Appendix I 
SAMPLE LETTER ON DHEV PATENT POLICY AS APPLIED TO RECOMBINANT DNA INVENTIONS; 
ADDRESSEES; RECOMBINANT DNA ADVISORY COMMITTEE 
DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE 
PUBLIC HEALTH SCRVICE 
NATIONAL INSTITUTES OF HEALTH 
BETNC&OA MARYLAND 20014 
September 8, 1976 
I am writing to solicit your views on the question of patent applications 
in the area of recombinant DNA research activity. 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 performance 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 terras of a prior 
agreement with the Department, they have solicited NIH's view on an 
appropriate plan for administration of this invention. 
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 
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