| On April 24, an article in the MIT Technology Review | | | | a short-lived embryonic stem cell company several |
| portrayed the immediate concern over the Wisconsin | | | | years ago. "I learned from venture capital investors |
| WARF/Thomson patents on stem cells as how the | | | | that these patents existed and that it would be |
| patents will affect basic academic research, which, in | | | | impossible to obtain funding from them," she says. |
| turn, could affect the development of stem | | | | This quote is significant for at least two reasons. |
| cell-based tools and therapies. | | | | First, one sees that venture capitalists were aware |
| The article mentioned a possible gambit by the state | | | | of the Thomson/WARF patents and saw them as a |
| of California to ensure cooperation among | | | | show-stopper as to VC investment in the field. Thus, |
| researchers of different states. The oversight | | | | as to small research entities spurning money from |
| committee of California's CIRM recently announced | | | | CIRM over disputes about patent royalty rights, one |
| that any California researchers who develop patented | | | | suspects such small entities do NOT have VC funding |
| discoveries using California state funds must share | | | | as a viable alternative. I suspect the length of time |
| their patents with other state researchers. Ed | | | | before payout is separately a showstopper as to VC |
| Penhoet of CIRM was quoted: "We hope WARF will | | | | funding; nothing here looks ready for |
| reciprocate." Of course, one issue is that WARF | | | | commercialization within seven years, a typical VC |
| presently has patents related to embyronic stem | | | | benchmark. Second, in the world of Bayh-Dole, it's |
| cells, and CIRM does not. Further, one would need to | | | | kind of scary that one professor/entrepreneur would |
| know details of what is shared. Does the sharing only | | | | not know of relevant patents of a Bayh-Dole |
| pertain to the use by researchers in academic | | | | grantee. Further, it's also scary that CIRM apparently |
| institutions, or does it extend to companies created | | | | had not anticipated the WARF play, which failure is |
| by such researchers? One of the prime selling points | | | | somewhat hard to fathom since the basic patent |
| to voters of states such as California and New | | | | issued years ago. |
| Jersey was that the state funding research would | | | | The basic WARF/Thomson patent is US 5,843,780 |
| recover expended money through patent royalties. If | | | | (issued 1 Dec 1998 to James A. Thomson, based on |
| everyone gets a free license, such a recovery is | | | | application 591246 filed 18 Jan 1996; the application |
| unlikely to happen. | | | | was a continuation-in-part of U.S. application Ser. No. |
| The article goes through the world of patent useage | | | | 08/376,327 filed Jan. 20, 1995. It was obtained with |
| as among different patent-holding universities. | | | | funding from the federal NIH, and thus represents a |
| Universities generally allow other institutions to use | | | | patent obtainted through the auspices of the |
| patented technologies without special permission. The | | | | Bayh-Dole Act. It is separately true that Thomson, a |
| litigated case of Madey v. Duke University is an | | | | few days after filing his basic patent application, |
| exception to this general rule, although it was a | | | | submitted a paper to the Proceedings of the National |
| patent-holding professor who sued a university. | | | | Academy of Sciences, which appeared as 92 PNAS |
| Furthermore, WARF requires universities to get a | | | | 7844 (1995). His effort at patenting did not impede |
| license to do embryonic stem cell research. "None of | | | | his efforts at rapid public disclosure. |
| us understand why we need a license...Why is this | | | | Kenneth Taymor, an attorney with the Stanford |
| technology any different?" says one | | | | Program on Stem Cells in Society, is quoted in the |
| technology-transfer official. The license of WARF to | | | | article: "The more that WARF presses its rights, the |
| the University of California, for example, permits | | | | more research will be impinged and the more likely it |
| scientists to use only a small number of embryonic | | | | will move offshore." This boogeyman won't hunt. In a |
| stem cell lines. And the license granted to the Howard | | | | different variant, research was going to move |
| Hughes Medical Institute, a nonprofit medical research | | | | offshore after Bush's restriction in 2001. |
| organization that funds scientists across the nation, | | | | Taymor and the article author Emily Singer simply |
| prohibits scientists from accepting funding from or | | | | neglect to mention the role that 35 USC 271(e)(1) is |
| collaborating with commercial companies unless the | | | | going to play in research on embryonic stem cells. |
| company has a commercial license from WARF. | | | | Therapies arising from embryonic stem cells are going |
| The article presents an interesting quote by Jeanne | | | | to need FDA approval. Work done to meet FDA |
| Loring, who herself is an author of an article criticizing | | | | requirements is insulated from infringement liability |
| the WARF patent royalty demand [311 Science 1716 | | | | through the safe harbor of 271(e)(1), as expansively |
| (2006)]: Jeanne Loring, a scientist at the Burnham | | | | interpreted by the U.S. Supreme Court in the case |
| Institute for Medical Research in La Jolla, CA, started | | | | Merck v. Integra. |