Donald S. Frederickson, M.D. 
November 30, 1976 
Page 2 
recombinant DNA procedure and organism. 
In the discussion of functions and processes required in the 
regulation of recombinant DNA research, I believe there 
should be an extension of that discussion to the regulation 
of the production and use of recombinant DNA organisms, or 
other inventions resulting from DNA research. From our 
past experience with inventions of processes or compounds 
where the maintenance of certain quality levels is required, 
we believe that a strong patent, and the careful definition 
of terms in the licensing of said patent, provides a very 
effective means of controlling quality, production, or use. 
I suggest that the use of patents as a means of such regula- 
tion be added to the list of issues for review that your 
Subcommittee will develop. 
Sincerely yours 
James S. Coles 
JSC :mm 
cc: C. H. Schauer 
cc: Willard Marcy 
[ 203 ] 
