(CN) – A federal judge in Manhattan ruled that the patents on two genes associated with hereditary breast and ovarian cancer are invalid because “DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature,” and cannot be patented. The ruling marks the first time a court has found patents on genes to be unlawful and will undoubtedly have a broad reach on the validity of current and future genetic patents. Twenty percent of human genes are currently under patent.
U.S. District Judge Robert Sweet ruled in favor of the plaintiffs, who consisted of the Association for Molecular Pathology – a group of patients and scientists – the American Civil Liberties Union and the nonprofit Public Patent Foundation , in deciding that patents for “isolated DNA” should not be granted.
The judge invalidated the seven patents owned by Utah-based Myriad Genetics related to the BRCA 1 and BRCA 2 genes, and denied Myriad’s motion for summary judgment. He also granted the U.S. Patent Office’s request to be dismissed as a defendant.
Sweet said he sought the governing principles of molecular biology and patent law when weighing his decision on the controversial issue, and recognized the far-reaching impact it will have.
“The resolution of the issues presented to this court deeply concerns breast cancer patients, medical professionals, researchers, caregivers, advocacy groups, existing gene patent holders and their inventors, and those seeking to advance public health,” he wrote.
The BRCA1 and BRCA2 genes have been linked to breast and ovarian cancer susceptibility.
Mutations along the BRCA1 and 2 genes are responsible for most cases of hereditary breast and ovarian cancers, according to the plaintiffs. Women with a history of breast and ovarian cancer in their families can choose to undergo genetic testing to determine if they have the mutations in their BRCA genes that put them at increased risk for these diseases.
This information helps women decide on a plan of treatment or prevention, including increased surveillance, preventive mastectomies or ovary removal.
The patents granted to Myriad gave the company the exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes and prevented any researcher from even looking at the genes without first getting permission from Myriad.
This made it impossible for women to access alternate tests or get a comprehensive second opinion about their results. It also allowed Myriad to charge a high rate for their tests, according to the plaintiffs’ lawsuit.
“The court correctly saw that companies should not be able to own the rights to a piece of the human genome,” executive director of Public Patent Foundation and co-council in the lawsuit, Daniel Ravicher said. “No one invented genes. Inventions are specific tests or drugs, which can be patented, but genes are not inventions.”
Judge Sweet wrote: “The claims-in-suit directed to ‘isolated DNA’ containing human BRCA 1/2 gene sequences reflect the (patent office’s) practice of granting patents on DNA sequences so long as those sequences are claimed in the form of ‘isolated DNA.’ This practice is premised on the view that DNA should be treated no differently from any other chemical compound, and that its purification from the body, using well-known techniques, renders it patentable by transforming it into something distinctly different in character.”
Plaintiffs argued that Myriad refused to license the patents broadly to labs that were capable of performing even more comprehensive tests than standard “full sequencing” tests.
“These labs would also include large rearrangement testing after a negative tests result is received from full sequencing,” the judge wrote. “In addition, labs would perform genetic testing on tumor specimens preserved in paraffin from deceased family members, which Myriad does not regularly perform even though, according to plaintiffs, such testing can often provide valuable genetic information for living relatives and is often necessary for accurate test interpretation.”
Judge Sweet’s 156-page opinion steered clear of the constitutionality of the issue because he had already granted summary judgment in favor of the plaintiffs.
“Today’s ruling is a victory for the free flow of ideas in scientific research,” ACLU attorney Chris Hansen said. “The human genome, like the structure of blood, air or water, was discovered, not created. There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas.”