September 28, 1976 
Dr. Donald S. Fredrickson 
Director 
National Institutes of Health 
Bethesda, Maryland .20Q14 
Dear Dr. Fredrickson: 
Thank you for requesting our views on the question, of patent applications 
in the area of recombinant DNA research activity. 
We feel that there are two quite distinct reasons why this matter deserves 
the careful attention which you are giving it. 
First, the profound and far-reaching nature of the patent claims, as we 
understand them, are such that should the patent be granted and be found 
valid, it seems that any application of recombinant DNA technology in the 
United States will require a license. There are serious questions respecting 
both the fairness and practicability of implementation of this kind of control. 
There are also public interest issues regarding the policing of this work in 
the United States and the effect which the limitation of at least the existing, 
far-reaching patent to the United States would have, encouraging nonlicensees 
to practise the inventions outside the United States. 
The other major issue, again primarily one of public interest, concerns the 
environmental and other safety issues addressed by the recently published 
guidelines and the extent to which the way in which the patents are handled 
impinges on developments in this area. 
Let us state our conclusions and follow them with some paragraphs of explana- 
tion. 
We feel that alternative 4 on page 3 of your letter is the most 
sensible way to proceed with two very important stipulations. 
First, we believe that any exclusive license, granted to anyone on 
any specific application of this technology, no matter how narrowly 
defined, and no matter for how short a period of time, would be 
extremely unwise. Secondly, using compliance with the NIH guidelines 
as a condition for licensing is a splendid idea, but the specific 
way in which this is implemented could be either the best or the 
worst feature of the program. We feel that the special needs of 
industry, which have not yet been properly considered* must be 
addressed in a fair and deliberate manner because it is from industry 
that the license fees are expected to come. We also have some 
concern about the nature of the enforcement of this compliance. 
Surely the universities are not set up to do this properly. 
* Our strong views on this subject have already been communicated to you. 
Cetus Corporation, 600 Bancroft Way, Berkeley, California 94710 Phone: (41 5) 549-3300 
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