Written Testimony for the House Subcommittee on Courts and

Intellectual Property of the Committee on the Judiciary

"Gene Patents and Other Genomic Inventions"

Submitted by the Kidney Cancer Association

July 13, 2000

Thank you for allowing me to talk to you today. I am Carl Dixon, the President and Executive Director of the Kidney Cancer Association ("KCA" or "Association") a voluntary, patient organization, which for over a decade has been dedicated to helping kidney cancer patients and their families deal with the physical, emotional and social impact of kidney cancer. I hold a JD from the University of Chicago's Law School and an MA from the Fletcher School.

As the only national kidney cancer patient organization, directed by patients for patients, the Association realizes the importance of a national policy which encourages and rewards the development of gene and genomic inventions.

Kidney cancer is an uncured disease. There are approximately 200,000 Americans who have kidney cancer. About 30,000 new cases are diagnosed each year. And each year about 12,000 Americans die from kidney cancer. The incidence of kidney cancer in the nation is increasing at an annual rate of about 3%. It is one of only three types of cancer with an increasing incidence. The average age of a kidney cancer patient at the time of diagnosis is 62.5 years.

The KCA appreciates the opportunity to provide written and oral testimony to the House Subcommittee on Courts and Intellectual Property of the Committee of the Judiciary (the "Subcommittee"). The Association is available to assist the Subcommittee with needed information as it continues to review gene patent and other genomic inventions.

The Association commends the Subcommittee for assessing and reviewing the complex subject of gene patents and other genomic inventions.

An important part of the Association's mission is encouraging research, so that kidney cancer ceases to be an uncured disease. Private sector research and development provides the best hope for finding new cures for cancer, including those likely to come from genes. At the same time, research and development is the riskiest form of investment, offering at best a very long term payback.

All of us are excited about the implications of the completion of the working draft of the sequence of the human genome. This project produced more than 22.1 billion bases of raw sequence data. Thus far analysis of this data shows 38,000 predicted genes, which have been confirmed by experimental evidence. There may be thousands more. Dozens of disease genes have already been pinpointed.

What makes up these genes? They are composed of Deoxyribo nucleic acids, DNA, that are associated with different proteins, such as histones. Genes are found in condensed strands, called chromosomes. Each of us has 23 pairs of chromosomes.

Among individuals there is genetic variation. The variations are commonly in the form of single nucleotide polymorphisms, also known as SNPs. Each SNP molecule in its natural state is simply a molecule with a double helix structure. In order to be used in any way each SNP molecule has to be processed into an industrial version.

In other words, it has to be taken out of its natural environment and isolated. Next each SNP molecule must be profiled--linked or associated with a specific condition, such as kidney cancer. This would then enable one to use the SNP molecule for example, to pinpoint a risk for or diagnose kidney cancer.

In fact, the Association is presently funding research to profile a gene or genes associated with kidney cancer. It recently awarded a grant to Stanford University's Department of Urology to begin this process.

What happens next? Once an SNP molecule is isolated, profiled and a useful application for it is found, then actual development begins. The discovery of a useful application results in the "industrialization" of the SNP molecule. At this point, a patent application for the SNP molecule would be filed. No one would begin the expensive process of drug development without intellectual property protection.

After securing protection for intellectual property--i.e., the isolated, profiled and industrialized SNP molecule--commercial development can begin. At this point in time the SNP molecule is analogous to insulin, interferons and interleukins. These are all molecules of naturally occurring substances which have gone through a similar type of process. All of these molecules are protected by patents having an initial term of 20 years from the effective date of filing. All of these molecules have lead to life saving therapies.

The Association respectfully requests that you treat a SNP molecule like these other molecules. All exist in nature but are useful only after they have been isolated, profiled and industrialized. All are life saving only after a medicine has been developed. SNP molecules should be subject to the same type of patent protection as these other molecules.

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. This development can take place only if commercial enterprises are able to commit substantial amounts of capital to research and development. These commitments will only be made if the commercially standard 20 year from filing patent term is available for the SNP molecule.

Respectfully submitted,

Carl F. Dixon

President and Executive Director