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ACLU Will Take Gene Patent Case to Supreme Court
WASHINGTON - When Jaydee Hanson, then-bioethics director for the United Methodist Church, spoke out publicly against gene patents over 15 years ago, some in the biotech industry compared his stance to the Catholic Church's persecution of Galileo, the 15th century astronomer who discovered the moons of Jupiter.
Hanson and 200 other religious leaders had released a statement that DNA in the human body and animals are natural objects and should not be subject to patenting. 
"It's kind of like saying two of your genes are in jail, but we are not allowed to report this information to you, even though it would save your life." (photo: opensource.com)
Patent supporters in the biotech industry disagree, arguing that "isolated copies" of genes outside the human body should be patentable and that the prospect of intellectual property rights on genes serves as incentive for further research.
On Wednesday, the American Civil Liberties Union (ACLU) announced it would ask the Supreme Court to rule on a patent by Myriad Genetics, a genetic diagnostics company based in Salt Lake City, Utah, on "isolated" BRCA-1 and BRCA-2 genes, two genes that can have mutations linked to breast, ovarian and prostate cancers.
Those with a stake in the case say any ruling from the court would have a major impact on patient care, scientific research, and rights to access human genetic information, as well on legal doctrine.
The gene patenting case has been moving up through lower courts since 2009, when the ACLU first filed a civil suit in a district court in the state of New York arguing that Myriad's patent on the genes should be invalidated.
District judge Robert Sweet agreed with the ACLU in 2010, but Myriad appealed, and the Federal Circuit Court of Appeals overturned Sweet's ruling in July, with two out of three judges siding with Myriad, affirming the company's right to patents on the two "isolated" BRCA genes linked to breast cancer.
Facing a mid-December deadline to appeal the lower court's ruling to uphold gene patents, the ACLU decided to move forward with the appeal in time for National Breast Cancer Awareness Month in October, said Sandra Park, an ACLU attorney working on the case.
"We consulted with our clients and made the decision to move forward, given the importance of the issues to patients and scientists," Park told IPS, adding that the Supreme Court would likely make a decision in the spring of 2012 about whether it will hear the case.
More than 4,000 genes have been patented, including copies of genes that make up 20 percent of the human genome, according to Hanson, who now works as a policy director for the International Centre for Technology Assessment (ICTA). In the past, Hanson and ICTA have successfully challenged patents on a beagle and other animals.
In September, Myriad sent the following comment to IPS: "Myriad defended its position in the courts and recently had a favourable outcome. We believe that isolated DNA and cDNA are patent-eligible material, as both are new chemical matter with important utilities which can only exist as a product of human ingenuity."
With its patents, Myriad holds exclusive rights in the U.S. to test the BRCA-1 and BRCA-2 genes for mutations and provide that information to doctors and patients. Those mutations place women at a much greater risk of developing breast cancer and some men at greater risk of developing prostate cancer.
ACLU: Patents make tests cost-prohibitive and block research
The ACLU represents a group of 20 other plaintiffs, including geneticists, pathologists and breast cancer survivor advocates, who maintain that the patents block patient care.
They argue that patients shouldn't have to pay for genetic information they could use to make life-or- death decisions, such as whether to get a mastectomy, especially when other genetic testing providers could offer that information if Myriad didn't have exclusive rights to sequence the genes.
Five to 10 percent of breast cancer cases are linked to mutations on the BRCA-1 or BRCA-2 genes, and those with the mutations have an 85 percent risk of developing cancer. Some insurance policies cover the tests, but other plans, especially those providing insurance for the poor, don't.
According to Park, Myriad chose not to enter into contracts with about half of all insurance programs in states that cover low-income people.
Ellen Matloff, a genetic counselor at Yale for over 15 years and a plaintiff in the ACLU case, said the cost of the test was a real issue for many of her patients.
According to her, "comprehensive" breast cancer test from Myriad for other breast cancer mutations costs 3,400 dollars and a supplementary test for the BRCA-1 and BRCA-2 genes, called the BART test, costs 700 dollars. Matloff said that 95 percent of patients she recommends for supplementary testing don't end up being tested because of its high cost.
"I know that we are missing mutations," Matloff told IPS, adding that the BRCA gene mutations are passed down maternally and paternally. "It is going to impact them, their children, their siblings their grandchildren, their nieces and nephews, and from a clinician's standpoint it is horrifying."
Gene patenting opponents also argue that in a new era in which full- genome sequencing is getting faster and cheaper, patents stand in the way of access to new knowledge about how certain genes are related to disease.
"The whole next phase of [research in] genetics and disease is to understand how genes work together," Hanson told IPS. "It is a huge task, and the patents just interfere with it."
Matloff expressed a similar concern that advanced knowledge about genes without access to that knowledge could create problems for patients and care providers.
"It is almost like saying, 'we have your genes right in front of us, it came out of your body, but we are not allowed to look at it, we're not allowed to interpret it, and we are not allowed to give the information back to you,'" Matloff said.
