Details of the patent argument
Geoffrey Karny, a patent lawyer in Virginia, doesn't buy the argument that gene patents hurt patients. "What they're trying to do is advance patient care," he says, suggesting the price tag is key to improving diagnostic tools. After his recent trip to Hong Kong and China, the connection between "cheaper" gene tests and pirated products, like DVDs, became obvious to Karny. "Myriad has done the heavy lifting. Of course, someone could piggyback on that and sell it for $100," he says. "But stuff doesn't just jump from lab to marketplace." Companies, he suggests, require patent protection to invest the "years of effort and millions of dollars needed to develop a product to be used in a clinic."
In China Karny also witnessed a growing biotechnology industry that could threaten the U.S. economy. "We need that tech here," he says, noting a special concern for small start-ups. "Why should investors put money into companies if they'll never get a return on that investment?"
The lawsuit has brought to the forefront broader ethical questions that had already been stirring: Where do you draw the line between what is considered a product of nature and what is a product of man? Where does discovery end and invention begin? In its complaint, the ACLU states, "An 'isolated and purified' human gene performs the exact same function as a nonisolated and purified human gene in a person's body."
The Hasting Center's Johnston suggests that Myriad and other owners of gene patents haven't really changed the gene—that it is still essentially a product of nature: "I'm sympathetic to people who say that it's like taking gold out of the ground," Johnston says. "You haven't created anything new."
Others take this argument one step further. "It was an error on the part of the patent office to grant the patents," says Marcy Darnovsky of the Center for Genetics and Society in Oakland, Calif., which has voiced their support for the plaintiffs in the case. "Things that are 'products of nature' should be a commons, like the air we breathe."
What about research on patented genes?
The ACLU's complaint also rests on the belief that Myriad's monopoly is stifling research. "If everybody had that gene, who knows what different kinds of diagnostics, what different kinds of treatments might emerge," says U.C.L.A.'s Greenfield. "Those could be patentable, but when you patent and monopolize the underlying basic research tool, maybe one company has a lot of incentive, but everybody else doesn't." She adds that there is actually little incentive for the patent holder to improve the quality of the tests or lower its price.
Myriad Genetics refused to speak about the case, as did the USPTO, both noting their policies against commenting on pending litigation measures. But in the 2008 PBS documentary, In the Family, Myriad founder Mark Skolnick responded to producer Joanna Rudnick's patent questioning very simply: "There's no controversy."
Karny would agree, actually calling the lawsuit "garbage." He adds, "If courts were to buy the argument, it would be devastating for the biotech industry and for our health in general." Karny compares the issue with a classic Mark Twain analogy. "Myriad has produced a flash of lightning and ACLU has given us a lightning bug," he says. "The court should squash the lightning bug."
Myriad's motion for dismissal will be heard on August 26 in New York's Southern District Court.
Subscription Center
See what we're tweeting about
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.
Reply | Report Abuse | Link to this