PATENTING LIFE

...in biology, has gone back to school to obtain a master's degree in business administration at Harvard...

...Ronald Cape, founder of Cetus and a Ph.D...

...Commenting to a reporter on the potential impact of the court's earlier decision favoring patent rights in the genetic engineering field, Kekich argued, "If you can come up with new or different forms of life and they can be used in a manufacturing process, I think you could at least make a claim they fall in the statutory limits...

...But the ruling made it clear that the Court of Customs and Patent Appeals, at least, is unlikely to set any strict bounds in the field of genetic engineering...

...Such technologies as genetic engineering provide the final denial of life's meaning by seeking to reduce all to the lowest common denominator...

...Several models of corporate structure have already evolved to take advantage of this prospective bonanza...

...David Jackson of the University of Michigan, is just getting under way, but hopes soon to conclude a major contract with "one of the Fortune 500 companies...

...These questions must be decided on a case-by-case basis...

...As if they were mouthing "newspeak" in George Orwell's 1984, judges now proclaim living organisms "an industrial product," and opine that there is no essential difference "between the living and the dead...

...As GE's attorney, Leo Malossi, indicated in arguing the company's case before the Patent Appeals court, it would be "fair" to say that if new life forms were not patentable, there would be little incentive for corporations to conduct research in the field...

...Cetus, with 150 employes, forty of whom have advanced degrees, is not the only thriving gene-therapy concern...

...Testifying before a Congressional subcommittee two years ago, Markey argued for increased genetic experimentation: "In today's world, when we desperately need scientific and technological solutions to our problems of energy, the environment, overpopulation — when we desperately need to increase the birth rate of discovery, invention, and innovation — this is not the time to encourage mental contraception and technological abortion...

...Such thinking does not arise in a vacuum, nor is it peculiar to the U.S...

...Adams decided to put the company's surplus capital into the field of recombinant DNA because, he told Nature writer Paul Dickson, "1 felt that this was the most exciting field of technology for investment for the immediate future...

...A microorganism, the University argued, is so close to "the periphery" of life that there should be no obstacle to patenting it, and indeed to proclaiming it non-living...

...On March 29 of this year, that court ruled by a 4 to 1 margin that private industry may apply for, and be granted, commercial patents for novel organisms created and designed in the laboratory...

...Upjohn patent attorney John Kekich anticipates a broad application of the ruling...

...We can not yet be certain where this legal precedent will take us...

...In this process, life is stripped of its essential meaning, its inherent value, its mystery...

...In this context, the March 29 decision of the Patent Appeals court takes on vast significance: It serves further to institutionalize a philosophy about life that must be challenged...

...All of life's properties can ultimately be reduced to the "physico-chemical...

...What computers and electronics were to the 1950s and 1960s, the creation of new life forms may be to the 1980s and 1990s...

...One such firm is Cetus in Berkeley, California, a corporation with a board of directors that reads like a who's who of contemporary biology...

...Another genetic engineering company, Genex, founded by Dr...

...Just as the computer industry has its Silicon Valley along the San Francisco peninsula, and the electronics-weapons manufacturers encircle Boston on Route 128, many of these new genetics companies are locating their headquarters in Rockville, Maryland, midway between the Bethesda campus of the National Institutes of Health and Fort Detrick, home of the most sophisticated (and dangerous) Government gene-splicing research...

...With this decision, the United States has taken an important step into a new age — the Ted Howard is co-author (with Jeremy Rifkin) of "Who Should Play God...

...What are the implications of transforming living, organic beings into material for manipulation and exploitation by economic forces...

...The court dismissed this argument in its decision with the derisory comment, " 'The sky is falling, the sky is falling!' cried Chicken Little...

...In the course of its own amicus brief in support of patents for life forms, the company noted that more than a century ago, Claude Bernard observed: "[A] created organism is a machine which necessarily works by virtue of the physico-chemical properties of its constituent elements...

...In its petition for certiorari to the Patent Appeals court, the PTO argued that since "the number of living things is vast," a decision in favor of life-form patents "opens an enormous range of subject matter to patentability...

...The most ambitious corporate development in the field has been initiated by a transnational corporation based in Canada, International Nickel Co...

...When the patent statutes were devised, it surely never occurred to anyone that some day life itself would be regarded as a patentable commodity...

...An appropriate rejoinder, we think is, "The more the better.' " Those are golden words to corporate executives, especially in the several dozen companies already in the business of creating and manipulating life through genetic engineering...

...Court of Customs and Patent Appeals in Washington, D.C...

...After the court ruled in favof of the companies in separate hearings, PTO took the case to the Supreme Court...

...The court, of course, vigorously denied it was opening the door to a brave new world: "We are not deciding whether living things other than microorganisms, are within [the patent law]," the opinion stated...

...Other firms abound: Hybritech, Bethesda Research, and more...

...It began when GE and Upjohn were denied their initial requests for life-form patents by the U.S...

