Showing posts with label patent. Show all posts
Showing posts with label patent. Show all posts
Monday, November 8, 2010
Friday, October 22, 2010
Patents and Genes
Judge Invalidates Human Gene Patent
http://www.nytimes.com/2010/03/30/business/30gene.html?ref=business
http://www.nytimes.com/2010/03/30/business/30gene.html?ref=business
Thursday, July 15, 2010
Legal Turn-around for Patenting Human Genes
A recent legal ruling which invalidates patents for BRCA1 and BRCA2 held by Myriad Genetics make a precedent setting case. Below is a a good article from Biotechwiz blog:
The District Court Judge of the Southern District of New York, Judge Robert Sweet will go down in History. Amidst much speculation and debate, the Judge, on March 29th 2010, ruled in the case of Association for Molecular Pathology v. U.S. Patent and Trademark Office, that the patents For BRCA1 and BRCA2 held by the company Myriad Genetics, were invalid. The decision was a highly anticipated one since this particular lawsuit has been hailed by many as being a direct attack on the company and the USPTO (The United States Patent and Trademarks Office). The issue of gene patenting has always been a controversial one and there have been heated debates for and against it. However, in recent times, we have seen with increasing unease, the extent to which essential health care testing, diagnostics and even treatments have slowly but steadily passed the truly needy patients by because of prohibitively high costs and monopolistic trade practices by many such companies in the name of millions of dollars sunk into research for the same.
The current judgement is a 156 page decision and invalidates about seven of the patents held by the company Myriad Genetics related to the BRCA1 and 2 genes that have been implicated in breast and ovarian cancers. If this decision is upheld by the Higher courts, it has the power to completely challenge many of the existing gene patents and change the face of Intellectual property law as we know it forever.
So what really is a gene patent. Wikipedia defines it thus: A gene patent is a patent on a specific isolated gene sequence, its chemical composition, processes for obtaining or using it, or a combination of such claims. Thus in essence, a gene existing within an organism is not patentable and neither is it of any use to us clinically if it remains as such. The moment it has been isolated, purified, it can be put to commercial use, as in for diagnosing clinical conditions such as cancers or treating them. This was presumably the premise underlying the grants of such patents in the first place. However, the premise seems to be rather ridiculous to me. Most of the genes under patent protection today (about 20 % of the genome is patent-protected) are not inventions but discoveries. If the mere act of isolating them from the body turns them into something ”novel” , then by that token a large number of chemical entities can be considered novel by simply isolating them from their parent source. This will lead to patents on a large number of ridiculous ‘inventions’. Writer Michael Crichton makes an emphatic point in an article in the New York Times. He says and I quote,” Gene patents are now used to halt research, prevent medical testing and keep vital information from you and your doctor. Gene patents slow the pace of medical advance on deadly diseases. And they raise costs exorbitantly: a test for breast cancer that could be done for $1,000 now costs $3,000. Why? Because the holder of the gene patent can charge whatever he wants, and does. Couldn’t somebody make a cheaper test? Sure, but the patent holder blocks any competitor’s test. He owns the gene. Nobody else can test for it. In fact, you can’t even donate your own breast cancer gene to another scientist without permission. The gene may exist in your body, but it’s now private property.”
I am sure most of my readers would agree with me that this situation is bizarre. It begs the question how could the USPTO be so irresponsible as to grant such patents in the first place? In the current ruling, Myriad Genetics, that holds the patents with the University of Utah Research Foundation, asked the court to dismiss the case, claiming that the work of isolating the DNA from the body transforms it and makes it patentable. Such patents, it said, have been granted for decades; the Supreme Court upheld patents on living organisms in 1980. In fact, many in the patent field had predicted the courts would throw out the suit. However, Judge Sweet made the point that such patents were “improperly granted” because they involved a “law of nature.” He said that many critics of gene patents considered the idea that isolating a gene made it patentable “a ‘lawyer’s trick’ that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.”
In an important observation, the court ruled as follows, “The identification of the BRCA1 and BRCA2 gene sequences is unquestionably a valuable scientific achievement for which Myriad deserves recognition, but that is not the same as concluding that it is something for which they are entitled to a patent.”
While browsing the net I came across an interesting perspective on the judgement, I quote from the author’s post, “This lawsuit against Myriad signifies a change in that it finally places the patient and the administration of genetic testing at the centre of the stage. Although the Court’s holding focuses on patent subject matter the court dedicates a significant part of the opinion to access to BRCA1/2 genetic testing. Myriad charges about $3,000 for testing an exorbitant amount compared to other genetic tests. Furthermore, Myriad does not allow other laboratories to conduct the testing – all samples have to be sent to its headquarters in Salt Lake City. The opinion tells the stories of women who were unable to test to find out whether they carry the BRCA1/2 genes because Myriad would not accept their insurance. It recounts the ordeals of women who could not get definitive answers through Myriad’s testing and were precluded from seeking testing elsewhere. It underscores that women were unable to get a second opinion of the test results because tests are conducted only by Myriad. It also discusses the efforts of doctors and laboratories that were willing and able to offer BRCA1/2 testing but were precluded by Myriad from conducting the testing.”
