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Wow, chalk this up as a pleasant surprise!  The Supreme Court has unanimously decided that "naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that [synthetic DNA] is patent eligible because it is not naturally occurring.”

This has major implications across a wide range of areas, including access to healthcare, biotechnology, and biomedical research.

Back in February 2012 when the firestorm against Komen was at its apex, I wrote a diary entitled "Breast Cancer Commercialization - It's Not Just Komen" that talked about how Myriad Genetics was at the forefront of trying (and up until this Supreme Court decision, succeeding) at patenting genes.

The defendants in this case, a biotechnology named Myriad Genetics, was founded in 1990 by a group of geneticists working to discover genes that were linked to the development of breast cancer.  The now well-known gene BRCA1 was the first gene identified to play a major role in the development of breast cancer (of course, only when mutations are present).

The Myriad Genetics team cloned BRCA1 and sought to use their knowledge of the gene for commercial purposes.

How does a company do this?

Since the presence of a BRCA1 and/or BRCA2 mutation renders vastly higher risk for developing breast cancer, the main test that physicians will do for individuals with a family history of breast cancer is sequencing of those two genes.  Sequencing two genes costs probably $50 at most today, and most of that is labor costs.

However, because Myriad Genetics has held patents for those two genes (and all experiments and research done involving those genes), they have been able to charge outrageous licensing fees for physicians, researchers, genetic counselors, etc. in order to do anything that involves BRCA1 and BRCA2.

As I wrote in my diary in Feb. 2012:

The research has been done, and the results are clear - if you are a woman who has either a mutant copy of BRCA1 or BRCA2, your likelihood of getting breast cancer is extremely high, and if untreated, you will likely die.

Thankfully, with aggressive preventative screenings and other intensive medical care, women with a mutant copy of BRCA1 or BRCA2 can extend their lifespan.

Of course, the critical piece of information is knowing whether you have a mutation in BRCA1 or BRCA2 in the first place.  This is where Myriad Genetics and their patents come into play.  If you have had breast cancer yourself or have a direct relative (parent/grandparent) who has had breast cancer, you likely already know what I'm going to say.  You see, Myriad Genetic's patents don't just cover the isolation and sequencing technique of the BRCA1 and BRCA2 gene - they are patents of the genes themselves.  Which means that any screening test that sequences and checks for mutations in your copies of BRCA1 and BRCA2 owes royalties to Myriad Genetics.  And according to cancer.gov, that can cost anywhere between several hundred to thousand dollars for each test (and two genes means two tests).  And as expected in the war on women from health insurance companies, your test may not be covered.  Don't take my word for it, it's information provided in the same cancer.gov link I provided just above.

Myriad Genetics has priced their licensing fees at several thousands of dollars per sequencing test, far out of the reach for millions of at-risk women.  Myriad also charges researchers working on BRCA1 and BRCA2 projects, which is an additional cost and barrier to getting research done in this era of NIH budget cuts.

This is a healthcare access issue!

Not to mention that the legality of patenting something as innate as our naturally occurring DNA is very questionable.

I haven't thought about it as much, but I think I'm more fine with companies being able to patent sequences that they engineer on their own.  Though, a desirable "engineered" mutation - like the Delta32 mutation in the gene CCR5 that makes humans immune to HIV infection - is also naturally occurring.  But that's a discussion for another time.

All in all, I am extremely pleased of this decision by the Supreme Court (and it was unanimous to boot!).  From the text of the ruling:

This holding is consistent with longstanding law establishing that “[l]aws of nature, natural phenomena, and abstract ideas are not patentable,” but instead belong to all inventors and to the public at large.
I couldn't agree more.  Millions of women will no longer be extorted by Myriad Genetics and finally be able to get access to much needed genetic screening to assess breast cancer risk.  That is a wonderful thing.

Originally posted to mconvente on Thu Jun 13, 2013 at 08:18 AM PDT.

Also republished by SciTech.

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Comment Preferences

  •  Tip Jar (230+ / 0-)
    Recommended by:
    mattc129, citizenx, glendaw271, cv lurking gf, MKinTN, Clem Yeobright, knitwithpurpose, NCJan, The Voice from the Cave, Arizona Mike, wilderness voice, Lost and Found, Pithy Cherub, Ishmaelbychoice, chuck412, josephk, leonard145b, side pocket, Lujane, zootwoman, inclusiveheart, PrahaPartizan, radical simplicity, Brecht, sfbob, Meteor Blades, cardboardurinal, aravir, copymark, radarlady, oortdust, tuesdayschilde, Youffraita, CroneWit, Avilyn, stevie avebury, asym, celdd, pixxer, phonegery, fixxit, Actbriniel, MadRuth, jfromga, kathny, maggiejean, maybeeso in michigan, madmsf, AoT, JanetT in MD, One Pissed Off Liberal, Daniel Case, MrLiberal, dotsright, Norm in Chicago, dansk47, Sue B, psychodrew, ichibon, The Free Agent, Gowrie Gal, S F Hippie, doingbusinessas, envwq, DownstateDemocrat, MsGrin, Nina Katarina, Russ Jarmusch, meagert, TracieLynn, Its a New Day, pat bunny, sostos, myadestes, genethefiend, cinnamon68, lovelylight, ColoTim, Box of Rain, sap, Dr Erich Bloodaxe RN, ActivistGuy, DBunn, doroma, Catte Nappe, parse this, cybersaur, spacejam, vahana, MRA NY, mungley, MartyM, buddabelly, Mimikatz, Nicci August, jadt65, miracle11, Words In Action, Cinnamon, lavaughn, kurt, J M F, sawgrass727, llbear, ChemBob, arizonablue, Linda Wood, Statusquomustgo, Yasuragi, Ptown boy in NC, thomask, Arrow, glitterscale, cpresley, zerelda, SaraBeth, Mr Robert, Simplify, HCKAD, Sandino, wasatch, dsb, Batya the Toon, Railfan, Laurel in CA, yoduuuh do or do not, Loquatrix, Pandora, rubyclaire, Lorikeet, spunhard, OrdinaryIowan, wader, shari, psnyder, antooo, AverageJoe42, OllieGarkey, Cassandra Waites, Jay C, kerflooey, jamesia, prishannah, chicklet, slowbutsure, mslat27, Susipsych, Chaddiwicker, dkmich, el dorado gal, solesse413, jan4insight, Anthony Page aka SecondComing, Aunt Pat, deepeco, ScottAC, p gorden lippy, greenbastard, Heart of the Rockies, Pescadero Bill, zerone, BachFan, petulans, science nerd, Loudoun County Dem, highacidity, begone, rosarugosa, sydneyluv, trumpeter, helpImdrowning, MouseThatRoared, JoanMar, Smoh, Panacea Paola, otto, USHomeopath, roses, peachcreek, TheMeansAreTheEnd, Joieau, trivium, Vico, Steven D, Kevskos, LilithGardener, blueoasis, Tinfoil Hat, profh, john07801, RandomNonviolence, Lindy, Involuntary Exile, Matt Z, onionjim, BYw, Mannie, elfling, nuclear winter solstice, YaNevaNo, twigg, Flying Goat, middleagedhousewife, Clive all hat no horse Rodeo, terabytes, Cecile, belinda ridgewood, TomFromNJ, rose quartz, Alumbrados, Paul Ferguson, bythesea, enhydra lutris, StrayCat, RoCali, Sychotic1, exNYinTX, bluesheep, stormicats, litoralis, Risen Tree, HarpboyAK, Nebraskablue, Wolf10, sodalis, Heart n Mind, Oh Mary Oh, opinionated, palantir, Neon Vincent

    It is done. Four More Years.

    by mconvente on Thu Jun 13, 2013 at 08:18:21 AM PDT

  •  Thanks for all the background information on this. (53+ / 0-)

    It helps to know exactly what the defendant was trying to achieve with their patents.

    This is good news for everyone, but especially those who  have an increased risk of breast cancer.

    "A teacher affects eternity; he can never tell where his influence stops." Henry Adams.

    by glendaw271 on Thu Jun 13, 2013 at 08:24:52 AM PDT

    •  The description that Pete Williams (35+ / 0-)

      gave about the decision was that the patent on the test that they have developed stands - it is the gene that can't be patented.  The fact that the gene can be studied by other groups of researchers opens up the possibility that others would develop test, but it also opens up more potential roads towards understanding and stopping the gene from causing cancer which is very good news.

    •  Does this also apply to other animal genes? (2+ / 0-)
      Recommended by:
      Aunt Pat, LilithGardener

      (non human animals?)

      ...Son, those Elephants always look out for themselves. If you happen to get a crumb or two from their policies, it's a complete coincidence. -Malharden's Dad

      by slowbutsure on Thu Jun 13, 2013 at 11:02:23 AM PDT

      [ Parent ]

      •  Implicitly, yes. (5+ / 0-)
        "naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that [synthetic DNA] is patent eligible because it is not naturally occurring.”
        Note that the text doesn't refer to HUMAN DNA. It refers to naturally occurring DNA. All of it, since it's not limited to some subset.

        Human.
        Animal.
        Plant.

