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Following President George W. Bush’s Aug. 9 announcement that federal funds would support limited stem cell research, Health and Human Services Secretary Tommy Thompson at the National Institutes of Health answered questions in a press conference about the patent implications of the newly announced policy. While it is understandable why these questions were raised, there is reason to believe that litigation in general, or patent litigation in particular, will not be a major stumbling block for pending research. The patent questions arise out of the fact that a number of entities hold valuable patents on the compositions and methods underlying stem cell research. James Thomson, a scientist at the University of Wisconsin at Madison, is at the forefront of the race to isolate human embryonic stem cells (hESC) in a laboratory. A Menlo Park, Calif.-based company, Geron Corp., provided significant funding for Thomson’s research and now shares patent rights on the technology with the Wisconsin Alumni Research Foundation, the licensing arm of the university. At his press conference, Thompson announced that Geron and WARF each pledged to cooperate with future research efforts. Ironically, despite their pledges, these two entities went to court on Aug. 13 to delineate the extent of their shared rights. Based on the realities of patent litigation, though, litigation between patent holders and entities intent on hESC research is likely still a ways off. Under the president’s new guidelines, federal funding agencies like the NIH will consider whether applications for funding meet certain standards. In the case of research using stem cells, the new requirements are 1) that the donation of the cells for research is supported by informed consent; 2) that the embryos exceed clinical need; 3) that the embryos were created for fertility purposes; and 4) that there was no monetary inducement to donate the embryo(s). As has always been the case with federally funded research, the licensing agreements between the grant applicants and current and future patent holders are not part of the NIH criteria. The grant applicants and the patent holders may negotiate material transfer agreements to license, share and use any proprietary information. These are the same agreements that underlie current research supported by private funding or stem cells derived from less controversial, though perhaps less effective, sources such as umbilical cords, placentas or adults. DEVIL’S IN THE DETAILS At this stage, it is arguably in a patent holder’s best interest to protect and then share or collaborate on its proprietary information. Right now, the promise of stem cells is somewhat theoretical. Scientists know how to “drive” stem cells toward creation of specific kinds of human cells, such as blood, heart, muscle, bone or skin cells. Scientists presume they can use healthy cells or tissue to combat disease or repair damaged organs. It is when these presumptions become a reality that the patent holder’s rights or trade secret information become lucrative. Because patent litigation is very costly, however, a patent holder is unlikely to file a suit for patent infringement unless the stakes are justifiably high. On top of that, sovereign immunity protects the government from patent suits. The scope of patent protection afforded to companies such as Geron and others will also play a part in the future of any stem cell patent litigation. Often the breadth of patents is overestimated. According to its Web page, Geron has rights to four patents related to hESCs. Any, all or none of those claims could be narrow or broad enough to allow for research that approximates the patented process but does not actually infringe the patent. Patent holders must also remember that their right to exclude others may be curtailed by equitable doctrines if they knowingly allow others to use their claimed inventions without enforcement of their rights. Where litigation could present itself in the near future is with regard to ownership of the cells themselves. The cells that create the cell lines are a form of property, as would be cells or tissue developed from those cell lines. But who owns them? The research facility, the faculty or the individual(s) whose fertilized embryo generated the progenitor cells? As mentioned above, one of the four requirements necessary for an NIH grant is that the embryos were donated with informed consent. Another criterion is that the embryos were created for fertility purposes. This means that a fertility clinic has to get the informed consent of the individual seeking treatment to donate unused embryos for use in stem cell research (to isolate stem cells, an embryo has to be destroyed, so the Bush policy also requires that the embryos had to have been destroyed before 8 p.m. Aug. 9). Proposed genetic privacy acts have incorporated strong informed-consent requirements. Many people, such as Boston University bioethicist George Annas, insist that cells obtained with insufficient informed consent must themselves be destroyed. Unlike the Clinton policy on stem cell research, the Bush policy has not yet spelled out what kind of informed consent would be required. There is no reason, however, why the administration could not impose equally, if not more, stringent informed-consent requirements. Who owns cells derived from embryos is, unsurprisingly, a novel issue in the courts. The California Supreme Court, in Moore v. Regents of the University of California (1990), is the only court to consider the issue of cells as convertible property. While being treated for hairy-cell leukemia, the plaintiff in Moore supplied blood, bone marrow, sperm and skin as part of his treatment at a university hospital. One of his doctors used a variety of cells to research the disease’s progress. The doctor’s research eventually led to a lucrative research agreement between him, the university and a private company; the agreement did not include the plaintiff. The plaintiff complained that the cells were taken without proper informed consent. The California court agreed and established a rule that a doctor must “disclose personal interests unrelated to the patient’s health, whether research or economic, that may affect his medical judgment.” The court did not agree that cells taken without informed consent amounted to conversion. It is likely that setting standards to establish cell ownership will be one of the details the Bush administration fills in before the anticipated January 2002 start date for funding requests. There are several other details to fill in that hopefully will lead to efficient and fair research, not unduly protracted or expensive litigation. Edwin S. Flores Troy, an associate with Dallas’ Gardere Wynne Sewell, has a Ph.D. in molecular immunology. Flores is part of the intellectual property practice section, where he focuses on biotechnology patent prosecution and litigation.

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