The Frankenstein Patent
GE’s Pseudomonas culture is a nonpathogenic strain and should have no difficulty on that account (although, according to the EPA, they have made no formal application thus far). The real question, however, remains: Precisely what long-term effect might the release of a modified organism have on the environment?
“That’s a good question,” says a researcher at the EPA laboratory in Edison, New Jersey, “and based on our current procedures, it wouldn’t be answered.” The question is, though, one that GE will probably have to answer. Even after the bug has been EPA certified, on-site approval must be given — at each oil spill — before application is allowed. And that approval involves state and local environmental regulation. One would suspect that it will require fairly persuasive evidence from the manufacturer to convince local environmental watchdogs that a genetically engineered microbe is also the sort of microbe that one would want in one’s own harbor.
On that front, General Electric will likely choose to argue that their modified Pseudomonas is not really, all in all, so different from the strains that already exist in nature. On another front, however, GE seems to be gearing up to present precisely the opposite argument. And that front, as suggested earlier, is the United States Patent Office.
In the spring of 1974, Chakrabarty and General Electric were granted a patent on the complex microbiological process, involving ultraviolet irradiation, that allowed the researcher to fit his Pseudomonas with a series of plasmids that would not, in nature, normally coexist in the same bacterium. The product of that process — the modified Pseudomonas — was at the same time denied patent.
According to GE’s Research and Development Center’s patent operation, the rejected patent regarding the microbe has been appealed and will be reviewed by the Board of Patent Appeals within two years. If appeal fails on that level, the case may then go outside of the patent office; to District Court or to the Court of Customs and Patent Appeals.
At this point, the details of the case are obscure. The issue at question appears to be whether one can patent a novel living organism, and the precedents seem both aged and foggy. One can, for example, patent hybrid plants, as long as they can be vegetatively reproduced.
Past that, however, no real precedent seems to exist in the GE case. One ruling, often cited, is more than a century old. At one point, according to a lawyer involved, GE even briefly considered calling the novel Pseudomonas bacterium a plant, since precedent already exists in that situation. The notion was immediately dismissed and by now the die appears cast: GE wants to patent its super bug, and they are willing to argue about it.
The Patent Office offers no comment. An examiner involved in the GE application for modified Pseudomonas says that “I can’t even acknowledge that there has been such an application”: such secrecy is standard procedure in the sphere of proprietary processes — those held by a company without the benefit of patent.
So the GE super bug — presently slumbering. Pyrex bound, in a small laboratory overlooking the Mohawk — may yet lend its name to some precedent-setting judicial decisions. Or perhaps not: The overall utility of microbiological techniques for oil-spill removal is still considered rather dubious and, at some point, the legal flak may overwhelm commercial potential of even the hungriest Pseudomonas.
But even so, Pseudomonas is only the beginning. GE, for example, is already publicly discussing the engineering of microorganisms capable of concentrating gold or platinum from waste substances — the innards of discarded automotive catalytic converters, for example — which bacteria can then be harvested and purified. And past that, numerous researchers, in this country and in Europe, are designing genetically engineered microbes tailored to turn out a variety of pharmaceutical substances from enzymes to antibiotics. Bacteria engineered to turn out insulin is a possibility that arises regularly in speculative discussions.
The questions — both environmental and legal — created by commercial use of engineered microorganisms cannot possibly go long without answers. In a sense, the environmental and public health issues have already been recognized and, at this writing, have already been the subject of more than one year’s vociferous discussion within the research community (see “The Pandora’s Box Congress,” RS 189, 1975). That discussion, which has thus far produced both a voluntary research moratorium and a still disputed set of guidelines, deals with the most sophisticated genetic engineering techniques presently available; the artificial recombination of DNA particles that would never meet in nature. Chakrabarty’s GE work, while it reads out in terms of a microbe that has never really previously existed in nature either, does not approach the implications of those more controversial techniques.
If the public health issues remain unresolved, the legal issues are even more so. Even the keenest legal mind will likely soon founder in the complexities of separating a patentable process from the non-patentable microorganism that was designed to perform it in the first place.
It would seem to demand almost preternatural caution, at this stage of the game, to draft legal precedents regarding the rights to novel life forms. Yet without the right of patent, the whole field of genetically engineered microorganisms might well drift into the alchemical realm of closely guarded secret industrial formulae; a condition in the case of colas or perfumes but which may well be far different when it comes to the artificial manipulation of life.
The solutions may turn out to be much simpler than expected. Only within the last 18 months or so have questions of this nature occurred on levels as practical as patent offices or agencies of environmental impact. The questions have been sudden, and for all their foreshadowing in speculative literature, fairly unforeseen in their specifics. That suddenness, perversely, is almost guaranteed to be belied only by the length of time those same questions will remain with us.
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