Sunday, April 14, 2013

Are Human Genes Patentable?


By Sharon Begley
NEW YORK (Reuters) - Soon after learning that his son had autism, Hollywood producer Jon Shestack ("Air Force One") tried to get researchers investigating the genetic causes of the disorder to pool their DNA samples, the better to identify genes most likely to cause that disorder. But his approach to scientists at universities across the country in the late 1990s hit a brick wall: They refused to join forces, much less share the DNA.

"Each thought they needed to hold on to it to publish and patent," Shestack said in an interview. "This seemed criminal to us."

The U.S. Patent and Trademark Office has granted patents on at least 4,000 human genes to companies, universities and others that have discovered and decoded them. Patents now cover some 40 percent of the human genome, according to a scientific study led by Christopher Mason of Weill Cornell Medical College. But if foes of gene patents have their way, that percentage could be rolled back to zero.
On Monday, the U.S. Supreme Court will hear oral arguments in a case that calls into question whether human DNA can be claimed as intellectual property, and remain off limits to everyone without the permission of the patent holder.

The lawsuit, filed in 2009 by the American Civil Liberties Union and the Public Patent Foundation, challenges seven patents held by Myriad Genetics Inc on two human genes linked to breast and ovarian cancer. A federal judge said the patents were invalid. An appeals court overruled that decision, and the case landed in the Supreme Court.

The legal issues center on whether the genes that Myriad patented, called BRCA1 and BRCA2, are natural phenomena. The ACLU says human DNA is a product of nature, and as such not patentable under the Patent Act. Myriad argues that its patents are for genes that have been "isolated," which makes them products of human ingenuity and, therefore, patentable.

As scholars debate the legal questions, two parallel issues have emerged: whether patenting genes thwarts scientific research, and whether it harms patients.

A coalition of researchers, genetic counselors, cancer survivors, breast cancer support groups, and scientific associations representing 150,000 geneticists, pathologists and laboratory professionals argue that gene patents can be problematic on both counts. The American Medical Association, the American Society of Human Genetics, the March of Dimes and even James Watson (co-discoverer, in 1953, of the double helix), among others, have filed briefs asking the court to invalidate Myriad's patents on genes called BRCA1 and BRCA2.

On the other side are Myriad and industry groups such as the Biotechnology Industry Organization (BIO) and the Animal Health Institute, which say that if gene patenting is ruled invalid, companies - with no guarantee they could profit from their discoveries - would stop investing in genetics research, to the detriment not only of patients but the economy.

SCIENTIFIC RESEARCH
Gene patent opponents say studies and surveys show that such patents tie the hands of scientists and thwart research.

A 2010 investigation by an advisory committee to the U.S. Department of Health and Human Services found that patent holders had barred physicians and laboratories from offering genetic testing for hearing loss, leukemia, Alzheimer's, Huntington's disease, a heart condition called Long QT syndrome and other disorders affected by patented genes.

In a 2003 survey, 53 percent of the directors of genetics labs said they had given up some research due to gene-patent concerns. And in 2001, 49 percent of members of the American Society of Human Genetics said their research had to be limited due to gene patents.

"The overabundance of gene patents is a large and looming threat to personalized medicine," Cornell's Mason said. "How is it possible that my doctor cannot look at my DNA without being concerned about patent infringement? Individuals have an innate right to their own genome, or to allow their doctor to look at that genome, just like the lungs or kidneys."
 
Mark Capone, president of Myriad's laboratory division, counters that gene patents, by rewarding research, help patients. He said scientific research has not been hindered by the biotechnology company's patents, citing 18,000 scientists who have published 10,000 papers on BRCA.
"These are among the most studied genes in the world," Capone said.
"We've been able to save thousands of patients' lives" by telling patients they have cancer-causing BRCA mutations, he added.

The BIO industry group supports Myriad, saying patents are crucial to "the development of therapeutic, diagnostic, environmental, renewable energy, and agricultural products," and without patent protection such scientific discoveries would not be made.

