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Breast Cancer Gene Lawsuit Argues Patents Invalid

bkuhn writes "The ACLU and the Public Patent Foundation have filed a lawsuit charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid. The lawsuit (PDF) was filed on behalf of four scientific organizations representing more than 150,000 geneticists, pathologists, and laboratory professionals, as well as individual researchers, breast cancer and women's health groups, and individual women. Individuals with certain mutations along these two genes, known as BRCA1 and BRCA2, are at a significantly higher risk for developing hereditary breast and ovarian cancers."

73 of 294 comments (clear)

  1. I don't understand it. by FlyingSquidStudios · · Score: 4, Insightful

    Can someone explain to me why it's legal to patent genes in the first place? I thought patents were supposed to be for new and unique inventions.

    1. Re:I don't understand it. by Duradin · · Score: 4, Informative

      Monsanto would be the one to ask about that.

    2. Re:I don't understand it. by click2005 · · Score: 4, Interesting

      IANAwhatever but I thought what was patented was the way these genes are found/isolated. Any drug/treatment that affects these genes will use that method.

      --
      I am a free slashdotter. I will not be modded, blogged, DRM'd, patented, podcasted or RFID'd. My life is my own.
    3. Re:I don't understand it. by ByOhTek · · Score: 4, Insightful

      It depends. If it is a gene you yourself designed, then it is a reasonable target for a patent (or, more likely, copyright). However, if it's a gene that occurs in nature, then it makes no more sense to patent that gene than a species of plant or animal, a rock you found walking into work in the morning, an ocean or a star (stellar, not media - actually, maybe both would make sense, thought the latter isn't natural).

      --
      Self proclaimed typo king, and inventor of the bear destroying coffee table (patent not pending).
    4. Re:I don't understand it. by HomelessInLaJolla · · Score: 4, Informative

      These patents do not cover only the gene sequence. These patents often are related to the methods by which the gene sequence was identified within the particular culture of cells from which it was taken. The patent may also cover the methods by which those cells were cultured or the methods by which those cells were derived from other cell lines. The patents also may cover the methods by which this particular sequence may be used to identify other tissues containing cells which, by matching this sequence, will match the cell line from which the sequence is derived--thereby solidifying the position of the inventors if a diagnostic test were to ever be developed. For example, in a question of a patient population with multiple cancers, or with multiple different forms of the cancer in question (breast cancer), are those patients viable candidates for treatment with a pharmaceutical which was developed specifically to target the cancer which is characterized by the DNA sequence given in this particular patent? We wouldn't want to develop a pharmaceutical to treat cancers characterized by sequence ABC and then give that pharmaceutical to patients with a similar cancer displaying sequence CBD.

      These are all very logical reasons why these patents exist. If you know how the industry works, though, none of them really hold any water in true practice. Patents are nothing but resume boosters for scientists and the patents rarely, if ever, actually monetarily benefit any of the named inventors except for the lead investigator(s). If you are socially and financially well-connected to begin with then your patent may help you. If not then the patent is the legal paperwork by which the company or group you worked for can use to cut you out of all profits. In most companies a large number of patents will translate into a significant salary increase or a promotion for the lead investigators but translates into little more than a token fee (usually around a dollar, or a single option of stock, or something similar) in exchange for which the employee signs away all rights to claim ownership of their own work.

      --
      the NPG electrode was replaced with carbon blac
    5. Re:I don't understand it. by fastest+fascist · · Score: 3, Insightful

      It depends. If it is a gene you yourself designed, then it is a reasonable target for a patent (or, more likely, copyright)

      Combine that idea with artificial, hereditary traits (designer kids etc.), and you have people who need permission from their friendly gene provider to reproduce. Bring on the GIAA lawsuits! Can't have people passing on copyrighted genetic material without authorization!

    6. Re:I don't understand it. by corsec67 · · Score: 2, Funny

      Monsanto sues God?

      --
      If I have nothing to hide, don't search me
    7. Re:I don't understand it. by drinkypoo · · Score: 5, Insightful

      I don't remember electing Monsanto. Perhaps we should be asking our elected officials why Monsanto is permitted to continue to exist after their numerous offenses against not just the citizens of the USA, but actually humanity. Even Wikipedia seems to have forgotten the contaminated agent orange thing :P

      --
      "You're right," Fisheye says. "I should have set it on 'whip' or 'chop.'"
    8. Re:I don't understand it. by starfire-1 · · Score: 4, Interesting

      I have a sneaking suspicion that you are right - this isn't about the gene itself, but how to isolate/observe, etc. That process could very well be an invention and it certainly cost R&D money to the original developer.

      I guess the question comes down to whether patent protection for health related concerns should be exempted as some (not myself) consider health care a right (I consider it a need and responsibility to procure, but not a right that I expect others to provide for me.)

      The plaintiffs are clearly attempting to use this case to overturn all health related patents (in the article) and in my opinion pull health related research from the private sector to the public sector. This would bolster the advocates of national health care and create another (unwritten) constitutional right.

    9. Re:I don't understand it. by Organic+Brain+Damage · · Score: 5, Insightful

      "Your" elected official? Did you give "your" elected official more money than Monstanto gave "your" elected official? I didn't think so. So she is not really "your" elected official. Is she? Of course not.

    10. Re:I don't understand it. by nomadic · · Score: 4, Insightful

      I don't remember electing Monsanto. Perhaps we should be asking our elected officials why Monsanto is permitted to continue to exist after their numerous offenses against not just the citizens of the USA, but actually humanity. Even Wikipedia seems to have forgotten the contaminated agent orange thing :P

      Because the elected official then turns around, quotes the Bible, and promises to lower your taxes, and you vote for him or her.

