On Thursday, the Supreme Court ruled that companies cannot patent isolated human genes that are naturally occurring.
The decision defeats the Salt Lake City company, Myriad Genetics Inc. who had previously been granted patents on the BRCA1 and BRCA2 genes that put women at a greater risk for breast and ovarian cancer—a topic that gained more attention when actress Angelina Jolie revealed she underwent a double mastectomy after discovering she carried the genes.
According to the court’s decision written by Justice Clarence Thomas, Myriad did not create anything new when it comes to the BRCA genes, since they are a product of nature; therefore patenting them is illegal.
However, Myriad did have a partial victory. The Supreme Court also ruled that synthetically-created DNA (known as cDNA) is patentable since it is not naturally occurring. In a statement about the ruling, Myriad wrote that the company has, “more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis test.”
Many individuals from the medical community are rejoicing. “[The decision] is brilliant, I am so happy about it,” says Dr. Cy Stein, department chair of medical oncology & therapeutics research at City of Hope, a cancer research hospital in Duarte, California. “Right now in 2013, this is not going to affect too many people immediately, but going forward into the future, this is big.”
Here are the reasons the decision is monumental:
1. There will be competition in BRCA testing: “Physicians will not be compelled to use the Myriad test exclusively,” says Dr. Stein. “This may help control prices, and will allow BRCA to be incorporated in a panel of genes that physicians may want to evaluate and test patients for. This cannot be done now.” Stein says that currently City of Hope cannot test its patients for BRCA in-house since it is under patent. Instead, they have to send out for testing. Now, Myriad still has a patent on the BRCA test, but if others develop new ways, there will be more screening opportunities.
2. Product development will speed up: The decision removes the threat of endless litigation if a product–for instance a screening method–is developed by one company that uses a gene patented by another.
“It’s actually chilling to think about what would’ve happened had this gone the other way,” says Dr. Stein. “Can you imagine if you had to go through this for every gene? You wouldn’t get anywhere. All of the genomics research that has been done would wind up in court. It would never be resolved.”
3. Biotech firms will have more freedom to innovate: Now, biotech firms will have greater freedom to operate. Potential competitive products cannot easily be quashed, the flow of research in all sectors–academic, industrial and clinical–will continue unimpeded. “Biotech investors can have confidence that products that are or will be in development will not taken over by larger corporations,” says Dr. Stein.
Daniela Hernandez, a writer for Wired, writes:
Although the patent incentive for discovering new genes is gone, the first person to isolate new sequences still has the best chance to build potentially lucrative applications, like novel medications, chemicals or biofuels, that can be patented. Already, scientists are at work trying to devise DNA-based programming code and biologics, for example.
4. There will be more personalized therapies that rely on gene sequences: According to Dr. Stein, most therapeutics in the foreseeable future are going to come from innovations in gene structure, gene function, or possibly silencing of messenger RNA (which is related to both).
“Many of our therapies will become more personal and more targeted. This seems to be the wave of the future, and would not be possible if each and every gene was patented by a different entity,” he says.