| What is a human being? In the past this was a | | | | reason we denied the case was the examiner |
| question appropriately contemplated by theologians, | | | | believed one or more of the claims encompassed |
| philosophers and anthropologists. But in the | | | | human beings. The question which can be raised that |
| contemporary world of biotechnology, it also has | | | | whether the case will affect future patent |
| become a topic for consideration by venture | | | | applications for chimeric lab animals, the answer may |
| capitalists, patent attorneys and legislators. | | | | be that the examiners always decide first if it is |
| Most members of the latter groups may wish to | | | | patentable subject matter and humans aren't. |
| avoid this uncomfortable, or at least impractical, | | | | Anything found in nature is not patentable subject |
| subject for as long as possible. | | | | matter. It has to be new, useful, non-obvious, and |
| But in collaboration with the social critic Jeremy Rifkin, | | | | fully disclosed in writing. Each patent application is |
| president of the Foundation on Economic Trends in | | | | reviewed on its own merits. |
| Washington, D.C., decided to force the issue by | | | | Thus it cannot be said that whether the case will |
| applying for a patent in late 1997 on embryos and | | | | affect future chimera patent applications or not. |
| animals containing human cells -- so-called "chimeras." | | | | Irving L. Weissman, a professor of cancer biology, |
| "Chimeras" are creatures composed of the cells of | | | | pathology, and developmental biology at Stanford |
| two genetically different individuals, usually combined | | | | University has created mice with brains that contain |
| at the embryonic stage. There are rare natural human | | | | about 1% human tissue. Weissman says recent news |
| chimeras who are born when the embryonic cells of | | | | reports that he plans to create a mouse with a |
| fraternal twins combine in the womb to create a | | | | 100% human brain are "inaccurate." A pioneer in the |
| single individual. Scientists have also deliberately | | | | field of stem cell research, Weissman is credited as |
| created cross-species chimeras like the "geep," in | | | | being the first scientist to identify and isolate |
| which embryonic cells from goats and sheep were | | | | hematopoietic stem cells from mice and humans. He |
| combined. The contemporary view suggests from | | | | says that the news reports were fueled by an |
| the Greek meaning "she-goat" the Chimera is a | | | | academic inquiry he made to find out, in theory, what |
| fire-breathing creature that has the body of a goat, | | | | his university ethics panel thought of the idea. He |
| the head of a lion and the tail of a serpent. Some | | | | says he has no current plans to create such a mouse. |
| sources have represented the Chimera with three | | | | The Newman/Rifkin patent is "a new attempt to |
| heads (the lion's head as the main, then the goat's | | | | block science," while the "use of human-mouse |
| head sprouted from its back, and the serpent's or | | | | chimeras is old," Weissman says. In 1988, J. Michael |
| Dragon's head on its tail), but the popular myth tells | | | | McCune patented the SCID-hu mouse, "a severe |
| of the single, fire-vomiting head. The very unlikely | | | | combined immunodeficient mouse with human organs, |
| aspect of the chimera has gradually turned its name | | | | bones, lymphoid tissue, thymus, and liver," says |
| into a synonym of a vain dream. | | | | Weissman, who is also director of Stanford's Institute |
| Leading anti-biotech activist have long opposed | | | | of Cancer/Stem Cell Biology and Medicine and a |
| corporations "owning" patents on living organisms (or | | | | cofounder of Stem-Cells and other companies. "The |
| on cells and genes). But do corporations really "own" | | | | precedent is there, the discoveries are long published, |
| genes or animals? What are patents? Patents are | | | | and people's lives have been affected by those |
| temporary monopolies (20 years) granted by the | | | | discoveries. Would they take back all those |
| government to inventors as a way to encourage | | | | discoveries and be happy if the therapies discovered |
| them to disclose publicly how their inventions work | | | | through them were taken away?" Weissman |
| so that other people will be able to use them. | | | | dismisses the Newman/Rifkin case as "typical Rifkin," |
| Often reviled by academic researchers, the patent | | | | adding that "one example doesn't hold. It doesn't |
| system is actually an information-disclosure procedure | | | | invalidate the others, so it's a hollow victory. The |
| that works somewhat like peer-reviewed scientific | | | | case is not the precedent they think." |
| publication -- that is, the first one to publish gets the | | | | Chimeric animals, and patents, are crucial to a |
| credit. Like patents, peer-reviewed research must | | | | biotech's ability to develop cures for human diseases. |
| disclose enough information so that other researchers | | | | To protect one's investment, for example, StemCells |
| can reproduce the experiment. The temporary | | | | has more than 43 US patents on its stem cell |
| monopolies created by patents are valuable, which | | | | technology, though none are on bioengineered mice. |
