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A Question of Scale

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This will come as a shock to absolutely nobody, but I'm going to say it anyway: there's nothing straightforward about intellectual property issues. A recent can of worms came in the form of a presentation at a National Academy of Science committee attempting to get to the bottom of gene and protein patents and what kind of impact they have on medicine and research. Debra Leonard, vice chair of laboratory medicine in the department of pathology and laboratory medicine at Weill Medical College of Cornell University, gave a compelling presentation against the current status of gene patents. Her issue was simple: as a pathologist trying to diagnose her own patients, Leonard was thwarted by legal teams at companies seeking to protect their own gene patent IP. Representing the College of American Pathologists, she related several episodes of receiving cease-and-desist letters that threatened legal action unless she stopped performing clinical diagnostics on her patients or forked over what amounted to thousands of dollars in royalty fees. (Many of these occurred in her previous job as director of molecular pathology at the University of Pennsylvania.)

Leonard says she was "totally surprised" when she received the first of what would be several such letters while at Penn, but after finding that she was not alone in her situation, she and some colleagues began looking into how gene patents were affecting fellow pathologists. "We've done a number of surveys," she says. Results are almost always the same: "about 25 percent of laboratories have had to stop doing a test because of patent enforcement, and about 50 percent of laboratories have gotten letters or have made decisions about not offering a test because of gene patents."

If your eye focused on the word "laboratories" in the last sentence, congratulations. You've come to the root of the problem.

Leonard's lab, like many pathology labs, culls the scientific literature for new associations between genes and disease to figure out whether a diagnostic test can be made for patients tested by that lab. Though the information about these links comes from the public domain, the genes in question are many times under patent — usually at a university or medical institution that has exclusively licensed it to a company.

If Leonard were an individual physician performing such home-brew tests on her own — and only her own — patients, it's likely she never would've received such cease-and-desist letters, experts say. But "it appears from her statements that she's running a commercial-scale diagnostic clinic as part of her practice," says Leslie McDonell, an IP attorney and partner at Finnegan, Henderson, Farrabow, Garrett & Dunner, whom I asked to review Leonard's presentation to the NAS committee. "Patents provide a means for individuals who innovate to get a return for their time and investment," she adds. "If you use the exact same test covered by a patent, you're using someone else's property."

Leonard's proposed solution — which does not address this problem of scale — is to expand an existing federal law that allows physicians to use patented surgical procedures without obtaining a license to include a similar protection for performing diagnostic tests on patented genes. A bill was introduced by Lynn Rivers, former Congressional representative, last year that would have accomplished that expansion. The bill, however, was never passed and Rivers was not reelected.

No matter how difficult these issues are, the good news is that people are openly discussing them. While patents for diagnostics make sense to give incentive for innovation, I'm still not convinced that people should be allowed to patent the genetic material itself. That's an issue that will no doubt be revisited countless times in the coming years, and it's likely that we'll hear a lot more about diagnostic-based legal skirmishes during that time, too.

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