A U.S. District Court judge's recent decision to invalidate patents on two genes commonly tested to determine risk for breast and ovarian cancers is an important step toward removing legal hurdles that have slowed the development of new genetic testing technology, according to a team of Duke University researchers.
Although Judge Robert Sweet's March 31 ruling does not sit well with some biotech companies and universities, Duke Institute for Genome Sciences & Policy (IGSP) researchers say that broad patent claims such as those made by Myriad Genetics and the University of Utah Research Foundation do more to block competition and discourage promising new technologies than to spur innovation.
The researchers' conclusions come from a series of case studies initiated in 2007 to examine genetic risk testing for 10 clinical conditions, including breast and colon cancer, cystic fibrosis and hearing loss. In seven of these conditions, exclusive licenses were a source of controversy, according to the case study results, which were published April 14 in a special issue of Genetics in Medicine. However, in none of these cases was the holder of exclusive patent rights the first to market with a test.
Gene patents are granted primarily for one of two reasons, says Robert Cook-Deegan, director of the IGSP Center for Genome Ethics, Law & Policy. The first is as a way for a biotech or pharmaceutical company to protect the therapeutics—made with the help of genetic material—that go into the development of a new drug. The second is to protect the intellectual property of companies that make genetic diagnostic tools that determine a person's susceptibility to disease.
Myriad claimed that the work its technology does of isolating the DNA from the body transforms it and makes it patentable. The judge in this case, however, found that isolated copies are not that different from non-isolated DNA. "This implies that isolated DNA is a discovery and not an invention and therefore not patentable," says Mark Bünger, a research director at Lux Research Inc.
The biotech industry's stance has been that its work is expensive and important and needs to be licensed so that this work may continue. This argument has been successful for the most part until now—more than 4,000 sequences from human genes, covering about 20 percent of the human genome, have been patented.
IGSP's research suggests that although exclusive licenses have been valuable for developing drugs and biologics that might not otherwise be developed, in the context of gene testing, exclusive patent rights are primarily a tool for companies and research organizations to eliminate their competition, Cook-Deegan says. The problem is not with the patents themselves but rather when overly broad patents are exclusively licensed to a single company or university, he adds.
One of the IGSP's goals was to analyze patients with similar medical situations but who had different levels of testing capabilities available to them. The researchers' role was to gather information about how much different gene tests cost and how the technology is licensed, and to provide research on how patenting these tests might affect healthcare, Cook-Deegan says.
When Duke researchers studied Myriad's tests, designed to find mutations in BRCA1 and BRCA2, they found Myriad's patent claims made it nearly impossible for patients to pursue alternative ways to test clinically for BRCA genes without that test infringing on Myriad's intellectual property.
The likelihood is that the health care industry will become more reliant on genetic material as time passes, but right now there are questions about whether performing genetics tests might get an organization sued, Cook-Deegan says, adding: "It would be quite a value to biotech to get some clarity on this."