Chimera Patent Application Holds Mirror to Biotech Society
Jurassic Park couldnt do it. Neither could Gattaca, nor a recent TV remake of Brave New World. What might finally get the public thinking and talking about negative consequences of genetic engineering is a different sort of theater litigatory guerrilla theater.
.....In a move that would have made Sixties radical Jerry Rubin proud, biotech critic Jeremy Rifkin and New York Medical College biologist Stuart Newman, a member of the board of directors of the Council for Responsible Genetics (CRG), have applied for a patent on a method for making "chimeras" by mixing human embryo cells with the embryo cells of a nonhuman animal. Unlike a hybrid, such as a mule, a chimera (the term is from Greek mythology) would contain cells of both species in all its mature tissues.
.....But Rifkin and Newman have no intention of ever making such a creature. Instead, they are trying to prevent others from doing so, and to point out the questionable morality of patenting any life form. Dr. Newman explains the project in the following GENEWATCH interview:
GENEWATCH: Let's start with a quick summary of the reasons you filed this patent application.
Dr. Newman: The purpose of the application is to challenge the U.S. and international patent systems by presenting them with something that is patentable under the prevailing interpretations of patent law, but represents something that would be shocking and unacceptable to most people. By taking the current statutes to their logical conclusion we hope to alert the public and its representatives to what they will encounter down the road if the market remains the sole arbiter of what is permissible in the area of biotechnology. If we are awarded the patent, which by current standards we should be, we will be able to prevent its development for a period of 20 years by denying licensing rights to the "invention" and mounting legal challenges to anyone who seeks to exploit it. If, on the other hand, appropriate legislation is put in place that excludes such subject matter from patent protection an alternative that both Jeremy Rifkin and myself consider to be much more desirable we will have helped set a precedent that at least some life forms should be excluded from patenting.
GENEWATCH: The CRG is opposed to all patents on life forms. Are you?
Dr. Newman: Yes, I am. Patent law permits patents on new processes, new uses of existing items, and new "compositions of matter," which traditionally have referred to synthetic chemicals not found in nature. The U.S. Supreme Court's 5-to-4 decision in Diamond v. Chakrabarty in 1980 decreed that a genetically modified bacterium was a "human-made invention," opening the way for placing any modified organism in the "composition of matter" category. Since then we have even seen patenting of mammals, such as the Harvard "oncomouse." But we are far from being able to fabricate organisms de novo, and the analogy between a modified organism and a synthetic chemical is a scientific absurdity promoted by those who seek to benefit commercially from such patents.
GENEWATCH: Is the application for a certain type of chimera, such as a composite of a human and a chimpanzee, or for the process?
Dr. Newman: The process of making interspecific chimeras in mammals has been part of the scientific literature at least since the reports in Nature magazine on "geeps" (goat-sheep chimeras) in 1984. Our application is for chimeras containing human cells, and their potential applications. Therefore, the criteria that make this invention patentable are those of novel composition of matter and novel use.
GENEWATCH: Are there people who would seriously want to create a creature like this? If so, what would they do with it?
Dr. Newman: A patent has already been applied for by a commercially connected Johns Hopkins University scientist for human embryo stem cells. The major research application for such cells would be in the construction of chimeric embryos. Some scientists undoubtedly hope that chimeric embryos would be useful for growing human tissues, and would not want to see the generation of fully grown, part-human animals. Others might not have the same reservations, particularly if the embryos proved useful and the prospect of transplantable hearts or other organs seemed realistic. These things generally proceed incrementally. Our patent application includes all these possibilities, from chimeric early embryos, which contain just a few human cells, to full organisms that are mostly human. Although many people might find the first of these possibilities to constitute acceptable research models, most people would currently consider the other end of the spectrum to be unacceptable. However, without some intervention at this time, we just might end up there.
GENEWATCH: Have you heard any response yet from the U.S. Patent Office?
Dr. Newman: Yes. On the day we announced that we had applied for the chimera patent, Bruce Lehman, commissioner of the Patent and Trademark Office (PTO), issued a statement that the PTO has the legal authority to deny patents that it considers to be "injurious to the well-being, good policy or good morals of society." In our understanding there are no such statutes on the books in the U.S., and although we would welcome legislation that would disallow our patent along with other life patents, the criteria should not be the personal taste of whoever happens to be PTO commissioner. We note, for example, that Mr. Lehman did not issue a similar advisory when a patent application for pigs containing human genes was announced.
GENEWATCH: Do you think this will end up before the Supreme Court?
Dr. Newman: Thats difficult to predict, but I think it is a real possibility.
GENEWATCH: Do you see a risk that this application could make other, less dramatic patents on life appear more acceptable?
Dr. Newman: Not at all. A large sector of the public, encouraged by various pundits and public figures, has shown a remarkable capacity to accommodate itself to all sorts of biotechnological fantasies. When cloning of humans was first raised as a possibility, the initial shock soon gave way to broad advocacy of its benefits. Individuals who have gone on record as encouraging human cloning include Senator Tom Harkin of Iowa and Dr. Nathan Myhrvold, chief technology officer at Microsoft. The legal scholar Lawrence Tribe has pronounced himself increasingly comfortable with the idea. Few have objected to the fact that the patent application filed by the team that cloned Dolly the lamb included the use of the technique in humans. Indeed, only by jumping ahead of the queue with our "pre-emptive strike" could we ensure that our patent would remain "dramatic" for more than a few months.
GENEWATCH: Some of your allies question your tactics. They worry that if the application does end up in court your position could be misunderstood by the average citizen. People would see you fighting for something you claim not to want, really. Could the public ever come to see you as a new Dr. Frankenstein?
Dr. Newman: I have heard from many people in the U.S. and overseas, including leaders in the international No Patents on Life movement, who have seen this story covered in the news. Not one of these respondents has misunderstood our intention, and the great majority have been positive about the tactic of using patent law to create obstacles to patenting organisms. In all the publicity and interviews we do, we are always at pains to make sure that our objection to the current patentability of such things is featured prominently. I think the essence of the No Patents on Life movement is that no one should privatize and hold exclusive rights to actual living organisms. The critics to whom you refer seem to object equally to a legal instrument that pertains to hypothetical organisms. This seems unnecessarily literal to me.
GENEWATCH: What do you hope will be the long-range effects of your patent application?
Dr. Newman: We would like to see legislation enacted that acknowledges that just because something is feasible, and potentially useful and commercially viable, does not mean it is automatically desirable. It may be that legislators would react most strongly to the fact that our application is for organisms that are "part human." But since patents have already been awarded for transgenic organisms containing human genes, it would be extremely difficult legally to exclude our invention and not those others. In my view, the only legally and scientifically consistent way to exclude human-animal chimeras from the patent process is by excluding all organisms.
GENEWATCH: Would you like to see legal limits on research? Where would you draw the line?
Dr. Newman: I do have objections to research that attempts to fabricate humans or humanoids for purely instrumental purposes. Putting one or two human genes in a mouse doesn't bother me too much, but animals that contained entire human chromosomes would begin to make me uncomfortable. I would like to see human cloning and the construction of human-animal chimeras outlawed.
GENEWATCH: How do you feel about using genetically engineered animals to grow human organs for transplants?
Dr. Newman: I would prefer to see such research concentrate on engineering specific types of cells or tissues, perhaps using host animals, rather than generating part-human embryos. In the long-term I would hope to see more reliance on attempting such engineering in tissue culture and less in experimental animals.
http://www.gene-watch.org/magazine/vol11/11-3ChimeraProject.html