Last night, President Bush announced expanded funds (see next blog) for research to reprogram adult cells to act like skin cells, but his proposed policy on patents would have more of an impact.

Bush called on Congress “to pass legislation that bans unethical practices such as the buying, selling, patenting or cloning of human life.” While current policy forbids federal funding to be applied to newer human embryonic stem cell lines, this is an actual ban. It could make certain kinds of work illegal, such as making new human embryonic stem (ES) cell lines by cloning human embryos, an advance reported recently by a US company. (Interesting that Bush didn’t include harming or destroying human life.)

However, that part of the legislation is unlikely to get anywhere. The US is actually unusual in that it does not forbid reproductive cloning of new human beings. Nobody is for this, but legislation to ban it always stalls because some legislators insist that bills also ban therapeutic cloning (to make ES cells), so those that back ES research withdraw their support.

What’s more interesting is the patenting part. Patents already exist on deriving human embryonic stem cells. These patents have been widely criticized for being too broad and its holder WARF for being too stingy. If Bush pushed for it, those patents could, perhaps, get invalidated because of this policy. Interestingly, that could bring the US much closer to the European patent position, and could mean a whole new playing ground for the WARF patents covering the derivation of human embryonic stem cells.

At first blush, this may seem like a boon to institutions who could have more freedom to operate. But it may not be as advantageous as one might think.

The University of Sheffield’s Aurora Plomer, Berkeley’s Ken Taymor, and Stanford’s Chris Scott wrote comprehensively on this issue recently in Cell Stem Cell. EU policy “prohibits the patenting of the human body at the various stages of its formation and development,” Human cloning is not patentable, nor is the use of human embryos for commercial purposes permitted. (Aside: But fertility clinics are legal. Why?) Their conclusion is that conflicting interpretations of this policy have stymied research and even allowed companies to play off each other. They even describe how Geron is trying to invalidate a German patent on stem cell derivatives on a morality clause.

Finally, Plomer et al point out that much of the damage may already be done. With other companies and institutions out of the race, Geron (the main holder of commercial rights for the WARF patents) and others that continued research have built up strong intellectual portfolios, much of which will still stand if original patents are invalidated. (Interestingly, they also argue that current US challenges to WARF patents could actually strengthen them, something the challengers don’t believe. (See our commentary by Jeanne Loring.)