        If it is not provably a sequence that doesn't (in effect CAN'T) occur in nature, it's not patentable.

        Why can't? Because if you attempt to patent a genetic sequence that you created in the lab, the easy attack on it is that the very same sequence could already exist in nature and thus be non-patentable. You'd need to prove that it doesn't exist.

        In the whole environment.

        Not even plausibly feasible. Not even with the help of PRISM.

        You'd need to be able to show that it doesn't exist... because it could NOT have occurred naturally for some reason... in order to begin to have a case to take to the Supremes, now.

        "Be just and good." John Adams to Thomas Jefferson

        by ogre on Thu Jun 13, 2013 at 01:26:00 PM PDT

        [ Parent ]

        •  Bacteria, archaia, fungi... (0+ / 0-)

          The point is that anything occuring in nature is not patentable.  

          This is an obviously correct ruling, based on precedents dating back to before the American Revolution, but patent law got really screwy in recent years, and embarassingly it seemed like the courts were allowing patenting of things found in nature.

        •  I think that's backwards (0+ / 0-)

          It's patentable until someone proves it exists in nature.

      •  Yes, and all other genes that exist anywhere (3+ / 0-)

        in nature; including all genes in all the organisms that haven't even been discovered yet.

        "They did not succeed in taking away our voice" - Angelique Kidjo - Opening the Lightning In a Bottle concert at Radio City Music Hall in New York City - 2003

        by LilithGardener on Thu Jun 13, 2013 at 02:36:02 PM PDT

        [ Parent ]

    •  Nothing Changes! (4+ / 0-)

      I think virtually everyone commenting on this diary including the diarist is misinformed.  Myriad will still "owns" the tests since it does not rely on "natural DNA" but instead on a technique call polymerase chain reaction (PCR) amplification.  Moreover, research on these genes has gone on unimpeded since their discovery by many many basic science and pharmaceutical labs.  Myriads "ownership" NEVER altered that.  As for different tests ... any test that uses something other than the "natural DNA" of the testee will infringe on the Myriad patent.  I certainly do not see this a "victory" against Myriad's monopoly - but rather a status quo!  And Myriad (and its investors) don't see this as a loss either.  Look at their stock ... it's up ~10%.

      •  So? (1+ / 0-)
        Recommended by:
        mconvente

        So somebody else can make a different test using a different technology. Or get a court to find that the patents are too broad, because they patent everything not just the specific invention, and destroy the progress that is the only legal justification for patents at all.

        We still have lots of problems with patents. Any PCR patent should have expired long ago - it was invented in the early 1980s, and has recouped its costs many thousands of times over.

        But we now have protected organisms' DNA from becoming someone's exclusive property. That is a major victory, even if not taking back everything already grabbed.

        "When the going gets weird, the weird turn pro." - HST

        by DocGonzo on Thu Jun 13, 2013 at 07:26:39 PM PDT

        [ Parent ]

        •  Not a single "method claim" was overturned (0+ / 0-)

          in the decision.  Thus, all diagnostic methods remain patentable ... and Myriad has the corner on the market.  Don't delude yourself into thinking this changes anything!  Moreover, "methods" are the foundation of the worldwide patent system. Myriad won.  So what if you can't patent a natural gene?

          •  Wrong (1+ / 0-)
            Recommended by:
            Adam B

            All diagnostic methods remain patentable, and Myriad has not patented all diagnostic methods - just some.

            Myriad had prevented competition from making any competing tests by patenting the genes. Now they can't prevent that competition any more, if they have a different mechanism to a new test. Myriad didn't totally lose, because lots of their assets weren't at risk. But what was at risk, their gene patents, they lost.

            Methods are not the foundation, they are a relatively recent abuse. Working models are the foundation, though the system has drifted by not requiring them.

            "When the going gets weird, the weird turn pro." - HST

            by DocGonzo on Thu Jun 13, 2013 at 08:23:59 PM PDT

            [ Parent ]

      •  PCR is out of patent already. (1+ / 0-)
        Recommended by:
        mconvente

        PCR was well-understood and used in college labs by the 1990s -- patents only last 20 years.

        Myriad can't, legally, have a patent on combining a natural product with an unpatented technique in an obvious way.  (And it is obvious -- the first thing any lab does to any DNA sample is to apply the PCR technique.)

        So this really does break Myriad's patent.  It's going to be necessary to develop a slightly different actual test for after the PCR, but that's just a chemical engineering problem, and someone will solve it.

      •  one thing I wonder about - short fragments. (0+ / 0-)

        So cDNA is patentable - that was expected. What differentiates a cDNA from just an "isolated" piece of genomic DNA? the splicing. The cDNA sequence differs at the splice sites. But  diagnostics typically depend on short oligonucleotide probes, not long cDNAs. An oligo sequence may have been derived from a cDNA, but unless the oligo sequence includes a splice site it may as well have been derived from genomic DNA - there's no difference in sequence. Which effectively means so long as the mutation you are looking for is at least  a few bp away from the nearest splice site you can make oligos to probe for it and not worry about infringing a patent.

        You still would have to worry about claims on methods that use the oligo or constructs that comprise the oligo though.

    •  This just made my job more difficult... (2+ / 0-)
      Recommended by:
      Adam B, Roadbed Guy

      As a cancer researcher who is trying to raise money to get a novel drug into clinical trials - one of the basic needs I face is how do I figure out which people should get my drug.

      As a result, I have developed a test that lets me know how to choose patients for the clinical trial - based on whether they carry genetic mutations that gives them the cancer that my drug treats.

      The ability to get ANYONE - especially Venture Capital groups - to fund my work just got harder.

      Without the ability to recover any funding for getting this test approved for use by the FDA - no one wants to pay for the development of the test.  Without this test, my clinical trials fail because I have to treat cancer patients without the mutation that my drug treats - and they get no benefit and therefore they make my drug look bad.

      I understand the arguments about not letting natural things be patented - but I just lost my ability to gain funding for future drug trials and diagnostic development.  

      If there is no profit (you can't make a profit without a patent) there is no drug or diagnostic test, and this ruling just sucked the profit out of diagnostic testing if it is based on gene mutations.

      So, if you develop cancer in the future - you can rest assured that this decision will have a negative impact on the ability to treat your specific disease with targeted low-toxicity therapies. You will have to rely on old medicines with greater toxicity instead.

      •  I think you a wrong (4+ / 0-)

        Of course I do not know your specific case.  However, mutation testing relies on the analysis of an "unnatural" product (PCR?) that is ultimately an indicator of the "natural" DNA.  You can still patent the test and the therapeutic compound ... which provides the IP (Intellectual Property) that make investors confident that they have something tangible (and salable) should the "company" go under.

        Of course I have a whole different argument about whether a cancer cure exists ... since there are approximately 10 billion combinations of cancer "driver" genes.  This largely overlooked fact by the cancer establishment means that ONE good targeted therapeutic is definitely not sufficient ... or even close to a cure!

      •  Profit over humanity. (4+ / 0-)

        The scary thing is I don't think you realize the implications of patenting human genes. If genes can be patented, then companies can own genes inside people's bodies. What if some greedy corporation tries to accuse you of "stealing" their property because you have their genes inside your body. You could essentially be charged and convicted of a felony and lose your constitutional rights.

        •  Back in 1998 in Canada Monsanto successfully sued (2+ / 0-)
          Recommended by:
          deep info, mconvente

          a farmer whose field had been contaminated by other growers. They wanted him to sign a contract to buy new seed every year.

          Schmeiser refused, maintaining that the 1997 contamination was accidental and that he owned the seed he harvested, and he could use the harvested seed as he wished because it was his physical property. Monsanto then sued Schmeiser for patent infringement.
          Perhaps this decision is a glimpse of the dawn of a new age of pushback against this sort of thing.
        •  WVU - your comment is nonsensical (0+ / 0-)

          Hopefully is was a snark.

          "let's talk about that"

          by VClib on Fri Jun 14, 2013 at 06:50:41 AM PDT

          [ Parent ]

          •  How so? (1+ / 0-)
            Recommended by:
            mconvente

            Not at all a Snark. Read Michael Crichton's book NEXT. He foresaw these problems almost a decade ago. There are serious legal ramifications to companies owning gene patents. If they can own genes, they can literally own material inside peoples' bodies. They might not own the person but material inside the person. It would be like a company having a patent over a human body part. Say you have a gene inside your body to which a company like Myriad has a patent. You now do not own the rights to the gene inside your body...Myriad or some like corporation does. You cannot "use the gene" in any way they do not wish you to use it. I think there's a problem there.

      •  Excuse me? (7+ / 0-)

        Nothing about the ruling says that you can't get a patent for a specific invention that deals with a naturally-occurring gene. You just can't get a broad conceptual patent that would cover every possible invention that could deal with the gene.

        In other words, you can't just stake out a claim on something you discovered, but didn't invent, and start demanding rent for it.

        You have to remember that the purpose of patents is to reward inventors, not for creating their inventions, but rather for disclosing how their inventions work rather than keeping it a secret that would die with them. That's because disclosure enables future inventors to build on their work and that, as some very wise people said 224 years ago, "promotes the Sciences and the useful Arts.". If something already exists in nature, however, there's no real way to prevent others from discovering it independently, and therefore the knowledge of it can't die with its discoverer, and therefore it's not necessary to offer an incentive to disclose it.