Many are not comfortable with the idea of patenting genes. Michael Crichton in his article talks about the need to have open access to information. He cites the poignant case of a disease known as Canavan Disease. This is a debilitating disease that is inherited and in which infants are unable to crawl or walk, suffer seizures and rarely survive beyond their adolescence. He goes on to document the ironic and heart-breaking history of the research that led to the development of the diagnostic test for this disease. Because of the lack of such a test in the first place, families who had borne children with the Canavan disease came together and donated tissue samples for study. They engaged a researcher to identify the gene and donated their time and money for the same. Eventually the efforts met with success. The gene was identified in 1993. The families managed to get the commitment of a New York Hospital that it would offer a diagnostic test for the defective gene to anyone who needed it for free. In a twist of fate however, the employer of the hospital, Miami Children’s Hospital Research Institute patented the gene and refused to allow any health care worker to use the test without paying a royalty. The families who had contributed did not believe in patenting and so did not put their names on the patent and consequently had no claims whatsoever on the fate of the research.
If companies were denied access to essential material for research like for example tissue and blood samples or even clinical data or the questionnaires filled out by the patients and/or their families, would they be able to pursue their research at all? Let alone come to a point where their “inventions” become money spinning prospects for the companies? If recognising their efforts and granting them patent protection means that they are going to use this as a license to charge whatever they please for the tests, prevent anyone else from coming up with a cheaper alternative and effectively making efficient healthcare the privilege of the few, I think this goes against the spirit of the law.
This is exactly the position taken by Judge Sweet in the above landmark decision. He has placed emphasis on the fact that accessibility of genetic testing is a key concern and that granting patent protection for superfluous claims is a dangerous trend. Whilst not passing any ruling on the larger constitutional issue of why the USPTO granted such patents in the first place, he has underscored a larger more important issue; One of the plight of the patients. It is more important now that we learn to strike a balance between protecting an inventor and the extent to which this protection should be granted in the face of abuse of exclusive rights and grants.
In 2007, the European Patent Office (EPO) rejected an appeal by Myriad Genetics and the University of Utah, and upheld an earlier decision to revoke some claims of patent EP705902 relating to the BRCA1 gene and its applications. There was widespread objection to the extent of this claim among European researchers, since it granted an effective monopoly to Myriad which they believed unjustified; six bodies filed objections, leading to a decision by the EPO in 2005 to substantially amend the patent, retaining only the claims relating to a specific nucleic acid probe and vectors containing gene sequences. The EPO has now rejected an appeal by Myriad and the University of Utah, and amended the patent, meaning that European laboratories retain the right to perform diagnostic tests for mutations in the BRCA1 gene sequence, which are associated with increased susceptibility to breast and ovarian cancer.
Thus, in countries where gene patenting is not recognised, testing facilities can be made cheaper and probably even more efficient than the original one. The point that we need to mull over here is this: can there be another method to make this system work for both the researchers and the end-users? For example, can we reduce the term of patent protection in such cases or put a ceiling on how much a company with patent protection can charge for a particular test/ treatment so that it covers its costs but does not profiteer and do so at the expense of patients for whom the research was meant to be in the first place. Also, if a company is found to be recklessly profiteering, can we not have punitive measures for the same? Or make exceptions in costs for patients who might not be able to spend so much for a single diagnostic test? If a patient desires to have another lab carry out the test in order to verify/ confirm/ have a second opinion, instead of the patent owning company blocking it out, can it not work out a cost sharing with other laboratories so that the system becomes more transparent?
This is one of those questions that begs deeper debate. We cannot afford to get defensive or offensive and merely argue. This problem needs urgent and fair solutions. One the one hand, the fate of Biotechnology companies hangs in the balance, as experts say newer companies will find it difficult to raise venture capitalist funding if they are not sure they will get strong patent protection. On the other, monopolistic patent protection granted on frivolous grounds is like playing with the lives of patients. I laud Judge Sweet for his gumption in giving the kind of decision that he has. It is indirectly a comment on the haphazard and mindless policy of the USPTO (contrast this with the behaviour of the EPO on the same issue).
I will write another article where I will attempt to analyse a few aspects of the judgment. But as for now, I will content myself with just saying this…… We are at the brink of a major change. How we use this opportunity will decide our fate in more ways than one!
