In this weekend's reading in The Immortal Life Of Henrietta Lacks we read about the first legal fights over the control, and ownership, of human cellular material. Court battles like these that took place in the early 1970s must seem like old history to you. 1973? The Beatles had broken up, Richard Nixon was President, and Disco was just beginning to define the decade. These are old battles. Surely they must be over, decisions must have been made - legal precedents and business models must have been established. Don't you think?How ironic then, to read about a case going before a federal courthouse in Washington D.C. tomorrow as in April 4, 2011 to settle the same fundamental questions as the ones we read of this weekend: are isolated human genes, and their respective sequences of bases - of As-Ts-Cs and Gs - patentable? More specifically, if a company analyzes and sequences two genes responsible for a percentage of the incidence of breast cancer in patients - and perform research to identify and analyze those genes in patients' cells - can they patent their product?
That is the central argument going before the court tomorrow in the case of Association of Molecular Pathology, et al. v United States Patent and Trademark Office. At stake is a profit potential of billions of dollars.
The company, Myriad Genetics, has sought a patent for a the BRCA1 and BRCA2 gene (Breast Cancer Susceptibililty Gene 1 and 2). The BRCA genes only account for 10-15% of all instances of breast cancer, but 80-90% of those women who have this gene do go on to develop breast cancer. Myriad Genetics discovered and has patented the genes. Only now, an appeals court is asking the federal court to determine if these genes can be patently or not - based on the the argument we read about in TILOHL, that "products of nature" cannot be patented.
Now, what about a "molecular diagnostic product"? Myriad Genetics, claiming a patent on the genes, has developed a product to determine if a woman has either BRCA1 or 2. It's called BRACAnalysis. Clever, huh? Here's the pitch:
"BRACAnalysis® assesses a woman's risk of developing breast or ovarian cancer based on detection of mutations in the BRCA1 and BRCA2 genes. This test has become the standard of care in identification of individuals with hereditary breast and ovarian cancer and is reimbursed by insurance."
Having discovered these genes, Myriad Genetics was awarded a patent on BRCA1 and 2. In 2010, a judge ruled that the BRCA 1 & 2 genes were unpatentable products of nature - and that BRACAnalysis, an offshoot of that illegal patent, resulted from exclusive research that Myriad Genetics did based on that patent. So - the product should not be allowed to be brought to market based on Myriad's "exclusive" rights to research, and develop products from, the BRCA genes.
Confusing? It is confusing to me, too - legal arguments can get pretty dense. Here's some backround.
In late 2009 a group of physicians, patients, and the ACLU, filed a lawsuit against Myriad, claiming that their exclusive patent on genomic information kept knowledge, research, and testing from populations of patients who could possibly benefit from them. In the case of the new test, women who are at a higher genetic risk of having the BRCA genes would be prohibited from testing for it unless they used the Myriad BRACAnalysis product.
The US Patent and Trademark Office countered with an argument defending its decision to award the patent, stating that Myriad had invented something truly beyond anything found as a "product of nature", and as such, was worth protecting with a patent certifying ownership.
In 2010 a judged tossed out the decision, saying that isolated, individual segments (genes) of DNA were no different - just segments - of the whole molecule found in nature. Therefore, he ruled that the patent office was wrong in their decision to award Myriad a patent in the first place.
One analyst viewed this reasoned decision as a reflection of the increasing knowledge and awareness of DNA in our society - that an isolated part is not really different from the whole. It is still a "product of nature". Looking at genes in isolation is representative of our information age. We view things in bits and bytes. Genes are bytes of genetic information.
Monday's decision will determine the availability of this test (and perhaps billions of dollars in profits) to perhaps millions of people around the globe. What do you think? Can we - should we - be able to own/patent genetic information? If not - if we remove the incentive to make a profit from such research, why should companies bother to conduct the research? Is less knowledge, less technology, fewer diagnoses, fewer treatment - the price we ultimately pay for this? Or should we allow Myriad Genomic, and others like them, the right to patent the essence of what it means to be human?
