Patents On Genes Can Be Challenged, Court Rules
6 CommentsBy Ed Silverman // November 3rd, 2009 // 7:21 am
A federal district court ruled today that patients and scientists can challenge patents on human genes in court. And the move allows a lawsuit challenging patents on two human genes associated with hereditary breast and ovarian cancer to move forward, according to the American Civil Liberties Union and the Public Patent Foundation (PUBPAT), which filed the suit.
In a statement, the groups say the filed their suit because the patents are “illegal and restrict both scientific research and patients’ access to medical care.” They also charge that patents on human genes violate the First Amendment and patent law because genes are “products of nature.”
“We hope this challenge is the beginning of the end to patents on genes, which limit scientific research, learning and the free flow of information,” Chris Hansen, a staff attorney with the ACLU First Amendment Working Group, says in the statement. “No one should be able to patent a part of the human body.” (Here is the opinion and here is more background).
The lawsuit was originally filed last May on behalf of breast cancer and women’s health groups, individual women, geneticists and scientific associations representing approximately 150,000 researchers, pathologists and laboratory professionals. The lawsuit was filed against the US Patent and Trademark Office, Myriad Genetics and the University of Utah Research Foundation, which hold the patents on the BRCA genes. The defendants had asked the court to dismiss the case. Myriad Genetics spokeswoman Suzanne Barton declined to comment, citing pending litigation.
Because the ACLU’s lawsuit challenges the whole notion of gene patenting, the groups maintain the outcome could have “far-reaching effects” beyond patents on the BRCA genes. Approximately 20 percent of all human genes are patented, they maintain, including genes associated with Alzheimer’s disease, muscular dystrophy, colon cancer, asthma and many other illnesses.
The specific patents challenged are on the BRCA1 and BRCA2 genes. Mutations along these genes are responsible for most cases of hereditary breast and ovarian cancers. The ACLU notes that many women with a familial history of breast and ovarian cancer undergo genetic testing to determine if they have the mutations on their BRCA genes. The info helps women decide on treatment or prevention, including increased surveillance or preventive mastectomies or ovary removal.
The patents granted to Myriad give the company the exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes and, the groups charge, to prevent any researcher from looking at the genes without first getting permission from Myriad. “Myriad’s monopoly on the BRCA genes makes it impossible for women to access alternate tests or get a second opinion about their results and allows Myriad to charge a high rate for their tests,” the groups argue.
Roger D. Klein, MD JD
From this pathologist’s standpoint, patents on human genes and the relationships between genetic variations and disease phenotypes, prognosis, and response to therapy a beginning to place an enormous burden on our ability to care for our patients. Pathologists have always analyzed bodily specimens for diagnostic, prognostic, and therapeutic tools. These analyses have involved both visual and chemical inspection. The science has continually evolved, enabling ever greater specificity through the addition of new tools such as antibodies and DNA probes. Molecular genetic testing is simply another iteration in this process, whereby we use a standard set of techniques to more accurately evaluate a patient’s specimen. Molecular evaluations will become increasingly important as greater numbers of genetic markers are found that predict drug responsiveness and/or disease course. Patents on human genes and the relationships between genetic variation and disesase phenotypes greatly obstruct our medical practices, and hinder our efforts to help patients.
Roger D. Klein, MD JD
From this pathologist’s standpoint, patents on human genes and the relationships between genetic variations and disease phenotypes, prognosis, and response to therapy are beginning to place an enormous burden on our ability to care for our patients. Pathologists have always analyzed bodily specimens for diagnostic, prognostic, and therapeutic tools. These analyses have involved both visual and chemical inspection. The science has continually evolved, enabling ever greater specificity through the addition of new tools such as antibodies and DNA probes. Molecular genetic testing is simply another iteration in this process, whereby we use a standard set of techniques to more accurately evaluate a patient’s specimen. Molecular evaluations will become increasingly important as greater numbers of genetic markers are found that predict drug responsiveness and/or disease course. Patents on human genes and the relationships between genetic variation and disesase phenotypes greatly obstruct our medical practices, and hinder our efforts to help patients.
David Sirbasku
This suit is nonsense. Many “natural products” are patented. This includes genes and parts of genes (i.e. nucleotide sequences). Taken to its conclusion, this suit will overturn MANY MANY patents the relate to natural products and their uses. The ACLU must stop or be thrown out of Court.
Jatmos
Sirbasku, your comment is nonsense. I’m sure you’re defending someone’s bread-winning idea, but it’s utterly ridiculous to patent a piece of a human being. When they can artificially replicate genes, then can patent those. In the meantime, no one should hold exclusivity over what kind of care a patient can recieve on parts of their very own body. If patents had been around when people first cut open a cadaver, should they have been able to patent your gall bladder? Would you agree to hiked-up prices and stagnated research if you had gall stones? Same idea, only deeper.
Jatmos
Further reading:
http://www.michaelcrichton.net/essay-nytimes-patentinglife.html
Jatmos
For further reading, search for Michael Crichton’s essay on Patenting Life for the NY Times.