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Gene Patents Stifle Patient Access To Medical Care And Critical Research ( 0) Printer friendly page Print This
By Press Release
Public Patent Foundation
Sunday, May 17, 2009

The American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT),  a not-for-profit patent reform organization affiliated with Benjamin N. Cardozo  School of Law, filed a lawsuit today charging that patents on two human genes  associated with breast and ovarian cancer stifle research that could lead to cures  and limit women's options regarding their medical care. Mutations along the genes,  known as BRCA1 and BRCA2, are responsible for most cases of hereditary breast and  ovarian cancers. The lawsuit argues that the patents on these genes are  unconstitutional and invalid.

"Knowledge about our own bodies and the ability to make decisions about our health  care are some of our most personal and fundamental rights," said Anthony D. Romero,  Executive Director of the ACLU. "The government should not be granting private  entities control over something as personal and basic to who we are as our genes.  Moreover, granting patents that limit scientific research, learning and the free flow  of information violates the First Amendment."

Today's lawsuit was filed in U.S. District Court for the Southern District of New  York on behalf of breast cancer and women's health groups, individual women and  scientific associations representing approximately 150,000 researchers, pathologists  and laboratory professionals against the U.S. Patent and Trademark Office (PTO), as  well as Myriad Genetics and the University of Utah Research Foundation, which hold  the patents on the BRCA genes. It is the first to apply the First Amendment to a gene  patent challenge.

The patents granted to Myriad give the company the exclusive right to perform  diagnostic tests on the BRCA1 and BRCA2 genes and to prevent any researcher from even  looking at the genes without first getting permission from Myriad. According to the  lawsuit, such monopolistic control over these genes hampers clinical diagnosis and  serves as a disincentive for research because Myriad not only has the right to  enforce its patents against other entities but also has the rights to future  mutations discovered on the BRCA2 gene. The gene patents are also illegal under  patent law because genes are "products of nature."

"Patents are meant to protect inventions, not things that exist in nature like genes  in the human body," said Chris Hansen, a staff attorney with the ACLU. "Genes  isolated from the human body are no more patentable than gold extracted from a  mountain."

Many women with a history of breast and ovarian cancer in their families opt to  undergo genetic testing to determine if they have the mutations on their BRCA genes  that put them at increased risk for these diseases. This information is critical in  helping these women decide on a plan of treatment or prevention, including increased  surveillance or preventive mastectomies or ovary removal. However, the fact that  Myriad can exclude others from providing this testing has several negative  consequences for patients: many women cannot afford the more than $3,000 Myriad  charges for the test; patients cannot get second opinions on their test results; and  patients whose tests come back with inconclusive results do not have the option to  seek additional testing elsewhere.

"Women whose doctors recommend genetic testing should be able to find out whether  they have the gene mutations linked to breast and ovarian cancer so that they are  able to make choices that could save their lives, and these patents interfere with  their ability to do so," said Lenora Lapidus, Director of the ACLU Women's Rights  Project.

"The patents on the BRCA genes block women's access to medical information necessary  for making vital health care decisions, impeding their control over their own  bodies," said Sandra Park, staff attorney with the ACLU Women's Rights Project.

Because the ACLU/PUBPAT lawsuit challenges the whole notion of gene patenting, it  could have far reaching effects beyond the patents on the BRCA genes. Approximately  20 percent of all human genes are patented, including genes associated with  Alzheimer's disease, muscular dystrophy, colon cancer, asthma and many other  illnesses.

"Scientific research and testing have been delayed, limited or even shut down as a  result of gene patents, stifling the development of new diagnostics and treatments,"  said Tania Simoncelli, ACLU science advisor. "The government should be encouraging  scientific innovation, not hindering it."

"Patenting human genes is counter to common sense, patent law and the Constitution,"  said Daniel B. Ravicher, Executive Director of PUBPAT and co-counsel in the lawsuit.  "Genes are identified, not invented, and patenting genetic sequences is like  patenting blood, air or e=mc2."

If Myriad's BRCA genes patents were invalidated, the clinicians, pathologists and  researchers represented by the ACLU and PUBPAT would be able to engage freely in  research, testing and clinical practice involving the BRCA1 and BRCA2 genes, and the  patients would be able to obtain second opinions on test results and have access to  genetic testing services from multiple, and perhaps more affordable, sources.

In addition to several individual women patients, plaintiffs in the case include:
•    Association for Molecular Pathology
•    American College of Medical Genetics
•    American Society for Clinical Pathology
•    College of American Pathologists
•    Haig Kazazian, MD, Professor in the Department of Genetics at the University of  Pennsylvania School of Medicine
•    Arupa Ganguly, PhD, Associate Professor in the Department of Genetics at the  Hospital of the University of Pennsylvania
•    Wendy Chung, MD, PhD, Director of Clinical Genetics at Columbia University
•    Harry Ostrer, MD, Professor of Pediatrics, Pathology and Medicine and Director  of the Human Genetics Program at New York University School of Medicine
•    David Ledbetter, PhD, Professor of Human Genetics and Director of the Division  of Medical Genetics at the Emory University School of Medicine
•    Stephen Warren, PhD, William Patterson Timmie Professor of Human Genetics and  Chair of the Department of Human Genetics at Emory University
•    Ellen Matloff, M.S., genetic counselor
•    Elsa Reich, M.S., Professor in the Department of Pediatrics (Human Genetics  Program) at New York University
•    Breast Cancer Action
•    Boston Women's Health Book Collective (Our Bodies Ourselves)

Attorneys on the case, Association for Molecular Pathology, et al. v. U.S. Patent and  Trademark Office, et al., include Hansen and Aden Fine of the ACLU First Amendment  Working Group; Lapidus and Park of the ACLU Women's Rights Project; and Ravicher of  PUBPAT. Simoncelli, the ACLU's science advisor, provides expert guidance on the case.

[A video of why we're fighting to liberate the breast cancer genes]

For more information and related documents, visit

Public Patent Foundation

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