Only God Can Make A Tree, But Monsanto Might Patent It

By Ken Fischman, Ph.D.
Sandpoint Reader

“Science is too important to be left to politicians or to a scientific establishment increasingly in bed with big business.”
– Dr. Mae Wan Ho, Institute for Science in Society (ISIS)
What is the one thing that a Christian fundamentalist and a secular liberal can agree upon? That the U.S. Patent Office (USPO) was dead wrong.

Legend has it that the Patent Office thought that they were merely granting a patent for a particular sequence of chemicals, but by approving a patent on an oil digesting bacterium, they had granted the world’s first patent on a living organism.
The fundamentalist would assert the USPO had committed blasphemy. The Progressive might turn to the Greek myth of Pandora’s Box, saying the USPO had released into the world all the troubles in that box.

It all began in the 1970s when Dr. Ananda Chakrabarty, a biochemist at General Electric, filed an application with the USPO for a patent on an industrial process for destroying waste oil.

In 1980, the U.S. Supreme Court upheld the validity of Dr. Chakrabarty’s application by a 5-4 decision. The Patent Office announced that henceforth they would consider “non-naturally occurring, non-human multi-cellular living organisms, including animals, to be patentable subject matter.”

The lid was off Pandora’s Box. It yawned wide open.

Genetic Engineering, Cloning and Chimeras:

In order to understand the controversies emerging from this and similar rulings, we need to examine the scientific techniques used to produce these new kinds of organisms.

Genetic Engineering (GE), cloning and the production of chimeras (pron. Ki-mee-rahs) are three very different techniques which are often confused in the public’s mind. All involve rearrangement of DNA, the chemical from which genes are made.

GE operates on the molecular level, and involves cutting out a piece of DNA (the “Trans-gene”), from one organism and its insertion into the genetic material of another organism.

For example, the “anti-freeze” gene from a Flounder can be inserted in potatoes, thus conferring on them the ability to survive severe frosts.

Chimeras are produced using cells and whole animals. Embryonic cells or tissues from another animal are injected into an embryo, thus producing an animal which is composed of two genetically different kinds of cells.

In one experiment, human embryonic brain cells were injected into a mouse embryo. They migrated to the mouse’s developing brain, thus producing a mouse whose brain contained 1% human brain cells. Scientists are now wondering what would happen if they injected enough human cells to make a mouse whose brain was 50 % or even 100%  human. Care to speculate?

Here’s another chimera scenario to contemplate.

When stem cells are taken from a very early embryo and injected into a different embryo, these cells are capable of developing into any kind of adult cell, depending on the nature of the host cells surrounding them. Suppose human stem cells were introduced into a male mouse embryo, migrated to the mouse’s reproductive glands and developed into sperm.

Suppose the same thing was done with a female mouse. Suppose these two mice were born and later mated. Of course, the Disney Company already has a copyright on Mickey Mouse.

Cloning operates on the cellular level. A cell’s nucleus contains the genetic instructions for the production of an entire animal. In this technique, a nucleus is removed from an adult animal’s cell, then placed inside the egg of another whose nucleus was previously removed.

The egg is then placed in the uterus of yet another animal and allowed to go to term, thus producing an animal genetically identical to the one from which the original nucleus was taken.

This is how the now famous “Dolly, the Sheep” was produced.

Human clones have already been created by transferring the genetic material from human cells into the de-nucleated eggs of cows and pigs. This was done not to create embryos and bring them to term, but in order to provide stem cells.

Even many of those who support legalized abortions find it disturbing that human embryos have been deliberately created in order to provide material for transplantation or other uses.

Somehow, they sense that it is different from using stem cells from embryos left over from in vitro fertilization procedures – procedures by which barren couples can have children. Those embryos would have been discarded anyway.

I understand how they feel.

When I started out in genetic research, I ran a laboratory that analyzed human chromosomes. Most of our work came from physicians who suspected chromosome defects in unborn fetuses. Although I knew that people might opt for abortions on the basis of my analyses, it did not bother my conscience because I was aware that that such defects usually result in gross birth defects.

However, with the passage of time, many requests for analyses started to come from people whose names identified them as coming from cultures which did not value women. I put two and two together and realized they were electing to abort only on the basis of gender. I was sufficiently disturbed at the use of my expertise for such purposes, that this was one of the reasons why I switched my research interests.