      Anyone willing to limit corporate power is typically not elected, and not because Monsanto gave them money but because of tax-cut and deregulation fanaticism.

    11. Re:I don't understand it. by Anonymous Coward · · Score: 2, Funny

      God countersues - what a patent portfolio. Oh, wait, are there any lawyers in heaven?

    12. Re:I don't understand it. by giminy · · Score: 5, Interesting

      Can someone explain to me why it's legal to patent genes in the first place? I thought patents were supposed to be for new and unique inventions.

      You don't patent the gene, you patent the process of identifying and using knowledge about the gene.

      The reason that it's legal to 'patent genes' is that is very, very, very (did I mention very?) expensive to discover which gene(s) control an aspect of a plant or animal. My girlfriend is a molecular scientist, so I get to hear about her research woes all of the time. Without some protection of a genetic discovery, it makes no financial sense for a company to actually do the research and discover which genes control an aspect of a plant or animal's composition. A discovery takes at least 5-6 years of research from several researchers, associated support staff, and requires some fairly expensive equipment.

      There seems to be a lot of people calling Myriad a big, evil, genetic patent holding corporation. All that I can say is, look at their financials. They spend hundreds of millions of dollars per year doing genetic research, and they make very little money in return for their investment. When I last examined their financials (beginning of 2008 I think), they had been operating at a loss since they went public. They are advancing human knowledge quite a bit, and they will probably go out of business for it within a few years. I posted their financials to slashdot some time ago (feel free to look up their tax forms, they're a publicly traded company). In 2007, they reported a huge operating loss and came out and said in their disclosure that they are in business because of continued shareholder investment.

      I, for one, see genetic patents as a necessary evil. If someone or some company is going to take the time and money to make a genetic discovery, they ought to be given some time to try and profit from that discovery. Genetic sequencing is not a quick nor an easy task -- there's a lot more to it than just throwing some genes in the PCR machine and pushing the 'sequence' button. For what it's worth, my girlfriend is also a likely candidate of the BRCA1 gene, as every female in her family that has been tested for it, has it. She is still okay with genetic patents. And no, we're not cold, heartless capitalists...we shop at the co-op, have a garden, brew our own beer, make our own biodiesel, and do all the things that good hippies should do...it's just that without Myriad, *no one* would know that having the BRCA1 gene was a precursor to breast cancer.

      Reid

      --
      The Right Reverend K. Reid Wightman,
    13. Re:I don't understand it. by RawJoe · · Score: 5, Informative

      One of the patents cited was 5,747,282.

      Claim 1 states:

      1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2

      I'm not any genetic engineer, but it seems they are receiving a patent on the specific DNA coding. So did they "discover" the code or is this code used to locate BRCA1? Seems pretty broad.

      --
      ?
    14. Re:I don't understand it. by Duradin · · Score: 4, Insightful

      And this is where someone should point out that this would be an excellent reason to support government funded general scientific research.

      It's expensive, offers little return on investment monetarily but could greatly benefit the populace.

      Corps aren't shelling out the cash like they used to on research that wasn't going profit the shareholders within a couple of years.

    15. Re:I don't understand it. by osgeek · · Score: 5, Insightful

      Or your elected official promises to tax the rich and give you free health care, and you vote for him or her... then turns around and behaves in exactly the same corrupt way that you expected "the other team" to behave.

      Despite that identical outcome, you'll pat yourself on the back that you elected the team that says the right things with Olberman cheerleading you the whole way - while Sean Hannity and his players are gnashing their teeth and decrying the corruption that was okay when it was their guys.

      Montasano gets rich, the Politicians get rich, freedoms and quality of life issues suffer... but at least you get to hate those other guys.

      We are so fucked.

    16. Re:I don't understand it. by DrOct · · Score: 2, Insightful

      Did "you" vote agaisnt that elected official? Did "you" work to campaign against that person? Did "you" campaign for another candidate? Did "you" do anything other than complain about Monsanto giving money to elected officials? If not, then yes they are "your" elected official.

    17. Re:I don't understand it. by osgeek · · Score: 2, Interesting

      That should really be the default for everyone in all societies. Maybe set up a licensing system. I think it was Steve Martin in Parenthood who said something like: You have to get a license to fish, drive a car, or fly a plane - but any moron can become a parent.

    18. Re:I don't understand it. by DrOct · · Score: 3, Insightful

      You know, I agree that there are probably some "rights" that aren't in the constitution, and that perhaps we don't have the "right" to, but the 9th amendment was put into the constitution for a reason:

      "The enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people."

      Just because it's not specifically mentioned in the constitution doesn't mean we can't determine that we do in fact have a given right, and the founders certainly understood this, or they wouldn't have bothered to add that amendment.

    19. Re:I don't understand it. by osgeek · · Score: 5, Funny

      Dude, don't come to Slashdot and make some logical argument about the good side of gene patenting and how this might be a complex issue where the knee-jerk reaction of "patents are bad!" might not apply.

      Before your little intellectual escapade, everyone was having a nice circle jerk criticizing the evils of human greed to try to make a buck based upon little knowledge and much angst.

      Your kind of informed opinion isn't appreciated here!

    20. Re:I don't understand it. by Scrameustache · · Score: 3, Informative

      I have a sneaking suspicion that you are right - this isn't about the gene itself, but how to isolate/observe, etc. That process could very well be an invention

      Everything I read says the patent is on the gene.
      http://www.wipo.int/wipo_magazine/en/2006/04/article_0003.html

      "Myriad holds U.S. patents 5747282 and 5710001 on the isolated DNA coding for a BRCA-1 polypeptide and on a screening method."

