Breast cancer patients sue Myriad for patenting human BRCA1 and BRCA2 genes

Myriad owns the rights of a diagnostic test for predisposition of breast cancer.

Breast cancer patients have filed a law suit challenging the patent granted for Myriad Genetics for human genes – BRCA1 and BRCA2- that are proved to be behind one of the most lethal cancers affecting women.

Testing for the BRCA1 and BRCA2 mutations that cause breast cancer and ovarian cancer can only be performed at Myriad labs and costs over $3,000.

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The BRCA1 and BRCA2 genes are present in every human. However, certain genetic mutations on these genes put women at a higher risk of developing breast and ovarian cancer.

Myriad Genetics, a private biotechnology company based in Utah, USA is currently holding the exclusive rights on the two human genes known as BRCA1 and BRCA2.

A European patent No. 699 754 relates to a “Method for diagnosing a predisposition for breast and ovarian cancer” and was granted by the EPO on 10 January 2001 to Myriad Genetics, the University of Utah and the United States of America.

Testing for the BRCA1 and BRCA2 mutations can only be performed at Myriad labs and currently costs over $3,000.

Breast Cancer Action (BCA), along with the American Civil Liberties Union, has filed a law suit in the U.S District Court for the Southern District of New York, a federal court,  challenging the legality of patenting human “breast cancer genes.”

BCA has been questioning the legality and validity of patenting a human gene since 1998, when BRCA1 & 2 were first patented.

The lawsuit could turn out be a landmark case as it evokes several cardinal ethical and legal issues that involve patent law, medical science, breast cancer activism and an unusual civil liberties arguments.

“The time has finally arrived for the courts to decide who owns our genes,” said Barbara Brenner, executive director of Breast Cancer Action.

When one company controls all the testing, less information and resources are available to both patients and researchers. Women unable to afford the $3,500 fee are prevented from access to the test; women seeking second opinions on any results they might receive have nowhere to go; and women of African, Hispanic, or Asian decent are at a significant disadvantage because they disproportionately receive ambiguous results when tested by Myriad.

“There are so many injustices and inequities in breast cancer,” Brenner said. “The time has come to address them in all their forms — as they affect genetic risk, as well as social, political, and economic realities. This case is an important first step.”

However, companies like Myriad have refuted the argument saying that the patent system promotes innovation by giving companies the temporary monopoly that rewards their substantial investment in research and development.

The argument may be convincing to the patent examiners, but it has long been a sore point for many scientists. “You can’t patent my DNA, any more than you can patent my right arm, or patent my blood,” said Jan A. Nowak, president of the Association for Molecular Pathology.

BCA hopes that it will open doors to better research and information, and ultimately better health care for women regardless of their economic situation or their racial background.

Breast Cancer Action is a non-profit education and advocacy organization that does not accept funding from pharmaceutical companies or any other organizations that profit from or contribute to the breast cancer epidemic.

Breast cancer gene test

The BRCA gene test is a blood test that uses DNA analysis to identify changes (mutations) in either one of two breast cancer susceptibility genes — known as BRCA1 or BRCA2. BRCA gene test can tell whether one carries an inherited BRCA gene mutation and receive an estimate of your personal risk of breast cancer and ovarian cancer.

The BRCA gene test is a type of genetic test that’s possible only for certain diseases that run in families, and it’s offered only to women who are at very high risk of breast cancer and ovarian cancer based on personal or family history. The BRCA gene test isn’t routinely performed on women at average risk of these cancers.

Having a BRCA gene mutation is rare, occurring only in about one in 1,000 people. Inherited BRCA gene mutations are responsible for less than 5 to 10 percent of breast cancers and about 10 to 15 percent of ovarian cancers. The majority of these cancers occur sporadically and aren’t inherited.

Myriad Genetic Laboratories is a leader in cancer predisposition testing. Myriad offers clinical tests to determine predisposition to cancer: BRACAnalysis for hereditary breast and ovarian cancer, COLARIS for hereditary colon and endometrial cancer, COLARIS AP for hereditary colorectal polyps and cancer, and MELARIS for hereditary melanoma and pancreatic cancer.