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Breast Cancer Gene Lawsuit Argues Patents Invalid 294

Posted by Soulskill
from the time-to-reconsider-my-patent-on-feet dept.
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."
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Breast Cancer Gene Lawsuit Argues Patents Invalid

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  • by FlyingSquidStudios (1031284) on Wednesday May 13, 2009 @08:34AM (#27936685) Homepage
    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.
    • by Duradin (1261418) on Wednesday May 13, 2009 @08:38AM (#27936749)
      Monsanto would be the one to ask about that.
      • by drinkypoo (153816) <martin.espinoza@gmail.com> on Wednesday May 13, 2009 @08:53AM (#27936959) Homepage Journal

        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

        • by Organic Brain Damage (863655) on Wednesday May 13, 2009 @09:05AM (#27937135)
          "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.
          • Re: (Score:2, Insightful)

            by DrOct (883426)

            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.

          • by drinkypoo (153816) <martin.espinoza@gmail.com> on Wednesday May 13, 2009 @10:06AM (#27938077) Homepage Journal

            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.

            • by shaitand (626655)

              No doubt, the two party system is a scam. We went from having every candidate as an open possibility to be judged on their own merit to only having two choices judged by the merits of a letter next to their name.

            • by Organic Brain Damage (863655) on Wednesday May 13, 2009 @10:28AM (#27938421)
              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.
              • Re: (Score:3, Insightful)

                by drinkypoo (153816)

                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.

              • by Whatsmynickname (557867) on Wednesday May 13, 2009 @03:27PM (#27943289)

                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) [laughtergenealogy.com]. 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.

          • Re: (Score:2, Insightful)

            by Akita24 (1080779)
            To paraphrase somebody much wiser than I: If your representative is in a higher tax bracket than you, you're not being represented.
        • by nomadic (141991) <nomadicworld@NOSpam.gmail.com> on Wednesday May 13, 2009 @09:08AM (#27937163) Homepage
          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.
          • by osgeek (239988) on Wednesday May 13, 2009 @09:27AM (#27937461) Homepage Journal

            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.

            • Re: (Score:2, Interesting)

              by maxume (22995)

              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.

              • by TooMuchToDo (882796) on Wednesday May 13, 2009 @10:16AM (#27938231)
                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.
                • Re: (Score:3, Insightful)

                  by drinkypoo (153816)

                  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.

                • Re: (Score:3, Informative)

                  by Thuktun (221615)

                  farming is like owning a vineyard

                  Arguably, growing grapes IS FARMING.

              • Re: (Score:3, Insightful)

                by shaitand (626655)

                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

                • Re: (Score:3, Informative)

                  also they sued the hell out of farmers which seeds had been cross pollinated with monsanto products, forcing the farmer to pay the licence for their products even if they've nor purchased neither wanted them.
    • by click2005 (921437) on Wednesday May 13, 2009 @08:39AM (#27936757)

      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.

      • by starfire-1 (159960) on Wednesday May 13, 2009 @08:57AM (#27937023)

        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.

        • Re: (Score:3, Insightful)

          by DrOct (883426)

          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,

          • by gambino21 (809810) on Wednesday May 13, 2009 @10:04AM (#27938049)

            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.

            • True, but as to the right of health care I would posit that you do not have the right to health care, but you should have the right for it to be available to you.
              -nB

        • by Scrameustache (459504) on Wednesday May 13, 2009 @09:42AM (#27937705) Homepage Journal

          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 [wipo.int]

          "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.

        • Re: (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 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.

          • by Zordak (123132) on Wednesday May 13, 2009 @11:34AM (#27939459) Homepage Journal
            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.
        • by shaitand (626655) on Wednesday May 13, 2009 @10:31AM (#27938481) Journal

          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.

          • Re: (Score:3, Interesting)

            by Sique (173459)

            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.

        • Re: (Score:3, Informative)

          by Autumnmist (80543)

          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 sequen

      • by RawJoe (712281) on Wednesday May 13, 2009 @09:12AM (#27937241)

        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.

        • by Ikonoclasm (1139897) on Wednesday May 13, 2009 @11:49AM (#27939713)

          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.

      • by osgeek (239988)

        At the end of TFA, Arthur Caplan makes the most reasoned point. Basically, he notes that the ACLU's attack is probably wrong. Rather than going after the whole genetic patents paradigm, just attack the validity of this patent. Has Myriad made a unique contribution to our understanding or processes that justifies their having exclusive rights to those discoveries? Or are they just gene-squatting?

        You don't want to see some land-grab situation with genes where the people who file the most paperwork reap fi

    • by ByOhTek (1181381) on Wednesday May 13, 2009 @08:39AM (#27936761) Journal

      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).

      • What if it is a gene normally not found in nature, but due to Monsato's irresponsibility, it 'infected' plants and now it is 'in the wild'?

        • Re: (Score:3, Funny)

          by corsec67 (627446)

          Monsanto sues God?

