The current administration's stance on stem cells is, rightly, the focus of frustration in stem cell circles within the United States. In particular, the misguided and convoluted policy announced in August 2001 has delayed progress in embryonic stem cell research.
But there's another stumbling block at least as important as the moralism of the 43rd president. That stumbling block is US Patent No. 6200806, which covers "a purified preparation of pluripotent human embryonic stem cells which (i) will proliferate in an in vitro culture for over one year, (ii) maintains a karyotype in which the chromosomes are euploid and not altered through prolonged culture, (iii) maintains the potential to differentiate to derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and (iv) is inhibited from differentiation when cultured on a fibroblast feeder layer."
The patent is held by the otherwise-laudable Wisconsin Alumni Research Foundation (WARF). As Glenn McGee writes on page 24 of this issue, WARF, "in this and two other patents, in essence owns virtually all imaginable characteristics of human embryonic stem cells."
Imagine for a moment that you run the WARF and you'll see the conundrum: You manage a portfolio of technology transfers and investments effectively, so much so that your organization contributes $65 million dollars to support research at the University of Wisconsin. A hefty chunk of that revenue comes from licenses on the stem cell patents: You can charge up to $400,000 a throw. The future looks even brighter because you can claim royalties from products produced using the patents. Unfortunately, you are a pariah. And the community is taking action. As we reported in The Scientist Daily News (www.the-scientist.com/news/display/25037/), this patent is being reviewed after complaints by a coalition of non-profit groups.
We first heard rumblings of this coalition's work last year as we probed California's Proposition 71, in which voters gave their nod to $3 billion in state bonds for stem cell research. Scientists and policymakers realized at that point that much of the funding would end up in Wisconsin's coffers, and that didn't make them happy.
The USPTO's review is happening none too soon. The bad news is that it will likely take several years to conduct-the PTOs chronic underfunding is something else that needs attention. Further bad news is that WARF have deep pockets and look set to mount a vigorous defense.
It's possible to see things from WARF's point of view: They are following the rules and the income is plainly being put to good use. But WARF need to look at the bigger picture. Academics and companies should not be wasting valuable research dollars on licenses. And if WARF compound the insult by squandering millions of dollars on legal fees they will not be readily forgiven. We'll continue to follow this story in our daily news.
Patents are a good thing. In general, they promote progress by encouraging research and development with incentives. But sometimes, they over-reach, and they impede progress rather than help it. This is one of those cases. The WARF patents point up the sometimes uncomfortable conflict between intellectual property rights and scientific freedom that many of our readers often feel as they find their way in the funding environment of the 21st century.
Let's apply pressure to change the current policy on embryonic stem cells. November 7th's midterm elections may provide an opportunity to do that. But let's also look at supposed proponents of such research and see whether their intellectual property rights are holding things up. If they are, time to make that change too. Sometimes the enemy is us.