|By PR Newswire||
|May 12, 2009 07:24 PM EDT||
Gene Patents Stifle Patient Access To Medical Care And Critical Research
"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
Today's lawsuit was filed in U.S. District Court for the Southern District of
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
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
"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
"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
Because the ACLU's 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
"Patenting human genes is counter to common sense, patent law and the Constitution," said
If Myriad's BRCA genes patents were invalidated, the clinicians, pathologists and researchers represented by the ACLU 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 PennsylvaniaSchool 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 UniversitySchool 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
Plaintiff and supporter statements and a copy of the complaint can be found online at: www.aclu.org/brca
SOURCE American Civil Liberties Union
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