DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE 
PUBLIC HEALTH SERVICE 
NATIONAL INSTITUTES OF HEALTH 
aCTHKSOA. MARYLAND 20014 
August 19, 1976 
The Honorable John J. LaFalce 
Member, United States House of 
Representatives 
Federal Building 
Buffalo, New York 14202 
Dear Mr. LaFalce: 
I am writing in response to your letter of August 9 requesting 
information on the Public Health Service patent policy with respect to 
recombinant deoxyribonucleic acid (DNA) research. The article in 
Nature , to which Dr. Krasner refers, summarizes the current patent 
policies of the Department of Health, Education, and Welfare (DHEW) . 
Through the "deferred determination" policy the Department retains 
the right to exercise ownership claims on a new invention that was 
developed under DHEW grant or contract. However, the inventor or 
his Institution may request the Department to waive the right to 
ownership so that the inventor can assert patent claims. In 
approximately 90 percent of the cases where a request has been filed, 
the Department has agreed to waive the right. 
In addition to this general policy, there is another departmental 
policy which provides for institutional patent agreements between 
DHEW and universities or other non-profit organizations. These 
agreements described in the Nature article allow the institutions 
on their own initiative to assert patent claims for Inventions 
developed under DHEW support. The Department currently has agreements 
with approximately 65 universities. These agreements set forth a 
number of conditions with which the institutions must comply, and 
the Department has the right to prescribe new conditions prospectively. 
Stanford has an institutional patent agreement with the Department 
and has filed patent claims on certain recombinant DNA research 
techniques. However, in view of the recent National Institutes of 
Health (NIH) guidelines on the conduct of this research, Stanford 
has requested the NIH to review its decision to proceed with patent 
claims. Dr. Donald S. Fredrickson, Director of the NIH, currently 
is conducting such a review. As part of that review. Dr. Fredrickson 
has been meeting with Mr. Norman Latker, HEW Patent Counsel, and 
Dr. Betsy Ancke r- Johnson , Assistant Secretary for Commerce who is 
also chairman of the Committee on Government Patent Policy. Further, 
the patent agreement is being reviewed in light of the NIH Recombinant 
DNA Research Guidelines that carefully prescribe safety conditions 
under which this research will proceed. 
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