Working With Stem Cells? Pay Up

In August 2001, I told a US Senate subcommittee that as much as half of stem cell revenue would likely end up going to patent holders because of absurd patents on the human embryo. No one seemed to care. The debate over embryonic stem cells then was whether it was ethical to do research on them.

That is mostly still true, but it won't be for much longer. With $3 billion for stem cell research coming down the chute in California, researchers are terrified. They fear that their own innovations will be credited inappropriately or result in unfair profits, because they will have to license the basic stuff of life from the University of Wisconsin Alumni Research Foundation (WARF). Wisconsin is the home of James Thomson, the researcher who successfully identified and cultured human embryonic pluripotent stem cells, roughly simultaneous to a similar experiment by John Gearhart at Johns Hopkins. All of that has led to complaints from two groups - the Foundation for Taxpayer and Consumer Rights and the Public Patent Foundation - that have now forced the US Patent and Trademark Office to reconsider the patents.

The taxpayers of California are none too pleased either. The $3 billion, they are beginning to gripe, was to go to stem cell research, and they're furious that someone who filed a patent on looking at the human embryo could collect royalties every time an embryonic stem cell is made, or used in a discovery, regardless of whether that cell came from Wisconsin.

So can someone own the cells that make up what is important about a human embryo? And if so, do we have to pay them every time we make our own embryonic cells, every time we make a medicine or other innovation from embryonic cells, and even when we use the cells to teach?

At least at the blastocyst stage, the answer is essentially yes. The broadest claim made by Thomson in US Patent No. 6200806 is to "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." WARF, in this and two other patents, in essence owns virtually all imaginable characteristics of human embryonic stem cells.

Wisconsin also controls five cell lines, which the state's former governor, former Secretary of Health and Human Services Tommy Thomson, just happened to authorize under the Bush "ethical cells" policy of 2001 as among those cell lines in which "the evil had already been done," so the cells were doubly blessed.

Basically, if it looks like an embryonic cell, you'd better pay up. And if you try to make something out of your own embryo - yes, the one you made with your own body, from your own body - well, hope you have good lawyers.

In one among many of its attempts to avoid what could and should be a reversal of these patents stemming from the decision to review them, Wisconsin's Governor Jim Doyle has announced that companies who fund work at universities and nonprofits in that state will not have to pay any licensing fees. Previous attempts to ameliorate the problem have been more aggressive: offering to provide the cell lines at lower prices or to cross-license in a friendly way, for example. It wasn't enough for Californians, and now it appears it won't be enough to stop right-thinking people everywhere from filing suit, on moral grounds if nothing else.

The protection of patents is supposed to extend to "things under the sun made by man." There has yet to be a serious challenge to the absurdity of patents on disease genes, and the even more absurd notion that the ability to find, to discover, constitutive parts of an embryo means that you own them.

Well, that's one patent we can throw over the side of the WARF.

Glenn McGee is the director of the Alden March Bioethics Institute at Albany Medical College, where he holds the John A. Balint Endowed Chair in Medical Ethics.