Sample letter to the NIH Recombinant DNA Molecule Program Advisory 
Committee. 5 ' 
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NATIONAL INSTITUTES OF HEALTH 
BETHESDA. MARYLAND 20014 
August 27, 1976 
Dear 
As you may know, Stanford University and the University of 
California have proceeded to file a patent application on a process 
for forming recombinant DNA. This invention was generated in perform- 
ance of an NIH grant. A number of other Universities, including the 
University of Alabama, may also file patent applications on derivatives 
of recombinant DNA research. Notwithstanding Stanford’s right to file 
under the terms of a prior agreement with the Department, they have 
solicited NIH's view on an appropriate plan for administration of this 
invention. A copy of their letter on the matter is enclosed. 
These patent activities, the certitude that other important 
inventions in this field are forthcoming, and the public's apprehension 
over control of recombinant DNA research compel inquiry into whether 
the Department’s normal policy of allocating invention rights is 
consonant with the concerns about this research or whether special 
treatment would be more appropriate. 
Invention rights are normally allocated in either of two ways 
under Department patent regulations: 
First, if a University or other nonprofit institution seeks to 
enhance its technology transfer capability, the Department may enter 
into an Institutional Patent Agreement (IPA) . This provides to the 
institution the first option to ownership in all inventions made in 
performance of Department research, subject to a number of conditions 
deemed necessary to protect the public interest. Some of the more 
important conditions are 
(1) a royalty-free license permitting the Government and those 
functioning under Government direction to practice the invention, 
(2) a limit on the term of any exclusive license granted, 
(3) Department authority to withdraw specified grants from the 
agreement , and 
(4) the right of the Department to regain ownership due to public 
interest considerations or the institution’s failure to take 
effective steps to commercialize the invention. 
A more detailed outline of such conditions is enclosed. 
* [Editor's note: Essentially the same letter was sent on September 7, 
1976, to representatives of private industry and to witnesses who had 
testified at the Director's Advisory Committee meeting on February 9-10, 
1976.] 
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