      Ah, AND on a screening method. Patents on human genes (isolated DNA coding) make me confused; wary.

      --

      You can't take the sky from me...

    21. Re:I don't understand it. by Daniel+Dvorkin · · Score: 4, Insightful

      Without some protection of a genetic discovery, it makes no financial sense for a company to actually do the research and discover which genes control an aspect of a plant or animal's composition.

      Which is why most such research is done in university labs, not corporate. There has been for decades a perfectly good method of advancing scientific knowledge and turning it into usable technology: academic researchers, paid primarily with public funds, do the basic science, and that fraction of it which turns out to be commercializable gets taken up by corporate engineers. This balance started to fall apart with Bayh-Dole and Diamond v. Chakrabarty, and things have been getting worse ever since.

      --
      The correlation between ignorance of statistics and using "correlation is not causation" as an argument is close to 1.
    22. Re:I don't understand it. by maxume · · Score: 2, Interesting

      Except farmers fucking looooove Roundup Ready crops.

      I don't mean all of them or anything, I just mean the vast, vast majority of them. By the time they have fertilizer, time and fuel put into the land, licensing the seeds and spraying the herbicide are details.

      --
      Nerd rage is the funniest rage.
    23. Re:I don't understand it. by gambino21 · · Score: 5, Informative

      I think this is what you were getting to, but I just wanted to clarify. The constitution actually doesn't grant us any rights. By default you have the freedom to do whatever the hell you want, and the only thing the government can do is decide which of your innate rights it wants to take away. The founders understood this and argued about whether a bill of rights was necessary, because all it does is state rights that we already have. The first ten amendments don't actually grant us any new rights, they only list rights that the government is not allowed to take away.

      It's too bad that most people don't understand this and believe that they only have the rights that they are given by the government. It should be the other way round, meaning you have all rights except for those that the government explicitly takes away.

    24. Re:I don't understand it. by drinkypoo · · Score: 5, Insightful

      Not my elected official, ours. While you are technically correct, attitudes like yours are self-defeating. We make them our official again by holding them accountable. We begin by making people aware of their culpability.

      The greatest trick the two-party system ever pulled was convincing voters that voting for "third" parties is a waste.

      --
      "You're right," Fisheye says. "I should have set it on 'whip' or 'chop.'"
    25. Re:I don't understand it. by stranger_to_himself · · Score: 2, Informative

      I have a sneaking suspicion that you are right - this isn't about the gene itself, but how to isolate/observe, etc. That process could very well be an invention and it certainly cost R&D money to the original developer.

      You are both wrong. In the US genes can be patented and then any future therapy based on targeting that particular gene falls under the patent.

      This is not the same as patenting a process or a particular therapy, which most people (myself included) would argue is reasonable use of a patent.

    26. Re:I don't understand it. by TooMuchToDo · · Score: 5, Insightful

      As an IT professional/business owner who took up farming for the fun of it (124 acres to start, slowly buying up more land), farming is like owning a vineyard. You barely break even most years. So do I blame farmers who are trying to make their lives easier with Montasano products? No. I do blame Montasano for their practices, and because of that don't use their products myself.

    27. Re:I don't understand it. by shaitand · · Score: 2, Insightful

      Isn't the cost of the seed that people are upset about. It is the vicious seed company that first of all has the audacity to patent and license life and then has the nerve to punish farmers who dare to produce seed from their own plants. Last but not least they prosecute everyone who ever thought about buying or selling a seed and many who didn't.

      There have been thousands of small shops that don't even sell seeds of any kind put out of business because Monsanto suddenly decided they were stealing their seed and threw their legal might against them. It doesn't matter if did it, if the other guy has a few billion to throw at you and you don't have a pot to piss in you lose.

    28. Re:I don't understand it. by DrOct · · Score: 2, Insightful

      Oh I absolutely recognize that it's a vote. It's a vote to let others decide things for you.

    29. Re:I don't understand it. by Akita24 · · Score: 2, Insightful

      To paraphrase somebody much wiser than I: If your representative is in a higher tax bracket than you, you're not being represented.

    30. Re:I don't understand it. by Organic+Brain+Damage · · Score: 3, Insightful

      But voting for third parties is a waste. The third party candidates will be corrupted by campaign finance the minute they get elected. Unless you're talking about a third party that only runs in-human robots for office. The root problem with US democracy is campaign finance. Until we deal with campaign finance (aka legalized bribery of elected officials), all the rest is re-arranging deck chairs on the Titanic.

    31. Re:I don't understand it. by shaitand · · Score: 3, Insightful

      Lets not confuse this issue, this isn't about someone having a right its about taking one away.

      In the case of a gene the key to isolating it is just a sequence of DNA.

      It seems to me to be a pretty reasonable barrier that you can patent something you create but not something you discover.

      Mathematics (even math that is really complex and so mystifies people like algorithms, software, etc), chemical compounds, genetics. These are all things that were already there waiting for someone to stumble upon them. In other words, no matter how much time and effort you spent hunting for them they are a discovery and not an invention. There is nothing to stop you from utilizing your discovery (or sharing it for that matter but somehow I think companies would quickly find themselves hobbled without being able to read about the discoveries of others) to make inventions but the discovery itself should not be patentable.

      'This would bolster the advocates of national health care and create another (unwritten) constitutional right.'

      Every right is a natural right. As someone else already pointed out, government doesn't grant rights, it takes rights away. You are freest without any government at all. What is the purpose of society if it isn't to keep the people who form it safe, healthy, and secure? Sounds to me like you are a moderately successful individual who just doesn't want to pay his fair share of taxes and thinks his success entitles him to priority when hes sick.

