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Patents, Practices and the Progress of Stem Cell Research

If doing embryonic stem cell makes you unpopular, holding the patents on embryonic stem cell research could make you a pariah. Not only are you in a position to profit from the destruction of human embryos, but you could also be the greedy patent-holder standing between disease sufferers and a cure.

Meet the Wisconsin Alumni Research Foundation (WARF). Founded in 1925 to manage University of Wisconsin-Madison professor Harry Steenbock’s patented process for irradiation of foods, WARF was dealing in academic inventions long before the 1980 Bayh-Dole Act explicitly encouraged institutions to do so. These days its extensive portfolio includes a group of important patents issued to another UWM professor, James A Thomson, following his derivation of human embryonic stem cells in 1998.  The Thomson patents have generated controversy for their necessary relationship with the destruction of human embryos, and because they provide significant control over the development of what many consider to be a very important area of research. I long ago gave up looking for consensus on the morality question, but I believe we may be moving toward a place where access-conscious practices and policies are the norm for public sector patent holders like WARF.

The patents claim rights to a purified preparation of primate embryonic stem cells, a purified preparation of human embryonic stem cells, and a method for isolating each. A couple of years ago, Sander Rabin described them in Nature Biotechnology as effectively covering “all [embryonic stem] cells and downstream products, regardless of how the cells are derived.” In consequence, anyone wanting to derive or use embryonic stem cells in the United States has needed a license to do so. When the U.S. National Institutes of Health set up its registry of embryonic stem cell lines in 2001, it had to do some serious negotiating to ensure that NIH-funded researchers could use lines meeting President Bush’s funding criteria without breaching the Thomson patents.

The stem cell patents are being challenged on the grounds that the inventions claimed were obvious in the light of previous scientific research, and WARF has been accused of not making the inventions available easily and widely enough, even though it has not charged license fees for much academic and nonprofit use. When the California Institute of Regenerative Medicine (CIRM), responsible for managing Californian taxpayers’ $3 billion stem cell initiative, proposed that its grant recipients would return to the state a portion of any eventual profit they might make, a WARF attorney suggested that WARF might assert its patents and seek license fees from the commercial partners of CIRM grantees. But in late January, WARF announced two new policies and a “clarification” that should make some U.S. research use of embryonic stem cells easier. Companies that sponsor stem cell research at academic or nonprofit institutions will no longer need licenses from WARF, and researchers will be able to share stem cells with each other for free.

The clarification explains that CIRM will not need licenses to fund stem cell research and that WARF will not expect a share in any royalties eventually provided to CIRM by its grantees. (Anyone commercializing stem cell research, regardless of where their funding comes from, will still need a commercial license, however.) As the patent holder, WARF is not under any legal obligation to waive its rights in this way, but in the decade since the controversy over Myriad’s use of its patents on the “breast cancer genes” (BRCA1 and BRCA2), practices and policies that facilitate research have become more fashionable, particularly amongst public sector patent holders.

Angela Wasunna and I discuss this kind of practice, as well as others than can reduce barriers to research and care potentially caused by patents, in “Patents, Biomedical Research, and Treatments: Examining Concerns, Canvassing Solutions,” published as a supplement to the current Hastings Center Report. But however much these practices catch on in the public sector, their effect is circumscribed. Access to eventual treatments, and even to some inventions needed for ongoing research, almost always also depends on private industry, which – although it has come a long way in facilitating access, particularly to drugs in poor countries – is also always bound to seek profits. Making commercial products widely available without asking companies to betray their shareholders will require attention to much more than patents.

– Josephine Johnston

Published on: March 2, 2007
Published in: Emerging Biotechnology, Stem Cells

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