(Don't worry about either side of the argument - chances are it will go to the Supreme Court!)
8 comments:
This topic is a tricky one to take a side on, and I can easily see how the argument could become heated. It does in some sences make me midly uneasy at the idea of companies turning human cells into a big profit/business type of setup.And it is very simalur to stemcell research and using emblic. cord from one child to help the other to help with their cancer treatments. However, Just looking at what we read, do I think that we can lay clame to our cells after they leave our body and do things such as patent them? I personally do not feel that there should be some intesive ownership to your Cells once you say die or donate, or are in a research group. Once your Cells leave your body in my opion that should be it. What are you going to do with them? Even if say someone was to clone you from the cells that a doctor gathered from you, it would not be you. Yes it would look like you, but it would be like if you had a twin, you would be geniticly the same but you would not be placed in the same envoriment or faced with the same life challenges and therefore turn out drasticly different people. I do understand that this is a can for some people be a widly upsetting notion to consider and an invasion on ones privecy however your cells can help to save lives, and make huge advancement in the world. Now should people be gaining a profit off of your cells, prob. not but they really are not your cells any more. they no longer are in your body or providing any fuction to you. And as sad as it is to say, money and people who extort and make money from other people is just how the world works. Having our Cells used is kind of like celling a house, once you move out you give the deed to the next guy and say do what ever you want to it, its no use to me any more even though at one time this was my dream house.
Amelia
I don't think a company should be allowed to patent a gene. To me that just sounds ridiculous. It's like patenting hair and saying that no one else is allowed to have hair because I did it first. Other companies should have every right to study whatever genes they may discover. Whatever machines or tools they my create for the BRACAnalysis or whatever is fair game, but something seems completely wrong about patenting genes. You can't own something that we all have inside of us, something this is within every living organism.
People like Henrietta should, in my opinion, be entitled to payment. Doctors and companies should not be allowed to profit because of someone else's biological material. If Henrietta had willingly donated her cells to science then i would say that she wouldnt be entitled to anything either. Companies shouldn't profit from cells and genes themselves, but from the tools and machines they develop in the process
I agree that this is a touchy subject to comment on. I liked Mimis comparison to the house situation, but she leave out on important part. When you move and your house belongs to another person, yes it is not longer yours, but people usually don't just give away houses for free. You are expected to pay for a house to make it yours. I think that there could be some kind of compromise where people are paid one initial fee for giving away their cells to research and that is the end of it. There is no was to continue to pay people for how much their cells would be used because it would be so hard for scientists and doctors to calculate how much that actually is.
So yes I think there could be some sort of fee for taking a person's cells, unless someone wants to just donate them. And there should also be guidelines as to what happens to their cells. Everytime someone gives away cells they should make sure to sign a contract stating how much, if anything, they are getting paid for their cells, and what type of research their cells would be used for. Also like Mimi mentioned they could state weather they would be ok with something extreme like being used for cloning or not.
-Sarah
First of all, I think that the whole medical field has become too focused on money. This one patent should not be worth billions of dollars. I know that medicine is expensive and they need money for research and technology and supplies and man power. But their are millions of people who are living without medication that could save their life . Now our society has put a monetary value on life. You are more likely to get treatment at a hospital if you are rich; that is not fair. And i know life is not fair, but it should not be like this.
Also, I am not surprised that this case is taking so long. We have formed a society where you cannot be the accuser, the judge, and the executioner. With added people is added time.It is wasted time; people could be helped with this and because of the case they are not getting that help.
Also, I think patenting a genetic code is a little absurd. Everyone has genetics. I think patenting this is like people who insure their body parts. Mariah Carey insured her legs for 1 billions dollars; Jennifer Lopez insured her butt for 300 million; and David Beckham insured his legs for 70 million. It's ridiculous and i think patenting a genetic code is as well. They should receive credit for their discovery but this is absurd.
