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Goatboy wasn’t real. He was a half-man, half-goat character created by comedian Jim Breuer for Saturday Night Live. Goatboy was a figment of the 1990s, but he evolved from a distinguished past. Goatboy is a chimera. In Greek mythology, a chimera is a creature with a lion’s head, a goat’s body and a serpent’s tail. In modern times, chimeras have been defined more loosely, and they have also become a reality. In 1984 a chimeric “geep” was produced by combining sheep and goat embryos. More recently, scientists in China reportedly made a chimera by fusing human skin cells and rabbit embryos. These chimeras were allowed to develop for a few days before being destroyed. A group in Minnesota has created chimeras that have human blood flowing through pig blood vessels. This is the stuff of legend, song, supermarket tabloids and patent law. Under recent legislation and current Patent and Trademark Office policy, humans are unpatentable. Would Goatboy qualify as human? This question is not merely philosophical. As biotech research increasingly enters the world of cloning, gene therapy and stem cells, questions of “humanity” must be addressed. Chimeras aren’t just a useless novelty. They can be used to study developmental pathways, hopefully leading to medical treatments for diseases. A chimeric animal with human kidneys could be used for renal toxicology studies. An animal chimera that could produce human livers for transplantation would be a godsend for those with cirrhosis. But the fate of these types of organisms is up in the air. Twenty-five years ago, in Diamond v. Chakrabarty, the U.S. Supreme Court established that living organisms can be patented. Although the Court’s decision was based on a patent for genetically engineered microorganisms, the decision has been broadly interpreted to permit patents on other life forms. The Court noted that the key issue in determining patentability is not whether the patent covers living material. Instead the question to ask is, does the patent cover a product of nature, or is it manmade? This leads to the oft-quoted standard that “anything under the sun made by man” is patentable. A few years after Chakrabarty, the Patent and Trademark commissioner issued a notice on the PTO’s policy on higher organisms. Nonnaturally occurring, nonhuman multicellular living organisms, including animals, would be considered patentable subject matter. The notice also stated that human beings would not be considered patentable subject matter, citing the Constitution’s prohibition on slavery. Shortly after the commissioner’s notice, the famous Harvard oncomouse patent was issued. The oncomouse, which had been genetically modified to contain a cancer-causing gene, was hailed as a biotechnological breakthrough. It is a valuable research tool for studying the mechanisms of cancer, and can also be used to test drugs. (More on this later.) Much has happened in the world of biotechnology since then. Cloning, once the stuff of science fiction, has become a reality. Debate rages around the use of embryos in research. Embryonic stem cells are in the news as often as celebrity divorces. But until recently, little had happened in the past 20 years to change the law regarding patents on living organisms. In 2004 the appropriations bill that sets the budget for the patent office included a unique provision. The so-called Weldon amendment (after Republican representative Dave Weldon, who introduced it) prohibited the use of federal funds to issue patents on a “human organism.” This language differed slightly from the patent office’s existing policy, which excluded the patenting of “human beings.” But how human must something be to qualify as a human organism? The Weldon amendment and the commissioner’s notice do not address this. Neither have the courts. Presumably, a transgenic animal with one human gene, or even a few human genes, isn’t human. Patents to these types of transgenic animals have been issuing for years: U.S. Patent No. 5,625,126 claims a transgenic mouse containing the human genes for making antibodies, and U.S. Patent No. 5,602,306 claims a transgenic pig that produces human hemoglobin. What about an animal with a human liver? Is that human enough to be human? Probably not. Chimeras created by transplanting an organ of another species are not transformed into the other species simply by the presence of a foreign organ. Pig heart valves have been used for years to replace human ones, but no one considers these valve recipients to be pigs. (Well, at least without viewing their table manners.) What if, instead of a human liver, an animal were created with a human brain? This seems a little closer to the line of being human. But what about a chimera made by fusing human embryonic cells with another species? The patent office answered that question late last year. Stuart Newman filed a patent application in 1997, which claimed, among other things, chimeras made from humans and other primates. After several go-rounds, the claims were finally rejected as being directed to nonpatentable subject matter. The patent office considered this invention human. Since Newman elected not to appeal, the question of whether a court would view chimeras made with human cells as “human organisms” is still open. The patent office doesn’t seem to interpret the Weldon amendment as prohibiting claims to methods of cloning. At least one patent for methods of cloning mammals, which didn’t specifically exclude humans, was issued last year. Cloning and chimeras aren’t the only biotechnology advances on the government’s mind. Much social and legal controversy surrounds embryonic stem cells — undifferentiated cells derived from a blastocyst (young embryo). If left in the embryo, stem cells ultimately would develop into a person or animal. So are embryonic stem cells a “human organism”? Representative Weldon doesn’t think so. In a speech before Congress, he argued that “human organism” does not encompass stem cells. The patent office seems to agree, since it has issued patents to human embryonic stem cells. Lack of patent protection might not be the only thing standing in the way of biotechnology. Some states have already enacted laws banning human cloning. Several pieces of federal legislation have been recently introduced that, if passed, would ban specific biotechnological advances, some before they even happen. For example, if adopted, the Human Cloning Prohibition Act of 2005, currently in committee in the House and Senate, would make human cloning illegal. And if proponents of the Human Chimera Prohibition Act of 2005 get their way, Goatboy may never come to be. This is in stark contrast to the current U.S. legislative policy on embryonic stem cells. The federal government does not prohibit embryonic stem cell research, and even provides funding for it, under limited circumstances. Some states even encourage it. California recently passed an initiative that would provide for billions of dollars in funding for embryonic stem cells. Other states are following suit in an effort to prevent “brain drain” to California. The United States isn’t alone in confronting these tough issues. Several countries have adopted a “morality standard” for determining whether an invention is patentable. For example, Japanese and European patent law excludes inventions that they consider contrary to public order or morality, such as human cloning. World Trade Organization members that have signed on to the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) can prevent certain inventions from being patented in the interest of public morality. Europe has gone one step further. The European Patent Office, in response to a 1998 European Union directive, specifically lists biotechnology inventions that are unpatentable. These include processes for cloning or modifying the germ line of human beings (those cells that turn into sperm and eggs), the human body at various stages of its formation, processes to produce chimeras from germ cells or embryonic stem cells, and uses of human embryos for industrial or commercial purposes. Canada has adopted an even more conservative approach. In rejecting the Harvard oncomouse patent application, the Canadian Supreme Court held that patentable subject matter does not include higher life forms. Canada has specifically rejected the “anything under the sun made by man” approach. Although other countries have taken a more hard-line approach, what is patentable in the U.S. is still “anything under the sun made by man” — except perhaps man himself. It remains to be seen whether courts will agree with the patent office’s fuzzy standard as to what “man” is. Andrea Kamage is an associate, and Julie Heider is a student associate, at Sterne, Kessler, Goldstein & Fox. The content of this article reflects the present thoughts of the authors, and not the firm’s.

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