        Sometimes truth is spoken from privilege and falsehood is spoken to power. Good intentions aren't enough.

        by ebohlman on Thu Jun 13, 2013 at 02:43:25 PM PDT

        [ Parent ]

        •  Medical Greed (0+ / 0-)

          Lots of people in medical research can't distinguish between finer points like you just did, if there's any suggestion at all that their possible profits are at risk.

          Of course the prohibition on making anyone's DNA the exclusive property of another person or corporation will prohibit a patentholder from interfering with another person's research on that DNA. So this ruling will encourage progress in cancer research, like so many protections from patenting.

          But it does threaten some of the vast profits that patents are used to exploit in the name of "progress". That will make many in the medical industry squeal.

          "When the going gets weird, the weird turn pro." - HST

          by DocGonzo on Thu Jun 13, 2013 at 07:30:40 PM PDT

          [ Parent ]

      •  Too Bad (2+ / 0-)
        Recommended by:
        Risen Tree, mconvente

        If your work depends on making people's DNA the exclusive property of some corporation, then I'm glad your work is harder. Even if it is the magic "cancer research".

        I'd rather people, including myself, get cancer than that our DNA is owned by your corporation. And both my mother and young sister died of it, making my risk pretty high.

        "When the going gets weird, the weird turn pro." - HST

        by DocGonzo on Thu Jun 13, 2013 at 07:28:08 PM PDT

        [ Parent ]

        •  DocG - the comment had nothing to do with (0+ / 0-)

          changing the probabilities that someone would be stricken with cancer, rather changing the odds that they might survive it.

          "let's talk about that"

          by VClib on Fri Jun 14, 2013 at 06:53:34 AM PDT

          [ Parent ]

          •  Same Difference (0+ / 0-)

            Do you think that makes a difference?

            "When the going gets weird, the weird turn pro." - HST

            by DocGonzo on Fri Jun 14, 2013 at 03:30:37 PM PDT

            [ Parent ]

            •  Aa aomeone who has survived (0+ / 0-)

              Stage 4 cancer because of effective chemotherapy I would hope so. I am alive today because people risked tens of millions in the hopes they would save lives and make hundreds of millions. I am glad they did both.

              "let's talk about that"

              by VClib on Fri Jun 14, 2013 at 09:20:19 PM PDT

              [ Parent ]

              •  Not What I'm Talking About (1+ / 0-)
                Recommended by:
                VClib

                No, what I'm talking about is that I said "get cancer", when by that I include "use your test". Do you really thing my shorthand instead of the fully explicit statement makes any difference at all? Did you really not know what I meant?

                Maybe not, since you're still going on as if I didn't mean I'd rather not get the cancer tests if having them means they own my genes.

                You might disagree with that. But it's a false choice. There are plenty of genetic tests made by people who don't own the genes. And now nobody will own the genes, and every genetic test will have to succeed without a monopoly on the genes. The testing industry will not leave that market untapped, even if they have to actually compete.

                There will be DNA tests, there will be patents on some of them, there will be competition, there will be more reasonable prices. Which means that more people will be able to get those tests, though some people won't make fantastic profits - only adequate or better.

                That is a just medical system, at least one that's still capitalist. R&D budgets in the $billions don't require monopoly to profit and be incented to risk competing.

                "When the going gets weird, the weird turn pro." - HST

                by DocGonzo on Sat Jun 15, 2013 at 09:10:18 AM PDT

                [ Parent ]

      •  Isn't this cart-before-the-horse? (0+ / 0-)

        If (and that's a 1 in 500 "if" for an oncology drug  just starting preclinical trials) the drug is approved for people with the mutation, the  profits from its 50-100K pricetag would easily wipe out the cost of getting the diagnostic approved as well. Besides, the diagnostic that is submitted to the FDA could still be designed to be patentable.

        I really don't see this decision having any effect on incentives for developing biologicals for cancer.

      •  Dale - you need to review this decision (0+ / 0-)

        carefully and how the financial analysts and markets are treating MYGN. You are going to need to edit your business plan to be sure your diagnostic test falls within this ruling and can be eligible for a patent (I think it likely does).

        This is not a show stopper for you.

        "let's talk about that"

        by VClib on Fri Jun 14, 2013 at 06:49:33 AM PDT

        [ Parent ]

        •  We are... (1+ / 0-)
          Recommended by:
          VClib

          but, because my patent on the companion diagnostic was filed before this decision and the Mayo v Prometheus - our diagnostic claims are now invalidated.

          And, because the "invention" was published both as a patent and a scientific paper, we have lost the ability to file for new claims that take the recent decisions into account.

          We now must pay for development of a novel test and validate it for the FDA to allow for its use in our clinical testing to get the drug approved. Then as soon as the clinical trial is done, any CLIA certified lab can run the same test without investing a dime prior to our validation that it is worth using.

    •  Wish it had been done in time for my BRCA1 (2+ / 0-)
      Recommended by:
      deep info, mconvente

      "Diagnosis." But better late than never.

      Cats are better than therapy, and I'm a therapist.

      by Smoh on Thu Jun 13, 2013 at 01:02:44 PM PDT

      [ Parent ]

  •  I would like to see evidence of this claim (6+ / 0-)

    since it is completely outlandish:

    Myriad also charges researchers working on BRCA1 and BRCA2 projects, which is an additional cost and barrier to getting research done in this era of NIH budget cuts.
    In the bigger picture, the patent examiner was rather careless in this case to let one of the 87 or so claims go through specifying that gene (or gene sequence) gained patent protection.

    That was completely ridiculous - maybe similar to saying that sand can be patented.

    Many of the other claims were much more founded in reality - such as saying that if somebody figures out how to make sand into a computer chip, well yeah - that's probably a patentable invention right there.

    •  Here you go. NOT outlandish (28+ / 0-)

      Plaintiff Statements.  Focus on the one from Haig Kazazian, now at Johns Hopkins (but formerly of the University of Pennsylvania, where I am currently a cell and molecular biology graduate student):

      I joined this lawsuit as a plaintiff because my work as a genetic scientist and the work of my colleagues has been negatively affected by Myriad's BRCA patents.

      After the BRCA1 and BRCA2 genes were cloned in the mid-1990s, my colleague, Dr. Arupa Ganguly, spent considerable effort to set up a screening test for mutations in these genes that could be related to genetic disease. Ms. Lynn Godmilow, a genetic counselor, also worked with us, screening potential users of the test for appropriate family history, reporting of results to physicians, and follow-up.

      In the late 1990s, after we had tested over 500 women and a number of family members with risk of familial breast cancer for BRCA gene mutations, we received notice from Myriad to cease and desist the testing. Rather than risk being sued, we complied with Myriad's order. Unfortunately, now all of the BRCA gene testing must go through Myriad's lab, which charges almost twice our price for testing of these genes.

      Dr. Ganguly, Ms. Godmilow and I did significant work to set up the testing and we were very disappointed that we could not continue this service, which was of vital importance to women with a family history of breast cancer.

      Dr. Ledbetter's statement is an even better example of the patents limiting researcher.

      It is done. Four More Years.

      by mconvente on Thu Jun 13, 2013 at 08:43:37 AM PDT

      [ Parent ]

      •  That sounds like clinical medicine, not research (4+ / 0-)
        Recommended by:
        TheOrchid, ScienceMom, HiBob, VClib

        In fact the link you give says that:

        These laboratories provide clinical testing services to a large number of patients and families with genetic diseases (over 28,000 tests performed/year) and include biochemical genetics, cytogenetics and molecular genetics testing.
        IOW they were running a service that competed with Myriad, who had patented the procedure.
        •  The divide between the two is small today (10+ / 0-)

          You need substantial numbers of patients in order to do any sort of genome-wise association study with statistical power.  Genotype/phenotype correlations and the like.  Stuff that core biomedical researchers would do (like bio-statisticians and all)

          How else do you do that for a human disease without bridging the fields of clinical medicine and research?

          It is done. Four More Years.

          by mconvente on Thu Jun 13, 2013 at 08:50:05 AM PDT

          [ Parent ]

          •  The NIH doesn't really sponsor that type of thing (2+ / 0-)
            Recommended by:
            ScienceMom, HiBob

            it mostly sponsors mechanistic studies to understand the role of genes like BRAC1 in cancer.  I am highly dubious that Myriad sued anybody to stop that.

            This type of research is only peripherally related to the large scale clinical screening you referenced.  

            And from the link you gave, there was no evidence that the NIH was sponsoring the large scale screening that you claimed it was (although that certain is plausible, just not characteristic of their funding priorities).

            •  You could not be more wrong. (3+ / 0-)
              Recommended by:
              murrayewv, mconvente, deep info

              For starters, check out the 1000 Genomes Project.

              To put the torture behind us is, inevitably, to put it in front of us.

              by UntimelyRippd on Thu Jun 13, 2013 at 09:21:03 AM PDT

              [ Parent ]

              •  Umm, that has very little if anything to do (1+ / 0-)
                Recommended by:
                HiBob

                with breast cancer diagnosis.

