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Where have all the stem cell debates gone? In the spring of 2001, the right-to-life movement was agitating for stricter federal policies on funding stem cell research, and Congress was responding to that powerful political bloc; by summer, playing Solomon, President Bush gave a restricted green light to federal funding. Legal scholars, meanwhile, were debating whether an arm of the University of Wisconsin could justifiably claim patent rights to all human embryonic stem cells and demand “reach through” royalties on all stem cell therapies and treatments that might emerge years from now. The school had more immediate concerns. It was fighting with Geron Corp., a Menlo Park, Calif., company, over the terms of a license covering those rights. After Sept. 11, most of those public debates went the way of Gary Condit, to be replaced recently by somewhat surrealistic riffing on human cloning. A small Australian biotechnology company with operations in Athens, Ga., may help shift the debate back to stem cells. In mid-November, BresaGen Ltd. announced that it was planning to buy rights to an entirely different set of embryonic cell patents covering research conducted at Vanderbilt University. These patents, the company says, would give it “an unfettered path to the commercialization of a treatment for Parkinson’s disease and other diseases of the central nervous system.” (BresaGen is represented in U.S. IP matters by Atlanta’s Sutherland Asbill & Brennan.) On a tactical level, BresaGen’s proposed acquisition is — in the words of one knowledgeable party — a “Hail Mary strategy” meant to skirt the Wisconsin patents. As a broader policy matter, the deal may help rekindle the old arguments, especially the clash between intellectual property protection and fundamental scientific research. In high school biology we learned that humans and other animals develop from a single cell — the union of egg and sperm — that eventually divides and gives rise to specialized cells. Some of these cells make up the muscles of the heart, while others form the central nervous system. In this amazing biological march, embryonic stem cells are early participants. They form days after conception, before the fertilized egg has even tumbled out of the fallopian tubes into the uterus. They have not yet specialized, and are capable of developing into nearly any of the more than 200 human cell types. For about a decade, scientists have been trying to coax human embryonic stem cells to grow within a culture dish in the hopes that they will be the key to developing treatments for disease. The practice is controversial for those who believe that life begins at conception, because the isolation of stem cells requires the destruction of an embryo. Most of these embryos, which would otherwise be destroyed, have been donated by couples who are seeking treatment in fertility clinics. In 1998 University of Wisconsin developmental biologist James Thomson successfully isolated embryonic human stem cells and enabled them to reproduce without specializing. It was a monumental scientific advance, for which Thomson was awarded a broad and controversial patent. Thomson assigned the patent to the Wisconsin Alumni Research Foundation, known as WARF. Because federal funding for this research was restricted at the time, the university relied on private funds supplied by Geron for the research. In return Geron received an exclusive license for certain types of cells, including the neural cells that BresaGen desires. WARF and Geron assert that the Thomson patent covers all commercial developments involving human embryonic stem cells in the United States. There are many uncertainties surrounding stem cell research, but one of the few so-far undisputed facts is that Thomson is the “inventor” — from a patent law perspective — of isolated and cultured human embryonic stem cells. However, in mid-November, BresaGen announced that it planned to buy rights to patents that, in the words of its news release, “teach methods for the isolation of pluripotent stem cells.” (Pluripotent means the ability of a cell to develop into many other types of cells.) These patents are older than Thomson’s, and, according to BresaGen, trump Thomson’s. “We are confident of our position from a legal perspective,” said BresaGen chief executive John Smeaton in the news release. The inventor named on these patents is a British molecular biologist named Brigid Hogan, who left Vanderbilt last year to join the faculty of Duke University. Hogan was one of the early pioneers in embryonic cell research in the early- and mid-1990s. But there are two differences between Hogan’s work and Thomson’s. She worked primarily on embryonic cells from mice. And she was manipulating not stem cells but germ cells, which ultimately become reproductive cells. Stem cells and germ cells share many characteristics — such as the ability to develop into many other types of cells — but they are different. In order to isolate germ cells, for example, they are taken at a later stage in development from aborted fetal material. (Picking up where Hogan left off, a researcher at Johns Hopkins University in 1998 announced the isolation of human embryonic germ cells, proving that Hogan was onto something. Unfortunately for John Gearhart, the researcher, Thomson had beaten him to the punch by a matter of weeks.) Vanderbilt’s lawyers, Atlanta IP boutique Needle & Rosenberg, were clever, too — perhaps too clever. The ability to draft broad claims is the sign of a talented patent lawyer. But Needle & Rosenberg claimed more than Hogan had actually developed in the lab. They drafted the patents so that they were not limited to mice, although Hogan never actually sustained a colony of human embryonic germ cells for any length of time. Patents and scientific papers on the same subject often claim different things, as a recent paper on the famous CellPro case says. Avital Bar-Shalom and Robert Cook-Deegan write in the recent issue of The Milbank Quarterly: “The purpose of scientific publications is to offer evidence and rigorously interpret the results. The purpose of the patent system is the reverse: It is to mark boundaries on intellectual property, encompassing as many plausible future discoveries and applications as possible without invalidating the patent.” If the Hogan patents ever landed in litigation, a judge would have to make two key decisions. Do Hogan’s patents apply to humans, and does her work on germ cells enable others to understand how to isolate non germ stem cells? Experts at WARF and Geron say they are not concerned about the Hogan patents. “We are very familiar with the Hogan patents, and our opinion is that they don’t relate to human embryonic stem cells,” says David Earp, Geron’s intellectual property vice president. Adds Andrew Cohn, WARF’s government and public affairs manager: “We don’t see their patent interfering with ours.” After having made its announcement in November, BresaGen has been publicly silent about the proposed transaction, except to note that a shareholder vote originally slated for early February would not take place until late February or March “due to delays in the finalization of the necessary documentation.” Just as there are many uncertainties about stem cells generally, so too there are many with this transaction. The ownership of the Hogan patents is just one of them. At some time, Vanderbilt sold the rights to the patents to an Atlanta company known as Plurion, presumably a play on “pluripotent.” Plurion has been involved in stem cell activities for several years, but it has been remarkably low-key about its activities. BresaGen has agreed to buy the patent rights from Plurion in return for a 30 percent stake in BresaGen. As part of the transaction, two of Plurion’s directors will join BresaGen’s board: David Perryman, a partner at Needle & Rosenberg, which prosecuted the Hogan patents; and Mark Germain, a biotech investor. Early in his career, Germain was a corporate lawyer at New York’s high-flying Finley, Kumble, Wagner, Heine, Underberg, Manley, Myerson & Casey. Germain left about two years before the firm’s collapse in 1987. He went on to become managing director of D. Blech & Co. Inc., an investment house that rode the biotechnology boom of the early 1990s and eventually crashed on a day known as “Blech Thursday.” David Blech, the firm’s founder, pleaded guilty to securities fraud and was sentenced to five years’ probation. Along with other defendants, Germain recently settled a shareholder class action related to the collapse of the Blech firm. Germain confirmed that he worked at D. Blech but declined to comment further on any other aspect of his tenure at the firm, saying it was “ancient history.” Both Germain and Perryman declined to talk about the activities of Plurion, citing the ongoing discussions with BresaGen. In the meantime, BresaGen has a license from WARF that allows it to conduct internal research on human embryonic stem cells. The company is also one of a select number of organizations cited by President Bush in 2001 that is eligible for federal funding for embryonic stem cell research. So even if the deal with Plurion falls through, it will likely continue its stem cell work. Whatever happens, Brigid Hogan will not reap the fruits of her patents. Several years ago, when she was serving on National Institutes of Health panels relating to stem cells, she renounced any rights to her patents to avoid any possible appearance of a conflict of interest.

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