This essay is reproduced here as it appeared in the print edition of the original Science for the People magazine. These web-formatted archives are preserved complete with typographical errors and available for reference and educational and activist use. Scanned PDFs of the back issues can be browsed by headline at the website for the 2014 SftP conference held at UMass-Amherst. For more information or to support the project, email sftp.publishing@gmail.com

Opinion: Perspectives on Biotechnology

by Various Authors

‘Science for the People’ Vol. 12, No. 5, Month 1980, p. 11-18

The following three commentaries raise a number of issues concerning current developments in biotechnology research and engineering. We hope these pieces will provoke ongoing discussion of how we as progressive people should respond to these events.

COALITION SPEAKS OUT

The Coalition for Responsible Genetic Research is a national organization of scientists, environmentalists and health care professionals concerned about the use of genetic engineering.

On June 16, 1980 the Supreme Court, in a narrow 5-to-4 decision, ruled that genetically modified micro-organisms could be patented under existing U.S. patent law (Dimond vs. Chakrabarty #79136). In the same week the U.S. House of Representatives subcommittee on agriculture held hearings on an amendment of the little known 1970 Plant Variety Protection Act, which would extend its coverage to a set of vegetables hitherto excluded.

Though written from the limited perspective of Patent Law, the Court decision sets a legal precedent permitting the patenting, and therefore the private ownership, of a strain, line, or species of organisms. Previously one could own an individual corn plant, cow, or cucumber, but not all its descendents. The Court decision moves the right to propagate a strain of organisms into the realm of private property.

The technology for mammalian genetic and reproductive manipulation is rapidly developing; in vitro fertilization, transplantation of genes into mammalian cells, cloning of human genes in microorganisms; and very sophisticated forms of genetic screening. These technologies involve the generation of strains of micro-organisms carrying human genes—now patentable—as well as modified human cell lines, also likely to be patentable following the present precedent.

Corporate Ownership of Food Plants

The combination of the Court decision and recent agribusiness legislation will make possible the buying up of the world’s food plant resources by a relatively small number of large corporations, mostly pharmaceutical and agrichemical multinationals, who will almost certainly follow their current policy of discouraging the planting and maintenance of non-patented and wild varieties, thus decreasing the overall genetic variation in surviving food plant varieties. This constitutes a serious long term danger to the security of the world’s food supplies.

In recent years agrichemical and pharmaceutical multinationals have been buying up small seed companies both in the U.S. and Europe. Since the Patent Laws previously excluded plants, they have lobbied for special interest legislation to permit private ownership of plant varieties. For example four companies, Sandoz, Ciba-Geigy, Pioneer and DeKalb control two-thirds of the maize varieties in the U.S. The existence of a vast variety of wild and unpatented varieties makes it difficult for them to sufficiently control the market. In Europe the large seed companies have therefore pushed programs to suppress the growth of wild and unregistered varieties. The resulting genetic uniformity is useful from their point of view, rationalizing sales of pesticides, fertilizers, and farm machinery, and increasing total market penetration and therefore selling prices.

However, from an agricultural point of view, increased genetic uniformity is a disaster, since the genes needed for the next generation of plant strains, for resistance to new pests, survival in altered environments, or new food needs, disappear from the earth.

Private Patents and Biomedical Research

The extraordinary advances in biomedical knowledge that underlies the new biotechnologies came almost entirely from publicly funded scientists working in university, medical school, and government laboratories. A cornerstone of the productivity of American biomedical scientists has been the free exchange of scientific materials and information, based upon participating in the shared endeavour of increasing public knowledge of life processes. Private patenting interferes with this free exchange. Once organisms are in the public sector they cannot easily be patented. An individual planning to apply for patents is unlikely to freely distribute the material, or information about it, until the patent has been granted.

Private Appropriation of Public Resources

As noted above, modern biotechnology was developed from the billions of taxpayers’ dollars invested in biological and biomedical research, starting with the Public Health Services Act of 1944, and later with the formation of the National Science Foundation and the National Institutes of Health. The final applications of the technology to construct a patentable organism, though perhaps performed in a corporate laboratory, represent the last links of a very long chain, none of which was privately financed.

