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"I'm in Favor of Patent Reform"
15 May, 2007 12:35 pm
The US Patent and Trademark Office has just revoked three stem cells patents hold by the Wisconsin Alumni Research Foundation (WARF). These patents, issued from Dr James Thompson's studies at the University of Wisconsin, have been contested for several years. The biologist Jeanne Loring is one of the long-term opponents of these patents. She answers our questions.
I have two reasons. The most important is that the patents were issued on work that was obvious and should not have been patented. The parent patent (the one that gives WARF the right to keep everyone else from using human embryonic stem cells) was based on Jamie Thomson simply culturing monkey embryos using the methods that almost everyone was using to derive mouse ES cells. The methods were published in 1981, and in more detail in 1983 and 1987, and I knew the methods by heart. On the basis of the monkey work, the patent was issued to cover all primates, including humans. The patents cover the cells themselves, not just the methods to make them, so there is no way to avoid the patent by making the cells in a different way.
The second reason is WARF's behavior. The patent system isn't perfect, and a lot of patents shouldn't have been issued. I might have ignored WARF's patents, but WARF was very aggressive about extracting license fees from people who wanted to use the cells, and I thought something had to be done. No other country but the US would allow human ES cells to be patented. WARF applied in the EU but was turned down by the EPO. But because of the US Patent, if a scientist in Europe or Asia made a human embryonic stem cell line and brought it to the US, WARF would claim it.
To what extent do you think that these patents have slown down the development of stem cells research in the US?
Until the NIH made WARF the official stem cell bank for the US, researchers had to pay $5000 to WARF for each cell line, and each investigator, even in the same department, had to pay separately. The result in my department was that about $25,000 went straight to WARF from our NIH grants. This is a considerable amount for us. After the NIH gave them the contract to bank the cells, WARF could only charge $500. In January this year, after we challenged the patents, WARF began allowing researchers to share cell lines. So WARF has relaxed their policies, but we have to keep in mind that as long as they hold these patents, they have the right to have any policy they choose.
The effect on biotechnology in the US has been chilling Even a start-up biotech company was required to pay $100,000 upfront, and $25,000 a year afterward, just to have the cells in their labs. If they developed a commercial product, the royalties would be much, much more. This was discouraging to both small and large companies, who either didn't have the money to invest or didn't want to waste their money. Some large companies who wanted to perform research on human ES cells simply do it outside the US.
Do you think the debate needs to extend to the whole field of biotechnologies?
The patent system was meant to protect inventors and encourage development of inventions. But patents are increasingly being used as weapons to destroy competition. I'm in favor of patent reform. The US Supreme Court recently ruled that there needed to be stronger definitions of what is obvious, so that patents can't be granted for trivial changes in methods or materials. I strongly agree. The WARF patents would not have been granted if the standards were higher.
Interview by Clementine Fullias
Jeanne Loring works at the Burnham Institute for Medical Research.
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