Contact l Sitemap

home industries issues reasearch weblog press

Home  » Industries » Pharmaceuticals

Myriad Loses Patent to Breast Cancer Genetic Test

by Richard SmallteacherCorpWatch Blog
June 13th, 2013

DNA sequence exhibit at the Science Museum in London. Photo by John Goode. Used under Creative Commons license.

Myriad Genetics has lost its right to be the exclusive U.S. commercial provider of genetic screening tests for breast cancer or ovarian cancer. The American Civil Liberties Union (ACLU), which sued the company, claimed that the patent would limit scientific research as well as health care options for women.

Mutations in the BRCA1 and BRCA2 genes significantly increase the risk of cancer. By discovering the location of the genes, Myriad was able to develop tests to detect the mutations for which it charged over $3,000. No other company was allowed to do research on the genes without permission from Myriad.

In a unanimous decision released today by the U.S. Supreme Court, all nine judges agreed with the ACLU.

“Myriad did not create anything,” Justice Clarence Thomas wrote in the decision. “It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. Groundbreaking, innovative or even brilliant discovery does not by itself satisfy the criteria (for a patent)

The Myriad patent has long been deeply controversial.

“For women as they are trying to make these major life decisions, it is very helpful for them to have a second opinion. By having only a single lab offering that testing, it is impossible really to be able get that second opinion, either in the way the test is performed or in the interpretation of such a result,” says Dr. Wendy Chung, a clinician and a geneticist at Columbia University. “You’re essentially stuck in a situation of a mediocre test.

The Myriad screening test is also mostly based on results gathered from white women. The patent has limited further research to see if the results are accurate for women of other races, says Kim Irish of Breast Cancer Action who cites the example of Runi Limary, an Asian woman who received ambiguous results when she had genetic testing done. “Runi was told that this “variant of uncertain significance” has been seen in Asian women, and that these ambiguous results seem to come up more for women of color,” says Irish.

The ACLU filed a lawsuit against Myriad, the University of Utah Research Foundation and the U.S. Patent and Trademark Office in May 2009. A federal judge ruled against Myriad in 2010 but the company won on appeal at the U.S. Court of Appeals for the Federal Circuit.

James Watson, one of the two scientists who discovered DNA, filed a friend of the court brief that stated: “(W)e would not want one individual or company to monopolize the legal right to the beneficial information of a human gene—information that should be used for the betterment of the human race as a whole.”

The U.S. Patent and Trademark Office has long accepted claims that include DNA sequences – an estimated 35,000 such patents have been approved.

However the Obama administration recently began to limit this approach. “The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is ‘isolated’ from its natural environment than are cotton fibers that have been separated from cotton seeds or coal that has been extracted from the earth,” wrote lawyers for the U.S. Department of Justice in a legal brief in 2010. "Common sense would suggest that a product of nature is not transformed into a human-made invention merely by isolating it.”

The ACLU welcomed the decision. "Today, the court struck down a major barrier to patient care and medical innovation," said Sandra Park, an ALCU lawyer. "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."