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Front Page Award

The Newswomen's Club of New York has awarded Publisher and Editor-in-Chief Merle Hoffman its prestigious 2010 Front Page Award for political commentary.

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To the Oklahoma Lawmakers: poem by Lauren Zuniga
OTI Online
Fall 1991

On the 8th Day We Created - What?
by Rita Robinson


Less than 10 years ago, requests to patent animals wouldn't have challenged the ethical and intellectual beliefs of scientists, politicians, philosophers and religious leaders.

Rapid advances in our ability to manipulate genetic material, however, have sparked interest in the commercial uses of living organisms. The "invention" of bacteria to gobble up the debris of oil spills triggered the movement and led to a 1980 decision by the U.S. Supreme Court that a live, human-made microorganism is patentable.

The debate over whether to permit such patenting goes beyond simple legal questions on [the humanness of] animal welfare. It involves the appropriateness of biotechnology itself and other ethical issues, such as the morality of creating novel organisms by transferring genetic information between species.

The "invention," after all, is alive, although not human. Thus far the practice has resulted in efforts to amend the patent code and has fostered serious public policy discussions and debate on how old laws can come to terms with new technology.

Animal manipulation is a reality. So is patenting such animals. The question, therefore, isn't just one of "is it right to alter non-human life," but "if we do alter non-human life forms, is it right to patent the manipulation?" In 1988, following another broad decision that ruled polyploid oysters were patentable, Harvard University received an animal patent on a genetically engineered mouse that contained a cancer-causing gene, now known as the "Harvard mouse." It was the last animal patent issued, although approximately 100 other animal patents are awaiting approval.

Whereas the oyster passed unnoticed, the mouse caused a stir, though perhaps, for the wrong reasons. Animal manipulation, scientists point out, was practiced by farmers for thousands of years under the guise of animal husbandry, implying that new technology, like genetic manipulation, simply speeds up the process. Patenting, then, stands as the new kink in husbandry, and the one most debatable and controllable.

Congress enacted the first patent act in 1790, and has updated or reinterpreted it ever since. The Patent Act of 1952 clearly stated that "anything under the sun that is made by man" was patentable, but the U.S. Supreme Court has held that laws of nature, physical phenomena and abstract ideas are not patentable. Thus, patent laws, to say nothing of animal rights, can be subject to interpretation.

Before 1980, the Patent and Trademark Office (PTO) wouldn't consider granting patents for "inventions" involving microscopic living entities because they were considered "laws of nature." During this period, though, patents were given to certain food yeast compositions, vaccines, insecticides and dairy products that contained living things. Yet, in the eyes of the public, these "things," like the oyster, didn't resemble animals as we generally think of them.

Ronald R. Garet, professor of law and religion at the Law Center, University of Southern California, wonders how human beings can lay claim to any animal. He reflects on farm-style animal husbandry, but points out that it occurred on such a small scale and over such a long period, that "our powers were hidden from us."

"When you look at the goats and pigs of medieval farms, they are nothing like nowadays. But when this evolution took place over a long time frame, no one would have had the arrogance to believe they could capture it for his or her family or themselves. Someone who had an ability to breed a more effective hunting dog or sheep with better wool wouldn't have thought of themselves as the 'creator,'" says Grant.

"We have a vocabulary that we have spoken for a very long time. We hide the ongoing transformations from ourselves. Where is the natural baseline to measure things by?" he asks.

Of more importance than trying to establish this natural baseline or an "in the-beginning concept," may be a responsibleness or stewardship over the natural world. "While that is somewhat anthropocentric and places us at the center of the scheme, it also expresses a view of interconnections. We have, to some extent, abandoned that view of interconnectedness and obligation to other species. So the bonds to other creatures have deteriorated and haven't been replaced with anything to take its place," says Garet.

Norm Daniels, a philosophy professor at Tufts University, addressing the issue of "cheating" in relation to technologies such as new drugs that enhance performance, agrees with Garet that a natural baseline is nonexistent. "In a certain sense all the domesticated animals today are efforts at animal husbandry. In the past we've lived with interbreeding by doing it naturally without taking patents out on the products. I suppose if there is an element of cheating, it would only have to do with deviating from a past practice when no one took credit for it or had to take out a patent."

Patents for development of experimental animals, such as the Harvard mouse, provoke questions whose answers often lie in areas laced with mine fields. Because the issue of "manufactured animals" is not resolved, seven initiatives and bills were considered or introduced during the 100th and 101st Congress. All aimed to either prohibit the patenting of genetically altered animals or deal with infringement rights of altered animals. The bills died, and have not been reintroduced in the current 102nd Congress.

Meanwhile, a de facto moratorium exists on the animal patents awaiting PTO decisions that has effectively, even if momentarily, put a lid on the issue.

It's a "hot potato" according to insiders because issuance of a new patent will raise the hackles of animal rights activists and create other complex dilemmas. As it now stands, development and use of the altered life forms can continue unabated.

Without legislation, the rule is that nonhuman animals are patentable based on the Supreme Court decision in 1980. It was strengthened by the PTO's 1987 policy statement that non-human animals could be patented. "Until legislation changes, that is the law in a nutshell," said Kevin O'Connor of the Biological Applications Program, Office of Technology Assessment, a research body charged with advising Congress on new technologies.

