Biotech Firm Loses Supreme Court Fight To Patent Human Genes
June 13, 2013

Biotech Firm Loses Supreme Court Fight To Patent Human Genes

Lawrence LeBlond for - Your Universe Online

A Salt Lake City, Utah-based genetics firm has lost a battle in court to keep a patent on naturally-occurring human genes.

The US Supreme Court has shot down Myriad Genetics Inc.´s bid to patent breast and ovarian cancer genes, ruling that human genes cannot be patented. The decision has immediate benefits for some cancer patients but may have long-lasting repercussions for biotechnology research.

The decision, written up by Judge Clarence Thomas, marks a victory for patients, researchers and geneticists who have claimed a patent on the genes would raise costs, restrict crucial research and force women to have their breasts and ovaries removed without sufficient facts about their cancers.

The unanimous judgment reverses three decades of patent awards by government officials, as well as the patents held by Myriad Genetics Inc. on a popular breast cancer test brought into the public eye when Angelina Jolie revealed that she had a double mastectomy because of a defective gene involved in the case.

Jolie said in a statement last month that her mother died of ovarian cancer and that her maternal grandmother also had the disease. She said she carries a defective BRCA1 gene that also puts her at risk of developing breast and ovarian cancers, which led her to have her natural breasts removed to try to avoid the same fate.

Thursday's ruling stated that Myriad´s assertion that the DNA it isolated from the body for its breast and ovarian cancer tests were patentable was dismissed because it in fact violates patent rules. The court ruled that the laws of nature, natural phenomena and abstract ideas cannot be patented.

Myriad first came into the spotlight in 2009 when the American Civil Liberties Union (ACLU) launched a lawsuit against the genetics firm for limiting breast and ovarian cancer research with its human gene patents. The ACLU claimed then that the patents were invalid and unconstitutional.

"This is going to turn into one of the watershed events in the evolution of the bioindustry," John Sterling, Editor in Chief of GEN, said in a May 15, 2009 statement.

And in fact it has.

Myriad Genetics used its patent to come up with its BRCAnalysis test, which looks for mutations on the breast cancer predisposition gene (BRCA). Because of previous patent rights, Myriad sells the only BRCA gene test. Opponents of the gene patents say the company can use its patent rights to keep others from working with the BRCA gene to develop their own tests.

But Thursday´s ruling brings down the barrier and will allow other researchers to begin testing with the BRCA gene, potentially bringing their own versions of the cancer test to market.

"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," Sandra Park, a lawyer for the ACLU Women's Rights Project, told HuffPost's Jesse J. Holland.

Some companies have billions of dollars tied up in research investments with Myriad and other human gene patent holders and have argued that without the ability to recoup their costs through the profits that patents bring, breakthrough scientific discoveries to combat all kinds of medical diseases, illnesses and conditions would not happen.

But Judge Thomas wrote that “Myriad did not create anything“¦ To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”

“It is splendid news for patients, for physicians, for scientists and for common sense,” Mary-Claire King, the geneticist who in 1990 discovered the abnormality on chromosome 17 that proved to be the so-called breast cancer gene, told USA TODAY. “The marketplace will now be open.”

More than 40,000 patents related to genetic material have been approved by the US Patent and Trademark Office since 1984. For its own patents, Myriad has tested more than a million women since the late 1990s for mutations that often lead to ovarian and breast cancer.

While a federal district court sided with challengers of the patents in an earlier hearing, a divided court of appeals that handles patent cases sided with the company in a subsequent ruling. However, the Supreme Court decision is likely the final rule on the matter, and should give medical research firms a foothold on bringing less expensive cancer tests and screenings to market.

The Supreme Court Justices generally agreed that Myriad deserved credit for its process of isolating the gene and its use — but concurred that it did not have any rights on a patent for the gene.

"In isolation, it has no value," Justice Sonia Sotomayor said. "It's just nature sitting there."

While the decision was unanimous among the Justices, several of the more conservative judges noted a complete denial of patent rights could jeopardize investments by other biotechnology firms, which could limit progress on a range of research.

The court ruled that synthetically created DNA, known as cDNA, could still be patented because it does not occur naturally.

Judge Thomas also noted that there are still ways for Myriad to make money off its discovery. “Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent,” he said.

He noted, however, that the case before the court did not include patents on the application of knowledge about the two genes.

The human gene patent case is 12-398, Association for Molecular Pathology v. Myriad Genetics, Inc.