The Court decision creates a situation where the public will have to buy back the very products it has financed over the past 35 years.

If patents are granted the NSF and NIH should insist that its grantees assign patents back to the government, and not to private corporations or individuals.

Control of Hazards

In rendering genetically modified microorganisms private property the Court has made it even more difficult to regulate and oversee the potential health hazards associated with genetically modified microorganisms. Many of these micro-organisms, designed for specific commercial processes, may have deleterious consequences for the health of workers, individuals in the community, or for other organisms in the ecosystem. Though this is true of many byproducts of industrial processes, organisms that have been genetically modified constitute a new form of pollution—self-reproducing. The regulation and control of these agents will require much greater scrutiny and social input than that required for the regulation of self limiting agents. What is profitable for the pharmaceutical industry may be hazardous to the children of pharmaceutical workers.

Lack of Government Regulation

The Court decision gives the green light to the commercial exploitation of genetic manipulation technology. Unfortunately Congress has passed no laws to regulate this emerging industry, and no government agency has explicit responsibility for it. The National Recombinant DNA Advisory Committee has recently announced that regulating commercial production processes are outside its jurisdiction.

Human Genetic Engineering

The technology now exists to introduce foreign DNA into human cells, including germ line cells which are passed on to the next generation. Many laboratories are working on medical applications to human genetic diseases. New reproductive technologies, such as in vitro fertilization, make available to medical researchers human sperm, ova, and the early stages of the embryo outside the womb, plus the technology to transplant the embryo back into the womb.

Preparation for attempts to transplant human DNA into human cells often involves cloning of the DNA in micro-organisms or viruses. The Court decision does not exclude these organisms from the patentable group. Similarly specially modified cells, including sperm and egg cells, might be patentable under the decision.

We believe that the Court decision is not in the public interest:

Plant, animal, and microbial life forms, and their inter-relationships provide the foundations for human life. They are too important to human survival, health and prosperity, to permit them to be owned by individuals or corporations.
Neither humans, nor their cells or tissues, nor their genes nor any segment of their genes, should be allowed to be owned by an individual or a corporation. To the extent that materials such as human cell lines or strains of micro-organisms carrying segments of the human genome, become available for research, or even in production of pharmaceuticals they should remain a public trust.
Congress should pass explicit legislation removing life forms from the realms of private ownership and private patents.

REPRODUCTIVE TECHNOLOGY AND WOMEN

Gena Corea is the author of The Hidden Malpractice: How American Medicine Mistreats Women.

The men who brought us the Pill, the IUD and diethylstilbestrol (DES) are now presenting us with in vitro fertilization (IVF). It is, they tell us, the savior of infertile women. So too did they herald DES as a savior of motherhood through its alleged, though unproven, ability to prevent miscarriages. In a similar manner, they proclaimed the Pill as the sexual liberator of women.

We are still reeling from the effects of that earlier experimentation on our bodies.

In the decades to come, we may learn whether the women under the care of IVF pioneer Patrick Steptoe suffered ill effects from the administration of human menopausal gonadotropin, human chorionic gonadotropin, clomidphene, indomethacin, morethindrone, and 17-hydroxyprogesterone. Perhaps we will find out whether the trauma inflicted on their ovaries by needle punctures to suck out ripe eggs had any deleterious effects. Maybe we will find out whether the surgical manipulation of the ovary adversely affected that organ’s secretion of hormones and all the bodily processes influenced by those hormones.

(Then again, we may never find out. Ill effects on experimental subjects tend not to be found when no one looks for them. Moreover, Steptoe’s patients may be among the many women who, during the course of “prophylactic” hysterectomies recommended to them in their middle years, have their ovaries excised along with their uteri.)