    32. Re:I don't understand it. by drinkypoo · · Score: 2, Insightful

      Until we deal with campaign finance

      It's called not being such a fucking sheep. Do we REALLY have to vote for one of the two candidates that has the most advertising? 50% of voters say they want change but we elect the incumbent about 95% of the time. The majority of those who say they want change are lying. They want things to stay the same.

      --
      "You're right," Fisheye says. "I should have set it on 'whip' or 'chop.'"
    33. Re:I don't understand it. by rochberg · · Score: 3, Informative

      it's just that without Myriad, *no one* would know that having the BRCA1 gene was a precursor to breast cancer.

      Really? Then why is there research on the topic that predates the company? Here's a paper from 1994 that includes at least one co-founder of Myriad: http://www.sciencemag.org/content/vol266/issue5182/index.dtl. Of course, 1994 is after the founding of Myriad in 1991-1992, but you already pointed out that the research takes 5-6 years. Additionally, that paper cites work from http://www.sciencemag.org/cgi/content/abstract/250/4988/1684, which was published in 1990 (before Myriad). The title of that article is "Linkage of early-onset familial breast cancer to chromosome 17q21."

      My understanding of the history of Myriad is that they are an example of university research commercialization. That is, the company was founded to establish and protect intellectual property based on work that was done by researchers at the University of Utah. A lot of universities are doing this now, where start-up companies are formed to expand on and profit from research. If the start-ups do well, the universities get a share of the profits.

      Just one problem... As this was university research, it was almost certainly publically funded through grants from NIH, NSF, etc. Hence, we US taxpayers funded the research, not Myriad. Yes, Myriad continues to do research to further develop their products, but Myriad's flagship is still BRACAnalysis, which is the product of university research.

      Furthermore, Myriad aggressively pursues their IP rights. In 2001, they sent cease-and-desist letters to the Canadian government, claiming that ANY BRCA1 or BRCA2 testing method other than BRACAnalysis violates their patents. So, yes, they are claiming ownership of ALL information relating to the genes, and not just the process. Many provinces are fighting back, and the outcome of those legal battles is unclear.

    34. Re:I don't understand it. by Zordak · · Score: 4, Informative

      Just to add a little clarity, you cannot patent anything that occurs in nature. But these folks managed to convince the courts that these genes are not naturally occuring because they don't occur alone in nature. They always occur in some kind of gene sequence. It's somewhat analogous to if gold only occurred naturally in ore, and you were therefore granted a patent on pure gold once you figured out how to extract it. I'm not saying this is good (in fact, I think it's ridiculous), but that's the theory.

      --

      Today's Sesame Street was brought to you by the number e.
    35. Re:I don't understand it. by cryptolemur · · Score: 3, Informative

      It's not correct, the location was known a year or two before Myriad was even founded ("Linkage of early onset familial breast cancer to chromosome 17q21. Science 1990"). And I think it was sequenced two years before Myriad filed the patent, and published in Science ("A strong candidate for the breast and ovarian cancer susceptibility gene BRCA1. Science 1994") by University of Utah (a co-patenter), National Institute of Health (6 grants) and McGill University, adding "Sequences of PCR primers used to amplify each exon of BRCA1 are available upon request" as academia researchers often do.
      In Europe the patent was revoked, because Myriad's screening test was found to be inaccurate and the patent prevented making improved tests.

      So, no. Myriad did not add any knowledge, and the patent did prevent others adding too...

    36. Re:I don't understand it. by Zordak · · Score: 2, Insightful

      GP was correct to cite the claim. The abstract means nothing. The patent is on the isolated gene.

      --

      Today's Sesame Street was brought to you by the number e.
    37. Re:I don't understand it. by Sique · · Score: 2, Interesting

      Mathematics (even math that is really complex and so mystifies people like algorithms, software, etc), chemical compounds, genetics. These are all things that were already there waiting for someone to stumble upon them.

      Mathematics are both: invented and discovered.

      Think about real numbers: There are at least three methods to describe the continuum, invented by Bolzano & Weierstrass, by Cauchy and by Dirichlet. Those definitely are inventions. The discovery was, that all three are equivalent, and axiomately setting one you can prove the others.

      --
      .sig: Sique *sigh*
    38. Re:I don't understand it. by drinkypoo · · Score: 2, Insightful

      Farming is like owning a vineyard? Also, teaching is like grading papers.

      So do I blame farmers who are trying to make their lives easier with Montasano products? No. I do blame Montasano for their practices, and because of that don't use their products myself.

      Let me just go ahead and invoke Godwin here; The Nazis were just doing their jobs, too. The difference is that instead of killing people, Monsanto is "just" destroying their livelihood. Oh, wait... thousands of Vietnam vets have cancer because Monsanto couldn't keep their manufacturing processes clean. Same evil, different market.

      --
      "You're right," Fisheye says. "I should have set it on 'whip' or 'chop.'"
    39. Re:I don't understand it. by AK+Marc · · Score: 2, Insightful

      Unless you are saying that if person A is willing to provide me with health care (for whatever reason), then it violates my right for person B (the government, or whoever) to prevent them (prevent does not mean refusing to pay for it).

      You lost me on that. The right to life is clearly a right. I've never heard anyone argue against that. But the right to something without the right to protect it is useless. The right to life is useless if, say, the government could grab you and throw you in a cell with no food and water until you died. So, apparently, everyone agrees there is a right to life, and some rights that go along with that to protect the right to life. Where the line is drawn is the only thing that's ever in question.

