Fighting over Tissues

“What?! What you mean you got her cells in your lab?” Bobbette Lacks yelled across the dining room table. Bobbette had just discovered that her mother-in-law's cells were being used in research labs across the world, despite the knowledge or permission of any of the Lacks family members, even Henrietta.

The treatment of biological materials in science has vastly changed since 1951, the year Henrietta’s cells were taken and immortalized in culture. While sixty years ago it was common practice for doctors to collect tissue samples without the knowledge of the patient, doctors must now obtain the consent of patients before removing any tissue. Depending on the nature of the informed consent agreement, patients may exercise the right to direct the destruction of their donated tissue after donation. Although a precise definition of tissue ownership has not yet been specified for every possible scenario, the definition has been narrowed as more cases have presented themselves in court.

The 1990 case of Moore v. Regents University of California, established a patient's right to awareness of the intended use of the tissues they have willingly donated. In Greenberg et al. v. Miami Children's Hospital Research Institute, Inc., et al. (2003), the court clarified that tissue ownership is transferred to the recipient upon donation, granted informed consent was obtained for the tissue sample(s).

The advent of DNA sequencing technologies has further blurred the line regarding ownership of genetic material. Since the first human gene was patented in 1980, somewhere between 3,000 and 5,000 genes have been patented in the U.S. alone. The process of gene patenting has since changed, however. In the 2013 Association for Molecular Pathology (AMP) v. Myriad case, the court clarified that the patenting process applies only to inventions, not discoveries. In other words, a gene sequence found to exist within an organism is not considered patentable, whereas a DNA sequence synthesize in a lab could be patented. Overall, the court’s ruling reduced the types of genetic materials whose applications could be restricted on the basis of intellectual property. Given the growing collection of sequencing data, it is critical that we ensure the simultaneous protection of patients and scientists.