds
research mostly at US universities and hospitals, but also at companies and foreign research institutions. The research conducted
by outside entities under grants and contracts constitutes the extramural program. In addition, about 10% of NIH's nearly
$29 billion budget funds research conducted through the intramural program, which involves approximately 6,000 doctoral-level
This article describes opportunities for licensing these inhouse scientists' inventions, and for collaborating on research
to invent new technologies or add value to existing ones.
The NIH intramural program has a long history of innovative accomplishments in the medical sciences. It is also home to the
largest hospital in the world dedicated solely to biomedical research.2 Through the years, clinical trials conducted at the hospital have led to innovative medical treatments and an impressive
series of "firsts," including: a cure for childhood leukemia; the implant of an artificial mitral heart valve; the use of
lithium to treat bipolar disorder; gene therapy clinical trials; and the use of antiretroviral therapy to treat HIV.
While groundbreaking clinical research is conducted at the NIH Clinical Center, much of NIH research is basic: it establishes
the scientific foundation for later research. Sometimes, the research results in inventions like tools used in academic and
industrial laboratories. Examples include the HIV protease gene and protein used to develop HIV protease inhibitors; a multidrug
resistant (MDR) tumor cell line used to test chemotherapeutic drugs for their ability to overcome MDR; and vectors derived
from vaccinia virus used to produce recombinant proteins. Other inventions benefit the public through their commercialization
by the private sector. Through the Office of Technology Transfer, the NIH licenses inventions made by its scientists. Table
1 provides examples of commercialized therapies based on unique NIH technologies.
Table 1. Innovative NIH technologies commercialized by companies
Through the Office of Technology Transfer (OTT), NIH makes available a full range of licenses for commercial evaluation and
for the sale of commercial products and services. These may be patent licenses, in the case of claims covered by pending or
issued patents, or biological material licenses for materials when no patent has been filed. NIH typically seeks patent protection
in the US, Canada, at least some countries of the EU, Australia, Japan, and occasionally in some emerging market or developing
countries, such as Mexico, China, and India. The breadth of filings is usually influenced by the willingness of a licensee
to pay the costs of extensive foreign filing. Biological material licenses are available for the manufacture and sale of products
in countries where no patent protection is obtained and the invention is embodied in a unique biological material.