    40. Re:I don't understand it. by Autumnmist · · Score: 2, Informative

      Nope you are both wrong. This *IS* about the gene itself. The patent is extremely broad and covers such things as:

      1) the "normal" sequence of the BRCA1 and BRCA2 genes
      2) the fact that various mutations in those genes are associated with breast cancer

      Researchers/doctors are unable to offer alternative tests because offering a test requires being able to compare a patient's sequence with the (patented) "normal" sequence. But Myriad refuses to allow this, so even scientists doing basic research can't sequence their subject's BRCA1/2 genes!!!

      Since Myriad Genetics even owns a patent on the "fact" that certain mutations are associated with disease, researchers/doctors aren't even allowed to interpret the results for their patients because doing so would utilized the patented fact that the patient's mutation is associated with breast cancer.

      Read the article and/or complaint filed. This lawsuit has been a LONG time coming.

      YEs it IS that ridiculous. The patent office was dumb/ignorant when they awarded the patents and it's about time this mistake was challenged.

      --
      --- "Many of the truths we cling to depend greatly on our own point of view." ~ Ben Kenobi, 'Return of the Jedi'
    41. Re:I don't understand it. by Ikonoclasm · · Score: 4, Insightful

      They're patenting the sequence of amino acids. They say this is patentable because it excludes the introns and is after the post-transcription modifications. Patent law excludes naturally occurring phenomenon. The sequence is a naturally occurring phenomenon after the excision of the introns (don't ask about the language, we know it's goofy) and post-transcription modifications. It all occurs in nature and is thus unpatentable. However, the USPTO has decided that whatever happens after translation is patentable, which makes no sense from either a legal or scientific standpoint (which I happen to have experience in both).

      I was finishing my undergrad degree in Genetics and working for a patent agent writing claims and detailed descriptions for biotech patents when I discovered this loophole in patent law. I was livid as I knew first hand how toxic IP law is to scientific fields and had assumed, based on the explicit language of the law, that my chosen field would be only minimally affected.

      Basically, the prosecution is going to have to call on some good expert witnesses to explain every stage of how DNA is translated and transcribed into proteins. They'll need to put it in language a judge/jury can understand while also constantly pointing out what the law currently says you cannot patent a natural occurrence, which a gene sequenced from a living organism most certainly is.

      As others have mentioned, custom genes that are made in a lab and did not evolve naturally, those are perfectly reasonable to patent. Hell, even mixing and matching parts of different, naturally-occurring genes into a new gene is reasonably patentable. Patenting a naturally occurring sequence that exactly matches the gene as it has evolved to function in the cell is a gross violation of the law.

    42. Re:I don't understand it. by rgarbacz · · Score: 2, Insightful
      That is why the company would be very welcomed in the PO if they invented a medicine to cure this type of cancer based on the gene sequence, but till then keep researching. The same nobody was granted a patent for deuterium, but everyone showing an effective fusion power generating machine is very welcome in the PO.

      Please do not misled the public, the news (I have read about it on the cnn site) clearly states that the genes itself were patented: Myriad and the research foundation hold patents on the pair of genes - known as BRCA1 and BRCA2. The methods of sequencing the genes are known, and there is nothing about any new revolutionary way they do the research in the article, so considering the above and the definition of patents:

      ... patent provides the right to exclude others[4] from making, using, selling, offering for sale, or importing the patented invention for the term of the patent ...

      I see a real legal problem for people who by chance have such a gene. Of course nowadays no-one would think about such implications (I hope), but the fact that reading books aloud violates the copyright law is nowadays not only a concept, but an implemented practice.
      So:

      • a cancer medicament - yes, patent it
      • a new revolutionary method to sequence genes - yes
      • a gene which many people already have - no, it should not be patentable
    43. Re:I don't understand it. by I'm+not+really+here · · Score: 2, Insightful

      I'm pretty sure God could represent himself just fine, being omniscient and all...

      --
      Before commenting on the Bible, please read it first
    44. Re:I don't understand it. by Thuktun · · Score: 2, Informative

      farming is like owning a vineyard

      Arguably, growing grapes IS FARMING.

    45. Re:I don't understand it. by TooMuchToDo · · Score: 2, Interesting

      When I was comparing farming to a vineyard, it was reflecting how neither make any money unless you're lucky, and you hope to simply break even most of the time. Please dial the pompous ass vibe a bit.

    46. Re:I don't understand it. by John+Newman · · Score: 5, Informative

      it's just that without Myriad, *no one* would know that having the BRCA1 gene was a precursor to breast cancer.

      Are you ^!&%! kidding? Are people so bamboozled by the FUD of pharmaceutical companies that anyone who doesn't know the truth assumes that the big, nice company must have sunk a ton of time and money into finding this gene from scratch, and without them the gene would never have been found? The truth is very, very different, and this is why Myriad is so hated in the scientific community.

      BRCA1 was discovered by Mary-Claire King, now a geneticist at the University of Washington, following over a decade of government-funded basic science work that started when she was a graduate student and then junior faculty at UC Berkeley. Back then genetics was hard work - not hard like today, *really* hard. When she started no one really believed that one could even find a gene for a trait that wasn't expressed 100%, it just seemed too complicated to pick one mutation out of a huge haystack when you had to allow for some people having the bad mutation yet having a normal phenotype. Remember this is before the human genome project, before automated sequencing; she even started before PCR. Just pinning the candidate gene down to one small region of one chromosome took over a decade of work by dozens of people.

      As the process came towards fruition, they first narrowed the field to a small part of chromosome 17 (paper), then made a laborious map of the region of interest (paper), and then together with a group at the NIH, they identified the actual single gene we now know as BRCA1, sequenced it, and spelled out the mutations in it that caused breast cancer in the affected families (paper1, paper2). Notice that all of this was done completely in the public eye, with all of her lab's results published immediately so as to help other researchers advance the field with her. It was good science.

