Donald S. Fredrickson, M.D. 
Page 2 
September 30, 1976 
Need for Adherence to the Guidelines : 
It appears entirely appropriate for NIH to administer 
patents and licenses in the recombinant DNA research 
activity area in a manner that will require commit- 
ments from patent holders and licensees to observe 
appropriate safeguards, including adherence to the 
guidelines. As you know, the various pharmaceutical 
manufacturers engaged in research in this field have 
indicated a willingness to follow appropriate guide- 
lines and have offered suggestions with respect to 
their further development. 
Therefore, we recommend that NIH adopt in principle 
option 4 as outlined on page 3 of your letter of 
September 7. We suggest, however, that it should 
not be necessary for the Department to approve 
individual licensees, but that patent holders include 
in license requirements that licensees agree to follow 
the guidelines. 
We feel that the overwhelming public health consider- 
ations applicable to research in the recombinant DNA 
field should prompt NIH to include this basic require- 
ment in its further negotiations with the universities. 
In all probability, these universities would have no 
objection to including in their license agreements 
guideline adherence requirements. 
Dissemination of Research Information : 
As noted in your letter, the present patent system 
provides incentives for research and development in 
a manner consistent with the public interest. It 
also provides for prompt publication of data involving 
new inventions. To forestall inappropriate delays in 
the processing of patent applications in the field of 
recombinant DNA activity, such applications could 
receive "special" treatment in the Patent and Trade- 
mark Office. The Office could be requested by HEW 
to accord "special" treatment to applications in 
this field. A precedent exists for such treatment 
in the field of inventions associated with environ- 
mental protection. 
[127] 
