The ruling has been welcomed by campaigners worried about private control over something as basic to life and medicine as genes. Supporters of the patent claim, though, that it could harm genetic research by undermining the intellectual property rights that they say attract major private investment to the discipline.
US patent law says that material related to laws of nature cannot be patented, but Myriad Genetics argued that it was the method of isolating the gene and not the gene itself that was the subject of its patent.
Myriad had identified two gene sequences, BRCA1 and BRCA2, that were linked to breast cancer. The US District Court for the Southern District of New York said that patents the company held over them were "improperly granted".
"The identification of the BRCA1 and BRCA2 gene sequences is unquestionably a valuable scientific achievement for which Myriad deserves recognition, but that is not the same as concluding that it is something for which they are entitled to a patent," said Judge Robert Sweet in his ruling. "Because the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter."
The American Civil Liberties Union (ACLU), which brought the case, said that by allowing gene patents the US Patents and Trademarks Office (USPTO) had given organisations exclusive rights to test, study and look at particular genes.
"This is a huge victory for women’s health and scientific freedom," said an ACLU statement. "Myriad has already said that they will appeal, but if this decision is upheld, it will mean that the thousands of researchers and clinicians who have the ability to conduct BRCA testing and provide results to women, will no longer be prohibited from doing so."
The ruling dismissed Myriad's claims that the process of isolating genetic material created something distinct and patentable. "Many … including scientists in the field of molecular biology and genomics, have considered this practice a 'lawyer’s trick' that circumvents the prohibitions on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result," said the ruling.
Proponents of gene-related patents argue that the identifiable, quantifiable intellectual property rights that patents represent are a valuable asset for researchers in attracting financing for their investigations of genetics.
Opponents, though, pointed to the high cost of patented treatments. The ACLU said that Myriad charged $3,000 for a test related to the breast and ovarian cancer genes involved in the case and that this cost would fall once it no longer had a monopoly on the test.