GENE VARIANTS

The BRCA1 and BRCA2 genes account for most inherited forms of breast and ovarian cancer. They can be used to detect risk, and aid in treatment options.

Myriad has sole access to its proprietary database of BRCA sequences, which show whether a particular DNA change is dangerous. In 2004, Myriad stopped sharing that information with a breast cancer database run by the National Institutes of Health. Capone said the company was concerned that the information was being used not for research purposes, as intended, but to guide patient care.

Critics say the move has impeded research on BRCA, in particular studies to figure out the significance of rare variants and how such anomalies interact with other genes to increase or decrease the risk of cancer.
"Myriad's exclusive control has led to the misdiagnosis of patients and has precluded the deployment of improved genetic tests," said Lori Andrews, a law professor at Chicago-Kent College of Law, who wrote the American Medical Association's brief to the Supreme Court.

Geneticist Wendy Chung of Columbia University Medical Center cites the example of three sisters who sent their DNA samples to Myriad for BRCA analysis several years ago. The result was ambiguous: the women had a "variant of unknown significance" so they elected to have prophylactic mastectomies in case the mutation was cancer-causing. The women were very unhappy when, years later, Myriad re-classified the variant as innocuous.

"I think we could have moved a lot faster if the country's scientific brainpower could have analyzed patients' BRCA" rather than rely on Myriad, said Chung. Independent scientists could have studied not only whether a variant is dangerous or benign but also whether that risk is modified by the presence of other genes — crucial information when a woman is agonizing over whether to have her breasts removed, she said.
Capone said Myriad was not familiar with Chung's patients, but when a woman has a BRCA variant of unknown significance, the company recommends that she be treated according to her family history - aggressively if many close relatives have had breast or ovarian cancer, conservatively if not.

Myriad acknowledges that it has restricted what BRCA tests patients can get. For instance, since 1996 its standard test (which now costs $3,340) has looked for simple mutations in the BRCA genes, analogous to a misspelled word. Until 2006 it did not probe for large rearrangements in the DNA, which are analogous to moving big blocks of text from one page of a book to another.

The company, which has a market value of around $2.1 billion, has seen its shares fall about 13 percent since the Supreme Court decided on November 30 to take up the case.

It won a similar case in Australia in February, when the country's Federal Court ruled that Myriad and Melbourne-based Genetic Technologies Ltd had the right to hold a patent on BRCA1. Trial judge John Nicholas found the material could be subject to a patent because it could not exist naturally on its own, inside or outside the human body.

The Australian findings are unlikely to influence the U.S. case. Justice Nicholas said evidence presented in Australia was different to evidence in the U.S. case, and there were also different constitutional settings for patent laws.

The case is Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al
(The story refiles correcting paragraph 25 to read "Until 2006" ... instead of "Until last year.)
(Editing by Howard Goller, Tiffany Wu and Gunna Dickson)


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Bradley Malave said...

It is quite bizarre to think that it would be possible for people to patent human DNA. I do on the other hand believe that it's a smart way for investors to make money. If a certain Genome is found that causes people to be smarter, taller, better looking etc. and figured out how to implement this into the sperm and egg so that the child could be selected into becoming what the parents wanted, this would be worth billions of dollars. In the name of science, I don't think it's wright to hold back that information because the more information that is provided for people to understand DNA then we can possibly figure out how to cure diseases as well.

Jeff Prizzia said...

I believe the subject of patenting human DNA is terrible. Human is a human, regardless of who they are or what they are. God did not put us on this planet to later have replications of human beings. The government has already messed up our seed for growing plant by patenting them. If human DNA is patent then this whole world will become nothing but machines. Manipulating such things like this will create a disaster later on in the future. I feel that the study of DNA has gone way too far now and must come to an end. There is a line to be drawn when it comes to schines and sometimes the government does not recognize that. We can find solution to curing life threatening diseases other ways besides replicating human beings and their DNA.

Jessica Alba said...

