Who owns your genes? The assumption of any sane person would be that he or she owns his or her own genes. I mean, how dumb a question is that?
Yet, in 2007, Dov Michaeli, MD, PhD, described how an American company had claimed ownership of genetic materials and believed that it had the right to commercialize those naturally occurring bits of DNA. Myriad Genetics began by patenting mutations of BRCA. Dr. Michaeli issued a call for action to support early efforts to pass legislation to restore and preserve individual ownership of one’s own genes. This is a historically important quick read/watch/listen. Give it a click.
In related legislation, the Genetic Information Nondiscrimination Act (GINA), originally introduced by New York Rep. Louise Slaughter in 1995, was ultimately spearheaded by California Rep. Xavier Becerra (now Secretary of Health & Human Services) to passage by the House of Representatives on April 25, 2007, by a vote of 420-9-3. Led by Sen. Edward Kennedy of Massachusetts, it was passed by the Senate on April 24, 2008, by a vote of 95-0. President George W. Bush signed the bill into law on May 21, 2008.
GINA is a landmark piece of legislation that protects Americans. It prohibits employers and health insurers from discriminating against people on the basis of their genetic information, and it also prohibits the use of genetic information in life insurance and long-term care insurance.
Its impact has been immense. GINA has been indispensable in promoting progress in the field of human genetics. By safeguarding individuals against discrimination based on genetic information, it has encouraged broader participation in research, built public trust, and stimulated advancements in genetic testing and personalized medicine. GINA’s impact extends beyond borders and has influenced much of the rest of the world.
As important as GINA was to the field, more was needed. National legislation to protect ownership of genetic materials has, despite many attempts, still not become law in the United States. However, in our system of divided government and balance of power, we also have independent courts.
June 13, 2023, was the 10th anniversary of another landmark event. The legal case is that of the Association for Molecular Pathology v. Myriad Genetics, a Salt Lake City–based biotech company that held patents on isolated DNA sequences associated with breast and ovarian cancer. The AMP, joined by several other organizations and researchers, challenged Myriad’s gene patents, arguing that human genes are naturally occurring and, therefore, should not be subject to patenting. In a unanimous decision, the Supreme Court held that naturally occurring DNA segments are products of nature and therefore are not eligible for patent protection.
This was a pivotal decision in the field of human genetics and had a broad impact on genetic research. The decision clarified that naturally occurring DNA sequences cannot be patented, which means that researchers are free to use these sequences in their research without fear of patent infringement. This has led to a vast increase in the amount of genetic research being conducted, and it has also led to the development of new genetic tests and treatments.
The numbers of genetic research papers published in scientific journals and of genetic tests available to consumers have increased significantly, while the cost of genetic testing has decreased significantly. The AMP v. Myriad decision is likely to continue to have an impact for many years to come.
Thank you, common sense, activist American molecular pathologists, Congress, the President, and the Supreme Court for siding with the people.Dr. Lundbert is editor in chief of Cancer Commons. He has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.