Critics of human gene patents claimed victory Thursday when the Supreme Court ruled that human genes found in nature — or isolated DNA — cannot be patented.
The court also ruled that synthetic forms of DNA—complementary DNA, or cDNA—are patent eligible.
The case of Association for Molecular Pathology vs. Myriad Genetics was brought by the ACLU and the Public Patent Foundation. The lawsuit, which was filed in 2009, challenged patents held by Myriad Genetics on two human genes, BRCA1 and BRCA2, linked to breast, ovarian and other cancers.
The BRCA genes gained notoriety recently when actress Angelina Jolie announced she was having a preventive double mastectomy after testing positive for one of the genes. The tests are costly and not always covered by insurance.
The suit against Myriad Genetics claimed that its patents on BRCA1 and BRCA2 gene mutations prevented vital research on and testing for breast, ovarian and other cancers.
The ruling essentially knocks down Myriad's monopoly on cancer gene testing and will allow research and testing on the BRCA1 and BRCA2 genes by other parties.
Justice Clarence Thomas, writing in a unanimous ruling for the court, stated, "A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring."
"Today, the court struck down a major barrier to patient care and medical innovation," said Sandra Park senior staff attorney with the ACLU Women's Rights Project, in statement sent to Yahoo News. "Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued."
The BRCA gene test is a blood test that uses DNA analysis to identify mutations on the BRCA1 and BRCA2 genes. Women with mutations on these genes face a higher risk of developing breast and ovarian cancers. Having the BRCA gene mutation is rare: According to the Mayo Clinic, gene mutation is responsible for about 5 percent of breast cancers and 10-15 percent of ovarian cancers.
A federal judge had earlier ruled that the patents were invalid, but an appeals court overruled that decision. The case made its way to the Supreme Court.
"You have to balance the monopoly because then people don’t have access to the building block," Laura G. Pedraza-Farina, law research fellow and visiting lecturer at Georgetown University Law Center, told Yahoo News.
Critics of the gene patents had argued that they inhibit research and innovation. “People can't use pieces of the BRCA gene to recombine them and find new treatments and find new diagnoses and find new things that will advance medicine and science as a result of these patents,” Christopher Hansen argued at the Supreme Court on behalf of the petitioners against Myriad.
“We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward,” Peter D. Meldrum, president and CEO of Myriad Genetics Inc., said in a statement provided to Yahoo News. “More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples’ lives and lowering overall healthcare costs.”
Some believe that the ruling will increase scientific research. "When the [BRCA] genes were first discovered in the early 1990s, it was heralded as a breakthrough moment," said Karuna Jaggar, Breast Cancer Action’s executive director. The health advocacy nonprofit joined the lawsuit against Myriad in 2009. "Their patents are impeding progress on breast cancer and ovarian cancer," she added.
The company has used its patent to come up with its BRACAnalysis test, which looks for mutations on the breast cancer predisposition gene, or BRCA. Those mutations are associated with much greater risks of breast and ovarian cancer. Women with a faulty gene have a three to seven times greater risk of developing breast cancer and also have a higher risk of ovarian cancer.
Myriad sells the only BRCA gene test. Opponents of its patents say the company can use the patents to keep other researchers from working with the BRCA gene to develop other tests.
Today's decision will undoubtedly have a ripple effect in the biotechnology field.
“Patents are a double edged sword, “ said Pedraza-Farina. “On the one hand, it fosters innovation, but then it stifles innovation because people can’t follow on you.”
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