                Although one objective is to correlate some types of disease with genetic variation, I have never heard the claim that that information would have any direct clinical relevance.

                The comparison to make might be that the 1000 genomes project is akin to pre-phase 1 drug discover efforts (which the NIH funds a lot of, that's its mission really) but then to take these discoveries into the clinic, private organizations (usually the reviled "Big Pharma") almost always have to step to do the subsequent clinical testing.

                •  Well, then you need to expand your listening. (3+ / 0-)
                  Recommended by:
                  mconvente, DocGonzo, deep info

                  Researchers all over the place are taking the 1000 Genomes data and incorporating it into all sorts of studies, including epidemiological ones.

                  To put the torture behind us is, inevitably, to put it in front of us.

                  by UntimelyRippd on Thu Jun 13, 2013 at 09:37:59 AM PDT

                  [ Parent ]

                  •  Umm, and you need to start listening to me (1+ / 0-)
                    Recommended by:
                    HiBob

                    because this is exactly what I said:

                    taking the 1000 Genomes data and incorporating it into all sorts of studies,
                    with the point being that the data itself is not clinically relevant, but has to be amplified in "all sorts of studies" to become that way.
                    •  I suddenly realize that we are having two (4+ / 0-)

                      different conversations here.

                      You are correct (I think), that the 1000 Genomes db is not something that would be the direct input into a decision-making protocol in clinical practice.

                      On the other hand, I also perceive that the line between clinical practice, clinical trials, clinical research, and more basic research is dissolving. This is not the sort of thing that will make the FDA happy, since it is difficult for them to enforce quality/validation/verification standards on research protocols that are not specifically performed in a clinical trial setting.

                      Consider the specific example I discussed in another comment: Private-service whole-genome sequencing. As far as I know, the companies who are doing it, aren't doing it under any sort of FDA-approved clinical protocol. Which in my experience would mean, for example, that they cannot offer the service to a hospital lab as part of a diagnostic protocol. Nonetheless, that is what people are going to want to do with the information.

                      And on the public side, I do have specific knowledge of a current attempt, funded by public money, though I don't know whose, to apply "whole exome" sequencing directly to clinical research and eventually to clinical practice ... when I learned of it, I was a bit mystified as to how they could navigate the regulatory systems that govern such things. I'm pretty sure that plenty of clinical research does happen on the NIH dime. I do not know how much of the original data going into such research ever finds its way directly into clinical application, but I suspect that as more and more clinical research comes to rely on genetic and epigenetic data, we will see more and more databases that start out as Research-use-only, but then make their way into clinical practice. (Ultimately, that will depend on the FDA's willingness to sign off on the data's validity.)

                      To put the torture behind us is, inevitably, to put it in front of us.

                      by UntimelyRippd on Thu Jun 13, 2013 at 10:17:32 AM PDT

                      [ Parent ]

            •  That used to be so (6+ / 0-)

              But now the NIH, and the NCI in particular, have focused much more on the clinical/translational side.  In fact, one might argue they've focused too much on that to the detriment of basic mechanistic studies.

              Forward thinking!

              by TheC on Thu Jun 13, 2013 at 09:32:06 AM PDT

              [ Parent ]

              •  Yes, that's true - I've had difficulty (0+ / 0-)

                finding actual $$s amounts of the NCI budget devoted to this but my sense is that it remains relatively minor (e.g., 20 to 25% of the entire budget - but still, if you look at how many R01's could be funded instead, it's a lot!).

          •  You do it without charging patients for the test. (0+ / 0-)
        •  Agree, testing is more clinical (1+ / 0-)
          Recommended by:
          Roadbed Guy

          It's nice that women with strong familial risk can more cheaply access genetic testing.

          But tests, in and of themselves, don't do much to advance research that will prevent breast cancer or cure it.

          "If you can't take their money, eat their food, drink their booze and then vote against them, you have no business being in DC."

          by Betty Pinson on Thu Jun 13, 2013 at 11:12:40 AM PDT

          [ Parent ]

          •  Tests can have an impact on research (2+ / 0-)
            Recommended by:
            helpImdrowning, deep info

            In some diseases, there is only one mutation that is causative (or perhaps a few mutations), rather than the spectrum of mutations that can cause breast cancer.

            Well, the more patients we screen (in this case, sequence their genes), the higher "n" number of patients we get to put in the database.  And the higher your "n" is, the better statistical power you get when you start analyzing genotype/phenotype correlations.

            If, through screening, we identify a causative mutation occurs in 90% of patients with a disease, then you can take that information and start putting it to use for pharmaceuticals.

            We have the ability to 3D model protein shapes, and more importantly, alterations of those shapes with a mutant amino acid present.  We can space-fit small molecules into that ever-so-slightly altered binding pocket, and hopefully a drug is identified that dampens any extra signaling activity that is caused by the mutation.

            This type of high-throughput screening works.  But we need to first identify a causative mutation and how it alters the protein.

            Compiling a large database from screening/sequencing tests is how we do this.  That's why the bridge between clinical medicine and research is dissolving, as I and other people have commented here have said.

            It is done. Four More Years.

            by mconvente on Thu Jun 13, 2013 at 11:29:32 AM PDT

            [ Parent ]

            •  The Cancer Genome Atlas (1+ / 0-)
              Recommended by:
              Roadbed Guy

              has already been doing this ... though I think it is an enormous waste of money since it has not yet discovered something that we don't already know!  But such is the "business and politics" of the NIH.  You seem to think that cancer is a "few mutation" process.  It is NOT!  Every solid tumor examined to date has 100's of mutations.  Embedded in these 100's of mutations is about 10 "driver" mutations that are the fundamental "cause" of the cancer since they affect essential characteristics that are required to develop a tumor.  A relatively simple calculation suggests that there are approximately 10 billion (with a "B") combinations of driver mutations.  Since there are only 7 billion people on the face of this earth ... it is highly unlikely that any two tumors are genetically identical.  Moreover, this "driver" problem occurs in a background of 90+ "passenger" mutations that are clearly different between tumors and even WITHIN tumors.  This whole "binding pocket" drug design hypothesis has basically NEVER worked.  The best example is Gleevec which was supposed to be "targeted" ... but in fact affects the activity of a number of related signaling molecules.  Research on the BRCA and/or any other genes has NEVER been affected by the Myriad (or other gene) patents.  And gene diagnostics will remain status quo with today's decision.  So most of the diarist comments are moot.  

              •  So true (2+ / 0-)
                Recommended by:
                Roadbed Guy, deep info

                This approach also focuses on the tumor cells only to the exclusion of the environment outside the cell.

                "If you can't take their money, eat their food, drink their booze and then vote against them, you have no business being in DC."

                by Betty Pinson on Thu Jun 13, 2013 at 01:01:55 PM PDT

                [ Parent ]

              •  I'm a cell and mol bio grad student at UPenn (0+ / 0-)

                I'm aware that cancer is not just one mutation; that as the tumor growths multiple and more complex DNA damage (like chromosome duplications and deletions) occurs.

                It is done. Four More Years.

                by mconvente on Thu Jun 13, 2013 at 01:41:32 PM PDT

                [ Parent ]

                •  Cancer is the natural state of cells (1+ / 0-)
                  Recommended by:
                  mconvente

                  The best understanding I've had of cancer is to realize that evolution, acting on the individual cellular level, encourages cancer.  After all, the cells which reproduce faster and acquire a food source are the survivors, y'know?....  just like bacteria.

                  The body has a complex set of anti-cancer systems in place, and if any single one of them breaks down or fails, you get "cancer".

                  This is very different from most human diseases.

                  Now there's some horrible parallels here.  Obviously, the problem with cancer, evolutionarily is that eventually it kills its host and then there's no environment for it to live in, and it all dies (Henrietta Lacks excepted).

                  Now, humans have been multiplying faster than rabbits, but we seem to be destroying the environment which we evolved to live in, and.... uh.... reminds me a bit of cancer...

            •  We've known about these genes since early '90's (1+ / 0-)
              Recommended by:
              Roadbed Guy

              Very little therapeutic benefit has come from the knowledge.

              We do need to spend more research funds on primary prevention of breast cancer. But focusing on these two genetic mutations hasn't, nor is it likely, they will yield much in the way of primary prevention or treatment.

              As a breast cancer survivor, I support Breast Cancer Deadline 2020 - an initiative focused on having the answers to primary prevention and treatments to stop metastasis by 2020.    We can't afford to spend 25 or 30 more years teasing apart the characteristics of every gene.  We need a more comprehensive approach that produces real targets that impact the most cancers more quickly.

              "If you can't take their money, eat their food, drink their booze and then vote against them, you have no business being in DC."

              by Betty Pinson on Thu Jun 13, 2013 at 12:59:48 PM PDT

              [ Parent ]

              •  Yeah, because to do correlations (0+ / 0-)

                requires sequencing A LOT of DNA from tens of thousands of patients.  In the early 90s it cost $3 Billion (with a B) to sequence an entire genome.

                Today?

