Biotechnology Law and Related Issues


1999 Genetics, Law and Society Conference, Saint Paul, Minnesota

Almost Human - And Patentable, Too
by Stuart A. Newman
July 01, 1999

What is a human being? In the past this was a question appropriately contemplated by theologians, philosophers and anthropologists. But in the contemporary world of biotechnology, it also has become a topic for consideration by venture capitalists, patent attorneys and legislators.

Most members of the latter groups may wish to avoid this uncomfortable, or at least impractical, subject for as long as possible. But in collaboration with the social critic Jeremy Rifkin, president of the Foundation on Economic Trends in Washington, D.C., I decided to force the issue in late 1997 by applying for a patent on embryos and animals containing human cells -- so-called "chimeras."

Rethinking scientific and legal precedent

Our motivations were straightforward: Ever since the 1980 Supreme Court decision in it has been legal in the United States to obtain a patent on living organisms and their descendants.

Moreover, Congress has drawn no line that would preclude a pre-term human embryo, if appropriately modified, from being patented. Nor has it indicated how many human genes or cells an animal would have to contain before it could not be patented by virtue of the constitutional protections due to members of the human community.


Can human embryos be patented?

As a working scientist concerned that the fruits of science not be used to society's detriment, I eagerly accepted Rifkin's invitation of several years ago to invent something novel, useful and non-obvious (the criteria for a work to be patented) but also so disquieting that it would alert the public to the inevitable consequences of the unbridled commercialization of the living world. The result was the human-animal chimera, which could contain anything from a minuscule proportion to a majority of human cells.

We did not have to produce this creature (and thus did not) but simply had to demonstrate its feasibility. Because we knew our invention was patentable under existing standards and law, we anticipated that a patent would be issued and that we then would have the option of exercising our right to prevent its implementation for the statutory 20 years.

Alternatively, we hoped that public indignation at the possibility that such part-human, part-animal organisms can be produced and patented might reasonably lead to a re-evaluation of the legalities that have made bona fide commercial ventures of this sort possible.

We are particularly concerned with the precedent of the Chakrabarty case, in which the Patent and Trademark Office (PTO) opposed the granting of a patent to Dr. Ananda Chakrabarty and his employer, General Electric Corp., for an oil-eating bacterium.

Courts overruled that decision, ruling, absurdly, that bacteria are "more akin to inanimate chemical compositions ... [than] to horses and honeybees and raspberries and roses" and, startlingly, that Chakrabarty's microbe was "a human-made invention." Notwithstanding the stated distinction, the Chakrabarty decision served as a precedent for the issuing of patents on mice, pigs and cows, some containing introduced human genes, as well as naturally occurring human bone-marrow cells.

A market for spare body parts

The impact of the decision has been felt worldwide, as the patent offices of many industrialized countries have followed the United States' lead on the patenting of life forms.

The folding of organisms into the world of fabricated commodities has caused shock waves within poorer countries and traditional societies. Because of patent laws in other countries, those poorer countries and traditional societies have been unable to prevent the privatization of products born as a result of 10,000 years of agricultural innovation and improvement, and of efficacious folk medicines with longer histories.

This patent-facilitated "biopiracy" also has included attempts to gain proprietary rights over the very genes of vanishing tribes, with the intention of eventually selling their specific disease resistances to the non-vanishing public. And those are just two of the many concerns raised by biotechnology that Rifkin and I hope to draw attention to with our patent request.

The proposed applications of our invention include the use of partly human embryos to test drugs and chemicals for toxicity, and the use of partly human animals as sources of transplantable organs for human patients. The purpose of our challenge is to promote the recognition that biotechnology is capable of producing items that, while legal and eminently useful, nonetheless will conflict with other cultural values, and therefore be considered immoral and undesirable.

At the time our original filing was announced in early 1998, advocates of "life patenting," including the scientist who patented the first mammal (a mouse that developed cancer at 40 times the normal rate) criticized us for scaremongering. They accused us of presenting monstrous concoctions that no responsible scientist would contemplate producing or patenting.

Since then, though, a Massachusetts biotechnology company has announced its intention to patent a technique for creating cloned embryos produced from human cell nuclei and cow eggs. And a California company with patents pending for human embryo stem cells has acquired the Scottish company seeking patents for the cloning techniques that led to Dolly the sheep.

Some scientists have speculated that the combined efforts of the latter two companies will lead to "mini-me" embryos and stem-cell lines suitable for providing replacement parts to paying customers throughout their lives. So perhaps Rifkin and I are not such scaremongers after all.

Can you really invent an organism?

As it attempted with the Chakrabarty patent application, the PTO rejected our chimera patent in its initial review. Of course, the major difference between the Chakrabarty case and ours is that the PTO no longer opposes patents on organisms. Instead, it would like to draw a line between obviously troublesome inventions of the sort we propose and other life forms they have allowed to be patented, such as human bone-marrow cells and pigs containing human genes.

Given the common evolutionary heritage and biological continuity of all organisms on Earth -- we share more than 98% of our DNA sequence with chimpanzees, for example -- this may be an impossible task. In our revised application, submitted in June, we have refined our claims in a way that will make the PTO's task of separating "moral" from "immoral" life patents extremely difficult.

Either the PTO will be persuaded to grant our patent, a prospect abhorrent to many people, or it will face a series of appeals that could lead to judicial or legislative acknowledgment that organisms are not inventions after all -- which is exactly what Rifkin and I would like to see.

Stuart A. Newman is a professor of cell biology and anatomy at New York Medical College and a founding member of the Council for Responsible Genetics in Cambridge, Mass. His e-mail address is newman@nymc.edu.

Related Links

Learn more about Diamond v. Chakrabarty. This article raises the question, “Who Owns Your Genes?” Is it possible to patent people? According to a Seattle Times article, that happened to the Guaymi people of Panama. This is an issue in the European Union as well. Get some more general information on patents.

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