By Mahin Ahmed
Genes, the basic units of heredity composed of sequences of nucleotides, have been at the forefront of the public eye since Gregor Mendel’s monumental pea plant experiment. Since then, many breakthroughs have been made in genetics, including gene cloning, mapping the entire human genome, and gene editing with CRISPR. As the study of genes continues to grow with contemporary society, so advances the ever-inconspicuous commercial enterprise of genetics. A controversial business, it has encountered many ethical dilemmas and garnered public disapproval based on bioethics and the privacy of its customers.
One recent source of public dispute is gene patenting, a process where one could patent a gene they “discovered” and claim royalties from others performing activities with the gene. A situation in which pieces of the human genome could be owned as intellectual property seems absurd and unethical to the majority of the public. However, this is exactly what happened in 1997 when The Miami Children’s Hospital and Dr. Rueben Matalon attempted to patent the gene responsible for Canavan disease, a rare autosomal recessive disorder, using research from donated samples given by parents of patients.
Daniel Greenberg, along with Fern Kupfer, Frieda Eisen, and David Green, were the patients’ parents who worked alongside Dr. Matalon, the children’s physician, and The Miami Children’s Hospital in a joint effort to find the gene responsible for Canavan Disease in order to determine screening methods or even find a cure. Along with financial support, the parents donated tissue samples from the patients’ blood, urine, and autopsy samples. Thanks to these samples, Dr. Matalon was able to isolate the gene and patent it as well as to develop a screening test for the disease. This allowed him to claim royalty payments whenever a screening test was done for Canavan Disease as well as to receive compensation for any further activities using the gene. Greenberg and the other parents were understandably appalled; they had funded Matalon both financially and with tissue samples from their afflicted children, and he had, on a whim, used their selfless contributions as a business prospect to gain fame and wealth.
The parents had thought that any screening test that had developed from research rooted to their donated samples would be given at an affordable price and that the research would be accessible in the public domain in order for further research on treatment of Canavan Disease. They took their case to Southern Florida’s district court, claiming that Dr. Matalon was at fault for lack of informed consent, breach of fiduciary duty, unjust enrichment, fraudulent concealment, conversion, and misappropriation of trade secrets. In a historic decision, the court ruled in favor of Dr. Matalon and The Miami Children’s Hospital, claiming that the parents no longer owned their samples when researchers used them for testing. Due to this case, researchers could assume ownership of donated tissue samples from then on.
The discussion regarding whether genes should be allowed to be patented continued with fierce debate on both sides of the argument after the ruling. Proponents of gene patenting claimed that the process allows for profit and success in a generally unprofitable field of study, which in turn keeps the research of genes alive in that company and generates the profits that allow the company to prosper. They further argued that gene patents encourage competition between companies and within the field itself as companies race to discover and subsequently patent new genes that could be beneficial for the common human good.
On the other side of the argument, many challenged the premise of gene patenting itself, claiming that researchers should not be able to set patents on what already naturally exists. They argued that people do not invent genes and therefore any gene discovered and research associated with it should remain in the public domain. Furthermore, they voiced their concerns that patent holders could set whatever price they wanted for treatments based on their patent of a gene, meaning patients would either have to comply with their prices or continue to suffer with their diseases.
All of these debates boiled over in the 2013 Supreme Court case: Association for Molecular Pathology v. Myriad Genetics, Incorporation, in which the Supreme Court ruled that human genes are “product[s] of nature” and that they could not be patented in the US. The ruling was paramount: genetic companies were enraged and much of the public was enthralled; it was a case that brought on a new era of public domain genetics.
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