The Gatekeeper 

What if scientists devised a strategy to tackle some of the world's most notorious diseases, but just one company held all the patents?

Page 5 of 6

Just as Sangamo's patents give it clout over how the technology develops, they also make it the gatekeeper of who develops it.

The tension between the desire to harness all available brainpower to study a potentially life-saving technology and the desire to play things close to the vest to maximize profits for shareholders is a common one in biotech, and companies like Sangamo have a cautious alliance with the academic world. Although Sangamo has about eighty collaborations with academic institutions, these collaborators often have zinc fingers shipped to them but are not given information about how to make them or refine them for maximum effectiveness — Sangamo considers that information the key to the kingdom.

While academics are free to research domains in which Sangamo dominates the intellectual property rights, they cannot commercialize their results without a license from Sangamo, Wolffe said. Additionally, as the Nature Biotechnology article noted, despite some pressure to make its zinc finger library "open source," Sangamo has not done so.

For good reason, Wolffe said — zinc fingers are hard to make and even harder to optimize, they're the fruit of years of labor, and at the end of the day, the company wants to make money for its shareholders, not give away the store. "I think some of the academic researchers would like us to hand over our libraries, but that's a bit like saying Merck is holding back small molecule [drug] research because they don't make their libraries available," Wolffe said.

In fact, companies have an incentive to hang on to their intellectual property for as long as possible, considering that it can take nearly a decade, as well as millions of research dollars, to develop a single product, and even then FDA approval is not guaranteed. The New York Times recently highlighted the strange fate of Berkeley's Xoma, one of the nation's oldest biotech firms, which, despite never bringing a drug to market, has remained afloat since 1981 by collaborating with bigger companies that need access to its proprietary technology for making antibodies. Companies that can find ways of generating revenue even while their test therapies are still in the development pipeline may stand a better chance of surviving in the notoriously hit-or-miss biotech world.

Dr. Carlos Barbas of the Scripps Research Institute, once a member of Sangamo's advisory board and one of the researchers whose work was acquired to found the company, split with Sangamo several years ago over disagreements about what it should keep proprietary. Today, he's one of its chief critics.

"I think they're distorting the complexity of the technology, making people think in order to use it they have to go through them," he said. "But a number of academic groups are trying to break that myth and show it's something that can be accessible without having to go through them."

Barbas, for example, launched a Web site that allows researchers to type in the sequence of a gene they're interested in, and get back what is essentially the recipe for a zinc finger that would target it. A handful of other researchers, some of them frustrated after failed attempts to collaborate with Sangamo, banded together as the Zinc Finger Consortium to pool knowledge and resources. Two of the consortium's founders did not respond to repeated requests for interviews, but one of them, Harvard's Dr. Keith Joung, explained the organization's purpose to Science magazine: "My interest is not to circumvent Sangamo's patents. I just want to make the technology available, easy to use, efficient, and robust."

Barbas believes that both Sangamo and healthcare consumers would benefit if the company opened up a little — after all, a 75-person company can't tackle every disease in the world, particularly the rarer ones with a smaller potential patient base. He also believes that what he calls the "high ticket price" of working with Sangamo has driven researchers to apply their efforts to competing technologies instead — particularly a gene repression technique known as RNA interference, or RNAi, that is becoming the hot new thing in biotech. "I believe Sangamo has crippled their [own] advances by keeping the technology in-house," Barbas said. "It also spurs the development of this other approach, RNAi, because researchers were not provided with any easy way into zinc fingers and they simply turned to another technology. As a consequence, RNAi is advancing far faster into the clinic than zinc fingers have."

While RNAi can't do everything zinc fingers can, Sangamo execs are well aware that the ease with which researchers can get the materials they need has both increased its buzz and given more researchers experience using it — things they'd like to have, too. "It would be in our own best interest to get the technology out there," Wolffe agrees. "At this state it's too complicated for it to be general usage, but we are seriously investigating ways to make it more user-friendly and get it out there."


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