The Wonderful World of Patent Laws

Fish that glow in the dark, goats that produce spider silk in their milk, giant Salmon, etc. These are the GE stories that most often reach the popular press. They sound like something out of science fiction, and yet they are fact. GE has opened possibilities of fantastic new combinations of living organisms, never seen in the natural world.

However lurid and eye-catching these stories are, there lurks beneath their surface even more far-reaching implications. If you really want to scare yourself silly, welcome to the wonderful world of patenting living organisms.

Admittedly, patents are not very sexy. If you want a cure for your insomnia, curl up with a good book on patent law some time. However, because GE patents are impacting our lives, you had better learn something about them.

A patent is a government grant of the exclusive right to make, use or sell an invention, usually for a limited period. Patents are granted for new and useful products made by or thought up by the mind of man.

As world trade continues “globalizing,” there are efforts to make the patent laws of most countries compatible. The Trade Related Aspects of Intellectual Property Rights (TRIPS) is an agreement, administered by the World Trade Organization (WTO), for this purpose. Among other things, TRIPS states that all countries must extend their patent laws to include living organisms.

The Legal Morass

Despite TRIPS, countries still disagree among themselves about the patenting of life forms. The European Union (EU), the collective voice for most of Europe, has issued a directive on patents, part of which states “the human body … including the sequence or partial sequence of a gene, cannot constitute patentable inventions.”

It also excludes from patenting: human cloning, use of human embryos and modifications of animals, causing substantial suffering without substantial medical benefit.

The first patent on a human gene was granted by the European Patent Office (EPO) in 1991. The EPO stated at that time that “DNA is not life.” Obviously, the EPO and the EU are not on the same page.

The Canadian Supreme Court in a 5-4 decision rejected a patent application for a mouse carrying a human cancer gene, saying that that the mouse failed to meet the definition of an invention.

On the other hand, patent office officials in several countries have expanded the concept of what can be patented, and ruled that living organisms themselves can be patented when they contain foreign genes.

Another troubling aspect of GE patents is the broadness of their applicability.

The Agricitus Company was granted a patent for all GE soybeans. Mycogen was granted an exclusive patent on any insecticide gene in any plant. The broadness of these patents has had serious consequences. Here are a few:

John Moore was a leukemia patient, who had his spleen removed in 1976. He signed a consent that stated the organ would be destroyed. Without his knowledge, his cells were cultured to produce anti-cancer drugs, now worth billions of dollars. The doctor was listed as the “inventor,” and the patent application was sustained by the California Supreme Court in 1990.

Scientists have identified two genes, BRCA1 and BRCA2, which predispose women who to breast cancer.

Myriad Genetics has patents on mutations of these cancer genes, and they ordered laboratories to either cease screening for these genes, or pay royalties. Myriad priced the tests at about $2,000. Who owns these genes, the women from whom they were taken or a commercial entity? In 2013, the US Supreme Court unanimously rejected Myriad’s claim, stating that human genes cannot be patented. Score a big one for our side.

A U.S. company, Biocyte, owns a patent on all umbilical cords from fetuses and newborns because they worked out a process for isolating and freezing them. They now have the right to demand fees from anyone extracting and using any human umbilical cells.

Genetic material is also being taken from Third World countries, being marketed and sold without the consent of the people from whom they were taken.

For instance, blood samples have been taken from traditional people, such as the Australian aborigines and the Saami of northern Scandinavia, and the genes isolated from them have been patented and marketed commercially.

Some pharmaceutical and agri-businesses employ Ethnobotanists, people who gather plants from exotic places. They make use of indigenous peoples’ knowledge of the location and medicinal properties of these plants. The companies claim that these materials only have “value” when they have been extracted and marketed commercially.

In their eyes, the knowledge gained in thousands of years, and use by traditional people is valueless.

For thousands of years, Third World farmers have lived sustainedly on small, subsistence farms, saving and exchanging seeds. Now, their way of life is being threatened by patents on GE seeds and food.

Dr. Mae-Wan Ho says (GE) “crops will further destroy livelihood and self-sufficiency through corporate patents on seeds that farmers cannot [legally] re-sow or exchange, and through Terminator seeds that are rendered sterile, breaking the very cycle of renewal and regeneration that is the essence of life.”

