November 2001

The Morphing Patent Problem

Absurdly broad stem cell patents are shutting down promising research.

By Seth Shulman

We've certainly learned a lot about stem cell technology recently. Late this summer, my friend George, a prominent stem cell researcher, could hardly get any work done he was so busy explaining stem cell lineages-hepatocytes, myocytes, osteoblasts-to the eager journalists and TV news crews camped in his lab.

It's still too early to tell, but we all can probably learn an important lesson about patents from the stem cell debate as well. In case you missed it, just as President George W. Bush decided to let federally funded researchers study those human embryonic stem cell lines already in existence, the public learned that a little-known private firm-Menlo Park, CA-based Geron-held a proprietary lock on them so tight that federal funding might be nearly moot. The situation was so dire a National Institutes of Health team scurried off to "negotiate" (read beg) for access to the sought-after stem cell lines.

How in the world is one company able to "own" such critical technology? Especially given that much of the work behind Geron's position-led by developmental biologist James Thomson at the University of Wisconsin-Madison-was done at a public university?

Well, it's a tragedy of errors.

First, the federal government deserves blame for dragging its feet in funding human embryonic stem cell research to begin with. Its politically motivated reluctance to get into this area left the door wide open for Geron to demand an exclusive license to the technology when it helped underwrite Thomson's early research in 1995. (While federal funding for embryonic stem cell research was banned from 1996 until the NIH issued new guidelines last year, Geron helped keep the field alive [see "The Troubled Hunt for the Ultimate Cell," TR July/August 1998].)

Second, we need to scrutinize the role played by an outfit called the Wisconsin Alumni Research Foundation (WARF), which guards the university's commercial interests in such matters. Most universities have similar technology licensing operations. And in this case, the Wisconsin foundation brilliantly performed its core job: securing a phenomenally broad patent on human-embryo stem cell research and on the stem cell lines themselves-and then inking the exclusive deal with Geron. The problem is that this private group was accountable to no one as the public guardian of a vital monopoly.