• Incyte. Incyte's strategy has been to offer nonexclusive licenses to its database. As of the time of the workshop, six companies (Pfizer, Upjohn, Novo Nordisk, Hoechst, Abbott Laboratories, and Johnson & Johnson) have contributed in the aggregate, around $100 million, exclusive of contingency payments and royalty payments for access to this database. Even as the Merck data continue to be placed in the public domain, Incyte continues to sign up new subscribers; there seems to be continuing value for the subscribing firms to obtain access to one of the private databases. This strategy is interesting not only for what it says about the nonexclusive-licensing strategy but because this is the most current information as to the relative values of the private databases versus the public-domain database.

The Informational Value of ESTs Is Rudimentary

None of the participants disputed the value of ESTs as research information, but several commented on the rudimentary nature of the information. Having an EST in hand does not guarantee a practical strategy for obtaining the identity of the gene of which the EST is but a fragment. Furthermore, if the gene identified is unknown, there remains substantial investment in understanding its function. It has been successfully accomplished in many cases, and many specific strategies have been developed over the years for approaching this task. Nonetheless, it remains fraught with uncertainty. In 1995 the Human Genome Organization (HUGO) issued a statement on ''Patenting of DNA sequences'' arguing that the nature of sequence information is so rudimentary that to limit access to it is to impede development of medical advances.

Several uses have been suggested for genes and gene fragments to claim utility requirement for patent protections. They include the use of genes or gene fragments for categorizing, mapping, tissue typing, forensic identification, antibody production, or locating gene regions associated with genetic disease. However, each of those suggested uses may not be carried out without considerable further effort and additional biological information that is not inherent in the sequence alone. Many of the workshop participants concurred with the HUGO statement that without databases to provide further information, the informational value of ESTs themselves is very limited.

William Haseltine, CEO of HGS, noted that patent applications filed by HGS for ESTs involve considerably more than simply identification of the gene fragments and involve information about the stage of development and tissue type in which those genes are expressed. He further commented that the importance of the EST database is not simply that the fragments are identified, but that the database itself provides a high level of information.



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