          • Re: (Score:2, Funny)

            by Anonymous Coward

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

            • If by God suing, you mean smiting the shit out of them, I'm all for it (sometimes it sucks not believing in a deity when there could be some sweet ass smiting involved).
            • Re: (Score:3, Insightful)

              I'm pretty sure God could represent himself just fine, being omniscient and all...
      • by fastest fascist (1086001) on Wednesday May 13, 2009 @08:48AM (#27936881)

        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!

    • by HomelessInLaJolla (1026842) <lajollahomeless@hotmail.com> on Wednesday May 13, 2009 @08:45AM (#27936841) Homepage Journal

      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.

      • by Asic Eng (193332)
        My boss likes to pressure me to patent "something". I always get out of it. If I patent something which is actually good, then I can not use my idea anywhere else. My job experience is part of my capital, I have no intention of signing that away.
    • Screw that, I'm jumping on the gravy train and patenting bunnies.

    • by giminy (94188) on Wednesday May 13, 2009 @09:10AM (#27937199) Homepage Journal

      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

      • by Duradin (1261418) on Wednesday May 13, 2009 @09:24AM (#27937413)

        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.

      • by osgeek (239988) on Wednesday May 13, 2009 @09:42AM (#27937703) Homepage Journal

        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!

      • by Daniel Dvorkin (106857) * on Wednesday May 13, 2009 @09:44AM (#27937737) Homepage Journal

        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 problem with this argument is that it is very short-sighted. Yes with current technology it is expensive to find/isolate/etc genes. It was even more expensive to do so 10 years ago. It was impossible to do so 20 years ago. However in another 20 years it could be cheap and not because of the work that these researchers are doing but because completely unrelated technology (better tools) will allow researchers to do the same work in 1/100th the time.

        The economic incentive for a company to pursue this type

      • 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.

        Right now that is true enough, but what happens in 20 years when the price to do the same research is 1/1000th of what it is now? Look at the cost to sequence the human genome today versus ten years ago for example. I wish laws had an expiration date, that would force them to be re-reviewed every 5 or 10 years, but as things stand now companies will still be able to patent genes when it costs pennies to the dollar what it costs now to discover them.

      • Re: (Score:3, Informative)

        by rochberg (1444791)

        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 [sciencemag.org]. 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 [sciencemag.org], which was published in 1990 (before Myriad). The title of that arti

      • by John Newman (444192) on Wednesday May 13, 2009 @02:44PM (#27942595)

        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 [nature.com], 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 [nih.gov]), then made a laborious map of the region of interest (paper [nih.gov]), 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 [nih.gov], paper2 [nih.gov]). 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

    • > 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.

      Agreed. That's why I'd let them patent the gene to breast cancer. If they invented breast cancer, then they're accepting responsible for it.

      I'll leave it to the lawyers in the Slashdot crowd to follow this to it's logical conclusion.

    • Congress thought it was a good idea.

  • by arthurpaliden (939626) on Wednesday May 13, 2009 @08:42AM (#27936807)
    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.
    • Re: (Score:3, Funny)

      by javilon (99157)

      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.

    • by sjames (1099)

      Reverse model. They claim ownership on a gene that confers a higher risk of cancer. Women who carries it and gets cancer should sue them for failing to properly control their dangerous property. Treat it like a dog attack.

  • by pzs (857406) on Wednesday May 13, 2009 @08:52AM (#27936937)

    Can anybody explain what patenting the genes actually means? The articles aren't too clear. They're still in the public databases: BRCA1 [ensembl.org] and BRCA2 [ensembl.org]. This includes the sequence, SNPs, transcript information and all the other goodies. In fact, the Ensembl home page [ensembl.org] 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.

    • Re: (Score:2, Informative)

      by maxwell demon (590494)

      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).

      • by pzs (857406)

        But in this case, aren't human beings violating the patent every time they reproduce, since this involves a new creation of a BRCA2 and BRCA3 gene? In fact, I guess every occurrence of mitosis is also a violation of the patent.

    • by Binty (1411197) on Wednesday May 13, 2009 @09:30AM (#27937533)

      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).

    • Re: (Score:3, Informative)

      by Calsar (1166209)

      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 g

  • When I was reading the article, it was like I was reading this novel: http://en.wikipedia.org/wiki/Next_(novel) [wikipedia.org]

    And here I thought that the Crichton book was just some random over-the-top science fiction. It's sometimes scary, when SciFi turns into reality.
  • by Supp0rtLinux (594509) <Supp0rtLinux@yahoo.com> on Wednesday May 13, 2009 @08:54AM (#27936977)
    Michael Crichton just popped up in his casket and gave these guys a huge HIGH 5

    Michael Crichton's Gene Patenting Rant [crichton-official.com]

    • by RingDev (879105)

      I find it a bit ironic that a publicly posted essay on the evils of patents is footnoted by an explicit definition of copy rights and an additional copy right notice.

      For someone who was so outspoken on opposing intellectual property, it intrigues me that his estate manager is exerting his intellectual property rights after his death.

      -Rick

      • by Sir_Lewk (967686)

        An author maintaining copyrights on his works and a corporation patenting parts of your body are two ENTIRELY different things.

  • I just want my wife's breast cancer _gone_... it's been 3 years now, post diagnosis.