      But wait, where's Myriad genetics so far? What's left to do? Didn't we already "discover" BRCA1? How could anyone patent it now? All good questions. The next thing to do was to make a copy of this gene, by itself, in a test tube. This would be preliminary work for all sorts of biochemical analysis. The act of copying a gene off of a chromosome onto a separate loop of DNA in a test tube is called "cloning". Cloning is still pretty hard even today, especially for long genes like BRCA1. It can take months, especially since you usually need to copy it in bits and then glue those bits together.

      What Myriad understood, and perhaps Dr. King did not, is that a cloned gene (that loop in a test tube) is patentable because it's considered "artificial", even if it's a perfect copy of a natural sequence of DNA. Myriad jumped in at this point, threw their whole company into cloning the gene and then patenting it, and did it before Dr. King or anyone else realized they were in a race. Ironically, Dr. King's lab had probably already cloned it in pieces (usually a prerequisite to sequencing) but hadn't made a complete intact copy yet, and certainly hadn't filed any patents. Myriad did none of the prior work on BRCA1. They did not come up with the idea of hereditary breast cancer. They did not do the laborious work of mapping where BRCA1 might be. They did not pinpoint the gene that was BRCA1. They did not sequence

    47. Re:I don't understand it. by Whatsmynickname · · Score: 3, Interesting

      But voting for third parties is a waste. The third party candidates will be corrupted by campaign finance the minute they get elected. Unless you're talking about a third party that only runs in-human robots for office. The root problem with US democracy is campaign finance. Until we deal with campaign finance (aka legalized bribery of elected officials), all the rest is re-arranging deck chairs on the Titanic.

      Voting for third parties is NOT a waste. The more parties the better. It means companies will have to corrupt more people. In fact, taken to it's logical conclusion, every person should be their own party (i.e., we should have NO PARTIES at all). Why can't we just elect an individual solely on what position that person has instead of us voting based on what group they are associated with? Must we always have to align ourselves with a group? Worse yet, limit ourselves to two rotten groups: Democrats and Democrat-lites?

      Campaign finance reform is EXACTLY LIKE email spam control and is a waste of time. No matter how many campaign finance reforms you put in, large companies will ALWAYS FIND a way around it, and leave the legitimate contributors out in the cold.

    48. Re:I don't understand it. by DarKnyht · · Score: 2, Insightful

      Or just have a media not motivated to paint them that way. Look at how they treated Ron Paul last election.

      Instead of using his Congregational photo like all the other candidates, they used one that made him look crazy. They never asked him a serious question, it was always something like "Who are you going to vote for when you lose?". They marginalized him because he wasn't their pick.

      I think having the media biasing debates and political news like that is a large part of the problem. Fox News, CNN, and MSNBC are all guilty of it. Look at what happened to the commentator on CNBC that was negative towards Obama.

      --
      Voting them all out of office, now that's change I can believe in.
  2. Re:A sad day by bothemeson · · Score: 4, Funny

    Surely if you patent the trolls parts instead then you've got them by their own petards :-)

  3. New Business Model by arthurpaliden · · Score: 4, Funny

    Patent a gene and then sue anyone who has it. Even better would be to copyright it and then get $700 per copy in the body.

    1. Re:New Business Model by javilon · · Score: 2, Funny

      Patent a gene and then sue anyone who has it. Even better would be to copyright it and then get $700 per copy in the body.

      Also, you could ban human reproduction as it involves unauthorized copying of copyrighted genes.

      --


      When his defense asked, "Which computer has Jon Johansen trespassed upon?" the answer was: "His own."
    2. Re:New Business Model by TheRealMindChild · · Score: 4, Informative

      You poke fun, but this happens with genetically modified corn

      --

      "When life gives you lemons, don't make lemonade. Make life take the lemons back!" -- Cave Johnson
    3. Re:New Business Model by gerglion · · Score: 2

      What is worse is that this happens unintentionally with genetically modified corn. How do you stop your corn fields from catching pollen from your neighbors' fields? "Mother Nature is infringing, not me."

      --
      I know you have come to kill me.
      Shoot, coward. You are only going to kill a man.
  4. Re:A sad day by Rary · · Score: 3, Insightful

    A sad day ... when parts of the human body can be copyrighted.

    They can't. Neither can they be patented (which, by the way, is completely different than copyright).

    What can be patented (but not copyrighted) is the process of performing diagnostic tests on a certain gene. To quote the article:

    "Myriad's patents give it exclusive right to perform diagnostic tests on the genes -- forcing other researchers to request permission from the company before they can take a look at BRCA1 and BRCA2, the ACLU said. The patents also give the company the rights to future mutations on the BRCA2 gene and the power to exclude others from providing genetic testing."

    This is not a good thing, but it does seem to fit within the scope of patents. This is more reason for patent reform.

    --

    "You cannot simultaneously prevent and prepare for war." -- Albert Einstein

  5. It's still in the gene databases by pzs · · Score: 2, Informative

    Can anybody explain what patenting the genes actually means? The articles aren't too clear. They're still in the public databases: BRCA1 and BRCA2. This includes the sequence, SNPs, transcript information and all the other goodies. In fact, the Ensembl home page still lists BRCA2 as an example for its search box...

    I can understand they might patent technology they have developed that is associated with those genes, which seems fair. But if all this information is still available, they haven't really patented the gene itself.

