PRIVATIZING NATURE'S CODE: A battle is waging over whether the isolation and purification of specific genes linked to cancer are products of man or nature.
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Defendants in a high-profile lawsuit that could have significant implications for thousands of patents on human genes have now asked a federal judge to dismiss the case, calling it a "thinly veiled attempt to challenge the validity of patents."
Two months ago, more than 150,000 researchers, doctors, activists and cancer patients filed a federal lawsuit in New York City against Myriad Genetics, Inc., the University of Utah Research Foundation and the U.S. Patent and Trademark Office (USPTO). Under the organization of the American Civil Liberties Union (ACLU), they are challenging the legality and constitutionality of gene patents, with a focus on two of the most controversial: BRCA1 and BRCA2. Both genes are associated with breast and ovarian cancers, and both are held by Myriad. The information encoded in our DNA should belong to everyone, the plaintiffs argue, and the current standards for obtaining a patent are too low.
"There's a sense that the privatization of certain things has gone too far," says Debra Greenfield, an attorney and postdoctoral fellow at the Center for Society and Genetics at the University of California, Los Angeles, who is not associated with the lawsuit. "Abstract things are being patented now, whether it's something in your body or a business method."
But in their motion to dismiss filed last week, Myriad and the University of Utah argue otherwise. "The patent system has worked exactly as it was designed to do," the defendants wrote, explaining that they "spent considerable time, effort and money, in competition with other researchers" to win the patents.
The history of gene patents
Almost 30 years ago, the U.S. Supreme Court held in Diamond v. Chakrabarty that a genetically modified bacterium was a patentable subject matter. The Court called the scientist's discovery of the bacteria with improved capacity for degrading crude oil, "not nature's handiwork, but his own." This opened the door for companies to pluck out a segment of DNA and put their name on it.
The USPTO has since granted thousands of patents for biological entities, always with the caveat that they must be first isolated, purified or modified in some way. Today, one out of every five human genes is privately owned. Those opposed to gene patents complain that no one without the permission of the patent holder is allowed to freely work with, or even think about using, this 20 percent.
Myriad is just one of many companies in possession of these genes, but is one of only a few that has not licensed the information to others to conduct research or create their own test. Since the mid-90s, the company has owned the exclusive rights to the BRCA1 and BRCA2 genes. Whereas only 5 to 10 percent of breast cancer patients have a mutation at one of these genes, those having it face a 40 to 85 percent chance they will develop breast cancer at some point in their lives.
Given these odds, a screening test for the mutations can provide useful information for women who are considering proactive interventions to prevent future cancer. "If you want the test done, you have to go through Myriad," says Josephine Johnston, director of research operations at The Hastings Center, a nonpartisan bioethics and public policy research institute. "And they hold those patents pretty close to their chests." The test currently costs around $3,000, although most insurance companies do cover it. "People think it's a pretty steep price," Johnston adds. "But when you have this kind of control, you can set the price. They could've made it $30,000 if they wanted to."
In another five years, the exclusive rights that the USPTO granted Myriad based on the isolation and purification of the two genes will expire. But according to many who oppose gene patents, that's five years too many—too many more women will be without a second opinion or an opportunity to purchase a cheaper test to help decide whether or not to undergo a radical surgical procedure.
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14 Comments
Add CommentCan someone explain what exactly Myriad patented?
Reply | Report Abuse | Link to thisWhat is the difference between their patent of BRCA, and a patent of say nuclear fission, where such a patent would forbid all other companies from building nuclear power plants? Clearly the latter is ridiculous, so I must be missing something...or am I not?
jonderry you are not missing something.
Reply | Report Abuse | Link to thisThe situation is analogous to the imperialist land grab of centuries past - while the natives were ignorant of what was going on around them, their birthright was stolen out from underneath them.
The first man who, having enclosed a piece of ground, bethought himself as saying “this is mine,” and found people simple enough to believe him, was the real founder of civil society. From how many crimes, wars, and murders, from how many horrors and misfortunes might not any one have saved mankind, by pulling up the stakes, or filling up the ditch, and crying to his fellows: “Beware of listening to this impostor; you are undone if you once forget that the fruits of the earth belong to us all, and the earth itself to nobody.” ~Jean Jacques Rousseau, A Discourse on the Origin of Inequality
We need to reverse this process before it is too late.
It's hard not to feel morally revolted by this and the patent office is clearly out of its depth here. Kudos to the plaintiffs. I don't buy Myriad's argument which seems to be that if we didn't award patents for isolating genes, the research would never be done. Cataloging and identifying the genetic patrimony should be publicly-funded and the fruits should be in the public domain. If the Myriads of this world then want to use that knowledge to actually invent something, then they earn their patent.
Reply | Report Abuse | Link to thisAbsolutely. There is a big difference between an invention and a discovery of a natural substance. If genes can be patented then the whole human genome can be patented, every species can be patented, rocks can be patented, newly discovered stars and galaxies can be patented (so no other astronomers can observe them!).
Reply | Report Abuse | Link to thisA patent is for an invention, not a discovery.
Reply | Report Abuse | Link to thisNaturally existing gene patents should not be allowed.
If cancer research companies think they deserve protection then they should apply the federal government for a special law protecting them.
As far as I understand you cant patent naturally existing genes, but you can patent the techniques/methods that target those genes. For instance Myriads method would be the primers that amplify certain sequences in the BRCA genes that can be sequenced and then analysed for mutations that cause the cancer, thus you now have an invention and therefore can be patented. Myriad have presumably done the research (this is expensive) and shown the increase risk in cancer from this gene. Patenting (before publishing) would protect themselves from someone else coming along and copying their ideas.