                Maybe, maybe $5,000.  And it's going lower very year.

                Sure, some scientists and physicians vastly overstated the impact this "genomics and personalized medicine" would have, or more correctly, how quickly this impact would be felt.  But we're getting there.

                I also object to your assertion that genes are not "real targets".  If anything, they are the targets to go after.   Or more specifically, the oft-misshaped proteins that mutant genes encode.

                Real science and medicine doesn't work by reading a "Top 10 antioxidants" list or any other similar type of thing.  The best preventative measure for many types of cancer is sequencing your genome to identify any potential risk mutations.

                It takes measured, detailed, meticulous studies, not only to satisfy statistical certainty with results but to ensure that any therapeutics we do develop are safe for humans - the lengthy but necessary clinical trial process.

                It is done. Four More Years.

                by mconvente on Thu Jun 13, 2013 at 01:32:57 PM PDT

                [ Parent ]

                •  LOL, Top 10 anti-oxidants (2+ / 0-)
                  Recommended by:
                  Roadbed Guy, mconvente

                  I'm a fan of evidence based medicine, not vitamins and supplements.  When I refer to the environment outside of the cancer cell, I'm referring to the tissues where it lands, the immune system, bone marrow, etc. Cancer growth is affected my more than what happens inside the tumor cells.

                  But I also believe, as do many researchers, that the process needs to be sped up.  There's a lot of places to look for the answers, but we have to find a way to narrow them down much more quickly.

                  The best preventive measure isn't testing for genetic risk, then lopping off your breasts.  That's a barbaric remedy that is only available to a small percentage of women who test positive for BRCA 1 or 2 mutations and have a high familial risk.  The best preventive measure is one we don't have yet, but should have by now. The best preventive measure should be something that is highly effective, non-invasive, affordable and prevents all or at least a majority of breast cancers.  A vaccine is probably the most likely solution, but precious little has been spent on developing one.

                  We also need to focus on another area that gets short shrift - prevention of metastasis - the condition that causes most cancers to become fatal.  

                  We spent the last 2 decades pouring billions into mammography research - a mediocre, often unreliable means of detecting breast cancer.  I don't want to see the same race to spend billions to test women for BRCA 1 and 2 (who aren't at risk of having those mutations) at the expense of research into areas that may bring more productive results that help actually prevent all types of breast cancer.  

                  I'm sleep deprived today, but will give you a link where you can find out more.  I plan to write a diary about this topic tomorrow.  

                  Here's a link to the Artemis Project plan to develop a breast cancer vaccine using, among other things, genomic mining.

                  Link

                  There's a similar Artemis Project now underway to develop treatments to stop metastasis.

                  Cutting off breasts isn't the answer, we need something better, soon.

                  "If you can't take their money, eat their food, drink their booze and then vote against them, you have no business being in DC."

                  by Betty Pinson on Thu Jun 13, 2013 at 02:29:26 PM PDT

                  [ Parent ]

    •  A blurb re: a reduced the price for NIH (1+ / 0-)
      Recommended by:
      mconvente

      ... after their price gouging, and its implications for human lives, became public knowledge:

      http://www.nature.com/...

      •  Now that a person's entire genome (2+ / 0-)
        Recommended by:
        mconvente, deep info

        can be sequenced for $1,000 - charging 3x to sequence on gene is unfathomable.

        But the link you gave is from 13 years ago when it was considerably more costly to do so (DNA sequencing is something like Moore's Law on steroids . . .).

        Some Myriad's entire business model seems to be becoming moot.  Probably not a good idea to buy stock in them (if that's even an option )

    •  The report I heard on MSNBC was that (12+ / 0-)

      this decision actually affects tens of thousands of patents.

      In other words, it wasn't one lone sloppy patent examiner.

      •  Well, there had to be the first examiner (3+ / 0-)

        who allowed this type of claim, and thereby set precedent.

        Maybe idiotic would be a better word than sloppy.

        •  There had to be some sort of (2+ / 0-)
          Recommended by:
          Roadbed Guy, mconvente

          policy or even a law, actually.

          I don't know enough about how it came to pass that the patent office started granting patents on human genes to companies.

          •  My hazy recollection is that they first (5+ / 0-)

            granted patent protection over genes (hundreds or thousands of them in one fell swoop) to the NIH, not companies.

            With the NIH claiming that the reason that they sought patent protection was to ensure that the genes remained "in the public domain" (e.g., to prevent exactly what Myriad is doing).

            But in the process opened the door to companies patenting genes for their own nefarious purposes (such as making money off of people's medical problems - the horror, the horror - how can we allow that type of thing in today's America?)

            •  So, that's interesting. (0+ / 0-)

              And there you go.

            •  Big problem has been the Federal Circuit (0+ / 0-)

              A while back, Congress transferred nearly all patent cases to the "Federal Circuit Court".  Patent lawyers proceeded to take over the Federal Circuit.

              The patent lawyers on the court proceeded to bully the patent office: whenever the patent office refused to grant some ridiculous patent, perhaps on mathematics or swinging a swing sideways or on something occuring in nature, the Federal circuit would overrule the patent office and force them to grant the patent.  (Why?  More money for patent lawyers!)  Eventually the patent office stopped even bothering and just let the illegal patents sail through.

              The system where the patent office is funded by fees from companies who want patents is also part of the problem.

        •  Not sloppy, not idiotic. (0+ / 0-)

          Merely following SCotUS per Chakrabarty.  The current Court, don't forget, is highly activist. The Myriad decision is part of that activism.

          The road to Hell is paved with pragmatism.

          by TheOrchid on Thu Jun 13, 2013 at 10:21:59 AM PDT

          [ Parent ]

      •  STOP Patent Trolls (4+ / 0-)
        Recommended by:
        MrLiberal, Samer, elfling, deep info

        While I have no delusions that this decision will lead to broader implications of 'patent trolling' - I am grateful that the SCOTUS has at least drawn SOME line in the sand here

        Corporate america is out of control in terms of the "ownership society"

        I, for one, am glad that SCOTUS has concluded what many of us intuitively know - namely that the idea of a corporation owning a patent on any part of our genetic code is absurd

        "I want to keep them alive long enough that I can win them to Christ," - Rick Warren, Professional Greed Driven Scumbag

        by josephk on Thu Jun 13, 2013 at 09:02:21 AM PDT

        [ Parent ]

        •  Did I give the impression that I disagreed (2+ / 0-)
          Recommended by:
          josephk, Dianna

          with the decision?

          My reaction to the news having heard nothing about the case before the decision came down today was to be at once relieved and dumbfounded as to how in the world patents would ever be granted on human genes.  Seemed crazy to me that there even had to be a SCOTUS decision on something as inherently wrong as that.  I also felt a bit relieved to find out that this court isn't totally off the deep end.

        •  This isn't the same issue. (1+ / 0-)
          Recommended by:
          Adam B

          Most patent trolls are for (usually) weak, overly-broad patents. Usually method patents. They do not actually practice the patent but bought it as part of an asset portfolio. They send you a letter like "we see you use clicking to navigate your website, you are violating our patent #128686868. Please send us $30,000 or face litigation."
          While I dont have the patience to read the whole patent. Myriad Genetics performed a crucial piece of research, and tried to capitalize on it by patenting something that was patently absurd. On the other hand, they no doubt spend 10's of millions doing this research, and want to get paid back. So this is a difficult issue.

          "You can die for Freedom, you just can't exercise it"

          by shmuelman on Thu Jun 13, 2013 at 01:14:12 PM PDT

          [ Parent ]

          •  Not difficult for that reason... (0+ / 0-)

            "Sweat of the brow" doctrine was rejected in copyright law over 100 years ago, and the same is true of patent law.  It really doesn't matter how much work the company put in or whether it wants to get paid back.

            The "patent bargain" is all about discouraging trade secrets: disclose how your invention works, in exchange for getting a monopoly for a while.  If there was a serious risk of Myriad actually keeping all the research secret, then that might justify a patent.  There wasn't, because they had to publish the research in order to get anyone to believe that they really had a test that worked.

    •  This is a standard problem in mol-bio (12+ / 0-)

      research and from what I've seen so far, this decision will not fix it.

      I've never looked carefully at the BRCA1 patents, but generally speaking, corporations have not been successful at patenting the DNA sequences themselves. Rather, they patent techniques and processes that operate on those sequences -- often in extremely general terms. Thus, for example, they will patent what is really a concept: "Any process in which any reagent binds to a DNA molecule incorporating sequence ACGTAGAGATGTCCC ..." The language itself is often scientifically meaningless -- DNA binding is like any other molecules-in-solution phenomenon, it happens in varying proportions under different conditions of temperature, concentration, and the presence of other molecules or ions. Indeed, under almost any conditions in which any useful DNA-based chemistry is happening, any single-stranded DNA molecule will bind, at least momentarily, to any other.