| encourages people to invest in the research and | | | | If the private sector cannot receive a patent on all |
| development projects of biotech companies. | | | | its work and invention, it's unlikely to engage in the |
| A Question Of Chimeras -- Activists try to patent | | | | work because it takes so much time and effort and |
| fear | | | | money. The ability to retain a return on one's |
| Scientists say ruling on protest patent won't have an | | | | investment is crucial. Thus it can be inferred that mice |
| impact on future chimeric-animal patents. Looking to | | | | are the backbone of biotechs, pharmaceuticals, and |
| cure a host of neuro-degenerative diseases, | | | | drug development. |
| Stem-Cells, a Palo Alto, Calif.-based company, has | | | | However, adding such complexes of genes to other |
| transplanted human neural stem cells into the brains | | | | creatures, say mice, would raise no ethical problems. |
| of thousands of mice. The mice are technically | | | | Why? Because mice simply couldn't develop humanlike |
| chimeras, a mix of two or more species. | | | | brains with self-consciousness. And such mice might |
| Such animals, especially mice, have been used to | | | | be useful for finding treatments for human brain |
| search for ways to cure human diseases including | | | | diseases The essential point is that certain types of |
| Parkinson and Alzheimer disease. The ability to | | | | brains, not genes, have moral standing. Human genes |
| evaluate human cells in a mouse or other animal is | | | | are not sacred, people are. |
| critical to translating scientific discoveries into | | | | The yuckiest thing of all would be if the public and |
| therapeutic medicine, thus the bridge to the clinic. | | | | policy makers were frightened by the Frankenstein |
| However, the use of such chimeric animals is the | | | | fantasies peddled by clever activists into slowing |
| focus of a complicated patent case that is raising | | | | biomedical progress that could ameliorate the |
| legal and ethical questions. In this case, opponents to | | | | suffering of millions. |
| the patenting of living things applied for a chimera | | | | Rethinking scientific and legal precedent |
| patent. The US Patent and Trademark Office | | | | Since the 1980 Supreme Court decision in it has been |
| (USPTO) refused to issue a patent for the | | | | legal in the United States to obtain a patent on living |
| human-animal chimera in the application, on the | | | | organisms and their descendants. |
| grounds that it would have been too nearly human. | | | | Moreover, government has drawn no line that would |
| In the volatile debate over bioengineered life forms, | | | | preclude a pre-term human embryo, if appropriately |
| many disagree about the ramifications of the recent | | | | modified, from being patented. Nor has it indicated |
| case. The critics of the biotechnology industry who | | | | how many human genes or cells an animal would |
| applied for the patent say the case has serious | | | | have to contain before it could not be patented by |
| business and research implications. But some leading | | | | virtue of the constitutional protections due to |
| scientists and industry observers say the case is just | | | | members of the human community. |
| another effort to grab attention in a field rife with | | | | Can human embryos be patented? The working |
| more heat than rational discussion. Stuart Newman, a | | | | scientist concerned that the fruits of science not be |
| professor of cell biology and anatomy at New York | | | | used to society's detriment, Rifkin's invitation of |
| Medical College in Valhalla, says he opposes the | | | | several years ago to invent something novel is |
| patenting of living things. Newman, working with | | | | eagerly accepted, but also so disquieting that it would |
| Washington, DC, activist Jeremy Rifkin, filed a patent | | | | alert the public to the inevitable consequences of the |
| application in 1997 for a theoretical creature he never | | | | unbridled commercialization of the living world. The |
| actually made. For "tactical reasons," Newman says | | | | result was the human-animal chimera, which could |
| he eventually split his patent application into two: one | | | | contain anything from a minuscule proportion to a |
| involving primates and the other focused on other | | | | majority of human cells. |
| animals. | | | | This creature is not to be produced (and thus did |
| Using what he calls the "embryo chimera technique," | | | | not) but simply had to demonstrate its feasibility. |
| Newman sought to patent a creature combining | | | | Because it was known that invention was patentable |
| human embryo cells with cells from the embryo of a | | | | under existing standards and law, it is accepted that |
| monkey, ape, or other animal to create a blend of | | | | a patent would be issued and then there would have |
| both. Other scientists have used similar methods to | | | | the option of exercising the right to prevent its |
| create a "geep" (part goat, part sheep), could be | | | | implementation for the statutory 20 years. |
| used for drug testing and as a source of organs to | | | | It is anticipated that public indignation at the possibility |
