Posting in Cancer
Myriad Genetics claims it 'owns' a genetic mutation linked to breast cancer -- ownership gone too far?
Reports from Australia have indicated that lawyers representing a U.S. biotechnology company have defended the grant of a controversial patent over a common genetic mutation linked to breast cancer.
Rejecting the idea that patenting a genetic variety within the human body is the first step to privatizing individuals, the court case involving the U.S. company, Myriad Genetics, is being anxiously followed by patient groups, legal teams, healthcare professionals and public figures.
Myriad Genetics aquired a patent for the BRCA1 breast cancer genetic mutation in 1994, based on the terms that could be considered an 'invention':
"Removing it from the body changed it chemically, structurally and functionally."
Myriad Genetics reportedly tested 'thousands and thousands' of people in order to identify the mutation within a cell genome, and the case hinged on the key point that once the isolated nucleic acid is removed from a body, then its chemical construction is different. Therefore, once removed, it can be considered an invention rather than a natural body chemical.
Not everyone agrees. Rebecca Gilsenan, principal lawyer representing Cancer Voices, said that the gene's key components, its chemical structure, is not changable depending on its location. Therefore, the genetic mutation should be considered a discovery, and not an invention.
If the gene discovery remains patented, then it is possible that a trend of 'body patents' may come into being -- and this could affect future patient care, rather than only cancer tests. In 2008, a Melbourne-based company that owns the Australian rights to Myriad's genetic patent contacted eight laboratories that were conducting cancer tests, insisting that all future tests would be conducted by them only -- as per their patent rights.
In the face of a Senate inquiry and public fury, the company backed down -- but not before the issue of such patents was brought to light and the motion to ban such patents was sought.
In 2010, this patent was overturned by a court based in the United States, and it has now been reversed by appeal, with the possibility of going further to the U.S. Supreme Court.
Is the genetic mutation a discovery, or an invention?
Image credit: Zitona
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That all those blood tests, mole removals, anything that passed through any lab may still be kicking around years later. Used for many different purposes, teaching, replicating, yes, cloning cells. Bits of you may live forever in labs. There is a famous line of cancer cells, taken from a patient and without her knowledge used in labs from Siberia to Florida to develop cancer treatments that have netted millions if not billions for the labs that produce them. Patient died in poverty and her family is entitled to none of it. This is not a new subject, just a new application.
Patenting the process is one thing, trying to patent the underlying gene is another and wrong both in law and in nature. The patent office, whether through ignorance or collusion, erred in granting a patent on the gene. In the Patent Law legal sense, a "discovery" of a naturally occurring substance, or process, in nature is not patentable. It's as simple as that. Here's hoping the Supremes get this right in a way that helps deal with the rest of the Patent mess as well.
Patenting the various parts of the human genome is akin to patenting the ABO blood type. Imagine how much more expensive a transfusion would be if one "manufacturer" had exclusive rights to type O (-) blood. Infants would suffer. There would be "shortages". It goes on and on. No, I don't think genes should be patented. Only the process of isolation (of which there are several) should be. Specific chemical modifications should be patentable as long as they are not already naturally present. If there were true ethics in the biologic agent sphere, they would take a good example from Dr Jonas Salk. His pursuit was elimination of polio, not earning money. How pure are the intentions behind patenting genes?
hmmm --- "the case hinged on the key point that once the isolated nucleic acid is removed from a body, then its chemical construction is different" If that is true then all they really have ownership over is something outside of the human body. If they claim that outside of the body it is chemically different - then they own nothing WITHIN the human body. Seems to me the company doesn't want to own the body so much as own a certain way of fighting a cure outside the human body. Of course they have to find the cure first. When dealing with medications in general - a Drug/Health company must patent their new compound/molcule from the beginning of the research. They may go thru as many as 10,000 patents before finding even one that can be brought to market. There may be as much as 20 yrs research - development and testing before going to the FDA. what we should be looking at is the process and how the company is hindering the health of all in general. If they do not allow others to use their out of body invention to find ways of combatting its growth then they risk the lives of millions. Unless they are willing to put Billions of dollars into finding a way to combat it themselves - they are endangering life itself.
