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At the hearing, Harold Varmus (Memorial Sloan-Kettering Cancer Center) stated that some of the issued patents appear to reward the obvious in DNA sequencing and diminish the innovative work required to determine gene function and utility. This new environment, he said, has led many academic institutions to establish expensive offices to protect intellectual property and regulate the exchange of biological materials that once would have been shared freely. The use of new scientific findings has been hampered, and the open exchange of ideas and materials has been inhibited, he continued. Dennis Hopper (Genentech, Inc.) testified that his company invests about $400million a year in the research and development of therapeutic products, focusing on identifying human proteins. He said patent protection and market exclusivity are very important considerations in making such investments. Jon Merz (University of Pennsylvania, Philadelphia) expressed concern about exclusive licensing of disease-gene patents that claim a gene sequence and one or more mutations leading to disease. In addition to covering all uses of the chemical sequences, patents claim all methods of diagnosing disease in a specific patient through the identification of the disclosed genetic alleles, mutations, or polymorphisms. Merz stated that some licensees thus are exercising their patent rights to prevent physiciansin particular, molecular pathologists from performing genetic testing on their patients. Merz pointed out that most disease genes are found, at least in part, through federally funded research. Exclusive licensing is contrary to the longstanding policy that the public should not have to pay twice. Merz recommends reserving exclusive licensing for inventions that require substantial downstream investment. Other witnesses said that patents should be even more available to encourage the development of critically needed medical advances. PTO Director Q. Todd Dickenson stated that both points of view are relevant and that his office is responsible for balancing them. To that end, he said, the PTO is finalizing guidelines to require the demonstration of real-world utility for gene-related patents, rather than just theoretical uses. |
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