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Are there relevant legal cases?

Whether repositories, collection sites, private practices that maintain patient medical records, or tissue donors have intellectual property claims may vary from state to state and is generally ambiguous. In two famous cases in which a patient and donors provided tissue that was used to obtain commercial products, patent claims for tissue ownership or compensation were not supported.

Moore v. Regents of the University of California et. al. (1990)

This is the landmark case testing patient ownership of products derived from excised tissue. John Moore was undergoing treatment for leukemia. Without his knowledge, his doctor developed a valuable cell line from tissue obtained from Moore's splenectomy and continued to collect blood and other biological material from him for years. The California Supreme Court rejected a property right claim of Moore's to the cell lines while also finding the doctor did not obtain adequate informed consent for his research. There are several differences between the Moore case and ethical issues for repositories: it is unclear whether Moore's cells were ever banked, the research was conducted on identified tissue and without informed consent, and the researcher was also the patient's clinician.

The Moore case did not involve a repository. While repositories may regard the Moore case as one which shows that tissue donors have no financial interests in commercial products developed by end-users, it is important to also emphasize the court's support for Moor'e right to informed consent for research on his tissue.

Key Point: There have been no legal cases about individual rights relevant to commercial repositories.

Key Point: The Moore case involved the use of patient tissue (without informed consent) by the patient's doctor to develop a commercial product.

Greenberg v. Miami Children's Hospital (2003)

The recent Florida case denied donors control over the commercialization of genetic tests developed from their tissue. Dan Greenberg along with other families with children afflicted with Canavan disease became advocates for Canavan research. Greenberg and others convinced Dr. Matalon to work on the development of prenatal and carrier tests for Canavan disease. Families provided Matalon and his research team with tissue, blood and urine samples. In addition, Canavan advocates built a registry of families with a history of the disease including a record of autopsy tissues that had been preserved. Advocates also provided financial support for the research. In 1993, Matalon identified the Canavan gene and developed screening tests at Miami Children's Hospital (MCH). By 1996, The Canavan Foundation was able to offer free testing. Without the Foundation's knowledge, researchers at MCH filed for and received a patent for the gene and the carrier and prenatal tests. One result of the patent which the Foundation opposed was a new licensing fee for people undergoing testing. Greenberg sued Matalon and MCH but lost the case in the Florida court. The court ruled that the researcher and the hospital had a right to patent their work.

The above two rulings, while hardly establishing a trend, recognize the intellectual property interests of researchers and prevent compensation to tissue donors for products developed from their donated tissue.

The issue of compensation and control over commercial products developed from donated tissue continues. In some cases, patients will only donate their tissue if they receive compensation and researchers have refused to do the research (See: Ashburn). In a few cases, where tissue donation to a repository is specifically for a clinical trial, donors may be compensated for time and travel expenses.