Dr. Petersdorf (cont) 
9/27/76 
Page Two 
justification for DHEW's policy of leaving patent rights to respon- 
sible universities (i.e., those having IPA agreements) is that the 
universities can do a more effective job of transferring technology — 
especially since the inventor is located at the university. 
If the proposal under Item (3) were implemented, it would be tanta- 
mount to admitting that the IPA procedure is not workable. Not so. 
In the final analysis, DHEW's IPA agreements already provide that 
the Government has "march in" rights (i.e., requiring the universi- 
ties to license widely) in cases where DREW declares that the inven- 
tion is "required for public use by governmental regulations, that the 
public health, safety, or welfare requires the issuance of such 
license(s), or that the public interest would otherwise suffer unless 
such license (s) were granted." 
Item (4) requiring that DHEW approve prospective licenses before they 
are granted by the university would introduce a time delay factor in 
the license negotiation process that might hamper effective negoti- 
ations by the university (or Research Corporation on behalf of the 
university). On the other hand, it might be feasible to modify IPA's 
to provide for pre-clearance of certain items (e.g., compliance with 
NIH safety guidelines), but only in connection with DNA-related inven- 
tions, or other sensitive inventions requiring close monitoring. Such 
pre-clearance should be initiated as soon as the invention disclosure 
is completed, so that the pre-clearance process would not stifle 
decisions on committing funds for patent applications and possible 
subsequent licensing negotiations. 
I do not understand the logic of approving only exclusive licenses, as 
suggested under Item (5), unless Dr. Fredrickson means that DHEW would 
not be concerned about these problems if the institution licensed on a 
non-exclusive basis. That doesn't make sense to me, since the problems 
he is concerned about need to be addressed, no matter whether licensing 
is exclusive or non-exclusive. 
The specific case that brought this matter to Dr. Fredrickson's attention is 
the Stanford-Calif ornia invention by Dr. Cohen and Dr. Boyer (see attached 
summary). In my opinion, this is a good illustration of the fact that the 
universities do act responsibly in their handling of invention rights dele- 
gated by DHEW. It may be necessary to implement some additional cross- 
checking with DHEW along the lines I suggested above in the handling of the 
DNA-related inventions, but I see no justification for disturbing basic 
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