MIT Technology Review Concern Over WARF’s Patent Rights Lawsuit From CIRM On Stem Cells Is Misplaced
On April 24, an article in MIT Technology Review described the immediate concern over 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 tactic by the state of California to ensure cooperation between researchers from different states. The California CIRM oversight committee recently announced that any California researcher who develops patented discoveries using California state funds must share their patents with other state researchers. CIRM’s Ed Penhoet was quoted: “We hope WARF reciprocates.” Of course, one problem 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 shared. Does the exchange only pertain to use by researchers in academic institutions, or does it extend to companies created by such researchers? One of the main selling points for voters in states like California and New Jersey was that state funding research would recoup the money spent through patent royalties. If everyone gets a free license, such recovery is unlikely.
The article travels the world of the use of patents in different universities that hold patents. Universities generally allow other institutions to use proprietary technologies without special permission. The litigated case Madey vs. Duke University is an exception to this general rule, although it was a patent professor who sued a university. Additionally, 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 lawsuit. [311 Science 1716 (2006)]: Jeanne Loring, a scientist at the Burnham Institute for Medical Research in La Jolla, CA, founded 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,” he says. This quote is significant for at least two reasons. First, you see that venture capitalists were aware of the Thomson / WARF patents and saw them as a roadblock to venture capital investment in the field. Therefore, as for the small research entities that reject CIRM money due to patent rights disputes, it is suspected that these small entities do NOT have venture capital funding as a viable alternative. I suspect that time before payment is a separate deciding factor when it comes to venture capital financing; nothing seems ready for commercialization in seven years, a typical VC benchmark. Second, in the world of Bayh-Dole, it’s a little scary that a teacher / entrepreneur doesn’t know about the relevant patents of a Bayh-Dole beneficiary. Furthermore, it is also scary that CIRM apparently did not anticipate the WARF move, the flaw of which is somewhat difficult to understand from the basic patent issued years ago.
WARF / Thomson’s base patent is US 5,843,780 (issued December 1, 1998 to James A. Thomson, based on application 591246 filed January 18, 1996; the application was a continuation in part of the US application. 20, 1995. Obtained with funding from the federal NIH and therefore represents a patent obtained through the auspices of the Bayh-Dole Act. It is separately true that Thomson, a few days after filing his Basic patent application, filed an article from the Proceedings of the National Academy of Sciences, which appeared as 92 PNAS 7844 (1995).
Kenneth Taymor, an attorney for the Stanford Program on Stem Cells in Society, is quoted in the article: “The more WARF exercises its rights, the more the investigation will be affected and the more likely it will move to shore.” This bogeyman is not hunting. In a different variant, the investigation would move abroad after the Bush restriction in 2001.
Taymor and the article’s author, Emily Singer, simply forget to mention the role 35 USC 271 (e) (1) is going to play in embryonic stem cell research. Therapies arising from embryonic stem cells will require FDA approval. Work done to comply with FDA requirements is insulated from liability for infringement through the safe harbor of 271 (e) (1), as broadly interpreted by the US Supreme Court in Merck v. Integra.
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). Los Angeles Times article far off base 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.