The infertile women among us who want to bear children face a problem which should command the most serious attention and concern. How, we might first ask, did we become infertile? Through infection caused by an IUD or an unnecessary caesarean section? As a result of a shock to the hypothalmus dealt by the injectable contraceptive Depo-Provera? Due to Pill ingestion? As a result of DES-induced uterine abnormalities? Through our exposure to pesticides like DBCP? In consequence of the pandemic spread of sexually transmitted diseases which this country makes only a token effort to prevent?

And are the physicians and researchers who, in many cases, caused our infertility the most appropriate persons to whom we should appeal for our cure?

During the past decades, as these physicians and researchers devised the contraceptives which have proven so devastating to our bodies, they have also been quietly working on IVF and other forms of reproductive technology. The motive behind their work, I would argue, is not a desire to help infertile women.

When these new technologies come into widespread use, they will increase male control over woman’s procreative power and over who will exist on our planet. Through the medicalization of birth control, abortion and childbirth—formerly household matters—men already exercise great control over that procreative function.

Now, by defining infertility as a medical matter and by claiming the authority to manage it through IVF, embryo transplants, and the artificial insemination of a surrogate mother (or, as one medical publication referred to the woman, a “surrogate uterus”), that control is increasing.

At the same time, “genetic counseling centers” are sprouting up throughout the land, temples for the fetishization of the gene. As the centers “educate” the public to the necessity of hunting down bad genes, male institutional control over procreation will further solidify.

And how will men use their control over procreation? This is one of the visions—a nightmare of selective breeding through the combination of population control programs and reproductive technology:

Technicians will harvest and freeze our eggs. Then they will sterilize us. (Or perhaps they will line some of us up and inject long-acting and hazardous contraceptives like DepoProvera into us.) An elite committee of white men will survey the harvest of eggs and sperm and then decide who will be brought to life, who may exist.¹

Not so far-fetched. The capacity for “quality control” in the production of human beings increases yearly. In 1978, The New York Times reported that Steptoe and his colleague, R.E. Edwards, had proposed freezing human embryos for later implantation. This procedure, the Times noted, would provide enough time before implantation to screen the embryo for “genetic defects” and to determine the sex of the embryo, the latter feat already accomplished in cattle, sheep and rabbits.

“Only embryos of the desired sex would be implanted,” the Times reported, a fact somewhat chilling to we of the undesired sex.

This, too, lends credence to the nightmare: Pill pioneer Dr. Carl Djerassi observed in his 1980 book, The Politics of Contraception, that IVF might make women more willing to undergo sterilization.

“If this currently controversial procedure ever becomes a routine, widely used method of conception,” he wrote, “it could have a major impact on the acceptability of sterilization among women.”

PATENTING LIFE: SOCIAL AND ETHICAL ISSUES

Sheldon Krimsky is a Professor of Urban Environmental Policy at Tufts and a member of the NIH Recombinant DNA Advisory Committee.

Recently, when I appeared on a Boston radio program to address the patenting decision on microorganisms, a caller asked whether a human clone could be patented. Recalling the Supreme Court’s decision in Diamond v. Chakrabarty, the first idea that flashed through my mind was: Is it manufactured? But obviously if the product is a person he/she cannot be patented on constitutional grounds. Persons have rights: they cannot be owned or enslaved (at least in modern enlightened societies). However, for any life form that does not possess personhood, and which came into being through a process conforming to the Court’s conception of manufacture, the question of patentability remains open.

The caller’s question first seemed far-fetched and irrelevant. But upon further consideration I began to recognize that questions of this nature are now meaningful and fall within the boundaries of legal and moral discourse. The Chakrabarty decision opens up many new problems in patent law and social ethics. I shall address some of these in five areas: (i) the relevance of life to a product of manufacture, (ii) patenting and the regulatory void, (iii) patenting human genes, (iv) patentability of higher forms of life, (v) patenting and the social good.

