Wednesday, May 31, 2006

Themes discussed by CIRM's IP group are old chesnuts

The patent pool idea, mentioned in the April 27, 2006 meeting of CIRM's IP group, has been discussed for a while. For example, Merrill Goozner discussed a version in his article "Prizing Stem Cell Research." However, one notes that Goozner's main idea, a prize for successful stem cell treatments, was not mentioned at the April 27 meeting. One also notes that the story of Jeanne Loring and WARF/Geron is mentioned by Goozner, although by reference to an article in Nature in May 2005, rather than to the article in Science in March 2006 (and the op-ed by Jennifer Washburn in the LA Times) which made their way into the CIRM transcript; this one story is being recycled.

The idea that the Bayh-Dole Act encourages patenting of basic research discoveries has been around for a while. Keep in mind that the patent at issue in the Metabolite v. Lab Corp case was generated by three university professors, not by workers in private industry. The patent at issue in Ariad v. Lilly was generated by university professors. The patent rights surrounding "Dolly the Sheep," created by research by government workers, ended up in private hands (Geron and ACT) and produced, among other things, a fierce patent interference.

Excerpts from Merrill Goozner, Prizing Stem Cell Research,

This slowdown in [pharmaceutical] innovation has led many observers to begin questioning some of the assumptions behind the current U.S. medical innovation system. Specifically, they’ve focused on how research institutions handle the intellectual property generated by biomedical innovators, which is the foundation upon which the current pricing and innovation systems rest.

The current rules of the road were established in 1980 by the Bayh-Dole and Stephenson-Wydler technology transfer acts, which govern university-based and government-based researchers, respectively. (...) The new laws encouraged universities and federal labs to patent basic science discoveries with practical use and gave them the right to grant exclusive licenses to private firms. (...)

The stem cell field, which is still years away from its first approved therapy, is a perfect example of commercialization fever. While James Thomson of the University of Wisconsin was isolating and growing the first embryonic stem cells with funds from Geron Inc., other stem cell researchers, including many key backers of Proposition 71, had already launched start-ups firms to commercialize patented insights based on adult stem cell research funded by the federal government. For instance, senior researcher Irving Weissman, who runs Stanford University’s Institute for Cancer/Stem Cell Biology and Medicine, holds numerous patents in the field and has launched at least three firms in recent years – Systemix Inc., Celltrans Inc. and StemCell Inc. Douglas Melton of Harvard, whose children have Type I diabetes and has garnered numerous sympathetic press accounts for his research efforts, founded two biotech companies, including Curis Inc., which is specifically devoted to developing stem cell products. Lawrence Goldstein of the University of California at San Diego, a frequent spokesman in the Proposition 71 campaign, helped start Cytokinetics Inc.

Article about Loring in Nature on May 18, 2005

In May 2005, a controversial article in Nature drew attention to the emerging patent thicket problem in embryonic stem cell research. [Meredith Wadman, “Licensing fees slow advance of stem cells,” Nature, published online May 18, 2005 (]. Jeanne Loring, an embryologist now at the Burnham Institute in La Jolla, California, claimed her start-up firm collapsed when it couldn’t get access to embryonic stem cells at a reasonable price from the Wisconsin Alumni Research Foundation (WARF), the University of Wisconsin’s technology transfer arm which owns the Geron-funded Thomson patents.

Patent pool recommended

CIRM can become the catalyst for cutting through this patent thicket. It can require that all of its grant recipients agree to donate the exclusive license to any insights, materials and technologies they patent with state funding to a common patent pool administered by a third party outside CIRM. [The article cites Ted J. Ebersole, J.D., Ph.D., Robert W. Edmond, J.D., Ph.D. and Robert A. Schwartzman, Ph.D., “Stem Cells – Patent Pools to the Rescue?” Sterne Kessler Goldstein & Fox, p. 1, available at IPBiz: the article may be found
here. The article does not explain why an entity in the position of WARF would want to participate in a pool. Recall that the Wright Brothers did not want to participate in a patent pool. The article also mentions issues with contamination of stem cell lines caused by use mouse feeder cells. One recalls that the restriction on federal funding by Bush in 2001 did NOT apply to ANY stem cell line in existence at the time of the restriction.]

Holding of Merck v. Integra misstated

Their concerns were driven by a recent court decisions (Madey v Duke University and Integra LifeSciences I, Ltd. v Merck KGaA) that, in the former case, limited universities’ royalties research exemption but, in the latter case, gave that exemption to pharmaceutical firms when developing new drug applications for the FDA. [IPBiz: Merck v. Integra indicates that the research exemption of 35 USC 271(e)(1) is available to ANY entity doing research reasonably related to obtaining federal approval, including INDs from the FDA]


Combining a patent pool, an open-source model of IP development and a shared prize system for developing stem cell therapies, the California state stem cell program can pave the way for a new medical innovation system for the 21st century, one that can generate cures for terrible diseases at prices that are affordable for all.

[IPBiz post 1615]


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