Tales about business interests in technology impeding the flow of academic information linger in the minds of many researchers like horror stories. But in most cases involving DNA patents, licensing concerns have not restricted sharing among colleagues in academe.
A study conducted by LeRoy Walters, professor of bioethics at Georgetown University, and six colleagues -- from academe and from private industry -- found that, even when universities grant exclusive licensing rights to companies, they insist on the right to share technology for academic research.
“The licensing of DNA patents by U.S. academic institutions: an empirical survey,” published this month in Nature Biotechnology, gathered data from 19 technology transfer offices at leading research institutions, some of which are among the most prolific DNA patent holders in the country. All of those respondents, according to the paper, generally retain the freedom to share technology for research purposes.
The paper suggests that 1999 guidelines by the National Institutes of Health, which urge grant and contract recipients to share “research tools with all biomedical researchers who request them,” set the tone for academic cooperation, and are widely considered by academic researchers to be stipulations of receiving grants. “It was almost like a gentleman’s agreement when it became clear NIH wanted people to share,” Walters said.
Of course, it might not be purely gentlemanly concerns that foster cooperation. A bit of back-scratching in the DNA department doesn’t hurt -- the old “you use our transgenic mice, we’ll use your ribozymes” deal. Or, as Walters put it, colleges insist on being allowed to share because it is “a mutual self interest matter,” as well as being a boon to higher education research as a whole.
As DNA patents have increasingly become old hat, technology transfer offices have increasingly learned not only how to share with academic institutions, but how to make sure an important invention does not get covered with cobwebs on the corporate shelf. For example, colleges might insist on a development clause, which allows an invention to be licensed elsewhere if a particular company is not developing it sufficiently or quickly. Or, with the most lucrative patents, like the Cohen-Boyer patents of recombinant DNA technology (which earned Stanford University and the University of California hundreds of millions of dollars) institutions license to many companies -- hundreds, in the case of Cohen-Boyer -- so the “failure to ‘work’ the invention is less a concern because licensing in nonexclusive,” the paper reads.
Another sign of the times, and of institutions’ growing experience with DNA patents, has resulted in colleges applying for fewer patents. DNA patents peaked in 2001 at 4,463. In 2005, only 2,741 DNA patents were issued. Technology transfer offices have become more savvy about the cost-benefit analysis of filing for a patent. “If it’s a gene that has a potential diagnostic application, you’re sitting there thinking ‘what’s the application?’” said Robin Rasor director of licensing at the University of Michigan. “For a lot of things, a lot of us are treating them like software, make them available for a reasonable price [by licensing without a patent]. It’s easier that way.”
Plus, since 2001, patent applications are published 18 months after the first filing, so information is available for research purposes. “We were nervous about [the change to publishing] at first, but it’s been great,” Rasor said. “You can elect to have it not published, but often your faculty member has already published something anyway.” Robert Streiffer, assistant professor of bioethics at the University of Wisconsin at Madison, added that one argument for patenting in general is that it increases information sharing. “Otherwise, findings might be kept as a trade secret,” he said.
Still, though colleges seem to be doing a good job of keeping communication channels open, each case depends on the individuals involved, and companies and the academy aren’t exactly passing out inventions like Halloween candy.
The most prominent problems occur not when two universities are talking, but when one of them has involved a business. In one well-known, but old case, Mark Skolnick, a government funded University of Utah researcher, discovered a human gene responsible for some forms of hereditary breast cancer in 1994. Rather than making it broadly available, Utah patented the gene and licensed it exclusively to Myriad Genetics, a start-up founded by Skolnick. Myriad later objected to researchers at the University of Pennsylvania using the gene to analyze samples from a National Cancer Institute study. Myriad required the researchers to pay to use Myriad facilities, rather than their own, which made the cost of the tests prohibitive.
Rasor said that there’s no obligation to make an invention freely available to everybody, but that “it makes sense to price it right,” often both financially and ethically. She added that, even when big companies are the sole funding source of university research, the companies often don’t even care about having the patent, so they don’t haggle with universities. “They would much rather buy it for a reasonable price than fight over a patent,” she said. Walters pointed out that companies have an interest in keeping good relationships with universities, and in avoiding the bad press that disputes generate.
In another case that enraged researchers, Pioneer Hi-Bred and Dow AgroSciences blocked researchers from studying a gene they patented for genetically engineering sunflowers after an Ohio State University researcher discovered that the gene might be passed to wild sunflowers, making them weedier.
Rebecca Eisenberg, a patent law professor at the University of Michigan who specializes in biomedical research, said that universities are becoming increasingly aware that they are not exempt from intellectual property laws. “One strategy has been to simply ignore patents on the theory we’re doing basic research, and our activities will not trigger infringement liability,” Eisenberg said. But she added that some universities that do that, when a faculty member publishes, they’ll get a letter saying “it’s come to our attention you are using blah-blah-blah technique. We hold the patent on this.” Eisenberg said that only happens between universities when a private licensor pushes for it. Rasor said the letter threats against colleges are practically never enforced.
Eisenberg added that, while some things are getting better, data hoarding between colleges and companies is still prevalent since the Bayh-Dole Act of 1980, which allowed colleges and companies to gain exclusive rights to government funded research. “It made companies more reluctant to allow universities to use information freely, because they view them as competitors,” Eisenberg said. “If you’re going to have a mixed system of public and private science, this is going to happen.”
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