MIT Technology Review Concern Over WARF Patent Royalty Demand To CIRM Over Stem Cells Is Misguided

On April 24, an MIT Technology Review article described immediate concern over 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 tools and therapies.

The article mentioned a possible gambit from the State of California to ensure cooperation between researchers from different states. The California CIRM Oversight Committee recently announced that all California researchers who develop patented discoveries with funds from the State of California must share their patents with other researchers in the state. Ed Penhoet of CIRM was quoted: “We hope WARF will return the favor.” Of course, one problem is that WARF currently has patents related to embyronic stem cells, and CIRM does not. In addition, one should know the details of what is being shared. Does the sharing concern only the use by researchers in academic institutions or does it extend to companies created by these researchers? One of the main selling points for voters in states such as California and New Jersey was that the research funding state would recoup the money spent through patent royalties. If everyone gets a free license, such recovery is unlikely to happen.

The article travels the world of patent use as among the various patent-holding universities. Universities generally allow other institutions to use patented technologies without special permission. The contested case of Madey v. An exception to this general rule is Duke University, although it was a patent professor who took legal action against a university. In addition, WARF requires universities to obtain a license to do research on embryonic stem cells. “None of us understand why we need a license … why is this technology any different?” said a technology transfer official. WARF’s license at 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, herself the author of an article criticizing the WARF patent royalty claim [311 Science 1716 (2006)]: Jeanne Loring, a scientist at the Burnham Institute for Medical Research in La Jolla, Calif., Started a short-lived embryonic stem cell company several years ago. “I learned from venture capitalists that these patents exist and that it would be impossible to get funding for them,” she says. This quote is significant for at least two reasons. First, we see that venture capitalists were aware of the Thomson / WARF patents and saw them as a brake on venture capital investment in the field. So, when it comes to small research entities that forgo CIRM money due to patent royalty rights disputes, it is suspected that these small entities do NOT have venture capital funding as an alternative. viable. I suspect that the time elapsed before payment is separately a halt as far as venture capital funding is concerned; nothing here seems ready for commercialization within seven years, a typical benchmark for venture capital. Second, in the world of Bayh-Dole, it is quite scary that a professor / entrepreneur is not aware of the relevant patents of a Bayh-Dole beneficiary. Plus, it’s also scary that CIRM apparently didn’t anticipate the WARF game, the failure of which is a little hard to fathom since the basic patent released years ago.

The WARF / Thomson basic 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 US application No. Serial 08/376,327 filed Jan. 20, 1995. It was obtained with funding from the Federal NIH, and therefore represents a patent obtained under the auspices of the Bayh-Dole Act. It is also true that Thomson, a few days after filing his basic patent application, filed a document in the Proceedings of the National Academy of Sciences, which appeared as 92 PNAS 7844 (1995). His patenting efforts did not hinder his efforts rapid public disclosure.

Kenneth Taymor, an attorney with the Stanford Stem Cells Program in Society, is cited in the article: “The more the WARF presses its rights, the more research will be hampered and the more likely it will be to travel abroad.” This boogeyman won’t hunt. In a different variation, the research would move offshore after Bush’s restriction in 2001.

Taymor and article author Emily Singer simply neglect to mention the role 35 USC 271 (e) (1) will play in embryonic stem cell research. Therapies derived from embryonic stem cells will need to be approved by the FDA. Work done to meet FDA requirements is isolated from liability for breach through the Safe Harbor of 271 (e) (1), as interpreted broadly by the United States Supreme Court in the case of Merck v. Integra.

The questions discussed in this article are linked to those mentioned in Ebert, Lawrence. (2006, April 13). Will Wisconsin Patents Block Embryonic Stem Cell Research ?. Ezine Articles. Retrieved April 24, 2006, from the site and Ebert, Lawrence. (2006, April 12). Los Angeles Times article Far from the Basics on Stem Cell Problems. Ezine Articles. Retrieved April 24, 2006, from the site

Source by Lawrence Ebert

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