Catalona And The Ownership Of Genetic Material
by Bruce Howell, Hughes & Luce LLP, Dallas, TX
The human genome is, simply put, a vast database. Six billion base pairs make up the genome, each containing information within itself and then linking to other base pairs in the complex organism we call life. And more today than ever before, this system of ATGC and the genes that these bases form along with the resulting proteins are a huge database from which information may be harvested for both the cure of disease, the understanding of life on earth and profit.
It is the latter that has produced the cases to-date that deal with the ownership of this human data. Whenever a discussion on the ownership of a person’s DNA comes up, it is always interesting to note how protective each person becomes when even the idea that someone else might own that data is raised. And yet, since human beings are mostly alike in their DNA structure, it is evident that the basic information of what makes up a human being genetically is, in essence, in the public domain since the publication of the human genome by the Human Genome Project.
But what about that tiny percentage of DNA that makes each one of us different? And what about the particular genetic information that identifies a rare disease? Can a person have ownership of that person’s own genetic material?
The cases to-date have been uniform in stating that once consent is given to the study of a person’s genome, the person loses the property rights to the information that makes up his or her human body. The two cases that dealt with this subject have squarely held that property rights in DNA are surrendered upon the granting of an informed consent to use tissue for research purposes. The question in these cases turns on whether or not informed consent is given, not whether there exists a property right. In the Canavan case, the court specifically declined to find a property interest in the body tissue and genetic information. Nevertheless, organizations such as institutional review boards are concerned about whether human subjects are being protected in clinical trials by being informed, inter alia, that they will lose rights in the human database when entering into such trials. An examination of consent forms drafted by pharmaceutical companies and research institutions shows this concern.
But what if informed consent is given? What if the participants have given consent to use of their material to a particular researcher, and then the institution claims that it owns the material, not the researcher? Has informed consent been given?
This is the situation in the case of Washington University v. Catalona . Dr. Catalona is a well known researcher in the field of prostate cancer research and had been employed by Washington University in St. Louis. Over the years, hea treated patients with prostate cancer and collected tissue samples from many of these patients, creating a large database of the genetic information of this disease.
When Dr. Catalona left Washington University, he sought to take the data from these samples with him to his new place of employment--Northwestern University. Dr. Catalona wrote to his patients and asked them if they wanted to transfer their samples to him at Northwestern, and approximately 6,000 of them agreed, signing the consent form to allow for such transfer. Washington University objected, stating that these samples belonged to the University and sued Dr. Catalona to stop the transfer, seeking a declaratory judgment action to the effect that the University owned such samples and the genetic information contained in them.
Several patients of Dr. Catalona whose samples were at issue were added to the case since they claimed that they had consented for him, not the university, to use the samples. They claimed ownership interests in the samples and that such interests were not being honored. The patients also claimed that, since their consent forms allowed them to withdraw from the clinical trials, they retained an interest in the tissue samples were being studied and could consent again to the transfer.
Thus, the question of the ownership of body tissue and in the DNA information contained therein came once again before a court.
In 2006, a year after the injunction hearing, the United States District Court (Eastern District, Missouri) granted summary judgment in favor of Washington University, holding that the patients had no rights in the tissues and, thus, the tissue samples could not be transferred to Dr. Catalona at Northwestern. The court based its decision on the reasoning that the patients had gifted the tissue to the University and, once gifted, they had relinquished control. A large part of the Court’s reasoning was based on the public policy of allowing medical research to continued unfettered.
The case has been appealed to the Eighth Circuit and fully briefed by both parties and amici from the patient advocate and medical research sides. While there are many other issues in the case, including evidentiary issues, the main focus of the appeal is the ownership of the tissues and the rights, if any, of the clinical trial participants. Oral argument was in December, 2006 and a decision is pending. Stay tuned.