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"progovernment." In this role I have had excellent relations with the pharmaceutical industry despite my sometimes opposing testimony. In contrast, one of my testimonies before a Congressional committee was challenged, and some aides attempted to refuse its admission to the record because the data I had presented were prepared at the request of a pharmaceutical company. I cite these instances to point out that cooperation with industry does have potential drawbacks. In my opinion, the benefits far exceed the risks. In summary, I believe that Udenfriend's invitation for increased cooperation to members of the industrial and academic communities should be considered seriously. I hope that a joint committee will be established to explore ways of improving communication and collaboration . The committee should also look into legal and other obstacles which constrain relationships among academia, government, and industry . Academic freedom should not be affected by research collaboration with the government or the pharmaceutical industry. Academic scientists must prove themselves worthy of this trust and dissociate research collaboration from other efforts on behalf of government or industry . A Lawyer's View of the Role ofPatents RONALD L. ENGEL* Myjob as an attorney with a technical educational background has on occasion placed me, like Dr. Udenfriend, in a position at the interface of the pharmaceutical industry and academic biomedical research. As a result, I, too, have been an observer of the overall pharmaceutical translation process and of the effect of government policies on that process. My first comment on Udenfriend's excellent paper is to note an additional aspect of the slowness of the translation process as it exists in our country. Specifically, a patent is granted in the United States for a term of 17 years from the date of issue. As a practical matter, application for patent must be effected early in the translation process. The result is that the effective duration of a patent is reduced for a portion ofthe translation time. A good example of this phenomenon can be derived from a project *Kirkland & Ellis, 200 East Randolph Street, Chicago, Illinois 60606. Perspectives in Biology and Medicine ¦ Winter 1980 ¦ Part 2 | S91 with which I have had professional involvement, namely, the marketing here and abroad of Depakine (dipropyl acetic acid). This drug was available for its antiepileptic utility in Europe many years before FDA clearance could be obtained in this country last year. This differential in market-entry timing resulted in a differential in the effective patent protection, for the clock was ticking away on the U.S. patent term while the regulatory clearance process had the effect of preventing domestic marketing. In short, one governmental policy of fostering innovation by patent protection was being impeded by another governmental policy of slowly and deliberately putting a new drug through the paces of the approval process. As a policy matter, the questions of whether the government should encourage innovation through the patent incentive or should require meticulous adherence to clearance procedures to prevent thalidomide disasters are related. The government clearly ought to be consistent and reconcile its policies so that the left hand does not take away what the right hand gives. This of course leads into the prime thrust of Udenfriend's remarks regarding patents, namely, the effect of patent policy on pharmaceutical translation and the state of confusion respecting that policy. Addressing the latter point first, I note that Udenfriend says there was a time when no pharmaceutical companies would consider investing in the development of any discoveries made with even partial NIH support. Far from overstating the case, Udenfriend has been charitable in his remarks. I have represented for many years Indiana University Foundation, which includes among its several activities the licensing of patentable ideas developed at Indiana University (for example, Crest toothpaste). Under appropriate circumstances, Indiana University Foundation has accepted funds from industry for subsidizing research in exchange for the grant of license rights under resultant patents. I found that commercial sponsors were insistent that no government money attach to their research in order to obviate any taint on the patent situation. Indeed, at one point in the 1960s, I reflected that there must be something wrong with a system which put me in the following...

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Additional Information

ISSN
1529-8795
Print ISSN
0031-5982
Pages
pp. S91-S96
Launched on MUSE
2015-01-07
Open Access
No
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