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?
- On Sexuality, You Weren't Born That Way, Says Paper
- Bubble-wrapped Sponge Creates Steam Using Sunlight
- Anomaly!: Book News And A Clip
- Reframing Body Weight As Baby Weight May Help Women Handle Pregnancy
- Petition: Let's End Dramatized Reporting Of "Doomsday" Stories - The Vulnerable Get Suicidal
- Post-Doctoral Positions In Experimental Physics For Foreigners
- Stem Cell Therapy Heals Injured Mouse Brain
- "i've often wondered https://en.wikipedia.org/wiki/Behavioral_sink ..."
- "Dylan, yes back online now. The Sun, and Moon are visible in all those places, of course, so if..."
- "Tina, I think it's best to try to understand the constellation argument because then you can just..."
- "People worry about a system entering ours and spelling doomsday for us all, however I believe if..."
- " I appreciate your hard work and look forward to any future publications with great interest, thank..."
- If Facebook Is Guessing Your Politics, You’re Probably Safe From Being Pigeon-Holed
- Pregnancy-Related Deaths Rising, But Why?
- Fauci: Don’t Make Policy Based on Animal Studies
- Exercise Could Save Your Liver
- Precision Medicine Stands On Imprecise Infrastructure
- Standing with Giants: A Collection of Public Health Essays in Memoriam to Dr. Elizabeth M. Whelan
- New small molecule compounds could treat Ebola virus infection
- Heroic firefighter who underwent most extensive face transplant is thriving
- Progress in vaccination against vespid venom
- Molecular signature shows plants are adapting to increasing atmospheric CO2
- Modelling water uptake in wood opens up new design framework