By Meredith W. Salisbury
From the time the very first patent applications based on DNA sequence were submitted, debate has fluctuated from murmurs to shouts as scientists, policy makers, entrepreneurs, and others attempt to sort out the ethics and legalities of patenting a naturally occurring chemical sequence.
Enter LeRoy Walters, a Georgetown ethicist who does not propose to solve this debate at all; rather, he says, he hopes the results of a study he and colleagues including Robert Cook-Deegan have undertaken will bring some solid data to the conversation and “[get] away from the anecdotes.”
Walters and his team have been working for more than a year surveying the 30 US universities that hold the most DNA-based patents — each had at least 70 — to get a glimpse of how the tech transfer and licensing processes governing these patents work. By press time, the team was still analyzing its data.
According to Walters, 18 of the 30 invited universities responded to the survey, providing his team with data on about 60 percent of the 4,400 DNA-based patents owned by all 30 schools. University responses indicate that of the patents they own, some 30 percent have never been licensed; just one to two percent of the patents had been licensed more than 10 times; and the remainder, more than two-thirds of the patents, had been licensed one to nine times.
One finding that came as a real surprise to Walters was that, of the patents that had been licensed at least once, “about 80 percent of the patents had been licensed already by the time the patent was issued by the USPTO,” he says. “What that means is that university tech transfer offices are out there licensing an invention not knowing whether they’re ever going to get a patent on it.”
The universities also surprised Walters by an informal agreement to maintain the research exemption — that is, to allow basic public-sector researchers to use these patented items without requiring a license — among all institutes. “If a university is asked to license [a patent to a company] exclusively, they will say … ‘We retain the right to use this internally at our university for basic research purposes and we also retain the right to license the invention to other nonprofits for basic research purposes,’” Walters says. “To me that’s really quite striking.”
In addition to the survey results, Walters is hard at work on a publicly accessible database of DNA-related patents. That effort began back in 1993 when he was chairing an advisory committee for a panel set up to examine DNA-based patents when the panel, and the office that funded it, were shut down by Congress. “The director [of that office] called me and said, ‘We’ve got boxes of patents that we had for this project. Would you be willing to accept the patents if we boxed them up and gave you a $5,000 grant to catalog them?’” Walters has been involved in the initiative, long surviving on a shoestring budget, ever since.
He spent much of that time “developing a good search algorithm for fishing the DNA-based patents out of the huge number of patents in the USPTO database,” he says. By now, Walters’ databank, which is updated weekly, contains about 35,000 patents — probably a tad on the high side, he says, but “we accept a little overage in order not to miss anything important.” Another parallel database is in the works for DNA-related patent applications.
“The public and policy makers should know what’s happening with this field and should have access to some kind of database of these kinds of patents to know roughly how many there are and who owns them,” he says.
Meredith Salisbury, editor of Genome Technology, can be reached at [email protected] Her Legal Probe column on legal and IP issues affecting the genomics industry appears bimonthly.