Exclusive licenses to gene patents are supposed to spur development of new technologies for gauging disease risk but actually do more to block competition in the gene testing market, say researchers from the Duke Institute for Genome Sciences and Policy (IGSP).
As single-gene tests give way to multi-gene or even whole-genome scans, exclusive patent rights could slow promising new technologies and business models for genetic testing even further, the Duke researchers say.
The findings emerge from a series of case studies that examined genetic risk testing for 10 clinical conditions, including breast and colon cancer, cystic fibrosis, and hearing loss. The studies appear April 14 in a special issue of Genetics in Medicine.
In seven of the conditions, exclusive licenses have been a source of controversy. But in no case was the holder of exclusive patent rights the first to market with a test.
"That finding suggests that while exclusive licenses have proven valuable for developing drugs and biologics that might not otherwise be developed, in the world of gene testing they are mainly a tool for clearing the field of competition, and that is a sure-fire way to irritate your customers, both doctors and patients," said Robert Cook-Deegan, director of the IGSP Center for Genome Ethics, Law&Policy.
"It's notable that a gene linked to cystic fibrosis is not subject to an exclusive license, yet there is now a vibrant market for tests to identify carriers of the cystic fibrosis gene. This suggests the problem is not patents, per se, but how they are being licensed, particularly by universities."
The case studies, originally undertaken at the request of the US Secretary of Health and Human Services Advisory Committee on Genetics, Health and Society (SACGHS), show that gene patenting itself is not necessarily the main problem. Rather, he says, the culprit is a troublesome combination of overly broad patents that are exclusively licensed to single companies.
More than two-thirds of the patents examined in the case studies are held by universities or other nonprofit institutions that depend on government or nonprofits for much of their biomedical research funding, often including the research leading to gene patents. Yet university licensing practices can end up harming genetic testing laboratories at other universities, or preventing development of alternative tests that might offer improved accuracy, lower cost or the ability to test for multiple gene mutations simultaneously.
The case studies of the gene patents come in the wake of a major decision last month in which a federal judge rejected seven patents on the BRCA1 and BRCA2 genes tied to breast and ovarian cancer, which are held by Myriad Genetics and the University of Utah Research Foundation.
Contrary to expectation, the Duke team's review of Myriad's BRCA tests found they are not particularly costly relative to other tests, despite their virtual monopoly on the market. However, broad patent claims such as the ones held by Myriad have made it nearly impossible to pursue alternative ways to test clinically for BRCA genes without the risk of patent infringement.
A separate study published by the IGSP team last month in Genomics showed just how broad some of the BRCA patent claims really are. They found that 15-letter stretches of DNA claimed in the Myriad patent are common throughout the human genome and could be found in 80 percent of the gene sequences placed in a publicly accessible database—GenBank—the year before Myriad sought patent protection.
Gene patents have been issued since the 1980s. Today, more than 4,000 sequences from human genes, covering about 20 percent of the human genome, are identified in at least one granted patent claim.
- PHYSICAL SCIENCES
- EARTH SCIENCES
- LIFE SCIENCES
- SOCIAL SCIENCES
Subscribe to the newsletter
Stay in touch with the scientific world!
Know Science And Want To Write?
- War On Doping And The Hypocritical Treatment Of Lance Armstrong
- How Marijuana Use Affects People With Bipolar Disorder
- Avoid These 3 Risk Factors, Gain 13 Years Of Quality Life
- The New York Times On Drugs - Wrong, Naive Or Misleading?
- The Borexino Detector And Its Physics Results
- Why Are Girls More Likely To Die In Pediatric Intensive Care Units?
- 1840s Shipwreck Leads To Important Beer Science Discovery
- "I think it would be very difficult to scientifically assess the effects of marijuana use on people..."
- "Actually that's exactly what the bible is all about real Aliens, not religion. So may i have one..."
- "Addiction is completely fake. Their goal is to push more people into 12 Step 'treatment' which..."
- "dave, you are proving to all your profound ignorance and worse you are revelling in it. How sad..."
- "You've touched on something that drives me insane-- the under-medication of dying patients by hospitals..."
- Grand tree of life: clock-like trend in new species emergence and diversity
- 7 promising compounds in spider venom with potential to relieve chronic pain
- Antiseptic prevents deaths in newborns
- Cellular sequencing technology provides deeper look at mitochondrial inherited disease risk
- Australian science infrastructure funding is being held hostage by government
Books By Writers Here