    1. Re:It's still in the gene databases by maxwell+demon · · Score: 2, Informative

      Patents don't mean the information is not available. Indeed, the whole point of patents is to make the information available, in exchange to a limited-time monopoly on its use.

      For example, if someone holds a patent on a time machine, then you don't violate the patent by describing, in arbitrary detail, how the time machine works. You do violate the patent by building it yourself (provided you don't have a license to do so).

      --
      The Tao of math: The numbers you can count are not the real numbers.
    2. Re:It's still in the gene databases by Binty · · Score: 3, Informative

      A bunch of folks have said in this discussion that patenting the gene doesn't patent the gene itself, but only the method of finding it, the method of using it, and other methods having to do with the gene.

      It is true that methods for doing all those things are patentable subject matter, but an inventor can also get a patent on the gene itself if the inventor is the first to purify that gene from its surrounding environment. The landmark case for this proposition (that chemicals found in nature are patentable in their isolated and purified form) is called Parke-Davis v. H.K. Mulford 189 F. 95 (S.D.N.Y. 1911). I tried to find a link to the case online, but couldn't find anything for free. The case concerns purified adrenaline, which before the invention at issue could only be used in conjunction with the rest of the junk in whatever gland produces adrenaline. The court held that purified adrenaline was different enough from the adrenaline found in nature that the substance itself could be patented. This is the basis for gene patents and also pharmaceutical patents (most of the drugs you take can be found in nature, just not in purified form).

    3. Re:It's still in the gene databases by Calsar · · Score: 3, Informative

      IANAL and IANAG (I am not a geneticist). However my wife works for Genbank (http://www.ncbi.nlm.nih.gov/Genbank/). She is a geneticist and we've discussed this issue. When a company patents a gene they have the rights to information and usage of that gene. This essentially halts research on the gene, because anything you discover is owned by the company with the patent unless you work out some type of licensing agreement. This is bad for medical research because a company won't study a disease if the gene is owned by another company. Any cure or medication they came up would not be usable without licensing. Considering the high cost of medical research, it's just not worth it do research unless you own the patent. Companies are in the process of patenting every gene they can find in hopes that one of them will be important for instance the genes described in this article that relate to breast cancer.

  6. Michael Crichton would be pleased by Supp0rtLinux · · Score: 4, Interesting
    Michael Crichton just popped up in his casket and gave these guys a huge HIGH 5

    Michael Crichton's Gene Patenting Rant

  7. Re:A sad day by toppavak · · Score: 2, Insightful

    I haven't looked at the patent itself but it sounds like its either a method patent that describes performing a diagnosis based on analyzing those genes or its a composition patent for PCR probes- the DNA templates used to amplify certain DNA sequences for detection purposes. Either way, patents like these really get in the way of getting effective diagnostic technologies to the people that need them. Bulk synthetic DNA is dirt cheap, but commercial probes are damned expensive since these companies have monopolies over the right to produce or use them as a diagnostic test. I don't understand pricing strategy when it comes to healthcare tech, the traditional rule-of-thumb approach of "charge as much as people are willing to pay" breaks down completely since people are willing to pay pretty much anything to keep on living... I think fundamental changes in the way healthcare is approached as a business will be necessary before we start seeing anything resembling universal global access to basic care.

  8. Patent limitations by Hodar · · Score: 2, Insightful

    You can't patent ice, snow or slush - why? Because these are naturally occuring items. You cannot patent a mathematical function (1+1=2), an obvious extension of a patent (make an iPod entirely chrome plated), naturally occuring item (wood), or something that has been in the public domain.

    No one invented the genes in our bodies, so how can anyone own a patent on them? If I patent the gene that turns Breast Cancer 'off' - then can I sue men and women who possess that gene without my permission? If someone has breast cancer, and it goes into remission - can I chose to 'gather my property' by imprisoning that person and extacting the gene that I own rights too?

    Crighton's book, "Next" was an excellent novel based on this entire theory. No one should have the 'rights' to any gene.

  9. Why can someone patent something nature created? by olddotter · · Score: 3, Insightful

    I don't think you should be able to patent discoveries, only inventions. Can a law scholar speak as to how we got to this point?

    Where is Larry Lessig?
     

  10. I actually RTFA by Anonymous Coward · · Score: 2, Informative

    I know, I know. We don't do that here. But it's a shame because it actually does help in this case.

    Basically, a company found that if a gene exists, the patient has increased risk of cancer. And so they made a test to determine if that gene exists. And then they patented their invention, because they want to be the ones to profit from their work.

    Other than "cancer" being important in the story, it's like any other patent case. A company made a unique discovery that they want to profit from. Other people don't like that a patent restricts them.

    Same old story.

  11. Re:A sad day by PPH · · Score: 3, Interesting

    What can be patented (but not copyrighted) is the process of performing diagnostic tests on a certain gene.

    Their particular diagnostic test or any diagnostic test?
    The former I can understand. The latter is yet another example of why we need patent reform. There is plenty of prior art in testing genes for the purpose of performing diagnoses. Once a broad claim has been made in another patent, or recognized in current practice, a narrower claim included in that should not qualify for a patent.

    --
    Have gnu, will travel.
  12. Procedures by Thaelon · · Score: 3, Insightful

    It's almost certainly a patent of the procedure for isolating/identifying/testing with the genes.

    This is why procedures shouldn't be patentable.

    By definition, they're not inventions, but procedures.

    --

    Question everything

    1. Re:Procedures by RawJoe · · Score: 2, Insightful

      I'm not so sure. One of the contested patents, claim 1 is:

      An isolated DNA coding for a BRCA1 polypeptide...

      No mention of a procedure, a method, a process, or a device used for, which is what many procedure patents have in their language.