  • Patent limitations (Score:3, Insightful)

    by Hodar (105577) on Wednesday May 13, 2009 @09:00AM (#27937071)

    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.

  • by olddotter (638430) on Wednesday May 13, 2009 @09:02AM (#27937101) Homepage

    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?
     

    • 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?

      Sure... We got to this point by only reading the misleading Slashdot summaries rather than the actual patent, and thus believe that it's a patent on something nature created.

  • it goes BEYOND definition of 'prior art'. that gene was there even before mankind was able to draw pictures on cave walls, leave aside any notion of a 'patent'.

    this incident shows how insanely stupid u.s. patent system and accompanying greed has gone. we are one step away from someone trying to patent homo sapiens sapiens. such patent applications should not only be rejected, but also heavily fined for trying to abuse the system.

  • I actually RTFA (Score:2, Informative)

    by Anonymous Coward

    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

  • The First Amendment argument that this patent limits the "free flow of information" is stupid and will be dismissed immediately. The whole point of patents is to grant a time limited monopoly on the use of that "information." If you have to use such a lame argument, you know at the beginning that you are going to lose.
    • by DragonTHC (208439)

      agreed their argument is flawed, but the concept of the the suit is valid.

      If the court upholds this patent, then we should hold them responsible for the effects of their patented genes.

      eg. sue them for their patented genes causing cancer.

    • by Asic Eng (193332)
      Well the point of a patent was supposed to grant a monopoly on an invention, not on information in general. E.g. if I make a map of a city, I can not patent that map (though I can copyright it instead). I can patent the design of a machine which collects that data. This way nobody is prevented from collecting their own data (using their own methods) and publishing their own map. Gene patents - on already existing genes - prevent just that, though.
  • Procedures (Score:4, Insightful)

    by Thaelon (250687) on Wednesday May 13, 2009 @09:24AM (#27937417)

    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.

    • Re: (Score:2, Insightful)

      by RawJoe (712281)

      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.

  • This is a good example of why I donate money annually to the ACLU:

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

  • From what I understand, there's a few common methods that everyone uses to deal with genes.

    Translating to code.

    Genenome.extractGene(chromosome, subPart) : Gene
    Gene.getEncoding() : GeneEncoding
    GeneEncoding.equals( ... ) : Boolean

    Those are standard things that everyone can do.

    So to find out if a gene is responsible for something you take a whole bunch of normal people, and a whole bunch of people with a condition.

    You extract genes, and see where they are equal or not. Likely with some algorithm that's a lot

  • The Patents at Issue (Score:5, Informative)

    by Absolut187 (816431) on Wednesday May 13, 2009 @10:38AM (#27938571) Homepage

    The plaintiffs challenge various claims found in the following issued patents:
    5,747,282; 5,693,473; 5,710,001; 5,753,441; 6,162,897; 5,837,492; 6,033,857;

    Plaintiffs are asking the court to invalidate the claims under 35 USC 101 (statute which governs the scope of patent-eligible subject matter), and under the Progress Clause of the U.S. Constitution (which gives Congress the authority to create the patent system "to promote the progress of the useful arts"). (See page 19 & 29 of the complaint).

    The complaint alleges that four categories of claims are invalid: (1) Patent claims over natural human genes, (2) Patent claims over natural human genes with natural mutations, (3) Patent claims over any method, including non-patented methods, of looking for mutations in natural human genes, and (4) Patent claims over thought or abstract ideas.

    The complaint is crap.
    It is well settled that you can't patent anything that is naturally occurring.
    See the USPTO's discussion of this at: http://www.uspto.gov/web/offices/pac/mpep/documents/2100_2105.htm#sect2105 [uspto.gov]
    The complaint doesn't even mention any of the seminal Supreme Court decisions on this topic, such as Chakrabarty, etc.
    And the complaint never really explains how or why these claims are "unconstitutional".
    It looks like it was filed by a bunch of non-patent-lawyers.

    Here is what the Supreme Court has said on the matter:

    Congress thus recognized that the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions.

    As an example, here is one of the claims they are complaining about:

    An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2. (Claim 1 of the 5,747,282 patent)

    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.

    Plus, the U.S. already has a provision exempting doctors:

    (1) With respect to a medical practitioner's performance of a medical activity that constitutes an infringement under section 271(a) or (b) of this title, the provisions of sections 281, 283, 284, and 285 [All of the remedies for patent infringement] of this title shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.
    http://www.uspto.gov/web/offices/pac/mpep/documents/appxl_35_U_S_C_287.htm [uspto.gov]

    So basically this boils down to the media making a big deal about a topic it doesn't understand, based on a lawsuit filed by a bunch of lawyers (and clients) who don't understand it either. And of course it gives slashdotters a chance to bitch about how evil Monsanto is, even though this has nothing to do with Monsanto..

    • by radtea (464814) on Wednesday May 13, 2009 @11:56AM (#27939821)

      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.

  • Why sue? (Score:3, Interesting)

    by Maximum Prophet (716608) on Wednesday May 13, 2009 @12:39PM (#27940505)

    ... 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.

"Consistency requires you to be as ignorant today as you were a year ago." -- Bernard Berenson

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