PHARMACEUTICAL MANUFACTi/reRS 
Jf'W. Vf ///&// 
1155 FIFTEENTH STREET, N . W. 
WASHI NGTON, D. C. 20005 
C. JOSEPH STETLER 
PRESIDENT 
AREA CODE 202-296-2440 
September 29, 1976 
Donald S. Fredrickson, M. D. 
Director 
Public Health Service 
National Institutes of Health 
Bethesda, Maryland 20014 
Dear Dr. Fredrickson: 
We appreciate the opportunity to provide our views and comments on 
the patent policy considerations regarding DNA research raised in your 
September 7, 1976 letter. 
The scientific, moral and social responsibilities of the scientific 
community in the new field of recombinant DNA research and development have 
been the subject of much discussion in recent months. I know that you are 
generally familiar with the PMA' s September 22, 1976 testimony before the 
Senate Labor and Public Welfare Committee on this subject. Enclosed is a 
copy of our statement in which the PMA notes its support of the general 
approach of the June 23, 1976 National Institutes of Health "Guidelines for 
Research Involving Recombinant DNA Molecules." The pharmaceutical industry 
supports the concept of these voluntary guidelines, subject to minor 
modifications. The research-based drug industry will undoubtedly have few 
problems in achieving full compliance with the spirit of the guidelines. 
The PMA, and its member companies, also strongly support the present 
system of laws in the United States for protecting intellectual property 
rights. The United States patent law is an essential aspect of intellectual 
property right protection in this country, and we oppose any attempts to 
weaken this system to the detriment of both the public and the research and 
development community. Our support of the United States patent laws in 
providing an effective incentive to conduct research and to develop research 
results to commercial applications encompasses both Government and privately 
funded efforts. 
[ 106 ] 
Representing m a n ufa ctu rers of prescri p tio n pharmaceuticals, 
