When you went to sleep last Sunday night, 20 percent of your genome belonged to a researcher or company. One day later, following federal district court judge Robert Sweet's ruling, it belonged to you.
Some activists cheered the landmark decision on general principle, but for others, it was a business and medical matter. They say the end of gene patents could be a boon for patients, who will benefit from gene-testing companies competing for their business.
"They'll have to deliver products to the marketplace faster, better and cheaper. There's all sorts of ways to make money," said Dan Ravicher, executive director of the Public Patent Foundation and a plaintiff in the lawsuit, which pitted civil rights activists and patient groups against Myriad Genetics, a Utah provider of tests on its patented breast-cancer-risk genes. "I'm a strong conservative. I believe companies are good and competition is good."
Myriad and its supporters, including the Biotechnology Industry Organization, had argued that gene patents were necessary. They made commercial profits possible, and potential financial rewards drove research.
Ravicher's foundation, the American Civil Liberties Union, and their supporters — including the American Medical Association, American Society of Human Genetics and March of Dimes — said this simply wasn't true.
Beyond the absurdity of gene patents — imagine patenting gold, the human arm, or gravity — they said that patents had hurt patients, stifled business and stunted research. Myriad's monopoly prevented women from getting second opinions on their breast-cancer gene tests. More broadly, existing gene patents dissuaded researchers from studying sections of the genome that were already claimed, and high licensing fees discouraged would-be entrepreneurs.
In a public statement, Myriad Genetics said it would appeal the decision.
"My hope is that this ruling stands and companies will need to actually innovate and create new advances based on genetic findings, not dependent on sole access to them," wrote Linda Avey, CEO of personalized genomics company 23andMe, in a comment on the Genetic Future blog. "Rather than relying on obscure patent language and legal strategies, companies will need to develop products that are competitively positioned."
One area of competition will be in the interpretation of gene mutations. Gene testers don't just plug a DNA sequence into a computer and wait for the result. They use an arsenal of interpretive techniques, and must update their approaches with new research.
"There are a lot of algorithms that each of us uses. Some are more right than others. There are differences in how you study mutations, weight them, and interpret the data," said Wendy Chung, a Columbia University breast cancer researcher and plaintiff in the lawsuit.
Chung said that Myriad's tests are well-regarded, but they've lagged in interpreting rare gene variants that each person has, but because they're so unique, have not been ascribed a clinical significance.
"On the academic side, there are a lot of people trying to computationally guess what the functions of these variants will be. Myriad has been conservative in saying, if we don't know what it is, then we won't make guesses," said Chung.
Gene-testing companies will also compete to do the best job explaining often-ambiguous genetic results to their customers. Business relationships with insurance companies and health care providers will become even more important. And companies will still be able to patent tools used to interpret genes.
"Companies can compete on quality, speed and taking the burden off hospitals," said Robert Cook-Deegan, a Duke University gene policy expert. The decision "does threaten some business models but it opens the gate for others."
Image: Dave Fayram/Flickr
See Also:
- Gene Patents Under Legal Attack
- Who Owns the Fountain of Youth?
- Scientists Apply for First Patent on Synthetic Life Form
- FDA, 23andMe Respond to Gene-Drug Test Article
Brandon Keim's Twitter stream and reportorial outtakes; Wired Science on Twitter. Brandon is currently working on a book about ecological tipping points.
