Making Gene Patents Work for Patients
By Michelle Geis Wallace, April 19, 2010
Two decades ago, the controversial decision to allow patents on human genes sparked a genetic gold rush. Corporations and universities rushed to file a flurry of claims on genes linked to specific diseases like breast cancer and Alzheimer’s. Since then, the patents themselves have invited plenty of criticism, but recently it’s the exclusive licenses often granted to companies developing diagnostics tests that have come under fire as anticompetitive – and damaging to patient care.
Defenders of exclusive license agreements – in which a patent holder on a particular gene (often, a university) licenses it to only a single company for development – say they are critical for accelerating patient access to genetic tests. But new research, published on April 14 in Genetics in Medicine, suggests otherwise. In a series of cases studies, scientists at Duke’s Institute for Genome Sciences and Policy (IGSP – a Burness client) found that exclusive licensing of gene patents does more to block competition and decrease patients’ access to testing than it does to spur innovation. Robert Cook-Deegan, Director of the IGSP Center for Genome Ethics, Law & Policy, said that while exclusive licenses may be beneficial in some fields, in gene testing, they mainly have become “a tool for clearing the field of competition.”
What could this mean for patients? An article in The Economist discussing the studies’ implications describes the real-world consequences of gene patenting:
[W]here gene-testing monopolies [that have exclusive rights to a given gene patent] do not accept the miserly reimbursements offered by Medicaid—the American government health scheme for the poor—the indigent suffer. Furthermore, the lack of a rival provider of tests to get a second opinion makes it impossible to ensure that results are accurate.
And the state of the market for gene testing suggests that rather than promote competition, as advocates claim, it seems that exclusive license agreements may do the opposite. The Duke researchers, examining the case of cystic fibrosis testing, noted that despite the lack of an exclusive license to a patent on a gene linked to the disease, there is nonetheless a vibrant market for tests.
These studies were released on the heels of a recent federal court decision invalidating seven patents held by Myriad Genetic on two genes linked to increased risk of breast and ovarian cancer. All of this is ammunition for gene-patenting critics, and it’s changing the way the public sees the issue.
Cook-Deegan and his colleagues say they are not out to demonize gene patents. They just want a fresh, objective examination of whether some existing claims are overly broad and whether exclusive licensing as it’s practiced now is really consistent with either patent policy, which is supposed to act in the service of innovation, or patient interests. And as single-gene testing gives way to whole-genome sequencing in the years to come, these questions – and the events of the past few weeks – will inform our next steps in law, science and policy.
DNA image credit (CC) Paweł Szczęsny of Freelancing Science.
