THE PATENTING OF RECOMBINANT DNA RESEARCH INVENTIONS 
DEVELOPED UNDER DHEW SUPPORT: 
An Analysis by the Director, 
National Institutes of Health, 
November 1977 
I . Introduct ion 
The need for the Department of Health, Education, and Welfare 
(DHEW) to establish a policy on the patenting of DHEW-supported inventions 
involving the use of recombinant DNA molecules has occasioned efforts 
to achieve a consensus of views from the public and private sectors. 
An account of these efforts, with relevant background and analysis, 
is presented here. 
On June 23, 1976, the National Institutes of Health (NIH) released 
guidelines to govern the conduct of NIH-supported research on recombinant 
DNA molecules. In this research, "genes" — that is, deoxyribonucleic 
acid (DNA) molecules — from virtually any living organism can be transferred 
to single cells from certain completely unrelated organisms. These 
experiments depend on the ability to join genetic material of different 
sources and then to propagate the resulting hybrid elements in single 
bacterial and animal cells. The NIH Guidelines establish carefully 
controlled conditions for the conduct of experiments involving the 
insertion of such recombinant genes into organisms such as bacteria. 
The guidelines were developed by a scientific advisory committee 
created by NIH in response to requests by many scientists engaged in 
this field of research. These scientists had previously called for 
a moratorium on certain kinds of experiments while appropriate guidelines 
were devised. In December 1975 the NIH Recombinant DNA Advisory Committee 
[ 3 ] 