| transplant into humans. After seven years and | | | | that such part-human, part-animal organisms can be |
| several rejections and appeals, the USPTO turned | | | | produced and patented might reasonably lead to a |
| down both of Newman's patent applications in | | | | re-evaluation of the legalities that have made bona |
| August 2004, saying, among other things, that this | | | | fide commercial ventures of this sort possible. |
| creatures would be too close to human. Newman and | | | | The new developments are particularly concerned |
| Rifkin let the six-month appeals period lapse and | | | | with the precedent of the Chakrabarty case, in which |
| declared victory in February 2005. Both Rifkin and | | | | the Patent and Trademark Office (PTO) opposed |
| Newman say they expect the ruling to prevent | | | | the granting of a patent to Dr. Ananda Chakrabarty |
| scientists and biotechs from obtaining similar patents | | | | and his employer, General Electric Corp., for an |
| for 20 years, the time a patent is usually viable. Rifkin | | | | oil-eating bacterium. |
| says crossing species boundaries is a form of animal | | | | Courts overruled that decision, ruling, absurdly, that |
| abuse and a violation of nature and human dignity. | | | | bacteria are "more akin to inanimate chemical |
| "The ruling has significant implications for the future | | | | compositions ... [than] to horses and honeybees and |
| of the biotech industry," says Rifkin, president of the | | | | raspberries and roses" and, startlingly, that |
| nonprofit Foundation on Economic Trends, and one of | | | | Chakrabarty's microbe was "a human-made invention." |
| the most vocal critics of biotechnology products such | | | | Notwithstanding the stated distinction, the |
| as genetically engineered organisms. | | | | Chakrabarty decision served as a precedent for the |
| The implications for commercial interests are | | | | issuing of patents on mice, pigs and cows, some |
| far-reaching. It means anyone applying for a patent | | | | containing introduced human genes, as well as |
| for human-animal chimeras ought to be turned down. | | | | naturally occurring human bone-marrow cells. |
| He expects the ruling to affect stem cell researchers, | | | | Future Challenges |
| too. There are people who are producing or who | | | | Legislature has not specifically addressed the question |
| express their intention to produce mixtures of | | | | of whether the humain beings can be patented or |
| humans and mice for research purposes in order to | | | | not. Similarly, the court in Chakrabarty did not |
| test the potential of human stem cells. This decision | | | | address whether human beings are patentable |
| does not block their ability to do that in their labs, but | | | | subject matter." The PTO (Patenr and Trademark |
| if they wanted to patent and market these mixed | | | | Office) commented that "when there are paramount |
| human and animal organisms, it would be more | | | | patent issues of first impression, in the absence of |
| difficult for them to commercialize it. However, some | | | | clear legislative intent and guidance from the courts, it |
| leading stem cell researchers say the case is unlikely | | | | is incumbent on the office to proceed cautiously." |
| to stop work on chimeric animals. | | | | The new circumstances have given an opportunity to |
| Twenty-five years ago, in Diamond v. Chakrabarty, a | | | | finally open up the question of whether or not the |
| US scientist Ananda Chakrabarty, who worked for | | | | PTO's current policy of conferring life patents on |
| General Electric at the time, obtained the first patent | | | | genes, cells, etc. is legal. With the PTO now saying |
| on a living organism, a genetically engineered | | | | that the ranting of certain patents on human cells |
| bacterium that consumes oil spills. The patent office | | | | may in fact be questionable, the question of the |
| originally denied the application, believing it could not | | | | legitimacy of life patents becomes an issue of great |
| patent living organisms, according to Brigid Quinn, | | | | public policy concern within the government itself. |
| USPTO spokesperson. The case landed in the US | | | | The question of whether the human gene pool and |
| Supreme Court, which held that "anything under the | | | | life itself can be patented is one of the great issues |
| sun made by man" could be patented as long as it is | | | | of the coming century. If the current PTO policy is |
| "new, non-obvious, and useful." | | | | allowed to stand, a handful of global life science |
| Since then, more than 436 transgenic or | | | | companies will gain control over the genetic blueprints |
| bioengineered animals have been patented, including | | | | of millions of years of biological evolution, giving them |
| 362 mice, 26 rats, 19 rabbits, 17 sheep, 24 pigs, two | | | | awesome powers over the biological marketplace of |
| chickens, 20 cows, three dogs, and many more. | | | | the 21st century. These legal challenges are designed |
| Many say the 1980 ruling led to the birth of | | | | to block and reverse this potential monopoly over |
| biotechnology in the United States. However, the US | | | | the biology of the planet. |
| law clearly prohibits the patenting of people. One | | | | |