The Relevance of Life

In Diamond v. Chakrabarty the fundamental distinction between living organisms and inert matter was ruled irrelevant by the Supreme Court as far as patenting is concerned. The Court held that the rearrangement of living matter in novel structures or combinations is no less a product of manufacture than analagous human arrangements of inert substances such as minerals. “Congress thus recognized that the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human made inventions.” Some may interpret the Court’s action as incorporating a metaphysical bias that advocates a chemical reductionist view of life processes. Indeed, the majority argued that the “manufacture” or “composition of matter” should apply no less to life forms than to machine parts or chemical products. There are two relevant questions here. First, is life more than the sum of its chemical parts? Second, if there are any unique characteristics (emergent properties, elan vitale), do they have any relevance to the question of whether life forms may be termed a product of manufacture?

Because there are unavoidable and irreducible differences between inert substances and life forms (this is true whether we adopt a vitalist or a reductionist metaphysics) the decision to patent microorganisms will introduce formidable problems in patent law. These issues will either find their resolution through a broad policy on the part of Congress or will be left to a case by case analysis in the courts. I shall cite one such problem. Do patent rights for an engineered microbe extend to its progeny? Since microorganisms reproduce themselves, we could easily have a situation whereby a patented bacterium escapes into the environment and multiplies. Except for the initial handiwork involved in the genetic alteration of the organism, human intervention plays no role in the propagation of the bacterium. Should each of the daughter cells be considered a product of manufacture, no less than the parent cells? If not, then the patenting decision may be a moot point. However, if patent rights are found to cover all progeny of the life forms in question, then we are introducing a radically new notion of manufacture into our ordinary discourse. Our language will have to tolerate statements such as: “A manufactured object can mutate and thus spontaneously revert back to a non-manufactured object.” “A manufactured object can reproduce itself.” “A manufactured object can evolve.”

How are we to determine that a given genetically manipulated organism is novel, i.e., has not occurred or does not occur in nature? Will it be sufficient to show that it had never been isolated under natural conditions? Or will verification that it is unstable in the wild suffice? And what if there is evidence that it could have existed during some past age when conditions were different than they are today? There is no precedent in patent law to answer these queries. Therefore, the courts will have to create policy or the Congress will have to establish new rules for patenting life forms per se.

Patenting and the Regulatory Void

By now it is generally known that a substantial regulatory apparatus has been put into place for NIH funded recombinant DNA work. It mostly affects academic research. Industrial DNA activities are covered by a voluntary compliance program that is being administered by the NIH. What relation, if any, does patenting have to the issue of regulation?

The reason one would want regulation of industrial practices in genetic engineering (not only recombinant DNA but other processes that produce new or modified life forms) is that one takes seriously the prospects that:

Recombinant DNA research is a radically transforming technology;
Synthetic biology, like synthetic chemistry, is not going to be a free lunch, from the point of view of health and the environment.

It is reasonable to anticipate that the Supreme Court’s decision in Chakrabarty will provide greater economic incentives to firms for investing in genetic engineering research and development. (Ultimately this is an empirical question, since the effect could be negligible.) If the industrial activity develops more rapidly as a result of investment confidence spurred on by the extension of patent rights to microorganisms per se, then those apprehensive about the present laissez-faire attitude toward the biotechnology industry should be more concerned after the decision. Taken simply as a symbolic action, at the very least, the Court’s patenting decision acts as a stimulant for commercial gene-splicing activities at a time when there is still concern about the large scale production and distribution of modified life forms.

Patenting Human Genes

While humans are not patentable entities, the Supreme Court has left open the possibility of patenting human genes. Bacteria that possess the genes for human insulin or interferon are already in advanced stages of development. Beyond the issue of the patentability of a bacterium with a single gene insert, let me pose the question: Can we patent Shockley’s genes? Patentability is not excluded because matter is living, nor, apparently, because the entity consists of a system of cells. But of course, Shockley’s germ plasm is not patentable on the grounds that it is a product of nature. However, suppose his genes are engineered to some degree. Then his germ plasm might indeed qualify as a product of manufacture. Who would want to patent Shockley’s genes, or anyone else’s for that matter? And what could possibly be done to change them to qualify as a “product of manufacture?” With the growth of human reproductive technologies, commercial sperm depositories have been established to exploit the demand for artificial insemination and in vitro fertilization. A recent New York Times report cites seventeen sperm banks in the U.S.²

If there are profits to be made in huckstering human germ plasm, patenting may be sought as a means of protecting one’s investment.

