On April 24, an article in the MIT Technology Review portrayed immediate concern about the Wisconsin/WARF/Thomson patents on stem cells as how patents will affect basic academic research, which, in turn, could affect the development of stem cell-based tools and therapies.
The article mentioned a possible move by the state of California to ensure cooperation between researchers from different states. The California CIRM oversight committee recently announced that any California researchers who develop patented discoveries using California state funds must share their patents with other state researchers. CIRM’s Ed Penhoet was quoted: “We hope WARF reciprocates.” One problem, of course, is that WARF currently has patents related to embryonic stem cells and CIRM does not. In addition, it would be necessary to know the details of what is being shared. Is the sharing only relevant for use by researchers at academic institutions, or does it extend to companies created by those researchers? One of the main selling points for voters in states like California and New Jersey was that state-funded research would recoup money spent through patent royalties. If everyone gets a free license, such a recovery is unlikely to happen.
The article covers the world of patent use among different patent-holding universities. Universities generally allow other institutions to use proprietary technologies without special permission. The litigated case of Madey v. Duke University is an exception to this general rule, although it was a patent-holding professor who sued a university. In addition, WARF requires universities to obtain a license to conduct embryonic stem cell research. “None of us understand why we need a license… Why is this technology different?” says a technology transfer official. WARF’s license to the University of California, for example, allows scientists to use only a small number of embryonic stem cell lines. And the license granted to the Howard Hughes Medical Institute, a nonprofit medical research organization that funds scientists across the country, prohibits scientists from accepting funding or collaborating with commercial companies unless the company has a commercial license from WARF.
The article features an interesting quote from Jeanne Loring, who is the author of an article criticizing WARF’s patent royalty claim. [311 Science 1716 (2006)]: Jeanne Loring, a scientist at the Burnham Institute for Medical Research in La Jolla, CA, started a short-lived embryonic stem cell company several years ago. “I learned from venture capitalists that these patents existed and that it would be impossible to get funding from them,” she says. This quote is significant for at least two reasons. First of all, one sees that venture capitalists were aware of the Thomson/WARF patents and saw them as an impediment to venture capital investment in the field. So, as for the small research entities turning down CIRM money over patent royalty rights disputes, one suspects that these small entities do NOT have venture capital funding as a viable alternative. I suspect that the length of time before payment is a separate deciding factor when it comes to venture capital financing; nothing here looks ready for commercialization seven years from now, a typical VC benchmark. Second, in the world of Bayh-Dole, it is a bit scary that a professor/entrepreneur does not know the relevant patents of a Bayh-Dole beneficiary. Furthermore, it’s also scary that CIRM apparently didn’t anticipate the WARF game, whose flaw is somewhat difficult to fathom since the basic patent was issued years ago.
WARF/Thomson’s basic patent is US 5,843,780 (issued December 1, 1998 to James A. Thomson, based on application 591246 filed January 18, 1996; application was a continuation-in-part of US application Ser. U.S. Serial No. 08/376,327 filed January 20, 1995. Obtained with funds from the federal NIH and therefore represents a patent obtained under the auspices of the Bayh-Dole Act It is true separately that Thomson, a few days after filing his basic patent application, filed a paper with the Proceedings of the National Academy of Sciences, which appeared as 92 PNAS 7844 (1995) His effort to patent did not impede his efforts for rapid public disclosure .
Kenneth Taymor, attorney for the Stanford Program on Stem Cells in Society, is quoted in the article: “The more WARF pushes for its rights, the more the investigation will be affected and the more likely it will move abroad.” This boogeyman will not hunt. In a different variant, the investigation would move abroad after the Bush restriction in 2001.
Taymor and the article’s author, Emily Singer, simply neglect to mention the role that 35 USC 271(e)(1) is going to play in embryonic stem cell research. Embryonic stem cell-derived therapies will need FDA approval. Work done to meet FDA requirements is insulated from infringement liability through the 271(e)(1) Safe Harbor, as broadly interpreted by the US Supreme Court in Merck v. Integrate.
The topics discussed in this article are related to those mentioned in Ebert, Lawrence. (2006, April 13). Will Wisconsin patents block embryonic stem cell research? EzineArticles. Retrieved April 24, 2006 from http://ezinearticles.com/?id=178431 and Ebert, Lawrence. (2006, April 12). Very off base Los Angeles Times article on stem cell issues. EzineArticles. Retrieved April 24, 2006 from http://ezinearticles.com/?Los-Angeles-Times-Article-Way-Off-Base-on-Stem-Cell-Issues&id=178050.