...Though many scientists regard such experimentation as dangerous — particularly on the industrial scale, where vast quantities of potential disease-causing microorganisms can be grown in cell cultures — researchers claim that such benefits as the inexpensive production of human insulin or somatotropin, a growth hormone, far outweigh any possible hazards...

...but in that we shall doubtless succeed some day...

...Today, according to the British science magazine Nature, Cetus is worth some $65 million, and is experiencing rapid growth...

...here between the living and the dead...

...What does it reveal about our society and ourselves that we are willing to put a patent on life itself...

...The case specifically dealt with claims of GE and Upjohn for patents on microorganisms created in their research facilities...

...There are small, entrepreneurial companies founded by scientists who hope to cash in on their years of research in "pure science" — research often funded at public expense by Government grants...

...This, at least, should be clear: When those in power blithely call life "a machine" or "an industrial product" or a "tool of manufacture," then we had best take note of what is happening in our world...

...It is not just the ruling of the Patent Appeals court that is disturbing, but also the philosophy at the base of that ruling...

...because we call properties vital which we have not yet been able to reduce to physico-chemical terms...

...Perhaps Genentech, the San Francisco genetics company, has unwittingly provided an answer...

...And once this has been done, this final reduction will move all life toward that "periphery" where life does not have to be treated as life at all...

...Peter J. Farley, president of Cetus, possesses a medical degree and a master's in business from Stanford...

...According to Chemical and Engineering News, the new crop of recently launched genetics firms "are combining intense research efforts in new areas of biochemical technology with aggressive management practices...

...any sound reason for making the distinction...

...A year later, the company purchased 10 per cent of the stock in Genentech...

...Both corporations, leaders in the new field of genetic manipulation, appealed this ruling to the Court of Customs and Patent Appeals...

...GE was granted ownership rights on a microorganism that eats petroleum...

...The court held . . .life is largely chemicals' While the smaller firms seem to have the jump on the market, larger, established corporations are not about to concede the field...

...Patent and Trademark Office (PTO...

...Or, as the court held in its opinion, "life is largely chemicals...

...And the University went on to assert: "Recognition of the difficulty that skilled scientists are experiencing in drawing a bright line between life and its absence effectively destroys the argument that life itself is not only the essential characteristic of any living being — even a microorganism — but the one which, so long as unaltered, precludes patentability...

...Chief Judge Howard T. Markey seems especially intent on securing the "benefits" of genetic manipulation for society by making the field commercially viable...

...But with the advent of the modern biological revolution and ever more sophisticated techniques of genetic manipulation, scientists, corporate executives, and patent lawyers are joining forces to claim exclusive ownership rights over laboratory-produced life forms...

...Patenting life A major corporate breakthrough toward genetic engineering Ted Howard Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor...

...The worth of the individual and the meaning of life are being eroded every day by powerful social and political forces...

...Emphasis added...

...The judges simply affirmed the scientific reductionism that permeates modern genetics, an assumption that every facet of life — reproduction, disease, mental ability, even emotions and behavior — can be "explained" in terms of a chemical base...

...Today we differentiate three kinds of properties exhibited in the phenomena of living beings: physical properties, chemical properties, and vital properties...

...By 1978, INCO had established a scientific board headed by Dr...

...Chemical and Engineering News, a trade publication, describes the current momentum in the field: "Like distant thunder that is drawing ever closer, recombinant DNA technology, or gene splicing, is moving inexorably toward practical application...

...And Allen Otten, writing in The Wall Street Journal, cited the view of one unnamed corporate lawyer who commented that the ruling "raises the question of whether ultimately someone could patent a human being...

...Every year, thousands of items — electronic gadgets for the home and factory, writing paper that glows in the dark, new designs for $40 running shoes, widgets and whatsits — are patented under this provision...

...The March 29 ruling could turn out to be the final act of a legal drama that has been played out for the past three years...

...Age of Genetics — which may work drastic changes in our laws, our ethics, our economics, and our politics...

...Just a few years ago, Cetus was a small, struggling company searching for a market — a market "of untold potential," as one of the firm's early internal memos described it...

...There, in the stiff language of Nineteenth Century scholarship, lies the essence of the matter...

...Surely where the line between life and nonlife is so fine as to baffle even the experts in the art and at times cannot be drawn with conviction, compositions of matter or manufactures near the periphery cannot conveniently be deemed patentable or unpatentable on so ephemeral a ground...

...But what about higher forms of life...

...But the term 'vital properties' is itself only provisional...

...Many microorganisms — "industrial products" that produce hormones, drugs, perhaps even food and energy — will be subject to patentability...

...His thoughts were echoed in the court's ruling...

...In an amicus brief supporting the patent appeal by General Electric, the University of California at Berkeley, an institution seeking to patent the results of genetic engineering research conducted by its own scientists, attempts to confer a patina of intellectual legitimacy on the scientific reduction-ism drawn upon by the court...

