When Lisbeth Ceriani was diagnosed with breast cancer, she wanted a blood test to find out if she carried one of the two dreaded BRCA genes, which could increase her risk of ovarian cancer by up to 50 percent. She decided that if she were a carrier, she would have doctors remove her ovaries. But the sole purveyor of the BRCA tests, Utah-based Myriad Genetics, refused her insurance. Myriad holds the patent on the BRCA genes, and thus exclusive R&D rights, so there were no alternative tests, and Ceriani found herself unable to make a decision about her future health.
This May, Ceriani and five other women in similar straits joined the American Civil Liberties Union and organizations representing 150,000 scientists and filed suit against Myriad and the U.S. Patent and Trademark Office. The coalition claims that Myriad’s patents on the BRCA-1 and BRCA-2 genes are invalid according to the legal argument that “products of nature” are unpatentable. The plaintiffs hope a win could end gene patenting—the practice of securing ownership of a gene because you have found a new use for it, such as a diagnostic test. “Patents give companies total control over a gene,” argues Sandra Park, an attorney with the ACLU Women’s Rights Project. “There is a monopoly on testing, and companies can set whatever price they want.” (Myriad charges $3,000 for the BRCA test.)
Lisbeth Ceriani, 43, and Her Daughter, Bella
Myriad is digging in its heels. The company refused comment on this story, but it “strongly believes its patents are valid and enforceable and will be upheld by the courts,” said Richard Marsh, Myriad’s general counsel, in a statement. History is on Myriad’s side: Nearly every suit challenging the legality of gene patenting has lost. Patent law identifies products of nature as unpatentable, but the Patent and Trademark Office treats genes as exceptions if they have been isolated from their natural state as part of an organism’s genome. The patent office has issued thousands of gene patents—totaling 20 percent of all human genes—on these grounds, allowing companies that hold patents to reap substantial profit by creating diagnostic tests and charging other parties fees to conduct research on those genes.
The wall of legal precedent that faces opponents of gene patenting is formidably high, acknowledges Kenneth Berns, a microbiologist at the University of Florida. All the same, he cheers the ACLU’s attempt to scale it. “Human genes are not something anybody invents,” Berns says. “When you patent genes, you put a stop to research and development on new therapies, because no one can do anything without permission.” Myriad’s absolute control over the BRCA genes, for example, has hampered research into the significance of minor variations within the gene found in non-Caucasian ethnic groups.
Bill Warren, a life-sciences expert at the Sutherland law firm in Atlanta, thinks challenging the concept of gene patenting might be misdirected. The ACLU could be better off arguing that Myriad’s patents required no real innovation and are therefore moot. “A court recently decided that the gene-sequence claims in a particular patent were invalid because they were obvious,” Warren says, “but it would be highly unlikely for the federal circuit to reverse its long-standing position on the patentability of isolated human genes.” He also dismisses the plaintiffs’ claims that gene patenting is stagnating advances in the biotech industry. “Patent protection supports expensive drug development and clinical trials,” he says. “Those things could not proceed without a limited monopoly.”
A system in which biotech firms can make money without stifling research might be the best solution, according to David Ewing Duncan, director of the Center for Life Science Policy at the University of California at Berkeley. Duncan proposes a government-run initiative that subsidizes research connecting gene sequences with particular diseases. Any company could lease these public results for a limited time to make and sell genetic tests for profit. This would give biotechs a revenue stream while encouraging research, a tactic that has worked in vaccine development. Although the Myriad-ACLU faceoff is unlikely to yield such an unconventional settlement, biologists will be watching the case. “You can’t really invent around genes,” Park says. “They’re the fundamental basis for everything else that comes after.”