No one thing that is not created by a human or corporation should be patented. Mutated genes, unless the mutation is caused by a company or person (and who would want to claim they created a cancer causing gene!) should be patentable, period. I am beginning to think that not only the general population is getting dumber as time moves forward, but those in the courts are as well. The lack of a good education is going to deal us all many headaches. Hope logic and reason survive.
And it shows up in one of my family as a cause of disease - I will be bringing a lawsuit for negligent attempted homicide for not controling it properly. Seems only fair. If they own it, they are responsible for the damage it causes.
What moron judge would let that happen??? Seems like we have to beat the sence into these golddiggers.
I don't think that patenting the BRC mutation is valid in that the BRC mutation is a previous art (?) that existed before discovery. The same goes for any naturally occuring bit of genetic material. What could be invented would be a non natural combination that acts like a gene. The real problem is that we are all caught between profit oriented medical care and a natural need for help in healing. This is a short term way of thinking and fails to work in the long term.
No one should be able to patent the DNA of another person. DNA & all our genes belong to each individual person!
So if this patent is approved, then everyone that has had this mutation leading to breast cancer should sue them for pain and suffering!!!
The basic problem is that when the patent laws were written, not much was know about genetics--thus if you bred or found a particular trait, you could patent it. As things went on, it became more important to know which genes controlled the trait--you could no longer patent the entire organism as easily. Copyright/trademark/patents all need to be re-worked as things have changed a lot, and are changing more daily. Copyrights & patents are TEMPORARY monopolies granted by the State under the condition that you disclose the invention. Over the years, the actual 'disclosure' has been ignored by the office--disclosure means you should be able to replicate the device from the patent filing, but for decades most patents have been written to obscure rather than disclose details...such patents should never, by rights, been issued. The purpose is to get inventors to disclose their inventions to encourage others to developed improve them. Like many government intents, this has been subverted by private interests. One change which would be a vast improvement (besides ensuring that documentation really does 'disclose' the invention,) would be to stop treating IP crimes as civil matterrs and treat them as the criminal theft that they actually are. By treating them as civil matters, whoever has the deepest pockets will win..small companies & individuals generally lose such cases because they run out of money, whereupon they are bought out cheaply. This is because civil suits are brought privately and each side pays their expenses, with the winner usually getting their expenses paid for by the loser. Criminal cases are handled quite differently, since crimes are by definition acts against the State, as well as the involved victims. Criminal cases are prosecuted by the government, and the responsibility of the complainant lies primarily in providing the government with sufficient evidence of violation for prosecution. A patent holder is assumed to have a valid claim until proven otherwise (since the government awarded them the patent.) Our most recent travesty in patents is the change from 'first inventor' to 'first filer.' This change makes it extremely easy to use industrial espionage to steal other's work, as most complex patents require quite a bit of work to bring to market. As with other changes, this favors the larger companies. Patent periods should probably be expended, since the 20 ears of a patent is just about equal to the time it takes to move new developments from lab to market. Periodically there are pushes to increase copyright--currently to forever. But the purpose of copyright is again, to encourage distribution of the work and encourage others by providing a period of time in which you hold a monopoly, so as to provide compensation for the creation. Copyright, designed to protect the creators of work, was rapidly subverted quite early on by publishers, who, finding that creators were usually broke, began buyng all rights for a single one-time fee...thus becoming the owner of the copyright with the exploitation monopoly. (Poe's "The Raven" produced some income for him as he read the poem in theaters for audiences, but like most of his work, the real earnings went to the publisher. Some parts of the publishing world still operate under this model--most regrettably in the publication of scientific papers, since distribution of such work is vital to the advancement of science, and is furthermore time-critical. This capture of the information makes the cost of doing research much higher, drive individuals out of research because without money, there is no access to the current work, and this know way to integrate new findings into your research. Spider Robinson made the observation many years ago, that because music is a subset of sound determined by largely physical and mental characteristics of humans, the number of different patterns of music is limited, thus, if copyright is extended too long, there will be no available music copyrighted. My thought is--if you want to copyright the genes which cause cancer, then you should become responsible for the damages done by your 'invention.' This is in line with my feeling that if you want to prevent abortions, you should personally be held responsible for the care of unwanted children. If you claim the mineral rights and mine the land, then you are responsible for ensuring that your actions do no damage to others. It only makes sense that those who benefit from the exploitation of resources be held responsible for all costs incurred due to that exploitation...an idea which would hold oil companies responsible for their oil cradle to grave, air/land/sea pollution and all. None of these are likely to happen, because government's primary purpose is to move public resources into private hands while leaving all of the responsibility and costs of clean-up to the public--who nearly always sold the resources for tiny percentages of their true value...because public property sales are made by individuals within the government, who are very interested in personal profit.
