© ISTOCK.COM/-OXFORDSeventeen years ago, Arupa Ganguly received a disturbing legal letter asking her to stop her work. Recently appointed to the faculty at the University of Pennsylvania’s Perelman School of Medicine, Ganguly, along with her colleagues, was offering screens for BRCA1 and BRCA2—two genes involved in DNA repair that, when mutated, increase a woman’s risk of developing breast and ovarian cancers. But in the late 1990s, molecular diagnostics company Myriad Genetics had acquired patents covering the BRCA genes, as well as dozens of BRCA mutations and methods to isolate and detect them, establishing a monopoly over the use of the genes in diagnostic testing. In the cease-and-desist letter received by Ganguly, the company asserted that the right to perform BRCA screens and return results to patients belonged solely to Myriad.
“I was very angry, to say the least. I was disappointed. I was sad,” says Ganguly, now the director of the Genetic Diagnostic Laboratory at Perelman. “But I had to go with it. No one was going to fight Myriad because, they thought, ‘A law is a law.’”
Following receipt of that letter, Ganguly avoided working on genes that were not in the public domain. Then, a decade later, the Association for Molecular Pathology organized a lawsuit to challenge Myriad’s BRCA patent claims, and Ganguly testified to a US District Court in New York that Myriad’s action had compelled her to halt BRCA research and screening. Over the next few years, the case made its way through the US Court of Appeals for the Federal ...