When Lisbeth Ceriani, a 43-year-old Massachusetts woman, was diagnosed with breast cancer last year, her doctors recommended that she undergo genetic testing to see if she carried mutations in the BRCA1 and BRCA2 genes that increase risk of breast and ovarian cancers. She had several risk factors for inherited cancer, including relatives who had died from breast and ovarian cancer. “My dad’s mother wasn’t diagnosed with ovarian cancer, but we feel sure she had it after reviewing her symptoms,” Ceriani says.
When Ceriani’s doctors submitted her blood to Myriad Genetics—the only company that offers a sequencing test for BRCA mutations—the company refused to process it, saying that Myriad did not accept Ceriani’s health insurance. She could not afford to pay for the test herself (it costs nearly $4,000), so she did not have it done. If there had been a cheaper test or a company that took her insurance, she would have known quickly what her best treatment options were.
There is only one test for BRCA mutations because Myriad controls the BRCA genes. The U.S. Patent and Trademark Office awarded the company its first patent in 1997; by 2000 the patent office had awarded it eight more, in effect giving Myriad ownership of the genes. Accordingly, the company is allowed to decide who may study the genes and has written cease-and-desist letters to university geneticists working on alternative BRCA sequencing tests.
This year Myriad’s patent was challenged in court by the American Civil Liberties Union on behalf of 20 plaintiffs, including the American College of Medical Genetics, the Association for Molecular Pathology, and various individuals, including Ceriani. The lawsuit charges that the BRCA patents—and gene patents in general—violate established laws that prohibit the patenting of products and laws of nature. According to the ACLU, “Human genes, even when removed from the body, are still products of nature.”
Critics also argue that the process of locating specific genes does not warrant the awarding of patents. “A number of researchers had been looking for the genes related to breast cancer and knew where the genes were likely to be,” says Arupa Ganguly, a geneticist at the Hospital of the University of Pennsylvania and one of the plaintiffs in the ACLU suit. “Essentially the work was done for Myriad already. Everyone knew where the gene was.” Myriad has refused to comment and in July filed a motion to dismiss the lawsuit. That motion was denied by a New York federal district court in November.
Robert Cook-Deegan, director of the Institute for Genome Sciences and Policy at Duke University, does credit Myriad with discovering specific mutation sequences and building a public database of genetic variations—both valuable contributions. But he says that many scientists believe Myriad’s control has slowed or blocked research, and it “certainly has made researchers more cautious in how they report relevant findings.” At the least, geneticists in the United States do not have the option of making a more accurate screening test because doing so would infringe on Myriad’s patent.
The ACLU argues that gene patents as a whole inhibit the free flow of ideas and should not be awarded. “Gene patents defy common sense,” says Chris Hansen, one of the ACLU lawyers handling the case. “If you’re at a cocktail party and you tell people human genes are patented, almost everyone will say that can’t be right.”
Right or not, about 20 percent of all human genes already have been included in patent claims. Whether that number will stand or even grow will depend on how the ACLU suit is decided.
