Scientists urge caution on changing patent scheme for human genes

WASHINGTON - Despite fears that businessmen will exploit the human genetic code for profit, preventing companies from patenting their genetic work will only delay the fight against diseases, advocates told a congressional panel Thursday.

''The development of cures for uncured diseases, such as kidney cancer, will come out of the human genome project only if commercial development can take place,'' said Carl F. Dixon, president of the Kidney Cancer Association.

And businesses won't invest money into research and development without the expectation of getting something back, said Randal Scott, president and chief scientific officer of Incyte Genomics, Inc. of Palo Alto, Calif.

Incyte holds about 500 gene patents, the largest private amount in the nation. There have been about 6,000 issued so far by the U.S. Trademark and Patent Office.

''In the absence of patents, it will become much more difficult for companies like Incyte to obtain access to capital,'' Scott told the House Judiciary intellectual property subcommittee. ''This in turn will inevitably slow the development of genomic information and technologies, which will have a seriously negative impact on the promised acceleration in health care research.''

Critics have complained that gene patents should not be issued to companies because companies may restrict research access to the information.

While Congress will not consider any new patent legislation this year, the U.S. Patent and Trademark Office will decide on new regulations for gene patents this fall.

This comes less than a month after two teams of scientists from the Human Genome Project and a private company, Celera Genomics, of Rockville, Md. completed a rough draft of the human genetic code - nature's instructions for making and maintaining human beings.

Identifying human genes will make it possible to treat or prevent cancer, inherited disorders and some diseases, experts say.

The patent office's new rules with more stringent requirements on ''real world'' use for gene patents will help keep squatters from just putting their name on genes and hoping it will become valuable, said Todd Dickinson, the patent office's director.

''One simply cannot patent a gene itself without also clearly disclosing a use to which that gene can be put,'' he said.

For example, raw DNA sequence data, such as that recently generated by the Human Genome Project, is not patentable, he said.

Dickinson does support gene patents. ''Without the funding and incentive that are provided by the patent system, research into the basis of genetic diseases and the development of tools for the diagnosis and treatment of such diseases would be severely curtailed,'' he said.

However, Nobel Prize winner Harold Varmus, director of Memorial Sloan-Kettering Cancer Center, said the new rules might not go far enough. ''A patent could be issued for a gene or a portion of a gene based on still quite superficial and potentially misleading information about the properties of the gene or about how it might be used to diagnose, prevent, or treat disease,'' he said.