Dr. Donald S. Fredrickson 
September 28, 1976 
Page 3 
public interest is now paramount. The way in which the licensing is imple- 
mented, therefore, must encourage this prudence in every possible way. Open 
licensing is one such way. Careful consultation with industry prior to 
announcement of any particular guidelines is another way. 
It is our feeling that the practise of these inventions in the United States 
is likely to be more stringent and proper than elsewhere. This will serve no 
useful purpose if the corollary is that most of such work is -therefore done 
outside the United States. 
Another distinction which must be clarified arises from the second paragraph 
in the public relations release attached to your letter. It is said that the 
patent would cover commercial use of the process, but not academic or indus- 
trial research. I think it's clear that some of the nightmares which the 
guidelines are intended to obviate, if they were in fact to happen, could 
just as easily happen in industrial research (not covered by the patent) as 
in subsequent "commercial use." In fact, one could even surmise that the 
commercial use would be safer having been extensively tested during the 
period of industrial research for safety, among other parameters. How does 
one intend to police this industrial research? Could one circumvent the 
patent by conducting the industrial research (not covered) in the United 
States and then implement the commercial use in some other country? A not 
very difficult scenario for a multinational corporation! 
So there are certainly some very loose ends and it is probably unreasonable to 
expect the granting of a patent to tie them up. It is even more unrealistic 
to justify the patent as a means of tying them up. 
We feel quite differently about subsequent patents of a narrower nature, of 
which we believe the University of Alabama patent to be an example. Whether or 
not it is, one last point comes to mind. One can anticipate that a category of 
patents which would issue from this work would address the specific industrial 
processes (such as those mentioned in the press release to produce insulin and 
other hormones) made possible by the development of "new" bacteria. This is 
the real commercial payoff, the objective of the industrial research. As is 
the case with current microorganism strain development and selection programs 
in. the antibiotics industry, the companies can be expected to jealously guard 
their unique microorganisms as being integral to the patented commercial pro- 
cess. The nature of recombinant DNA research means that these microorganisms 
will also have to be vehicles of an EK2 or more stringent type. The present 
guidelines insist upon the free availability of all such vehicles within the 
scientific community. It is unlikely that industry will want to invest much 
money and many years toward the development of such microorganisms if they are 
required to make the end result of all this work freely available. 
We have probably only scratched the surface. We are carefully studying a wide 
variety of possible commercial applications of recombinant DNA technology and 
it is clear to us that large scale profitable industrial use is many years 
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