      The bottom line of most of these patents is that what they patent is any system that detects the DNA sequence of interest -- an overbroad claim that prevents anybody from developing a better test (where better = cheaper, more reliable, less intrusive, or whatever), and indeed, can even prevent basic researchers from studying the original molecular biology itself. It's impossible to study the BRCA1 gene without detecting it, which means every experiment you do carries an enormous overhead of royalty payments -- and by "every experiment", I mean, imagine a rack of "plates", each holding 96 small wells, each holding a separate tissue culture, and each at some point being treated with reagents purchased in licensed kits whose prices include enormous IP costs. "every experiment" means "every single one of those individual cell cultures".

      Michael Crichton was a gigantic dick, but he mostly got this one right. Our IP system is a complete clusterfuck, both in the realms of molecular biology, and in the realms of software systems. Supposedly, we allow the government to create IP in order to stimulate innovation -- but the current system has been corrupted to where it often does exactly the opposite.

      To put the torture behind us is, inevitably, to put it in front of us.

      by UntimelyRippd on Thu Jun 13, 2013 at 09:06:41 AM PDT

      [ Parent ]

      •  In a similar vein, many many researchers (1+ / 0-)
        Recommended by:
        deep info

        really chafed under the patent restrictions of the thermostable polymerases used in PCR a while back.

        You know, since these enzymes were naturally occurring and all, and isolated from Yellowstone National Park samples at that (that's public resource, no?)

        •  OK, so the "natural laws" may not be applied (3+ / 0-)
          Recommended by:
          ScienceMom, Panacea Paola, deep info

          consistently.

          But I think people are a lot more cautious about anything involving commercializing DNA, particularly naturally occurring human DNA sequences, because we view it as a scientific extension (or really, initiator, if you will) of our selves.

          It's a whole philosophical thing.

          Of course, I'm interested in public and private institutes start doing higher scale gene therapy applications.

          Will any part of engineering the Delta32 CCR5 mutation into HIV-positive patients be patentable?  Because even though the approve is novel (and they're already doing it at low scale here at Penn), the mutation is by all definitions "naturally occurring".

          In this instance, it's just a advantageous "naturally occurring" mutation as opposed to a deleterious oncogenic mutation.

          A lot of things still at play here.

          It is done. Four More Years.

          by mconvente on Thu Jun 13, 2013 at 10:01:32 AM PDT

          [ Parent ]

      •  That's what I don't get (3+ / 0-)
        Recommended by:
        Panacea Paola, Sychotic1, deep info

        Isn't that just patenting a discovery? How is it not that the specific method is what is patented, and if someone else comes up with a different method of getting the same discovery, that's outside the original patent?

        How could that have ever passed muster before this ruling nixed it?

        Government and laws are the agreement we all make to secure everyone's freedom.

        by Simplify on Thu Jun 13, 2013 at 10:28:09 AM PDT

        [ Parent ]

        •  Bad patents were sailing through (1+ / 0-)
          Recommended by:
          Simplify

          If you want to see a long sequence of them, try reading a "software patent".

          There've been 20 years or more of complete junk patents issuing.  The last time a patent system was this broken, it was the Dutch one, hundreds of years ago, and the Dutch Parliament reacted by abolishing patents entirely.

    •  BTW, just to get an idea of how completely (5+ / 0-)

      unworkable are Myriad's patents (and those of similar genetic testing companies): Today you can send in tissue samples and have your entire genome sequenced for a price comparable to what Myriad charges for testing for BRCA1/BRCA2.

      One unavoidable side effect of sequencing your genome is that BRCA1 and BRCA2 will be detected if they are there. Thus, all of the whole-genome sequencing companies are continually and inevitably in violation of the Myriad patent (and who knows how many others).

      Within a year or two, the price for whole-genome sequencing is likely to drop to $1000. At that point, it will likely be not only feasible, but reasonable for every person in the country to have their genomes sequenced as a matter of routine preventative care. What then for such ludicrous detection patents?

      To put the torture behind us is, inevitably, to put it in front of us.

      by UntimelyRippd on Thu Jun 13, 2013 at 09:18:24 AM PDT

      [ Parent ]

      •  And what if whole genome sequencing (0+ / 0-)

        becomes cheaper?  What then?  What is the benefit of having that information if you have no realistic or humane way to prevent or treat a disease?

        Wouldn't time and money be better spent on finding real preventions and cures instead of racing to get detection tests to market for the quickest profit?

        The problem is in biotech and other companies focusing all their attention on detecting genetic mutations and almost no effort on finding a way to deal with them.

        Frankly, learning you're BRCA 1 or BRCA 2 positive, then having to lop your breasts off to prevent it is ridiculously barbaric.   Shouldn't we be spending money and effort to prevent breast cancer instead of chopping off healthy breasts?

        "If you can't take their money, eat their food, drink their booze and then vote against them, you have no business being in DC."

        by Betty Pinson on Thu Jun 13, 2013 at 11:23:26 AM PDT

        [ Parent ]

        •  Cancer is a hard problem (1+ / 0-)
          Recommended by:
          mconvente

          See my comment above.  The problem is that cancer is the natural state of cells, evolutionarily speaking -- think of bacteria, which are more "normal" cells than the cells in our body, and you'll understand.  

          Our body has a great number of "anti-cancer mechanisms", but if even one of them fails, we will get cancer.  This is why each cancer is different.  (Very roughly speaking, tamoxifen is connected with the signalling system for an important anti-cancer mechanism, which is why it's so effective for most types of breast cancer.)

          The BRCA1 and BRCA2 mutations are defects in the anti-cancer mechanisms.  In order to counteract them, we have to first understand what the anti-cancer mechanisms are  -- what the normal allele (version) of the gene does, as opposed to the "mutant" version -- and then we have to figure out how to replicate the appropriate signals which were not being sent due to the genetic defect, or suppress the inappropriate signals which were being sent.  

          This is going to take a lot of research.  Identifying the correct gene site is actually an important step; the next step is working out what the healthy version of the BRCA gene site does (what protein it produces, what that protein does, etc. etc. etc.)  That will take years.

          •  True, its very complicated (0+ / 0-)

            and in the last decade we haven't made a lot of progress.  

            That's why I support the "Accelerating the End of Breast Cancer Act".

            It calls for a Commission to oversee strategies to move breast cancer research forward more quickly, with oversight by the Institute of Medicine and the ability to evaluate progress of breast cancer research and report it to the public.

            Here's some of the language

            SEC. 7. CHAIRPERSON AND COMMISSIONERS.

                (a) Chairperson-

                    (1) DESIGNATION- Of the members of the Commission appointed under section 6(a), the President shall at the time of appointment, designate one to serve as Chairperson of the Commission.

                    (2) QUALIFICATIONS- The Chairperson shall be an individual who, by reason of professional background and experience, is especially qualified to manage areas of study pertaining to ending breast cancer by January 1, 2020.

                    (3) RESPONSIBILITIES- The responsibilities of the Chairperson shall include--

                        (A) approving all new study projects and areas of study of the Commission based on innovation, impact, and scientific and technical merit;

                        (B) developing criteria (including milestones) for assessing, and overseeing assessment of, the success of the study projects and areas of study of the Commission;

                        (C) identifying opportunities for seed grants and other funding through awards, prizes, grants, and contracts to achieve the mission described in section 5(a); and

                        (D) terminating study projects and areas of study of the Commission that are not achieving the mission described in section 5(a).

                (b) Commissioners-

                    (1) IN GENERAL- The Chairperson of the Commission may appoint members of the Commission to oversee one or more areas of study of the Commission.

                    (2) RESPONSIBILITIES- A member appointed under paragraph (1) shall, with respect to one or more areas of study, be responsible for--

                        (A) recommending novel proposals, projects, and collaborations based on scientific and technical merit to achieve the mission described in section 5(a) with a focus on strategies for the primary prevention of breast cancer, and methods to prevent breast cancer metastasis;

                        (B) identifying ideas and opportunities to achieve the mission described in section 5(a) that are intellectually compelling, innovative, and imaginative, including such ideas and opportunities not being prioritized for breast cancer relevance within Federal agencies or programs or the private sector;

                        (C) working with other relevant Federal agencies to identify areas of concurrent interests in order to maximize Federal investment and stimulate collaborative projects;

                        (D) identifying opportunities for transdisciplinary, cross-cutting collaborations; and

                        (E) monitoring the progress of study projects and areas of study and recommending restructure or termination.

            SEC. 8. COORDINATION AND NONDUPLICATION.

                To the maximum extent practicable, the Commission shall ensure that the activities of the Commission are coordinated with, and do not duplicate the efforts of, programs and laboratories of other government agencies.

            SEC. 9. EVALUATION OF THE COMMISSION.

                (a) In General- The President shall seek to enter into an agreement with the Institute of Medicine of the National Academy of Sciences under which the Institute, after the Commission has been in operation for 3 years, completes an evaluation of how well the Commission is making progress towards achieving the mission described in section 5(a).

                (b) Inclusions- The evaluation under subsection (a) shall include--

                    (1) a recommendation on whether the Commission should be continued or terminated; and

                    (2) a description of lessons learned from operation of the Commission.

                (c) Availability- On completion of the evaluation under subsection (a), the Commission shall make the evaluation available to the Congress and the public.

            SEC. 10. TERMINATION.

                The Commission shall terminate on June 1, 2020.