REFERENCES:
1. http://www.genomicslawreport.com/index.php/2010/03/30/pigs-fly-federal-court-invalidates-myriads-patent-claims/#comment-6174
2. http://www.phgfoundation.org/news/3854/
3. http://www.nytimes.com/2010/03/30/business/30gene.html
4. http://www.pbs.org/wgbh/pages/frontline/shows/snitch/procon/sweet.html ( A general Interview with Judge Robert Sweet)
Link to Biotechwiz: http://biotechwiz.com/?p=605
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.
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.
Saturday, November 7, 2009
Women's Health at Risk with Genetic Patents
Recognizing Far-Reaching Implications of ACLU Anti-Gene Patent Case, Court Denies Myriad’s Motion to Dismiss
November 04, 2009
By Turna Ray
A New York federal district court has denied Myriad Genetics’ motion to dismiss a lawsuit challenging its patents covering BRCA gene mutations associated with hereditary breast and ovarian cancer based on the novel circumstances presented in the case and the sweeping implications of the issues involved.
The American Civil Liberties Union filed the lawsuit in May on behalf of four scientific organizations — representing more than 150,000 medical professionals, researchers, women's health groups, and individual women — alleging that the BRCA gene patents held by the University of Utah Research Foundation and exclusively licensed to Myriad stifle research and limit women's treatment options. Additionally, the lawsuit, Association for Molecular Pathology, et al. v. US Patent and Trademark Office, et al., challenges the constitutionality of Myriad's patents on the BRCA1 and BRCA2 genes, by asserting that Myriad’s exclusive licensing practices hinder the free flow of information and therefore obstruct the First Amendment protecting free speech [see PGx Reporter 05-13-2009].
However, Myriad and other defendants challenged the plaintiff’s ability to bring the lawsuit, by filing a motion-to-dismiss memorandum, calling ACLU's case "a thinly veiled attempt to challenge the validity of patents" [see PGx Reporter 08-05-2009].
In deciding to dismiss Myriad's motion to dismiss on grounds that it lacked technical merit, Robert Sweet, the federal district court judge on the case, recognized the "uniqueness" of the plaintiffs' case with regard to "scope and significance of the issues presented, and the consequences of the remedy sought." Furthermore, the court acknowledged the right of the plaintiffs, particularly "women facing the threat of breast cancer … who are in the midst of their struggle with the illness," to challenge the practice of gene patenting.
"The challenges to the patents-in-suit raise questions of difficult legal dimensions concerning constitutional protections over the information that serves as our genetic identities and the need to adopt policies that promote scientific research," the court said in its decision.
In its decision, the court cited the example of Plaintiff Wendy Chung, a professor of molecular genetics at Columbia University who studies genetic and environmental factors linked to hereditary breast and ovarian cancer. Although Chung's lab sequences BRCA1/2 genes of research participants, researchers cannot inform subjects of their mutation status because of Myriad's patents.
Additionally, the court cited numerous examples provided by the plaintiffs where academic studies that would essentially improve BRCA sequencing methods were stopped by Myriad, who informed researchers that their work would infringe the firm's patents.
For example, according to court documents, in 2005, Yale DNA Diagnostics Laboratory asked Myriad for permission to perform genetic screening of BRCA genes looking for large rearrangement mutations correlated with cancer risk. Studies had previously shown that Myriad's full sequencing test missed some large gene rearrangements associated with disease risk. However, Myriad informed Yale that BRCA testing could not be done by the university's laboratory as it would infringe the company's patents.
November 04, 2009
By Turna Ray
A New York federal district court has denied Myriad Genetics’ motion to dismiss a lawsuit challenging its patents covering BRCA gene mutations associated with hereditary breast and ovarian cancer based on the novel circumstances presented in the case and the sweeping implications of the issues involved.
The American Civil Liberties Union filed the lawsuit in May on behalf of four scientific organizations — representing more than 150,000 medical professionals, researchers, women's health groups, and individual women — alleging that the BRCA gene patents held by the University of Utah Research Foundation and exclusively licensed to Myriad stifle research and limit women's treatment options. Additionally, the lawsuit, Association for Molecular Pathology, et al. v. US Patent and Trademark Office, et al., challenges the constitutionality of Myriad's patents on the BRCA1 and BRCA2 genes, by asserting that Myriad’s exclusive licensing practices hinder the free flow of information and therefore obstruct the First Amendment protecting free speech [see PGx Reporter 05-13-2009].
However, Myriad and other defendants challenged the plaintiff’s ability to bring the lawsuit, by filing a motion-to-dismiss memorandum, calling ACLU's case "a thinly veiled attempt to challenge the validity of patents" [see PGx Reporter 08-05-2009].