I can foresee another circumstance where patent requests for human genes may generate interest. And this is where we begin to see how frivolous and exploitative recombinant DNA research and industrial cloning can become. Consider a new line of cosmetic creams with oils or hormones produced from the genes of a glamorous star. Is my imagination playing tricks on me or could this form of genetic peddling have an appeal to Madison Avenue? “Cosmetics with the Hormones of Your Favorite Personality.” It hardly matters if the personality proteins are not the slightest bit different from those of us common folk.

In both the examples I cited, there is an unsettling aspect to the patenting of human genes. Perhaps it is because it fosters a genetic aristocracy. Who you are as a person will become secondary to your genetic blueprint. Or perhaps there is something venal about the private appropriation of human genetic resources.

To return to an ancillary question, what modifications could be made in human germ plasm to qualify it as a product of manufacture? Perhaps someone will discover a sequence that enhances the biochemical activity associated with certain desirable traits, or that gives people an advantage over viral disease or cancer, or that allegedly promotes longevity.

Eleven years ago an eminent biologist Salvadore Luria alerted us that his field was developing the instruments for shaping human evolution.

We should not ignore the possibility that genetic means of controlling human heredity will be put to massive uses of human degradation even outside the military context. Huxley’s nightmarish society might be achieved by genetic surgery rather than by conditioning, and in an even more terrifying way since the process would be hereditary and irreversible.³

We are all vulnerable to fantasies of archetypal offspring. By extending the rights of patenting to human genes through modified germ plasm, we have a tacit approval to unleash the terrifying power that Luria describes.

Patenting Higher Organisms

If we genetically modify the germ plasm of a bull to qualify as a product of manufacture, can we patent the germ plasm? Does the patent extend to all the progeny? Presently, a single bull can provide the sperm for hundreds (perhaps thousands) of offspring. Someone can own the bull, and sell the sperm, but there is no entitlement to ownership of all the progeny.

Let us suppose that in addition to genetically modifying the bull’s germ plasm (where progeny cows provide a higher yield of milk), we learn how to duplicate, in unlimited quantity, our product of manufacture. The patenting of this product could be tantamount to owning the genetic strain of a species. Moreover, we might be able to achieve mono-herds, the livestock counterpart to monocultures. But by narrowing the genetic variation of livestock to improve upon certain qualities and promote uniformity, we could be duplicating the hazards faced worldwide in agriculture where the variety of crops has been dramatically reduced. Genetic homogeneity, whether in crops or animals, is vulnerable to a single catastrophic event that a variegated genetic pool could overcome.

It is notable that some countries which permit patenting of microorganisms do not grant similar patent rights to higher life forms. Under the European Patent Convention and under the German Patent Act, plant and animal varieties and biological processes for their production are excluded from patent protection.⁴

From the Chakrabarty decision the Court drew no lines on patenting life forms. The brief filed for General Electric argued that each case should be decided on its own merit by the courts, even those cases involving human genetic engineering. I cite a remarkable passage from their brief.

As to humans, constitutional problems would seem to afflict a patent granting someone the right to exclude others from reproducing a human being. A more precise consideration is appropriately postponed until a case or controversy makes a decision necessary.⁵

In his majority opinion Justice Warren Burger made it very explicit that the Court was quite restricted in rendering its decision. “Our task, rather, is the narrow one of determining what Congress meant by the words it used in the statute; once that is done our powers are exhausted. Congress is free to amend para. 101 so as to exclude from patent protection organisms produced by genetic engineering.”⁶

As I have shown, there are more issues involved in the patenting decision than legal semantics. The question is: Do we leave these issues to be resolved in the courts on a case by case approach or do we need a broad national policy? I propose that we start by convening a commission with the explicit mandate to consider the social and ethical issues of patenting life forms of all varieties. With the commission’s recommendations Congress should accept the tacit invitation of the Supreme Court and develop a policy that is comprehensive and that can serve as a guide for future court cases and as a safeguard for future generations.

