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Some patent experts are wary of the prospect of more players coming to the table during drug development talks. As the number of components and tools that contribute to the drug development rises, so do the costs, say pharmaceutical attorneys. “Their owners want to keep a position at the bargaining table in the future, and the bargaining table has to become bigger, and it gets harder and harder to conclude the next bargain,” says University of Michigan law professor Rebecca Eisenberg. Each deal requires more scouting of companies and more monitoring of technologies, concurs Ross Oehler, vice president of U.S. patents for Aventis Pharmaceuticals: “You may see it as a single technology, but how many layers are there under that?” The added complexity cuts into the industry’s efficiency and productivity. Possible side effects include patients paying higher prices, and companies forgoing research on medicines with limited profit potential. U.S. society allows the private sector to develop drugs in order to promote competition that otherwise would be difficult to generate, says Eisenberg. If PXE International Inc. injects humanitarian demands into a profit-motive world, the gears of drug development could grind even harder. “Would they rather control? Or would they rather have the problem solved?” she says. “If they’d rather have control, they may be slowing down the ultimate solution.” Additionally, basic patient group expertise is suspect. One slip in PXE International’s impressive effort to master law, science, and public relations is the application they have given to researchers who want access to their bank’s blood and tissue. The document has a passage that stipulates, “Any patent shall be applied for jointly.” The group had not sent a copy to patent counselor Patrick Waller of Boston-based Testa, Hurwitz & Thibeault until this spring. Upon hearing the passage, he pronounced the terms a little too pro se for his taste. “You can’t contract to make an invention,” he observed. “I’ll need to take a look at that.” Patient groups may defeat themselves in other ways. PXE International’s strategy of withholding tissues could be used by patients with greed in mind. Lila Feisee, director of intellectual property for the Biotechnology Industry Organization, has written that, “if donors of tissue samples start demanding that they receive royalties on any medical products that arise from the samples, they will undermine a long-standing and noble tradition in this country of voluntary and charitable donations to medical research.” Most of the 900 companies in her association continue to lose money, she says, and are vulnerable to a major change in the status quo. And even a small group such as PXE International could spark that change, says Elisa Eiseman, an analyst with RAND’s Science and Technology Policy Institute. Patients’ growing influence could degrade the science. “A disease group may have an interest that may or may not be borne out by the science,” says Eric Campbell, a health policy researcher at Massachusetts General Hospital and Harvard Medical School. “If they’re the only game in town, and they have all the tissue, they may be able to influence the design of the study.” To be sure, adds Campbell, patients wouldn’t be alone in acting on self-interest. In a journal article based on a recent survey of 1,600 laboratory scientists, he indicates that faculty who engage in commercialization were 3.15 times more likely to report either that they delayed publication of the research results for six months or more, or that they refused to share information, data, or materials with other scientists. Patients are the right parties to restore balance among the competing interests, asserts Patrick Terry. The goal is to identify where patients’ interests overlap with those of drug companies and researchers. Thomas Turano, PXE International’s lead patent attorney at Testa Hurwitz, sees compelling common ground for all: “They want to get the science out to the people. Keep in mind that these are terrible diseases.” Officials at universities note that it would be hypocritical for drug and biotechnology businesses to malign the effects of PXE International’s intellectual property demands. Company representatives commonly withhold from academics microscopic biological specimens they possess that seem to promise scientific advances. Unless, that is, they get property rights. “Sometimes the faculty members are saying, ‘How dare the companies demand these things!’ ” says Lita Nelsen, head of technology transfer at Massachusetts Institute of Technology. “ I’m afraid I’m a pragmatist. If you own something, and somebody else wants to borrow it, you kind of can set whatever restrictions you want.”

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