In deciding to dismiss Myriad's motion to dismiss on grounds that it lacked technical merit, Robert Sweet, the federal district court judge on the case, recognized the "uniqueness" of the plaintiffs' case with regard to "scope and significance of the issues presented, and the consequences of the remedy sought." Furthermore, the court acknowledged the right of the plaintiffs, particularly "women facing the threat of breast cancer … who are in the midst of their struggle with the illness," to challenge the practice of gene patenting.
"The challenges to the patents-in-suit raise questions of difficult legal dimensions concerning constitutional protections over the information that serves as our genetic identities and the need to adopt policies that promote scientific research," the court said in its decision.
In its decision, the court cited the example of Plaintiff Wendy Chung, a professor of molecular genetics at Columbia University who studies genetic and environmental factors linked to hereditary breast and ovarian cancer. Although Chung's lab sequences BRCA1/2 genes of research participants, researchers cannot inform subjects of their mutation status because of Myriad's patents.
Additionally, the court cited numerous examples provided by the plaintiffs where academic studies that would essentially improve BRCA sequencing methods were stopped by Myriad, who informed researchers that their work would infringe the firm's patents.
For example, according to court documents, in 2005, Yale DNA Diagnostics Laboratory asked Myriad for permission to perform genetic screening of BRCA genes looking for large rearrangement mutations correlated with cancer risk. Studies had previously shown that Myriad's full sequencing test missed some large gene rearrangements associated with disease risk. However, Myriad informed Yale that BRCA testing could not be done by the university's laboratory as it would infringe the company's patents.
Thursday, July 16, 2009
The Unethical Patent
Patenting life or genetic molecular entities involved with human medicine have profound negative effects on society in many ways. The patenting of the BRCA1 and BRCA2 genes involved in breast and overian cancer is a good example of the problems capitalistic ownership of "life" can bring to suffering patients.
Here is a story written from another blog:
Will breast cancer gene lawsuit end gene patenting?
Earlier this month, the American Civil Liberties Union joined the Association for Molecular Pathology, the American College of Medical Genetics, the Boston Women's Health Book Collective, and numerous other plaintiffs--including individual breast cancer patients--in filing a lawsuit against Myriad Genetics, the U.S. Patent Office, and the directors of the University of Utah Research Foundation. Myriad Genetics has patents in the U.S. for the BRCA1 and BRCA2 genes, the presence of which has been linked to an increased risk of breast or ovarian cancer. The suit alleges that such gene patenting is unconstitutional, in large part because "ease of access to genomic discoveries is crucial if basic research is to be expeditiously translated into clinical laboratory tests that benefit patients in the emerging era of personalized and predictive medicine," and such patents restrict the use of the genes.
Earlier this month, the American Civil Liberties Union joined the Association for Molecular Pathology, the American College of Medical Genetics, the Boston Women's Health Book Collective, and numerous other plaintiffs--including individual breast cancer patients--in filing a lawsuit against Myriad Genetics, the U.S. Patent Office, and the directors of the University of Utah Research Foundation. Myriad Genetics has patents in the U.S. for the BRCA1 and BRCA2 genes, the presence of which has been linked to an increased risk of breast or ovarian cancer. The suit alleges that such gene patenting is unconstitutional, in large part because "ease of access to genomic discoveries is crucial if basic research is to be expeditiously translated into clinical laboratory tests that benefit patients in the emerging era of personalized and predictive medicine," and such patents restrict the use of the genes.
The ACLU suit points out that:
Because of the patents, defendant Myriad has the right to prevent clinicians form independently looking at or interpreting a person's BRCA1 and BRCA2 genes to determine if the person is at a higher risk of breast and/or ovarian cancer. Because of the patents and because Myriad chooses not to license the patents broadly, women who fear they may be at an increased risk of breast and/or ovarian cancer are barred from having anyone look at their BRCA1 and BRCA2 genes or interpret them except for the patent holder. [...] Many women at risk cannot even be tested because they are uninsured and/or cannot afford the test offered by Myriad.
Because of the patents, defendant Myriad has the right to prevent clinicians form independently looking at or interpreting a person's BRCA1 and BRCA2 genes to determine if the person is at a higher risk of breast and/or ovarian cancer. Because of the patents and because Myriad chooses not to license the patents broadly, women who fear they may be at an increased risk of breast and/or ovarian cancer are barred from having anyone look at their BRCA1 and BRCA2 genes or interpret them except for the patent holder. [...] Many women at risk cannot even be tested because they are uninsured and/or cannot afford the test offered by Myriad.
For more on this topic go to the author's blog site ...here.
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