I feel that patenting or putting a price on anything human has such a negative connotation in history that patenting genomes or DNA will never be fully accepted. Not to compare it to such extremes, but to say someone owns or has the rights to any part of another humans body brings up unhappy thoughts of slavery or prostitution, in other words, dehumanization. While patenting DNA may help scientific advancements in curing cancer and other diseases, I don't think it is right to label a part of another human being as your own. The article showed a good point- what if a doctor decides to withhold important information about your own body for fear of copyright infringement. Due to this, I must say that I agree that just like hearts, lungs, and other body parts, DNA cannot hold a label and a price over it.

Alexsys Grishaber said...

I believe that this a great study that we have discovered. It awesome to hear about what the human mind can find out. However, i believe that isn't something we should become to familiar with. People could depend on this way too much and it can lead to bigger problems that we probably aren't ready for. I just believe with this type of project we lose our self humanity with it. Every family in the world would be trying to change or alter something and that just isn't right. Sometimes technology can be a bad thing even though it helps us tremendously.

James Ward said...

The idea of human gene patents at first seems monstrous. However the argument that the specific gene could not exist on its own, in or outside the body, making it a product of human ingenuity is valid. But if these patents hinder further research on a wider scale then maybe they should be found unconstitutional. After all the purpose of this research in the first place is to progress human health and society, not for a specific group to profit.

Remy Gallo said...

I think it is absurd that a company can put a patent on something inside your body. If Myriad couldn't make money off of their discovery then many more people would be able to take the expensive test and their lives should be saved. Also, if the test they invented wasn't patented then other companies could do it. I understand that everything is about money nowadays but it seems only fair that everyone should get treated for their illness without having to worry about money. The scientific research shows that 53% of lab directors have given up research because of gene-patent concerns. If someone wants to be recognized for discovering a gene I can understand that, but I hope the U.S supreme court makes the gene open to everyone for investigation. It is in the interest of society.

Christina F said...

It is absolutely criminal that there are actually patents on human genes. The whole point of research is to be able to find out what causes these genetic disorders and mutations and discover how to prevent this from happening in the future. Research is meant to help save and improve human life, not help companies rake in obscene amounts of cash. I can understand that the patents offer a monetary incentive to scientists and labs to help promote research, but these patents should not instill the need for researchers to hoard and monopolize information. We are all in this together, and in order to find cures and causes for various illnesses, scientists all around the world should have equal access to crucial information.

Kay Mahoney said...

This is a very interesting debate because, while a patent on DNA would seem like a violation of human rights, the genome was separated by the scientists and is no longer something that could exist in nature without their procedures. The issue reminds me of many discussions that occur with the idea of free health care in that scientists, like doctors, would no longer have incentive to do research or find cures if they are not being credited or compensated for their work. However, from the article it appears as though such patents can be just as harmful because it limits the access (and therefore probability) of other scientists finding a cure. In matters of health, I believe situations should be approached not on a scale of profit, but on what benefits the people and yields the best results for the betterment of society. I wouldn't be surprised if the court ruling resulted in protection of the patents, however, because it seems as though government almost always allows for the security of profit to trump the security of the people.

Jessica Y. Sanchez said...

We live in such a capitalistic world that the greater good of mankind is being put on hold because of another’s greed. It truly sickens me to think about the time that has past, the cures that could have been found, and the lives that could have been saved, if Scientists were allowed to move freely and without the worry of a net gain. Although in an open-access market there is room for abuse, but I think guidelines should be met and rules should be implemented, but I don’t think the greater good should be totally be conducted as a money market business. Companies should not be allowed to hold rights to a particular DNA, in essence you are asking for DNA to be an open-access market, but it isn’t totally open access because the typical Joe isn’t going to spend money to buy the rights to DNA. I’m not sure if anyone is aware of Henrietta Lacks, but she was a woman whose cells were taken without her knowledge and helped create so many vaccines and advance knowledge. Her cells were so special because of their ability to multiply and live outside her body. Her cells’ being obtained without her knowledge was not right, but imagine if her cells were patented. Medical and Scientific advances such as gene mapping, research in Cancer, AIDS, the effects of radiation and toxic substances might have never occurred. So, I am completely against DNA being patented; it’s wrong.

