By Jorge L. Contreras
In 2009, the American Civil Liberties Union (ACLU) launched a unique lawsuit against Myriad Genetics, challenging fifteen claims of seven patents covering various aspects of the BRCA1/2 genes and their use in diagnosing risk for breast and ovarian cancer. In mounting this case, the ACLU assembled a coalition of lawyers, scientists, counselors, patients and advocates in an unprecedented challenge not only to one company’s patents, but the entire practice of gene patenting in America. And, against the odds, they won. In 2013, the U.S. Supreme Court ruled in Association for Molecular Pathology v. Myriad Genetics that naturally occurring DNA sequences are not patentable, a ruling that has had repercussions throughout the scientific community and the biotechnology industry.
In The Genome Defense: Inside the Epic Legal Battle to Determine Who Owns Your DNA (New York: Hachette/Algonquin, 2021), I describe the long road that led to this unlikely Supreme Court victory. It began in 2003 when the ACLU hired its first science advisor, a Berkeley-based cellist and non-profit organizer named Tania Simoncelli. At the ACLU, Simoncelli’s job was to identify science-related issues that the ACLU could do something about, from DNA fingerprinting to functional MRI brain imaging. A couple of years into the role, Simoncelli mentioned gene patenting to Chris Hansen, a veteran ACLU litigator who had been involved in cases covering mental health to school desegregation to online porn. At first, Hansen didn’t believe her. How could a company patent something inside the human body? But Simoncelli persisted, showing him articles and statistics demonstrating that, by 2005, more than 20% of the human genome was covered by patents. The realization led to Hansen’s oft-quoted exclamation, “Who can we sue?”