"It's kind of like saying two of your genes are in jail, but we are not allowed to report this information to you, even though it would save your life."
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26 Comments so far
Show AllThis is just another perverse symptom of capitalism.
Gene patenting as a form of corporate information control is as dangerous and evil an idea as the Iron Law of Wages or 'safe nuclear power.'
ACLU - good, but what took you so long......
Patents for naturally occurring chemicals, molecules, etc. are completely wrong. How about granting patents for simple chemical elements? Who ever got the patent on oxygen would have a great time requiring everyone to wear respirator masks that measured how much of it they were using and what they owed the patent holder. Anyone who didn't pay would have to stop breathing! Patenting natural substances is absolutely absurd!
What amazes is that gene patents were ever allowed to come into being. Those that exist should immediately be dissolved. Genes are not inventions. They occur naturally. Identifying them is a discovery. The proponents base their premise on the argument that isolated copies outside the body are not the same as the naturally occurring genes. It seems to me that the very usage of the word "copy" tells you it is not an invention. I just do not get the argument. "Copy" of other's work in any other academia context implies plagiarism. Plagiarism is not rewarded. Plagiarism is shunned. The discoverer, when copying, should always honor and give credit to the source. It makes no difference whether the source is human or nature.
This seems fundamentally a resource control mechanism argued from a perspective that technology is science (which it is not), and furthermore, that there is only one model of science, which is a blatant falsehood. It is necessary to poison (agrotoxification) in order to use GMO seed, for example developed through the use of public monies for research for privatization and commerce. Much of this strain of technology has been perpetrated through flawed research and is manifesting monumental failings.
Life as commodity is an oxymoron. To equate societal resistance to patent of gene technologies with the Catholic Church's persecution of Galileo is sadly delusional beyond measure and a perpetuation of convoluted values. Yes, technology is seated at the apex of "western civilization" among those for whom the billions of advertising dollars have been directed for the media indoctrinated, but that position has been acquired at the very least within an unsustainable 'semi-paradigm' run amok. This has been bolstered by centuries of precisely the paradigm inversion that the bio-tech industry cites (European crowns and the papacy prior to Vatican II) as its industrial colonization structure usurped and undermined the vast diversity from which it arose. It is gentrified social/ecological cannibalism. First, the system needs to clean up and be accountable for the toxic dumps and waste created in the policy of "planned obsolescence" without capacity to recycle prime materials. In the mean time billions of people are displaced for the insatiable cannibalization of the planet.
This is a front-loaded bulldozer riding the road of transnational colonization in the name of progress, utterly without accountability leaving depredation in its wake. There needs to be a moratorium on 'development' and fulfillment of the human rights provisions that have been deemed necessary - worldwide- in response to corporate purchase of governance structures and the shredding of the social contract. This has been done through application of a perversion of Darwinian theory of the "survival of the fittest". Economic "competition"/free trade is nothing more than another dimension hyper-derivatives now enforced by a stunningly violent and corrupt hubris.
Genes are not static commodities specimens occurring in isolation. There are ancient, highly effective medical and scientific models sustained and transmitted by human beings, integrated with the earth that are being destroyed by this model - without prior and informed consent, at the very least.
When a model divorces itself from the nature that gave rise to it, a de facto death sentence is signed. DO NOT let the industrial model claim that they are all individuals when the interdependency of the system makes ALL connected industries culpable for the depredation.
---"..argued from a perspective that technology is science."---
I assume you mean the other way around. Technology is patentable, a scientific discovery is not. Excellent comment at any rate...
The original Human Genome Project was started by the NIH, which as a public institution was releasing the human genome maps as public domain. But, this was put to a stop. The genome project was defunded so corporations could do it, patent it, and speculators could reap wild profit as the patents are bought and sold on the "free market", short-and-long, like stocks, pork bellys, or credit-default-swaps.
The very words "intellectual property" are a vile capitalist distortion of what patents were supposed to be. A patent is supposed to be simply a government-issued and protected _right_, for a limited time for an inventor to a control their invention. This is to allow an inventor able to recoup the expense of inventing, thus encouraging inventiveness.** Well, this does not sound like "property" to me any more than other government protected rights like free speech, due process,etc are "property". The founders could have never imagined that such a right would be turned into a tool of speculator exploitation.
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**The effectiveness of patents is arguable. There have been cases of patent-free governance, where the lack of patents spurred constant inventive improvements in a product to stay ahead of copycats.
why didn't God patent them?
I'll bet if they looked they could find a genetic mutation that promotes greed over anything else in the human genome. That mutation would probably be found in 99.99% of the 1%, maybe more.
Actually, it appears there is a gene controlling greed. There are parts of the brain in Republicans and other conservatives is different in size from liberals, the part that control fear and selfishness. Conservatives are personal cowards and greedy bastards by nature. The real irony would be to find the specific genes, patent them and charge the rat bastards for them.
