THE UPJOHN COMPANY 
KALAMAZOO. MICHIGAN 49001 
TELEPHONE (616) 382-4000 
W N HUBBARD. JR M D 
President 
July 16, 1976 
Dr. Donald S. Fredrickson, Director 
National Institutes of Health 
Bethesda , Md. 20014 
Dear Don: 
This letter is in response to your transmittal of June 23rd of the NIH Guide- 
lines on work with Recombinant DNA. 
The substantive response to your memorandum will be made by Dr. Joseph E. 
Grady who was present at the meetings as our representative. As you may 
recall, I was traveling in Russia with Marty Cummings and Mary Corning at 
the time of the meeting. 
It seems to me that both the NIH Guidelines and your decision to release them 
are important and valid steps in allowing so-called genetic engineering 
research to go forward with a minimized danger. The guidelines for contain- 
ment are careful, and, in my view, quite appropriate. 
From the particular point of industry, there are really two issues that present 
themselves. The first of these is the problem of confidentiality, given the 
Freedom of Information Act, of disclosing protocols and research results prior 
to the time the patent process has been able to react. This is an important 
issue since the patent is the legal documentation of priority of a customer- 
oriented effort. There are large numbers of possible accommodations available 
which would fulfill the intent of the guidelines you have distributed but at 
the same time protect the intentions of the patent system. It would seem to 
me that discussion should go ahead quite promptly to identify those accommodat- 
ions that would be both feasible and acceptable. 
The second concern from industry is a much more general one, but also trouble- 
some. Policies and purposes that are unexceptionable at their origin have 
a very unhappy tendency to become transformed through mindless application 
of regulation into Frankensteins . I realize the nature of the process and 
the sense of frustration that every government in the world feels at its 
failure to protect its citizenry from the dead hand of self-serving bureau- 
cratic regulations. This is a statement not directed at any one country, 
since, to my knowledge, there is not a single exception to the problem. Only 
recently academic scientists have begun to appreciate that they are also at 
peril in their ability to undertake socially beneficial and appropriate 
research in the face of regulatory actions which impede, if indeed they do 
not totally frustrate, the conduct of such research. It is my impression then 
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