Reply | Report Abuse | Link to this@ross; Your understanding is wrong. The patent is for the isolated gene and prevents anyone else from studying or otherwise using that particular gene.
Reply | Report Abuse | Link to thisRoss, I really don't think Myriad invented any new method for isolating any particular gene. They just discovered the relation of some particular gene in human genome to some cancer. That is not an invention. If any gene in human genome can be patented than all genes also. Even the genes in all other species. That is like a geologist discovering a new type of mineral and getting a patent for it, like he/she invented it in a lab!
Reply | Report Abuse | Link to thisI can understand Myriad to have a patent on, say, a method of isolating a gene, or for treating a condition caused by a certain gene, but to own a patent on a gene? That is ridiculous. Grant them patents on the research they created based of the gene, but leave the genes in public domain. If I have the gene in my body I have to ask Myriad for permission to perform tests on it? Absurd!
Reply | Report Abuse | Link to thisThe patent covers various mutated forms of BRCA that cause cancer (which of course is naturally existing!) and ways of detecting those mutations. They sell and have patented a kit based upon detection of those mutations they have found. You can still work on wild type BRCA, academic research is ok on the mutants i think, just not commercial interests. I agree with you that patenting a gene is ridiculous. Its very annoying that a company can identify the mutations that cause disease, and patent them, I think its crazy, they can charge what they like until the patent expires - but if you couldnt there would be alot less private funding into R&D. Many companies would wait for publications and just release kit after kit.
Reply | Report Abuse | Link to thisI personally don't even think that unnatural genes should be patentable. While I understand why they are, I do not think they should be patented. If you make GM corn that can resist drought and create its own nitrogen to help it grow in impoverished and arid parts of the third world, then that's great, but making it illegal for these people to save the seeds because it's patent infringement is immoral.
Reply | Report Abuse | Link to thisIf naturally occurring genes can be patented, then the next step is that people with those genes could be charged with infringement. It would be even worse for those who reproduced and "made copies" of those genes.
With GM crops, there are already lawsuits against people whose crops were pollinated by GM plants. They didn't ask the insects or the wind to pollinate their heritage crops with GM pollen, but they are still being sued over it.
The whole idea is just garbage. You shouldn't be able to patent something that can naturally make copies of itself. If I made a robot that made other identical robots, patented it and sold it to you, should I sue you when that robot makes copies of itself under your ownership?
I know this article isn't about GM crops, but it seemed relevant. I think that in this instance, the patent on these genes is just absurd and is strangling research on these specific genes. It allows them to hold a monopoly over them. What they have done is akin to saying "I came up with the idea of owning land... so no one else can own land." It's just plain stupid. Anyone who can't see this is blinded by money.
Whether you can patent a gene is a specific technical argument, but most of the commenters who are opposed to patenting genes seem to be opposed to the idea of patents in general. There are many abuses of the patent system but this does not seem to be one of them. In fact this seems to be a case of patents working exactly as the constitution intends: people invest capital, discover something new, patent it, and after a legally specified monopoly period, the knowledge becomes publicly available enriching the lives Americans and the world. Without a patent system, this knowledge would be available sometime between and long time from now and never. Whether the patent itself is valid is a question of law; and I think importantly there is nothing in the Constitution that would restrict genes from being patented if congress passes laws enabling it. This is a non-trivial legal question. The article laments that commercial enterprise on 1 in 5 genes is restricted by patents. I see that same fact and rejoice that in less than 20 years knowledge of 1 in 5 genes will become free for all time. Corporations are dangerous (as is anything with great power), but there are much better corporate misbehavior to get upset about in this world.
Reply | Report Abuse | Link to thisWho is opposing to patents?
Reply | Report Abuse | Link to thisI have some patent applications of my own.
Believe it or not.
I just oppose to trying to patent things naturally existed in nature. That is absolutely wrong. If you allow that then all scientists can take patents for everything they discover. If someone discovered a new galaxy then s/he can get a patent for it. So no other scientist can make research on it because it can be claimed that research means making money from that discovery (all research done by some funding isn't it?).
Same way gene patents opens way to stop any research on any gene. Nature is not belong to any company. They should get a patent only really they invented something new.
fb36, whether genes can be patented or not is a question of law. The law does prevent patenting of natural phenomenon (although the constitution does not require it to). As best as I can tell, the current administrative rules allow for patenting of genes. Upon further review I think the current rules are too broad and may not have a solid legal foundation. I have re-read the other posts on this article and with the exception of your comments (which are very focused on the patentability of natural phenomenon) most of the other comments question the moral basis for patents. To address your specific comments: allowing gene patents does not require the government to allow patents for galaxies. The philosophical basis for patents is utilitarian. We as a society grant a temporary property right to encourage the greater good. While the granting of those rights must be done in a fair way, we don't grant these rights to be fair to the patent holder, we grant them to improve society. If there were a useful purpose in granting patents on galaxies, congress could do so. This also in part why the ACLUs 1st Amendment argument is bogus in this case. They argue that the patent is invalid because it restricts free speech and free thought. Their line of thinking would not only invalidate almost all patents, but all copyright as well. It may serve everyone well if the ACLU successfully pushes back the boundaries of the current administrative rules, but the 1st Amendment argument is non-sense.
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