Tamir said...

I almost find it hard to believe that such a large percent of the human genome is patented; I believe that our genes are belong to each individual, as we are born with them and created from them. It is also disturbing that the patent holders gain the right to block doctors from diagnosing patients better and can influence the treatment of cancer patients. I believe that another reason genes shouldn't be allowed to be patented is because it is illegal to patent a natural molecule. "Trial judge John Nicholas found the material could be subject to a patent because it could not exist naturally on its own, inside or outside the human body." This does not make sense, because it is still naturally occurring in all life on earth.

Thomas Midolo said...

Human genes are meant to belong to whoever they were a part of. This is what makes people and the world diverse. This is what makes everyone different and makes people who they are. Patenting genes and implanting them in other humans is just unethical because you are taking a part of another person and giving it to someone else. We found ways to make everyone exactly like each other as possible already, now we are finding ways to make them identical to one another and patent their genes? This is not right. Medical reasoning is slightly different because if giving a gene to another person will make them stay alive longer or allow their quality of life to improve, then there should be certain circumstances to allow this. However, genes and individuality are the one thing government cannot take from you and should not take from you.

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Nikita Iyengar said...

I don’t think it should be made possible that human genomes can be patented. This is because through this article you see the negative outcomes, such as research being limited due to gene patents. It is a problem when a doctor cannot even look at a persons DNA because he may be worried about patent infringement. This is getting in the way of doctors helping their patients, and could have very negative effects if a disease could have been stopped earlier by examining the DNA, but didn’t because of a patent. People have a right to their own body and everything that it encompasses, including their genes, and they should be entitled to have their genes looked at it they feel necessary, and to have a law or patent that doesn’t allow them access to what is already theirs is just outrageous.

aziz savadogo said...

This is yet another example of big pharma,or in other words, hot to commercialize every aspect of a human being health.Applying patents to human DNA is not the best way to save thousands of patients' lives, but rather a great way to make money. Since the genomes are for diseases that affect women, patents would prevent most women from even knowing if they should seek treatment or not because of the high cost of the standard test (3340$). I agree that the company should be fairly compensated for its research, but I dont think they should have exclusive rights over the information as too many women who need the information unfortunately cannot afford the test.physicians and laboratories should instead pay a fee everytime they acess the database

Christie Homberg said...

The possibility of patenting human DNA sounds like something out of a science fiction film, and it's crazy to think that technology has come this far. I really hope this doesn't become something that is mainstream or regularly practiced. Our society has been increasingly consumed in the theme of "nature versus technology", and with an advancement like this the balance would definitely be tipped in favor of technology. This really just seems more of a way for investors to make money more than anything else.

Jaclyn Barbato said...

When something is pertaining to human health, no patent should get in the way of further research, especially when that research could lead to a cure. They claim that by removing patents, no company with the financial means would invest in medicines because they are not guaranteed a profit. This is an absurd theory. The patents should be lifted so that those who don't solely have profits on their mind can work towards a cure. Otherwise, these companies should be made to take an oath, the same way doctors are required, to make these patents available to people who will not discriminate based on profits.

Laura Sorrentino said...

The notion of patenting DNA sounds ridiculous. Aren't you supposed to patent ideas? or inventions? Human genes are definitely a part of nature and we did not create them. Yes, we've stripped them and modified them, but we did not create them. So patenting DNA would kind of be the same thing as patenting air or water right? That just sounds stupid. Although these companies have a defense and the patenting may be used for good, there still is no defense that is good enough to justify the failure to help people when they're in need. I believe patenting DNA will do more harm than anything else because any holder of DNA can choose to do with it which they please. This means that if a certain gene can assist in the healing or cure of a disease, the patent holder can change an outrageous amount of money for them to use it or can decide not to let them use it at all! That is so unethical. And in addition, many cures have been declined or have not been able to be tested because of these patents. DNA is what we are made of and if 40% of the human genome is patented, then where does that leave us? Controlled and shit out of luck especially when it comes the time that we will really these genes available to us and not just sitting there because someone decided it was okay for people to own them.

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