Last week, Federal District Judge Robert Sweet ruled that patenting a human gene amounts to nothing more than a "lawyer's trick." The decision, in a case about patenting mutations of two genes associated with breast cancer, called into question decades of precedent and thousands of biotechnology patents. Analysts are worrying about the companies that depend on those patents, biotech executives are working to put out the flames, and investors are trying to figure out whether to press the "sell" button just yet. Despite the uncertainties for the market, however, Judge Sweet's decision may set a precedent that ends up helping biotech researchers, businesses, and consumers, too.
The patents at stake in Monday's decision cover mutations of the BRCA1 and BRCA2 genes, which are strongly linked to breast cancer risk. Myriad Genetics, a defendant in the case, holds these patents but does not license them. This means that Myriad can set monopoly-level prices for its diagnostic test. Any woman who wants to find out if she has the mutation has to go to Myriad. As Rebecca Skloot noted for DoubleX, the monopoly means that women can't seek a second opinion—no other lab can run its own test to confirm a particular result, or to double-check the overall accuracy of Myriad's test.
In its defense, Myriad has made many of the standard arguments for granting patents. The company sunk time and money into analyzing the BRCA mutations and developing its diagnostic test. There'd be no way to get a return on its investment if every other company could piggyback on these efforts. The patients who have used the test have gained from this investment too. As Myriad wrote in its brief, "The future of personalized medicine looks bright, promising new ways of identifying and curing genetic disorders and other diseases, resulting in social and health benefits for everyone. Without patent protection, this future will not happen."
But these arguments don't extend seamlessly to the patenting of human genes. Myriad didn't simply patent a new process for diagnosing the presence of the BRCA genes. If it had, then other companies could try to develop their own tests, and the market would reward whichever is cheapest or most effective. Myriad's patents, though, cover the isolated DNA sequences that code for the mutated genes themselves. This blocks labs from creating their own tests unless they get a license from Myriad. Which the company isn't granting.
This kind of patenting can head off new research. In one survey of biomedical researchers, 30 percent of labs (subscription required) reported discontinuing or not developing diagnostic tests because of exclusive patent licenses. While other anecdotal evidence is mixed, in one study as many as three-quarters of researchers in the biotech industry reported that patents caused them difficulty in conducting their research. Take a look at scientific journals, and you can see this isn't just whining: After a patent covering a gene is granted, the citation rate for publications related to the gene declines (subscription required). This suggests that the patent is a real barrier to new research.
These research problems stem from the nature of gene patents. It's rare that there is a single gene scientists can point to as the sole cause of a disease or disorder. And when there are multiple genes and gene patents, each patent-holder has the power to halt associated research. Lori Andrews, a professor at the Chicago-Kent College of Law, explains the difficulty facing researchers in the current thicket of patent rights. Take the hypothetical example of a researcher who wants to study asthma and finds that there are 20 genes associated with asthma that are covered by human gene patents. "If even one of the holders of an asthma gene decided to exert exclusive control of the gene, research on cures and treatments would be stymied," Andrews explained in an e-mail.