Problems Inherent in  GE Technique

Those who defend the value of GE argue that cells and organisms in which genes have been inserted are similar to natural ones, and so there should be no concern over their safety.

They gloss over the fact that the inserted genes bring with them a great deal of other genetic material. A piece of a virus is attached to the Trans-gene, enabling it to penetrate the host cell’s defenses against foreign DNA and integrate into the cell. An antibiotic resistance gene from a bacterium is also attached to the inserted gene and used as a marker to distinguish which cells have successfully incorporated the Trans-gene. The Trans-gene is activated by attaching a gene from the Cauliflower Mosaic Virus to it.

In addition, some unwanted baggage comes along for the ride. Snipping the Trans-gene out of its original DNA is an imprecise process, and often pieces of or entire neighboring genes are included.

The location and number of copies of genes have profound effects on organisms. Yet, it is inherent in the GE technique that it can’t be controlled where the gene lands in a cell and how many copies of it are included.

It is possible that many of the abnormalities now being reported in GE organisms are caused by the technique itself. For example, some pigs containing Human Growth Hormone genes have arthritis, deformities and blindness. Some sheep with this Trans-gene develop Diabetes. It  is also not known whether some of these conditions are caused by stress from the industrial farming conditions that the animals are subjected to, or by something in their food.

GE genes for producing commercially and medically important chemicals, such as hormones, antibiotics and blood components, have been incorporated in farm animals.  The animals can also be used as reservoirs for organ transplants.
Critics warn that hundreds of different viruses, specific to pigs, could be transferred to humans along with the transplants. This could be dangerous. For example, many scientists suspect that a virus, somehow leaping the species barrier from monkey to man without the benefit of GE, started the AIDS epidemic. Historically, most human diseases are believed to have originated in domesticated animals.

There are other dangers posed by GE organisms. They have never been part of our food chain, and therefore they may have unanticipated effects on other animals that eat them and plants that absorb their genetic material.

Trans-genes are deliberately designed to cross species barriers, invade other organisms’ DNA and became part of it. This has already occurred accidentally in creatures that they were never intended to be part of. For example, genes from GE crops have been detected in soil fungi and in the DNA of bacteria and yeasts in the gut of Honeybees.

Ethical Dilemmas:

It is easier to count the number of Angels that can dance on the head of a pin than to navigate through the mass of conflicting laws, regulations and opinions concerning the desirability and rightness of patenting life.

For example, Molecular Biologists and the AgBioTech businesses maintain that the human DNA code is patentable because the intellectual effort to discover it raises it from a discovery to an invention.

They contend that people deserve the fruits of their intellectual work and that because GE research is expensive – often taking years from discovery to market – they have a legitimate need to protect their large research investment with a patent.

Opponents of GE see many problems with patenting living organisms.

They argue that all GMOs are expropriations from life, and therefore do not qualify as inventions, but only as discoveries. They claim that the terms used to define these technologies have been made deliberately vague in order to cover up our ignorance of biological processes.

Many religious denominations have also voiced their concerns. The Church of Scotland looks at living organisms as part of God’s creation or a product of Nature. It asks how humans can claim to have invented a GE animal or plant just because they have added one or two genes to an organism that already has thousands.

In their eyes, extending patents to living creatures violates a normal ethical distinction between what is alive and what is not.

The late Pope John Paul II, speaking for the Roman Catholic Church, strongly denounced the idea of patenting living organisms or their parts, stating, “ … not everything that is technically possible is morally acceptable.”

Where is the Beef ?

In addition, other critics of GE ask, “Where are the health benefits that the industry promised the rest of us?”

After more than 20 years and billions of taxpayer dollars spent on programs such as the Human Genome Project, all they have to show are patented gene tests.

It would be ironic if Right to Life fundamentalists and secular liberals found common cause in their opposition to patenting GE organisms. Together, they would be a force to be reckoned with.

 

      “We are incalculably far away from being able to create life de novo … the argument that the bacterium is Chakrabarty¹s handiwork and not nature’s wildly exaggerates human power and displays the same hubris and ignorance of biology that have had such a devastating impact on the ecology of our planet.”
– Key Dismukes, National Academy of Sciences, U.S.