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Here lurks a pigman. There goes a humanzee. These are not characters from the 1896 H.G. Wells novel The Island of Doctor Moreau. They are the subject matter of a patent application recently rejected by the U.S. Patent and Trademark Office (PTO). A century after the publication of the H.G. Wells classic, Stuart Newman filed a controversial U.S. patent application directed to human-animal chimeras. Newman’s 1997 application was entitled “Chimeric Embryos and Animals Containing Human Cells” and described, among other things, human-mouse chimeras, human-pig chimeras and human-chimpanzee chimeras. A chimera is an organism with components of at least two separate species that could not naturally mate. Chimeras contain two or more genetically distinct cell populations and can be made by fusing embryos from different species or transplanting embryonic cells from one species into the developing embryo of another. These are distinct from hybrids, like donkeys, which are the usually sterile offspring of two species that can cross-hybridize naturally. Once found only in mythology, chimeric animals are now a reality thanks to technological advances in molecular biology and cloning. British scientists produced a “geep” by combining a sheep and goat embryo in 1984. More recently, a human-rabbit chimera was produced in China by fusing human skin cells and rabbit embryo cells. The resulting chimera was destroyed a few days later. Chimeras are even being produced right here in the United States. Esmail Zanjani, professor of medicine at the University of Nevada School of Medicine, has created sheep that contain human liver cells. Potentially, these sheep could be used to make humanized livers for patients in need of liver transplants. Additionally, famed Stanford University researcher Irving Weissman, who was partly responsible for the first mouse with a nearly complete human immune system, is attempting to create mice evocative of the brainy rodents of the children’s book Mrs. Frisby and the Rats of NIMH. Weissman’s team injected human neural stem cells into mouse fetuses. These mice have been used to study how the virus responsible for chickenpox infects neuronal cells. The virus only infects humans, so the mouse model makes studying the virus and potential treatments possible. Weissman is planning next to inject human brain stem cells into a mouse in order to create a model for studying brain cancer, strokes, schizophrenia, Parkinson’s, Alzheimer’s and Lou Gehrig’s disease. Seeking a precedent In filing his chimera application, Newman did not wish to obtain a patent. Rather, he was seeking to establish precedent to prevent others from filing and obtaining patents directed to human chimeras. Newman, a professor at New York Medical College in Valhalla, N.Y., was backed in his venture by Jeremy Rifkin, a biotechnology activist and president of the Foundation on Economic Trends. The tension between the tremendous medical value of certain chimeras and the ethical issues have made the patentability and legality of creating such animals a hotly debated topic. Patents on life forms are nothing new. Organism patents date as far back as 1873, when Louis Pasteur received a patent to “yeast, free from organic germs of disease, as an article of manufacture.” The 1930 Plant Act allowed for patents on man-made plant hybrids that reproduce asexually. The landmark U.S. Supreme Court decision in Diamond v. Chakrabarty, 444 U.S. 102 (1980), 25 years ago, clarified that living, genetically engineered or man-made organisms are considered patentable subject matter. In making its decision, the court noted that the dispositive issue is not whether the product is living or inanimate, but whether it is a product of nature or made by the hand of man. In 1987, the commissioner of patents and trademarks announced the PTO’s policy on the patentability of higher organisms. The commissioner set forth the current PTO policy that nonnaturally occurring, nonhuman multicellular living organisms are patentable. However, human beings would not be considered patentable subject matter. The basis for this exclusion was rooted in the slavery prohibition of the 13th Amendment to the U.S. Constitution. The policy left open the question of just how human an organism needs to be to qualify as human. Just a year later, the PTO made good on its policy and issued the first patent to a mammal, with claims to a mouse that had been genetically modified to be predisposed to cancer. The famed “Harvard mouse” or “Oncomouse” is useful as an animal model for cancer. Indeed, the PTO has granted patents to transgenic mice that produce human antibodies. However, chimeric mice with human cells, rather than genes, may be considered too human for the PTO. By filing the application, Newman and Rifkin wanted to push the PTO to define just how human is human. The application seemed to hit home and provoke the desired reaction. Shortly after their application was filed, the PTO issued a media advisory stating that in certain circumstances, patents directed to human-nonhuman chimeras would not be patentable. Congress has also attempted to curtail human chimera research through budgetary constraints on the PTO. In 2003, the Weldon Amendment was introduced into the appropriations bill that sets the PTO budget. Named after Representative Dave Weldon, R-Fla., who introduced the amendment, this provision prohibits the use of federal funds to issue patents on a “human organism.” Like the PTO policy, this left open the definition of a human organism. Shortly after the Weldon Amendment was introduced, James Rogan, the director of the PTO at the time, sent a letter to Congress in support of the amendment. The letter stated that the amendment “does not alter the USPTO policy on the non-patentability of human life-forms at any stage of development and is fully consistent with our policy.” Not everyone was happy about the Weldon Amendment. The Biotechnology Industry Organization (BIO), issued a harsh criticism of the amendment. Among other things, BIO condemned the amendment as a danger to human-derived biotechnology inventions. The Section of Intellectual Property of the American Bar Association also issued a statement opposing the