Since no patents have been issued in three years, the question then becomes, "When will the next patent be issued?" and "How much of a furor is it going to cause?" Meanwhile, new animals are created and used without patents and no one complains.

Currently, the National Institutes of Health (NIH) is the largest user of genetically engineered animals for biomedical research projects. The U.S. Department of Agriculture and its Cooperative Research Service supports projects involving genetically engineered animals, as does the National Science Foundation. No single federal policy governs these research projects. An array of regulations and guidelines not subject to patents govern them. On the other hand, some federally funded projects could lead to patents on the animals being developed and tested.

Donald Elliott, General Counsel of the Environmental Protection Agency and Yale University law professor (on leave), says, "The government is very close to coming out with some regulatory measures that will allow us to go forward after many years of something like a de facto moratorium." Elliott added that the current administration "generally supports technology and believes we should regulate it rather than having a ban on it."

Of prime concern to the government is not animal rights activists, though the Harvard mouse caused quite an uproar and though the Humane Society of the U.S. has come out against animal patenting. It's the American farmer.

Farmers have always been free to purchase new stock and breed it to their own specifications. If patented, a farmer might infringe on someone else's legal rights. Therefore, some bills previously introduced exempted farmers from an animal patent.

Former Rep. Robert Kastenmeier (DWI) introduced a bill in the 100th Congress that would have exempted farmers from patents that would restrict them from reproducing or selling patented animals. Although adopted by the House of Representatives, the Senate took no action. He introduced a similar bill in the 101st Congress, but it, too, failed.

Kastenmeier, considered by many to be one of the most astute politicians concerning animal patenting, lost his office in the last Congressional election.

Distasteful wording by the patent office in the 1987 ruling on animal patenting has blocked some of the proposed bills. In trying to make clear that non-human animals could be patented, but not human ones, the 13th amendment to the Constitution, prohibiting a human being from having a property interest in another human being, was cited. "When that case came before the House Judiciary Committee, the chairman took exception to that interpretation. He wasn't comfortable that the rationale would hold up," said O'Connor.

The de facto moratorium on animal patenting and the problems faced by bills addressing the issue, seem to illuminate the issues of animal rights, genetic manipulation and technology. These issues, though, are only part of a much broader concept that humans must embrace.

There's nothing new in gene manipulation. Genetic alteration naturally occurs. The trigger now, however, is in the pull of human hands. The whole public debate is problematic because people on one side (scientists and geneticists) are highly trained and skilled in this area while the vast majority of those using the technology (such as farmers) have no basic grounding in it. That is a major chasm. So a fair number of people start thinking of a grade B horror film, and that can be a problem, says O'Connor.

Surveys in 1987 showed a high level of support by the American public on basic genetic engineering research. When people understood the benefits, about 80 percent said they would like to see that kind of research go forward. "But when you start speaking specifics, like releasing an organism into your neighborhood, or patenting an animal or using human gene therapy, the debate takes a different turn. Technology simply isn't neutral," says O'Connor.

"It isn't only the U.S. public that is concerned. We're looking at a history that is only a few years old and people are just starting to get their hands on it. Right now you can apply for a patent on an animal in the U.S. based on the Harvard mouse decision, but even so, it was rejected by the European Patent Office. Then, the European Patent Convention decided that the patent examiner had been incorrect and it's now on appeal," says O'Connor.

The issue of worldwide patent examinations and acceptability is becoming immensely important. It affects the world's trade and patenting policies. European countries remain the most skeptical of animal patenting on the grounds of animal rights.

"There is no problem with the issue of Japan because they simply don't care that much about animals," says Humanities Professor Daniel J. Kevles of the California Institute of Technology.

Kevles, who is writing a book on patenting life forms, says that because of the de facto moratorium, there is nothing to stimulate the public into action. "They're using the technology. There are simply no further animal patents being issued. The principle has been established. The only thing that can overturn it is the people who oppose animal patenting, and they haven't made a sufficiently strong case," he says.

Elliott, who remains optimistic about most new developments in genetic engineering, says, "I can think of no instance in which collective risk aversion and fear of the unknown has succeeded over the long run in preventing (as opposed to delaying the regulating) the introduction of useful new knowledge or techniques."

Kevles, speaking at a biomedical ethics seminar at the University of Southern California, reminded participants that "Looking at this technology in the abstract doesn't get us very far. Looking back to the '20s and '30s, what could we have done about control of nuclear power then?"

Kevles and others debating the issues of modern technology at USC concluded that in those early years we weren't even aware of some dangers inherent in nuclear power, and that, despite misgivings about what is known, technology moves ahead despite rhetoric and debate.

It has only been through laws and regulations that nuclear power was curtailed to any degree. The greatest danger, then, may be in trying to completely stifle new technology. If we try to halt the progress, it proceeds anyway, but without regulations and controls.

There is a need to debate laws that will govern what's allowable and what's not in animal patenting. We're past the stage of determining whether to allow invention of new life forms. They're already among us.


Rita Robinson is a freelance writer from Big Bear City, CA.


 

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