If they own the patent for the breast cancer genetic mutation, does that mean my mother can sue them for allowing her be given that mutation without her consent? No, then you don't own the mutation, do you?
As a naturally occurring chemical it is a discovery. The use of that chemical in a NEW was would be an invention. If, however, they are simply using the chemicals in the exact same way that a body is already naturally doing it, then its merely a discovery. For example: Scientist notices that a chemical has an effect on tissues. Scientist then applies that same chemical to a different set of tissue where for whatever the reason it does not naturally occur. THAT is an invention. Applying the same chemical to the same type of tissue in a different body where that chemical does not happen to be occurring is just discovery. Slight problem here. If a company has no way of making money of a discovery that has value, why would you expect them to develop it? The proof that something is working may cost a considerable sum to do. The delay of the release of the discovery may cost many lives that could otherwise be saved or improved. We need to find some kind of balance here. Perhaps a shorter lifespan patent that would allow a company to recoup costs and make a reasonable profit?
The late author Dr. Michael Crichton addressed this in an op ed editorial in 2007 (http://www.nytimes.com/2007/02/13/opinion/13crichton.html) and Dr. Robin Cook addressed this in a novel, Marker, published in 2005. I liked the resolution of Dr. Cook's book.
So, if they want to claim ownership, if I or my wife ever contract that specific type of breast cancer, can we sue them for not controlling their gene?
Than get it straight. MY BODY invented it. You discovered it. I will take my royalties as a bank check please.
A patent is supposed to be granted for an invention (a device, contrivance or process) of which a naturally ocurring gene sequence is not. The work (gene sequence) pre-existed any attempt to synthesize it. The process by which it was isolated is patentable but the actual sequence should not be. Otherwise, someone is going to try to patent "chemistry" as a whole. ! Personally, I would like to patent the process of the Earth revolving around the Sun ... think of the potential derived income from owning the patent rights to that. Farming, Solar Power, even Life itself would be subject to royalties payable to me ... mwah-hah-hah!!! The twits!!
I swear to God (as funny as that sounds) that members of the legal profession should be banned from participating in any natural science based case that they don't hold at least a bachelor's degree in. That includes, judges, lawyers, and jurors.
A product such as the seeds of manipulated plants that produce new fruits, or chemicals made from the new cellsto be used for a specific purpose should be patentable, but not the gene sequences used to derive them. Research into new uses for those sequences should not be affected by existing patents on the sequences themselves.
If it isn't a discovery it should not be patentable because it was previously revealed prior to obtaining the patent by those in whose bodies it was found and those who found it there and who isolated it by the same methods as those who obtained the patent.
It should be illegal to profit off of other peoples disease or misfortune. I'm all for making progress in medical science, but to make a business out of it and patenting parts of the human genome is just wrong. Information on such things should be given freely to the public and not held behind closed doors. There really is no current way to stop big business from selling you some "long term relief" instead of an actual 'cure' when the relief is just the moral equivalent of the 1800's snake oil. They would rather have long term profits and have people as slaves to there 'relief' then actually cure anybody... A$$h*le$!