amendment. The examination process Newman’s chimera application went through the normal examination process. Once a patent application is filed at the PTO, it is assigned to a patent examiner, who conducts a patent search and, if appropriate, issues an office action outlining the reasons for the rejection of any claims. The applicant may then submit arguments in response to the office action. This back-and-forth argument may go on for several rounds. The applicant may appeal the examiner’s decision to the Board of Patent Appeals and Interferences, and eventually to the Supreme Court. After several rounds of arguments, the PTO issued a final rejection to Newman’s application. By the time of this final rejection, the claims of Newman’s application were limited to human-non- human primate chimeras only. Among other things, the examiner asserted that human-nonhuman primate chimeras are nonpatentable subject matter. Specifically, the examiner argued that the chimeras encompass nonpatentable material because they are human. The examiner stated that the PTO “does not agree that humans are patentable subject matter.” Newman and Rifkin can’t claim victory just yet. The final rejection by the PTO is not precedential. If Newman and Rifkin really wanted to prevent others from obtaining patents to things that are “too human,” then they should have appealed the PTO’s rejection all the way to the Supreme Court. The question of how human is too human for patentability still remains. The United States is not alone in facing these issues. The Agreement on Trade-Related Aspects of Intellectual Property (TRIPS), of which the United States is a signatory, attempted to unify intellectual property protection across member nations by providing minimal mandatory patent standards. One of the TRIPS provisions stipulates that member countries may exclude from patentability inventions that are contrary to morality. The European Patent Office (EPO), consistent with the TRIPS morality provision, has specifically banned patents to human clones, chimeras or embryonic stem cells. In 1998, the European Parliament and the European Council of the European Union set forth a Directive on the Legal Protection of Biotechnological Inventions. The EPO adopted the directive by incorporating those biological inventions that were suggested as being unpatentable in the EPO rules. Specifically, the unpatentable inventions include cloning or modifying the human germ line of human beings, or the human body at various stages of development, and uses of human embryos for commercial or industrial purposes. The United States once had a similar standard. An 1817 court ruling excluded the patenting of inventions that are “injurious to the well-being, good policy, or good morals of society.” Lowell v. Lewis, 15 F. Cas. 1018 (C.C.D. Mass. 1817). The PTO and courts relied on this decision to deny patents under the fiction that morally controversial inventions were not “useful.” However, the courts have been reluctant to apply a broad morality utility requirement since the Patent Act of 1952. Even if Rifkin and Newman had been successful in blocking others from obtaining patents to human chimeras, this alone wouldn’t have blocked a rogue Dr. Moreau from creating hubeasts. One doesn’t need a patent in order to practice an invention, but merely to block others from practicing the same invention. The patent debate extends beyond human chimeras themselves to other biotechnological innovations necessary to making chimeras, including cloning and the use of embryonic stem cells. Do these advancements come at too high of an ethical cost? Does the use of human embryonic stem cells to create chimeras go against a moral and ethical line we would rather not cross? The PTO isn’t the only government entity attempting to tackle these thorny issues. Congress also faces these questions as it decides the fate of the Human Cloning Act of 2005 and the Human Chimera Prohibition Act of 2005. Both bills are currently in committee, and if passed, would amend Title 18 of the U.S. Code to ban human cloning and the creation of any human chimera. However, both bills go against current U.S. legislative policy regarding embryonic stem cells. Embryonic stem cells are cells derived from embryos and have the unique potential to develop into many types of cells. Currently, the federal government does not prohibit embryonic stem cell research and, under limited circumstances, provides funding for such research. Additionally, state governments, such as California, have passed initiatives that would provide for billions of dollars in funding for embryonic stem cell research. [See story, Page S1.] Recent guidelines issued Chartered by Congress, the National Academy of Sciences (NAS) has stepped in to provide a road map for how this area of research should be regulated. On April 26, the NAS issued its guidelines for human embryonic stem cell research. See www.nap.edu/books/0309096537/ html/. The guidelines do not call for a complete ban on human embryonic stem cell research resulting in chimeras. Rather, they allow for the creation of various chimeras contingent on review board approval. Also, certain chimeras would be banned such as human-primate chimeras and any animal chimera in which a human brain would develop. Other countries face the same ethical dilemma. A U.S.-backed resolution in the United Nations to ban human cloning was adopted on March 8. The declaration requests that all governments ban forms of human cloning that do not protect human life and dignity. The resolution has been criticized for being ambiguous and potentially halting or stifling important therapeutic research. Britain, Belgium and China have refused to implement the declaration, citing the important use of human embryos in medical research or “therapeutic cloning.” Indeed the debate rages on. The PTO, Congress and now the United Nations have attempted to set some sort of ground rules, but the waters of human chimeras are as muddy as ever. Andrea J. Kamage is an associate at Washington’s Sterne, Kessler, Goldstein & Fox. Julie A. Heider, who holds a Ph.D. in molecular biology, is a law student at George Washington University and a student associate at the firm.

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