MILES LABORATORIES, INC. 
UVJ <A ELKHART. INDIANA 46514 
MARSCHALL DIVISION 
Phone 219 264-8716 
TWX 810 294-2249 
Cable MILESLABS ELK 
September 24, 1976 
Donald S. Fredrickson, M.D. 
Department of Health, Education, and Welfare 
Public Health Service 
National Institutes of Health, Bldg. 1, Rm. 124 
Bethesda, MD 20014 
Dear Dr. Fredrickson: 
I am writing in response to your letter of September 7, 1976, asking for my 
views in the area of patents for the recombinant DNA technology. At the out- 
set I would like to stress that the views expressed in this letter are per- 
sonal and do not reflect, in any manner, a corporate policy statement of my 
employer. Miles Laboratories, Inc. 
The scientists and their respective institutions appear to have filed a 
conventional and valid patent application to cover some very remarkable 
discoveries made in their laboratories . Your letter indicates that this 
is a normal procedure for NIH funded research, that by prior agreement they 
had the right to file for such a patent, and past experience has demonstrated 
that inventions covered by such an agreement are transferred quite effi- 
ciently to the public sector. I feel that although this is an extremely 
significant technological innovation and that certain applications of the 
technology must be done with extreme caution, the granting of a patent and 
its subsequent licensing should require no special treatment or interfer- 
ence by NIH. 
The major concerns involved in this issue are, as you stated, the need for 
a free and open exchange of information that would aid in insuring compliance 
with accepted safety procedures. I feel that this could best be accomplished, 
in the present case, by allowing the established U.S. patent system to oper- 
ate in its traditional manner. My personal experience has been that concern 
for patent rights does not unduly restrict the exchange of sound, reliable 
scientific information. On the contrary, I would suggest that the patent 
system in our country acts to facilitate the flow of information by publiciz- 
ing and detailing an innovation while offering protection for the inventor. 
I think that the alternatives to this approach, government ownership or public 
dedication of the patent rights, would only serve to confuse and complicate 
the utilization of this technology by setting a new and unusual precedent. 
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