Saturday, July 10, 2010

Patent Issues and Biotech

A very good post on Patent Issues related to biotech interests....

Posted on July 10, 2010 From:

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

1 comment:

  1. Excellent Post