DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NATIONAL INSTITUTES OF HEALTH 
BETHESDA. MARYLAND 20014 
March 2, 1978 
Dr. Robert M. Rosenzweig 
Vice President for Public Affairs 
Stanford University 
Stanford, California 94305 
Dear Dr. Rosenzweig: 
Shortly after the release of the NIH Guidelines on Recombinant DNA 
Research in June 1976, you sent me a letter requesting that the 
National Institutes of Health review DHEW policies relating to the 
patenting of recombinant DNA research inventions. As you know, your 
letter prompted NIH to review current DHEW patent regulations govern- 
ing existing institutional patent agreements and to consider how 
recombinant DNA research inventions should be handled under the terms 
of those agreements. Over the summer and fall of 1976, NIH solicited 
comments from a broad range of individuals and institutions on this 
matter . 
An analysis of the comments received on the question of patenting 
recombinant DNA inventions was completed in December 1976, and was 
referred for review to the Federal Interagency Committee on Recombi- 
nant DNA Research. As you know, this Committee was convened by the 
Secretary of HEW, with the approval of the President, to address the 
extension of NIH Guidelines beyond NIH to the public and private 
sectors . 
In an interim report to the Secretary in March 1977, the Committee 
recommended that legislation be developed to govern the conduct of 
recombinant DNA activities nationally. On the basis of those recom- 
mendations, an Administration bill was drafted and was introduced in 
Congress by Senator Edward M. Kennedy and Representative Paul G. Rogers. 
Congressional hearings were held, but no bills were enacted in the past 
session. It appears, however, that new bills will be considered shortly 
by the relevant congressional committees. 
The Committee reviewed NIH patent policies with respect to recombinant 
DNA research in May, and the Public Health Service and the Office of the 
General Counsel completed a review of the report in December. The report, 
enclosed, provides an analysis of all comments received on this matter 
and of the Interagency Committee review of patent policy. On the basis 
of the findings contained in the report and my discussions with Dr. Julius 
Richmond, the Assistant Secretary for Health, and Peter Libassi, General 
Counsel for the Department, it is my recommendation that at least for the 
present, recombinant DNA research inventions developed under DHEW-NIH 
support should continue to be administered within current DHEW patent 
[1A] 