Sydney
I think that if you are in a situation that someone like Henrietta Lacks was in, you should be able to make money off of your cells. If your cells are being sold all over the world and making huge medical advances the the person who donated those cells should get a portion of the profit. I don't think however that you should be able to patent a gene and make money off of it. You did not make the gene you simply found it and introduced it to the world, and you are showing it's capabilities. I don't think that someone should be able to make money off of something that someone elses body produced. The only person that should be making money off of cells are the people who donate them (given they are still alive). In the book that Lacks's family makes a very good point that their mother's cells have made millions of dollars in the medical world, but still they can not afford medical help, and they are still poor. A family like that deserves a portion of the profit that is being made off of their mother's cells.
-Marley
Ok so I guess I don't really get what this is, I think they should be allowed to patent their product, but deffinatley not the brca genes,as for being the people who discovered the genes, I get where their coming from wanting to claim them, but I don't think it should be allowed, its human dna.I think that if they really want to be remembered for this then maybe allowing them to do something like nameing the gene would be ok.
I don't get it! How can you say that using DNA, which isn't even the scientist's in the first place, and say that it's your property and using DNA to help with breast cancer research has "never been done before." Scientists use cells everyday, for example, the HeLa cells, for research. So how does patenting something even work? Using cells for research has been done before, many times before, so patenting doesn't even work for the most part. Cells and DNA, I believe, are a product of nature, not something that scientists created in their lab. If you patent that "discovery," you are trying to patent the entire idea of cell/DNA use in research. It's ABSURD.
Something that really stuck out to me was the part in the blog that mentioned that women, who could seriously be at risk of breast cancer and need that test, have no place to go if they don't want to use THAT specific test. BRACAnalysis is essentially saying that no one else can conduct the tests that they are conducting. So, if a woman in serious need of a test does not want to use this specific test, are in huge trouble. Because there is a "patent" on this test/research, they cannot get the test at all.
You can't claim ownership of nature. I completely agree with the blog when it said that DNA is a product of nature. Any scientist/lab can use DNA and conduct experiments and tests on them. You can't own that right. It's ridiculous. Because really, when you are claiming ownership of this breast cancer test, you are claiming the idea of using DNA in breast cancer research as a whole. Where will be get with that? If only one research company can use that, we will get no where. We need the thousands of people that work everyday to help with breast cancer research, not just one company.
-Molly
OK, this is absurd, I definitely posted a response today in class and then double checked to make sure that it had worked before I deleted the response from the computer forever.
The only ting more absurd than having to remember what I wrote this morning, even though I clearly posted a response, is the idea that genes can be patented. I just doesn't make sense. Generally people put patents on thing that they invent, things that they create, for example, Dr. Gey should have patented his barrel roller doo-dad so that he could have made enough money to continue funding his lab. On the other hand, genes are no one's creations. Just because their scientists find/locate a gene, doesn't mean that companies should get to own their own piece of human DNA. The human genome, and the knowledge of how it works, belongs to all humans. We all deserve the right to know how our bodies work if someone has figured out how they work. I doctors/scientists/companies are looking for something to patent, why don't they patent the test to find the gene, they did create that, so it only makes sense that they should own it, better still, they could find the cure and patent that ensuring that it will be produced and distributed so that they can make money! However, when it comes to the actual gene, the scientist who found the gene deserve recognition, and nothing more. Quite frankly, science should not be about making money. For hundreds of years science has been about the search for the truth and the sharing of knowledge gained. Why should that stop now? I think that Sydney is entirely right, science, not just the medical industry, has become way too focused on profit. While there are still a few true scientific scholars out there, the entire scientific process has become convoluted by money and personal gain. Had scientists truly believed in the scientific process and the search for truth, they would not have denied the contamination of their cell cultures with HeLa cells, rather they would embraced the idea that they were wrong and begun anew their quest for the whole truth. As it is, they were too worried about money wasted to see that they had discovered something that was not real. My last thought is just this, perhaps if people weren't so focused on personal gain, people wold be getting the healthcare that they need rather than going into debt to stay alive.
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