This is just another example of how the patent system is twisted an broken. It's another example of the abuse of patents against the world in general. What do we need to prove this further in this case? Someone to buy out those patents and sit on them like most other patent trolls do, allowing nobody to do anything except pay through the nose? It would be too easy to keep others from actually finding a cure, while they just sit back and collect from treating the symptoms. Something that isn't impossible anyway, as rumors say pharms are already cashing in on that tactic, knowing the cure would not bring them a steady flow of cash for stockholders, and huge bonuses for executives. The Mutation is a naturally occurring problem that results in a disease (Cancer) unless they also want to take on the responsibility of it in the world too. (I'm not talking suing cancer victims over something they have no control over either.) They want the patent? Fine, let them flip the bills for all cancer victims related... and they better NOT game the system for sub-par care/treatments. But they better not claim ownership over a person either (OR their body parts)
It's a discovery, not an invention. You cannot patent what mother nature does. Now, you could patent a test for the mutation, as that is something that is developed by a person or company, but not the mutation it's self.
Nothing. Between taxes (a recurring fee for properties you are supposed to own, but can easily lose or have rights restricted on if not paid), trademarks that can interfere with even using your personal name, and corporate entities who could care less about anything that doesn't make them richer, buying anything they see that may be of value... that leaves us with the only thing we can own is our own INTERNAL thoughts (but for how long before someone institutionalizes thought police?) and now obviously, our own bodies are starting to be owned by these money-loving (and power hungry) corporations... So in essence we own nothing.
Only genes created by a human or coporation should be patentable. Existing genes should not be, as they were created by Nature and not man. Patents, I thought, where designed to help protect the work of those who invented or created - not to allow everyone to lay claim to what has already been created in nature. Only Nature would have any right to claim such patents, should Nature wish to do so. So far, Nature has shown no such inclination. :)
How are copyright and patent infringement acts against the state? The state doesn't own the patent or copyright, it merely issues them. If, as you recommend, we get patent and copyright law modified to more realistic ends, the point is moot anyway. Other than that, good post.
What the patents don't cover, is made up with copyrights where they can get away with it... allowing for no derivatives. Corporations have greased the wheels of governments to rewrite patent and copyright law to the point of indefinite lifespan/monopoly status, and where they haven't they have taken advantage of overworked USPTO employees to pass generic, abstract, and obscure processes and data to get it.
Human life is real money is merely an abstract idea we use for trade. It's obvious what's more important. Medicine should be completely publicly funded period. No one should die because they are poor. Come on every small child knows this to be self evident, people (mostly Americans) somehow let themselves be conned along the way.
Good points but I have to disagree that applying a chemical to a different set of tissue is an invention, this describes a therapy. Finding a chemical is a discovery, the method to make the chemical would be a process that can be called an invention, but the chemical itself is still a discovery. I have heard of other cases where a discovery of a gene defect led to patenting the treatment of that gene. The case that I remember involved the patient trying to get royalties from the company that developed a therapy using bits of tissue taken from the patient; the case was denied and the company allowed to sell the therapy.
If they "own" this mutation, then they are liable for any damages caused by that patent. If I design and patent a drug and everyone who uses that drug dies or incurs a significant financial obligation, then those damaged by my patent are due compensation (or their estate). Especially if they knew about the problem. Since it is a form of cancer, they "know". Since they are apparently using their patent to prevent the development of a cure, they are doubly liable for the intentional causing of damage. (Stupidity and Sarcasm Off!) I don't see how someone can patent something that existed as a publicly known "item" for years before their alledged discovery and patent. UGH! Scott
Also, as an after-thought, a patent has to be enforceable and "defended" (the patent owner has to stymy any attempts to use the patent without their permission). OK, try out this scenario ... I have the gene sequence you patented and as I result, I have breast cancer (for this example) and I'm not going to pay royalties ... go ahead, re-possess my cancer as payment for back royalties! LOL!
our own internal thoughts can be viewed as intellectual property and there ARE patents and laws to protect that.
I don't see how someone can patent something that existed as a publicly known "item" for years before their alledged discovery and patent. Next thing you know they will allow patents for a "rectangle with rounded corners"