October 14, 1976 
Dr. Donald S. Frederickson 
Director, National Institutes 
of Health 
9000 Rockville Pike 
Bethesda, Maryland 20014 
Dear Don: 
Recently you wrote to Mr. Robert Carow, a staff member of the Asso- 
ciation of American Medical Colleges, asking for the views of the 
Association with respect to the patent policy of the National Insti- 
tutes of Health as it might apply to discoveries arising from recom- 
binant DNA research. We have reviewed your letter to Mr. Carow to- 
gether with other materials relating to recombinant DNA research. 
After discussion, we recommend that you continue the present patent 
policy of the National Institutes of Health. We understand that 
Stanford and the University of California both have entered into 
institutional patent agreements with the Department of Health, Edu- 
cation and Welfare. Under the Department's normal policy of allo- 
cation of invention rights, we understand that the innovating insti- 
tution retains the primary right to convey ideas as patented intel- 
lectual -property. We see no reason to alter existing department 
guidelines on patent policy and believe that some version of the 
fourth option, set out on the third page of your letter, is the most 
appropriate choice. This option would permit institutions to exer- 
cise their option of ownership but require that all licensing of 
patented inventions be approved by the Department. 
We believe, further, that the NIH guidelines on DNA research should 
be extended to industry. In keeping with this belief the course of 
action you suggest, i.e., that compliance with the NIH guidelines 
on recombinant DNA research should be required of the secondary 
licensee, is the best course to follow. However, we hold that the 
enforcement of the secondary licensee's compliance with NIH guide- 
lines should be the responsibility of the primary patent holder and 
not the U.S. government. Our position follows from the fact that 
the government would not assume the primary role of enforcer in 
other patent circumstances. We hope that our views on this subject 
are helpful to you in reaching a decision and would be glad to dis- 
cuss the problem further if you desire. 
John F. Sherman, Ph.D 
Vice President 
[142] 
Suite 200/ One Dupont Circle, N.W./ Washington, D.C. 20036/(202) 4-66-51 OO 
