More harm than good?

http://www.economist.com/science-technology/displaystory.cfm?story_id=15905837&source=hptextfeature
Patenting genes is bad for diagnosis

Apr 15th 2010 | NEW YORK | From The Economist print edition
INNOVATORS deserve to be rewarded for their labours. That basic principle underpins patent law, which offers temporary market monopolies to those who come up with useful inventions. But in the case of gene patents America has been too generous in its application of that sensible principle, according to a set of studies published this week in Genetics in Medicine.

Normally, patents are not granted for naturally occurring phenomena or laws of nature. Nonetheless the American patent office controversially allowed firms to patent diagnostics involving single genes. This has permitted firms to create genetic tests that command monopolies over testing for various diseases. The most famous of these tests involve BRCA1 and BRCA2, two genes with variants linked to increased risk of breast and ovarian cancers.

Defenders of such exclusive gene patents remain unbowed by criticism. But chinks are appearing in their armour. In February a government-appointed committee of experts recommended that America liberalise its patent regime for genes, especially for genetic tests “for patient care purposes”. And at the end of March a federal court issued a bombshell ruling: the patents held by Myriad Genetics, a biotechnology firm, on the BRCA genes within the United States are, it said, “unsustainable as a matter of law”.

In addition, the studies published this week suggest that granting exclusive rights over genes may be doing more harm than good. At the request of the American government, a team of researchers from Duke University, led by Robert Cook-Deegan, spent two years examining the country’s markets for genetic tests for diseases ranging from colon cancer to cystic fibrosis. The chief question they sought to answer is whether the intellectual property arrangements involved helped or hindered public access to those tests.

Their conclusion? That the rules hinder access. For example, where gene-testing monopolies 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.

Even more striking is the claim made by the Duke researchers that patent exclusivity is not necessary to spur innovation in genetic testing. Dr Cook-Deegan argues that testing, unlike pricey drug development, has low barriers to entry and is relatively cheap, so a monopoly is not required to lure investors. As evidence, he points to the case of cystic fibrosis: unlike breast cancer, no monopoly patent blocks access to the relevant gene, and dozens of rival testing companies flourish.

George Church, a molecular geneticist at Harvard Medical School and a pioneer of whole-genome sequencing, is unpersuaded. Leaving aside the cystic fibrosis case, he says genetic testing benefits from incentives for innovation by luring in investors. He objects to the recommended reforms as “micro-manipulation of one small part of the patent system” that could have unintended consequences.

Still, the momentum appears to be favouring those who want reform of gene patents. Their grand hope is that the Myriad case, which is already under appeal by the firm at a higher court, will eventually be affirmed by America’s Supreme Court. Such legal arguments may take four or five years, by which time Myriad’s BRCA patents start expiring. Nonetheless, a ruling could be helpful. James Evans of the University of North Carolina thinks that granting patents on individual genes like BRCA leads to “fragmented ownership of the genome” that will interfere with the progress of whole-genome sequencing.

Dr Church could not disagree more. He says that when whole-genome sequencing arrives, single-gene patents will be of no use. When Myriad’s patents expire, the price of whole genome sequencing will have plunged so far towards $100 that it will no longer make sense to pay huge sums for a single-gene test anyway.