            "If you can't take their money, eat their food, drink their booze and then vote against them, you have no business being in DC."

            by Betty Pinson on Fri Jun 14, 2013 at 03:10:06 AM PDT

            [ Parent ]

          •  Also, I'm a survivor of triple negative bc (0+ / 0-)

            or basal-like breast cancer. When diagnosed it was on its way to becoming inflammatory bc.  I'm currently counseling several women who have TNBC, they get referred to me because I'm one of the longest living survivors in our area.

            Year before last, at the San Antonio BC Symposium, I was surprised to see research had finally been done to examine the genetic make up of basal like bc.  It was a mess, shocking to see how those tumors have so many mutations.

            "If you can't take their money, eat their food, drink their booze and then vote against them, you have no business being in DC."

            by Betty Pinson on Fri Jun 14, 2013 at 03:18:50 AM PDT

            [ Parent ]

  •  But will they? (0+ / 0-)
    I couldn't agree more.  Millions of women will no longer be extorted by Myriad Genetics and finally be able to get access to much needed genetic screening to assess breast cancer risk.
    Sure, anyone can do the sequencing now (for example, me in my garage) but interpretation of the results is the key thing that Myriad was being paid for.

    For example, do you think that Angelina Jolie or Chistina Applegate would have had their breasts removed on the advice of a $29.95 assay?  I'm going to guess, no they wouldn't have.

    •  No ones stopping the company (19+ / 0-)

      from getting paid to do sequencing.  What this does is stop the company from threatening any other company that also does sequencing, or the company threatening people who talk about this gene.

      "But the problem with any ideology is that it gives the answer before you look at the evidence." - President Clinton

      by anonevent on Thu Jun 13, 2013 at 08:44:36 AM PDT

      [ Parent ]

    •  Seriously? (4+ / 0-)

      "Gee, if this test were more expensive, I'd be more comfortable reducing my risk of dying horribly by 85%, but since the test was so cheap, I'm just going to opt for a nearly guaranteed cancer death."

    •  Interpreting these particular results is (1+ / 0-)
      Recommended by:
      deep info

      not difficult, and it is not what Myriad was being paid for. They were being paid for having a monopoly on the results themselves. Generally, the actually useful "interpretation" -- i.e., consultation in which the meaning and implications of the test results are explained to the patient -- is performed by genetic counselors, who in these parts anyway are typically staff members of the oncology clinic.

      To put the torture behind us is, inevitably, to put it in front of us.

      by UntimelyRippd on Thu Jun 13, 2013 at 09:09:52 AM PDT

      [ Parent ]

      •  There is really no difference between (3+ / 0-)
        Interpreting these particular results
        and
        having a monopoly on the results themselves
        insofar as there is no way to interpret the results without have "deep level" information about the results.

        In particular, as I suspect you are well aware, there is not one BRAC1/2 mutation but instead there are dozens

        So, a woman gets tested and finds that she has one of these mutations, or even more vexing, a mutation that is not yet in the databases.

        What does she do?

        Well, Myriad was counting on compiling a proprietary database linking each of these mutations to clinical outcome.  For example, mutations a, b, and z might have a 95% mortality rate and a radical mastectomy would be well advised.  By contrast mutations c, x, and y might lead to no clinical manifestion or only benign tumor formation and removal of a woman's breast(s) would be entirely unnecessary.

        A genetic counselor would have no insight into any of  this w/o having access to Myriads' database / results.

    •  There are other companies and labs out there (1+ / 0-)
      Recommended by:
      Roadbed Guy

      Another set of genes involved in hereditary cancer are the mismatch repair genes.  They are not, to my knowledge, under any patent.  As a result, if one wants to test those genes, they have multiple options to choose from.  Not surprisingly, it is much cheaper to screen those genes then the BRCA genes.  This ruling is great news!

      Forward thinking!

      by TheC on Thu Jun 13, 2013 at 09:35:30 AM PDT

      [ Parent ]

    •  Hopefully millions of women won't be tested (0+ / 0-)

      BRCA 1 and BRCA 2 genetic mutations are extremely rare.  Less than 10% of breast cancers are from inherited risk, and even fewer of those are from BRCA mutations.  IIRC, the number of women at risk of getting breast cancer due to the latter mutations is 1% to 2% of the population.  

      So, no, we don't need to be doing genetic testing of large numbers of women for these mutations, just because it will be cheaper.  Unnecessary testing of large numbers of women with little to no risk of being positive will still result in massive health care costs and will unnecessarily traumatize healthy women.  

      Then there's the whole issue of having the fact your took the test on your personal medical record.  The news of the past week has pretty much shown that electronic medical records are not going to be safe.  What are the risks to women who've had these tests when a potential employer or life insurance, credit card or mortgage company gets hold of them.

      This ruling is great, but it shouldn't focus the medical community on going out to screen as many women as possible for BRCA1 or 2 mutations.  That's bad public health policy.

      "If you can't take their money, eat their food, drink their booze and then vote against them, you have no business being in DC."

      by Betty Pinson on Thu Jun 13, 2013 at 12:07:01 PM PDT

      [ Parent ]

      •  We need a gene nondiscrimination act. (1+ / 0-)
        Recommended by:
        mconvente

        Frankly, everyone should be allowed to get complete genetic (and epigenetic, when it's possible) sequencing without worrying about the reaction of insurance companies, employers, credit card companies, etc.  It is none of their business.

        •  We tried for several years to pass one (0+ / 0-)

          The only one that ended up passing was a version that has very little in the way of penalties or enforcement provisions against those who discriminate.  Maybe some day.

          But in the end, knowing your genetic risk of getting a disease must be coupled with having access to real prevention or treatment.  

          "If you can't take their money, eat their food, drink their booze and then vote against them, you have no business being in DC."

          by Betty Pinson on Fri Jun 14, 2013 at 02:54:58 AM PDT

          [ Parent ]

    •  Why Not? (0+ / 0-)

      I think that a $40 HIV test positive would stop Jolie or Applegate from having sex anymore.

      What has the cost of the test got to do with it, if the cost is in fact not an indication of the reliability of the results? Things are valued according to their price? Jolie and Angelina never masturbated, because it was too cheap to be worth it? Don't breathe air? Never have a beer?

      "When the going gets weird, the weird turn pro." - HST

      by DocGonzo on Thu Jun 13, 2013 at 07:39:11 PM PDT

      [ Parent ]

  •  SO Pleasantly suprised (12+ / 0-)

    I couldn't figure out how they might affirm Myriad's claim - and it irritated the fuck out of me that Myriad was taking the billions of dollars of research into the human genome project and tweaking the research and claiming 'ownership'

    The "UNANIMOUS" decision is so awesome in what it means for long term sustainability - this is one of the best pieces of news for me in a VERY long time

    "I want to keep them alive long enough that I can win them to Christ," - Rick Warren, Professional Greed Driven Scumbag

    by josephk on Thu Jun 13, 2013 at 08:39:02 AM PDT

  •  As an adopted woman with fibrocystic breasts (5+ / 0-)

    this is especially good news for me.

  •  can anyone explain (5+ / 0-)

    why Myriad stock has shot up after this ruling?

    •  my brother mentioned that to me as well (0+ / 0-)

      Up 10%.  Odd.  Though very rare, it has happened before with other biotechs and small pharmas.  Drug gets rejected, stock up.  Maybe because it's a final shut door on the potential to waste more money chasing pipe dreams?

      But I don't think this is like that.

      It is done. Four More Years.

      by mconvente on Thu Jun 13, 2013 at 08:51:27 AM PDT

      [ Parent ]

    •  Some of the genes CAN be patented, (4+ / 0-)

      notwithstanding the title of the diary.  So much of Myriad's patent library will remain valuable.  

      •  and now there is clarity as to those? (0+ / 0-)

        I am guessing

        Touch all that arises with a spirit of compassion

        by Mindful Nature on Thu Jun 13, 2013 at 09:11:49 AM PDT

        [ Parent ]

        •  Yeah. Patent law is NOT my thing, but (4+ / 0-)

          from what I understand, those genes that were just isolated by Myriad cannot be patented.  Those that were created synthetically can be patented.  So some of Myriad's patents remain valid.  

          I'm guessing the stock price was depressed anticipating that all the patents would be invalidated, and bumped up a bit upon news that some of them are still good.  Just my $.02.  

          •  There's lots of reasons (3+ / 0-)

            That something can fail to be patent-eligible. The original isolated gene, the naturally occuring information, falls out because it's a discovery not an invention. That's the meat of the decision here. You cannot patent the information and prevent anyone else applying it.

            As I mentioned in a comment on another diary, the cDNA copy would have a real hard time passing the obviousness test, as making a cDNA copy of a mRNA as part of molecular biology resesarch was a standard technique even when I was active in the field in the 80s. You do it because RNA degrades if you look at it funny and you cant easily persuade a helpful bacterium to grow you new copies of it by the bucket load. once you've got that cDNA you can do that and then go on to sequence it to find the proteins amino acid sequence, see where it sticks to the genome to help isolate the gene and a host of other things.