...Most of these firms are conducting research in the area of recombinant DNA, a gene-splicing technique that literally produces new forms of life...

...As genetics moves out of the realm of theoretical research and into the commercial arena of patents, trade secrets, and marketing techniques, scientists have had to adapt to new realities...

...In the past year, such companies as Standard Oil, Monsanto, Searle, Schering-Plough, and Dupont have begun their own research, signed contracts with the scientist-entrepreneurs, or simply bought large blocks of stock in the smaller firms...

...Research assistance for this article was provided by Dan Smith of the Peoples Business Commission...

...Replying to the PTO claim that a decision in favor of patenting life forms would open the way to an "enormous" number of patentable organisms, the court rejoined, "It is heartening to think how many useful things may yet be invented and we are not moved to be restrictive in our interpretation of section 101 by mere numbers...

...Now, the issue of incentive has been resolved...

...In 1975, INCO established a venture-capital division in New York headed by Dan Adams, an American businessman...

...All of this frenzied activity has been based on the assumption that the companies doing the research would one day capitalize on it financially...

...So reads Section 101 of Volume 35 of the U.S...

...Other patents for genetic engineering techniques and new forms of life are known to be pending before the Patent and Trademark Office...

...This is not science fiction: The first court ruling conferring patent rights to major corporations for genetically engineered forms of life has already been handed down...

...The court, said the solicitor, Gerald Bjorge, was indulging in "wholesale judicial legislation," by extending the patent laws to "encompass living organisms — life itself...

...To most of us, a microorganism is of small consequence...

...At least half a dozen pharmaceutical companies — Eli Lilly, Miles Laboratories, and Merck, Sharpe and Dohme, among them — have been involved in recombinant DNA research since 1976...

...Life has no "vital" or sacred property, according to the source cited enthusiastically by Genentech...

...No one — not even a top executive of a Fortune 500 corporation — would argue at this time that genetically redesigned humans should ever be patented...

...Philip Sharp of MIT, who helped bring together other prominent American and European scientists to found a new genetic corporation, Biogen, a wholly-owned subsidiary of INCO...

...The Patent Appeals court ruling has lent substantial momentum to the inexorable march...

...The whole affair was sent back to the Patents Appeals court, which finally concluded the matter with its most recent 4-to-l decision...

...While most of America was engrossed with news of a potential nuclear disaster at Three Mile Island, attorneys for General Electric and Upjohn kept their attention riveted to the U.S...

...In its initial 1976 foray, INCO bought $500,000 worth of stock in Cetus...

...If that sounds rather eerie, so does the court's description of a genetically engineered life form as "an industrial product used in an industrial process in a useful or technological art...

...Under the court's ruling, Upjohn will become the proud corporate parent of a one-celled creature that produces the antibiotic lincomycin...

...Whether life-nurturing or destructive, ridiculous or sublime, human-made artifacts that fulfill the general criteria of Section 101 are subject to patentability, private ownership, and commercial marketing for profit...

...But where and how will we draw the line once we embark on a course of classifying life at "the periphery" as non-life...

...By extending the patent law to living organisms, the court has confirmed the economic potential of this budding industry, which Fortune magazine has predicted will soon become a "multi-billion dollar" enterprise...

...The company has amassed $35 million in equity funding...

...In fact, now that most of the major high-technology industries developed in the past two decades have begun to slow down, genetic technologies seem destined to become the major growth industry in the United States...

...Court of Customs and Patent Appeals...

...Robert Swanson, co-founder of Genentech, also claims two degrees — one in medicine, the other in business from MIT...

...Additional financing has been pumped into Cetus by the venture capital firm of Kleiner and Perkins, which was instrumental in supplying capital to Fairchild Industries during the go-go years of the electronics explosion...

...But deeply troubling fundamental questions remain unanswered...

...Walter Gilbert of Harvard and Dr...

...PTO had taken the position that life forms — even lowly microorganisms — are by definition living entities, and that Congress had never intended that these be patented...

...Noting that recent research with viruses has led some scientists to ponder whether these organisms are actually to be classified as dead or alive — as living beings or as chemical material — the University quoted one scientist as saying, "The gap between life and nonlife has disappeared...

...Genentech may end up beating Cetus into the commercial marketplace: In June of this year, the company announced that it had begun to produce recombinant DNA-derived insulin in large volume and hoped to have it on the market by 1981...

...After pondering whether artificially created life forms — composed of genetic information unlike any created in billions of years of evolution — could be patented, the court held that there was no justification for excluding an "invention" merely "because it is 'alive.' " Indeed, the judges ruled, "from the standpoint of construing the patent statutes, we do not see...

...Across San Francisco Bay, another firm, Genentech, established by two leading scientists, Robert Swan-son and Herbert Boyer, is worth several million dollars...

...Almost half of its stock is owned by such corporate giants as Standard Oil of California and Indiana Standard...

...Code...

...After all, as the opinion noted, "life is largely chemicals" and chemical compounds have always been subject to patentability...