      --
      ?
  13. good example of why I donate to the ACLU by bcrowell · · Score: 2, Insightful
    This is a good example of why I donate money annually to the ACLU:

    ACLU, PO box 96265, Washington, DC 20090-6265

  14. Comment removed by account_deleted · · Score: 4, Informative

    Comment removed based on user account deletion

  15. Comment removed by account_deleted · · Score: 2, Informative

    Comment removed based on user account deletion

  16. Re:The Patents at Issue by radtea · · Score: 3, Interesting

    The DNA in question must be "isolated". The DNA is not "isolated" when it is naturally occurring. Nobody is claiming your DNA that you were born with. Only an isolated DNA product.

    As the suit points out, removing a naturally occurring product from its original location does not make it any less a naturally occurring product, which cannot be patented.

    It's good that you've understood the nature of the patents (they are on specific sequences, not methods of isolating them or methods of using them.) But it's unclear why you, or anyone else, thinks that changing the location and surroundings of a naturally occurring molecule makes that molecule patentable.

    It is also not clear why this insane doctrine would be limited to genes. Suppose I find a new species (this happens many times a year, as most insect species for example have yet to be identified.) According the the USPTO I could patent "an isolated individual of species XYZ", thus preventing anyone from capturing an individual of such a species for any purpose.

    One could further argue that even studying that species in situ would violate my patent, as obviously the very act of observation constitutes "isolation" by an act of selective attention.

    Returning from that little speculative excursion, it's curious that you use the term "product" in your defence of this ridiculous policy, as that term makes it sound like something is being "produced" by the act of removing a naturally occurring DNA molecule from its natural environment. But of course nothing is being produced. There is no "isolated DNA product", there is only "isolated DNA".

    And again, it is not clear why "isolated DNA", which is not a product but a naturally occurring molecule, ought to be patentable when naturally occurring products are specifically excluded from patentability. It is also not clear why, if "isolated DNA" is patentable, why "isolated any-other-naturally-occurring-thing" is NOT patentable, as in my absurd new-species example above.

    --
    Blasphemy is a human right. Blasphemophobia kills.
  17. Re:Bingo! by Darby · · Score: 5, Insightful

    Of course, you are welcome to disagree that this will work because neither regulation nor free markets have a pristine track record, hence the continued debate,

    Well, you're falling into a very serious error here by setting up a false dichotomy. "Regulation" and "Free Markets" aren't in any way opposites. Regulation is absolutely 100% necessary to the existence of anything even remotely approximating a free market. "Unregulated markets" and "Regulated markets" are actual opposites. Unregulated markets will never be anything like a free market. A properly regulated market can approximate a free market.
    An actual free market doesn't exist, has never existed, and can't possibly ever exist under any conceivable set of circumstances. It's an idealized hypothetical thing like the various frictionless planes, pulleys and such from high school physics.

    As long as people keep pretending that the debate is how you framed it, then there will never be reasonable discussion of the issue in the public domain. This is especially true since the people who benefit from un or poorly regulated markets are the ones framing the debate since they're the ones who own all of the media outlets etc.

    claiming that the "right" wants to be ruled by powerful corporations because of deregulation is like claiming that the "left" likes to kill babies because they want to allow the choice of abortion.

    The right consists primarily of the people who own the powerful corporations and the idiots who have been duped into believing that "the Right" means "Liberalism" (Small government, fiscal responsibility, individual liberty etc) when the right is an inherently elitist philosophy. Heck, the right is called the right because the representatives of the church and aristocrats sat on the right in the French assembly. The right *is* theocracy, feudalism, fascism etc. The representatives of the people sat on the left, hence the term "left", and hence the association of the left with "the people" against the "elites".

    Liberalism came later and was a rejection of *both* the left and the right. Left and right are both about using the power of the state to screw people for your benefit. Liberalism is the philosophy that nobody or group should be able to use the power of the state for the purpose of screwing individuals.

    It is the philosophy that America was explicitly founded on. People today don't even know that. They think "Liberalism" means "whatever somebody calling themselves a 'Liberal' says" which is obviously a worthless definition. There doesn't exist another word in the English language apart from "Liberalism" to describe America's founding philosophy, so it makes it tough to discuss since the Left have coopted and the Right have demonized the term. This is because both the right and the left *despise* Liberalism and always have.

    So, you, by pretending that the right stands for liberalism and the actual right doesn't even exist aren't helping to promote a more honest dialog, you're helping promote a redefinition which removes the terms necessary to accurately describe the political landscape.

    The powerful corporations are perfectly happy to have massively oppressive regulation of the people for their benefit. The recent bailout is a right wing initiative. *I*, the individual, was robbed at the behest of said corporations for their benefit.
    When "the rich" are robbed for the benefit of "the people", that's the left. When nobody is robbed by anybody by the government, that is a distinctly different position from either of the above.

    That very real and very critical distinction is entirely eliminated by the redefinitions you're going with.

    That is one of if not the most critical thing standing in the way of honest, non-partisan debate in this country. We don't even have to words to have such debate.

  18. Why sue? by Maximum+Prophet · · Score: 2, Interesting

    ... filed a lawsuit charging that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid

    If someone owned the gene the might give me cancer, I'd sue the hell out of them to take it away.

    If a farmer's cow gets loose, and damages my property, the farmer is liable. If my car slips out of park, rolls downhill, and crashes into your car, I'm liable. If this gene tries to kill me, I should be able to sue the owner. "What?", you say, "You're the owner of your own genes". Well, not if this patent is valid.

    --
    All ideas^H^H^H^H^Hprocesses in this post are Patent Pending. (as well as the process of patenting all postings)