Patenting and the Social Good

Few would deny that the rights to patent inventions and novel products of manufacture have been a great incentive for the industrial development of technology. The patenting of processes that utilize life forms is well established. In the case of Chakrabarty’s oil digesting microbe, patents were filed for the process of manufacture, the method of dispersal, and the product per se. Some human genes are clearly desirable to clone in large quantities. Perhaps firms would not develop interferon or insulin if they could not obtain a secure rate of return through the assurance that they could capture a predictable portion of the market. A company that takes risks to commercially develop a product has the right to recoup its expenses and profit from its risks.

In this argument I want to address the issue of whether patenting is always in the public interest. The distinction of patenting of process and patenting of product is not relevant in this line of reasoning. My point is a simple one. While patenting as an incentive for development of new technologies and industrial innovation may operate as a general rule, there are specific instances where the public good is not achieved through private patents.

Let me use the case of a bacteria with a human interferon-producing gene. One recent estimate of interferon’s world wide market potential has been placed at $3 billion.⁷ Where is all this money going to come from?—research centers, government research grants, the consumer of health care either directly or through third party payments. Hardly a person would classify an interferon-producing bacteria as frivolous. But what would the patentability of the microbe do to its cost? Interferon is a product that has been widely acclaimed for its potential clinical benefits in the treatment of viral diseases and cancer. Its availability and price should not be determined by what are tantamount to monopoly conditions. What are the choices before us? Can we assume that through the patenting process we will achieve:

(a) The only or most efficient development of interferon;
(b) The greatest availability of interferon for research and clinical application;
(c) The best cost for the product so its full potential can be investigated as per (b)?

During periods of war, patent decisions do not dictate the price and production levels of tanks. We are presently engaged in a war against cancer in which our society has already invested billions of dollars. The weapons to fight this war must serve the public’s interest first and foremost. Congress has acted in the past to exclude certain innovative technologies from patentability. The production of fissionable materials and the military utilization of atomic energy were among the technologies excluded. The question remains whether special areas of innovation with gene-splicing and the manufacture of novel life forms should also be excluded from private control because of an overriding national interest. It is an issue that should be considered by our legislative branch of government and not left by default to the judiciary.

For more information: Linda Havarfield, CRGR, 530 7th Street, S.E., Washington, D.C., telephone 202-543-4312. Terri Goldberg, CRGR, 897 Main St., Cambridge, MA 02139, 617- 547-0370. Francine Robinson, CRGR, Suite 213, 502 Northwest 75th, Gainesville, FL., 904- 375-4140.

>> Back to Vol. 12 No. 5<<

REFERENCES

Becky Logan of Cornell University discussed this nightmare at the 1979 conference Ethical Issues in Reproductive Technology: Analysis by Women (EIRTAW). The two books coming out of that conference will be available this fall from Humana Press, Crescent Manor, P.O. Box 2148, Clifton, N.J. 07015. Ask for: H.B. Holmes: B. B. Hoskins: and M. Gross (Eds.), Birth Control and Controlling Birth and The Custom-Made Child: Women’s Perspectives.
Fleming, Anne, “New Frontiers in Conception,” New York Times Magazine, July 20, 1980.
Luria, S.E., “Modern Biology: A Terrifying Power,” The Nation, pp. 405-409, October 20, 1969.
Lederer, Franz, “A Perspective in Patenting Microorganisms Under European Convention: Prospects and Considerations,” American Patent Law Association Quarterly, Vol. 7, No. 3&4, p. 296, 1979.
Diamond v. Chakrabary, No. 79-136, a brief for the Supreme Court for the respondent, October term, 1979, p.37.
“Diamond v. Chakrabary”, The U.S. Law Week, 48, June 17, 1980.
European Chemical News, Vol. 34, April 14, 1980.