Better send the ACLU some more money before someone patents our children.
If one of this company's patented genes is in my genome, does that mean I have to pay them royalties when my cells divide?
This is a big issue; however, members of Congress from both parties are rather quiet on this. How many candidates even make this a campaign issue (rhetorical question)?
With the "Supreme" Court that we have now, anyone care to place any bets on who wins this suit?
Another case of full blown, hell bent for leather, case of capitalistic opportunism. I personally have mixed feelings about capitalism as a system, but no moreso than I have about all of the alternatives I have studied. All have their weaknesses. The problem is far less with the system than with the players. The psychopaths of the world will opportunistically exploit whatever system is used. The existential question becomes how to recognize, control, and deal with them when they do game the system, whatever it is.
Let's get behind the ACLU on this one for citizens rights of those yet to be born. Also note, For the sake of commerce perhaps if the developer of a process can create something good for others, then yes they should be allowed to recoup there start up costs and such, but in no way should the gift or creation of life be tweaked and then licensed as a new work exclusive only to it's liscense holder for ever?
Patents in fact STIFLE innovation.
I found this interesting. An electric car, that is still running gets 40 miles per charge, the same as the Hi_tech Chevy Volt.
It was built 115 years ago in 1896. All patents do is halt further innovation so that profits can be maximized for as long as possible.
Nice call GW and there is a light bulb made by Edison that has been turned on and off every day at his Florida workshop.
I hope the courts deny the right of these companies to patent genes...if the scientific community was properly funded by tax dollars through government funded university and teaching hospital systems....the notion of health for profit could be done away with...however when a society is based on the premise that everything has the potential to make one rich...society as a whole loses sight of the betterment of that society as a whole...and that includes universal and free access to life saving procedures and tests...
What are the odds with a corporation court running the nation? Nevertheless, good for the ACLU on this one!
what supreme court? they are the shareholders of the patenting corporations
" We believe that isolated DNA and cDNA are patent-eligible material, as both are new chemical matter with important utilities which can only exist as a product of human ingenuity.""
What exactly does that mean? Someone break it down for me. What exactly are "important utilities which can only exist as a product of human ingenuity"? "New chemical matter"?
Does this mean if I discovered a new species of alligator ideally suited for a new type of handbag, that I could patent it?
Poor Saddam Hussein and Ali Hassan al-Majid (aka Chemical Ali) were no doubt very upset and inconsolably crying on each others shoulders that their patents were infringed upon when people in the USA were suddenly being afflicted or dying from anthrax attacks.
However they were soon very much relieved when it was found out that the anthrax was in fact weaponized grade anthrax and manufactured by patriotic god fearing Americans right there in the good ol' USA itself and used in false flag attacks.
After a quick rewrite of history and plenty of media suffocation & redirection, the anthrax attacks in the USA were quickly forgotten about......although Colin Powell probably still fondly has wet dreams of his UN presentation with dancing girls holding vials of anthrax.
What America needs is a real fully patented biological human and that will save all that country's woes. For a nation quite literally and proudly built upon the whipped and raped backs of outright slavery and persecution, replacing today's social and financial slaves with real patented slaves will be not only a boon and a cure for the economy, but also could be used in warfare and when they've outlived their usefulness could be used in the oil industry after they've been thrown alive into mincer machines to be used as base material for new algae farm protein matter. A winning situation you surely must agree?
After careful and considerate consultation with Monanto, the slaves would of course be completely sterile and new batches would constantly need to be created. Money would need to be borrowed from such venerated and highly efficient institutions such as the Federal Reserve with appropriate loan fees created on every dollar in order to maintain the slave manufacturing industry. Again, another winning situation.
Having such slaves engineered to have striped red, white & blue colours as their overall skin pigmentation would prevent patent and copyright theft and make them easily discernible from regular humans.
There would of course have to be a house committee commission set up to investigate matters of patent infringement. It may very well be the case that people who claim to be regular humans have in fact been dabbling in illicit genes and would have to answer the question, "Have you now, or have you ever been a member of a gene organisation?" --- And of course these people would lie. They wouldn't even have to be considered 'human' and afforded any human rights or applicable for any passage of law since they've no doubt co-opted patented genes somehow. So off to slavery they go, or to fight wars, or more likely straight into the mincers they all go just to save time and money. Can't waste a valuable resource.
Genes, working for you and making life better every patented day.
That was a stitch! You should get it copyrighted, oh wait ....
This article is rather disturbing in that the arguments given here are not not very good and don't sound winnable to me. I hope it's just a case of bad reporting. The argument that something being patented makes it too expensive is a wash, it wont stand up. The salient point here against patenting of genes is that they are not new and original and discovering anything has never been justification for patenting in the past. Creating a process or technology to test for the genes is something new and different , but simply patenting naturally occurring genes is not and should be a no brainer when it comes to realizing that it isn't something patentable.