            Apart from the natural gene, everything else in Myriads patent claims depended on the natural gene and bog-standard techniques obvious to every single molecular biologist in the world, even the ones as out-of-date as I am. So by this decision, Myriads patent is toast. It may not know it's dead yet, but the point is that without the natural gene claim to hang the rest off as soon as they try to assert their patent somebody is going to come along and challenge the patent at the USPTO as invalid. That challenge will succeed and the whole patent will evaporate.

          •  Synthetic ones could be. (1+ / 0-)
            Recommended by:
            mconvente

            But not necessarily.

            The FACT that you synthesized them doesn't in itself make them patentable.

            Because if they are also naturally occurring, then they're NOT patentable.

            IF you can prove that they don't exist in nature, then they're not covered by ""naturally occurring ... product of nature...". But you'll have to PROVE that.

            Not just that you synthesized them. After all, they could very easily be naturally occurring. Myriad could not, after all, turn around and synthesize the genes that were in question and then patent them, because they are still identical to naturally occurring genes.

            You need to prove that they ARE NOT.

            Good luck with that. Proving that negative is going to be a bitch.

            UNLESS you can prove that they are BECAUSE they could not exist in nature. That's plausible, and could be done. Or at least arguably could.

            And that would not guarantee that they are patentable. It would simply put the question back before the court as to whether they are sufficiently different from a natural product to qualify as an actual invention.

            "Be just and good." John Adams to Thomas Jefferson

            by ogre on Thu Jun 13, 2013 at 01:35:05 PM PDT

            [ Parent ]

            •  Also, synthesis has to be novel (0+ / 0-)

              See the comment above by LimeyExpatDave.  Merely applying bog-standard techniques which people learned in COLLEGE in the 1980s in a completely standard way does not grant patent eligibility -- it's too obvious.

    •  My guess? (4+ / 0-)

      The stock price had already dropped in anticipation of a total loss; that they get to patent cDNA is a win.

      •  The cDNA patents will have to fall soon enough (2+ / 0-)
        Recommended by:
        mconvente, Adam B

        Turning mRNA into cDNA in the most straightfoward cookbook manner is the blatantly obvious thing to do to anyone with any training in "the art" (molecular biology), as LimeyExpatDave pointed out.  It's actually in the standard instruction manuals.  (Before I read his comment, I had actually assumed that Myriad had done something original in their testing.  Apparently not.)

        The Supreme Court is going to have to tackle the obviousness question head on soon enough, since there has been a serious problem with patents being granted on things which are obvious and standard and have been for over 30 years.  The cDNA patents will have to fall once obviousness is once again recognized as an actual reason to deny patents.

  •  Commies!! n/t (9+ / 0-)

    Don't tell me what you believe, show me what you do and I will tell you what you believe.

    by Meteor Blades on Thu Jun 13, 2013 at 08:47:30 AM PDT

  •  Wow! That's excellent news! (6+ / 0-)

    An acquaintance has been fighting with her insurer over getting the test, despite the fact that she has several factors that make her high risk for BRCA1. I hope things change rapidly on the testing front, so more women can get access without all the hassle that accompanies tests that are "too expensive."

  •  Great news! And this from a gene cloner :) nt (1+ / 0-)
    Recommended by:
    Words In Action

    We all understand that freedom isn't free. What Romney and Ryan don't understand is that neither is opportunity. We have to invest in it.
    Julian Castro, DNC 4 Sept 2012

    by pixxer on Thu Jun 13, 2013 at 08:58:50 AM PDT

  •  Did SCOTUS ban the licensing fees? (1+ / 0-)
    Recommended by:
    sjbob

    Is that the upshot of this, and it is immediate?  As in, yesterday a lab had to pay massive royalties to Myriad, but today they can tell them to shove it, and pay nothing?

    •  My guess is ... (2+ / 0-)
      Recommended by:
      Norm in Chicago, deep info

      that someone wanting the test now has the choice of paying the current rate for testing done by Myriad or waiting for competitors to offer their own testing at lower prices. Most probably other testing labs would not have incurred the start up costs yet, because the appeals court had ruled a few years ago in Myriad's favor and that was the current law.

      Few are the number of us, who see with our own eyes and feel with our own hearts. -- Albert Einstein

      by sjbob on Thu Jun 13, 2013 at 09:45:15 AM PDT

      [ Parent ]

  •  Is there some sort of secret rule ... (1+ / 0-)
    Recommended by:
    WVUCavalier

    ... of the Roberts Court that Justice Scalia has to write a concurring opinion even for pretty solid slam-dunk unanimous decisions. It's getting to be like "The Court held unanimously that two and two make four; SCALIA, J., filed a concurring opinion."

    At least in his uncharacteristically brief one in this case, though, he seems to have done it just to make absolutely clear that we know that, for once, whatever we may think he thinks, he knows jack about the underlying issue.

    I join the judgment of the Court, and all of its opinion except Part I–A and some portions of the rest of the opinion going into fine details of molecular biology. I am unable to affirm those details on my own knowledge or even my own belief.
    Fascinating. Not only is Nino for once humbled, he is so humbled he doesn't take shots at other justices or other cases.

    Given that the decision is longer on explaining the underlying science (probably a good idea, since everybody knows that this case will be a key precedent as genetics develops, taking us closer and closer to the singularity, over the course of this century, and this way the basis for the current Court's understanding will be available in the record for future Courts that may have to rule on trickier cases with issues presently found only in science fiction) than legal reasoning, this is understandable

    •  Succession plan? (0+ / 0-)

      Is Roberts grooming Tony to take over the Court when he retires?  That would be incredibly embarrassing, Scalia doesn't seem like a very bright man.

      "If you can't take their money, eat their food, drink their booze and then vote against them, you have no business being in DC."

      by Betty Pinson on Thu Jun 13, 2013 at 12:30:21 PM PDT

      [ Parent ]

      •  Doubt it (3+ / 0-)
        Recommended by:
        Adam B, WVUCavalier, deep info

        Scalia is nearly 80 and is one of the oldest justices on the Court, if not the oldest. He's definitely the most senior.

        Not that it matters what Roberts would think about who would succeed him. Chief Justices have no real say in the matter.

        And I know it might look like that from some of his more recent opinions, but very few people familiar with his jurisprudence, even those of us who often disagree with it, would call him dumb (that's why I found it amusing that he confesses ignorance here ... he so rarely does). His concurrences often ask annoying but pertinent questions about the opinion. And I think someone here noted that you can at least follow his logic even where you don't agree with the underlying premises. And he's usually quite lively and readable ... you know he's not farming the writing out to the clerks (some study found that of the current justices he's the one most likely to be doing his own writing, based on the consistency of the style).

        •  Scalia contradicts himself frequently. (1+ / 0-)
          Recommended by:
          mconvente

          Read one opinon, and the logic makes sense, but read another, and the logic is likely to contradict the logic in the first opinion.

          Idiot savant might be the right phrase; he's smart in some ways, but he's genuinely stupid in others.  He seems to be unable to recognize that he's frequently letting his biases decide his decisions and rationalizing backwards from the results.  A consistency check would cause him to notice what he's been doing, but he hasn't made one.

          •  That I would agree with ... (0+ / 0-)

            For instance, in his Ontario v. Quon concurrence, he chastises the Court for deciding not to establish a sweeping electronic-privacy precedent in the face of rapidly evolving technology because "the times they are a-changin' is a feeble excuse for dereliction of duty." OK, cute, but in other cases he's decided to back off.

            It's more noticeable in his later years (just like Hugo Black and William O. Douglas). His earlier years were the glory days.

            If you want to read Scalia at his angry best while agreeing with him, read his dissent in National Treasury Employees Union v. Von Raab. There weren't many of his that Stevens joined.

        •  Sorry, forgot the snark tag (1+ / 0-)
          Recommended by:
          deep info

          with a couple of exceptions, SCOTUS is more of a carnival side show these days when it comes to average Americans like me.  I'd rather joke about it than try to take it seriously.  It's too depressing.

          "If you can't take their money, eat their food, drink their booze and then vote against them, you have no business being in DC."

          by Betty Pinson on Thu Jun 13, 2013 at 01:23:24 PM PDT

          [ Parent ]

    •  Perk of seniority (0+ / 0-)

      Combined with Scalia's boundless capacity to be impressed with his own ideas.

      Sometimes truth is spoken from privilege and falsehood is spoken to power. Good intentions aren't enough.

      by ebohlman on Thu Jun 13, 2013 at 03:34:28 PM PDT

      [ Parent ]

    •  Part I-A (0+ / 0-)

      His concurrence is meaningful in that he doesn't concur with Part I-A.

      "When the going gets weird, the weird turn pro." - HST

      by DocGonzo on Thu Jun 13, 2013 at 07:43:27 PM PDT

      [ Parent ]

  •  'Naturally Occurring DNA Cannot Be Patented' (9+ / 0-)

    ...not just human.  This decision will have enormous impact for those of us with infections where information has been kept private because of existing or potential patents.  This is a great day for current and future generations!

    "This is the best bad idea we have by far..." ~Argo

    by MsGrin on Thu Jun 13, 2013 at 09:19:26 AM PDT

  •  A correction (8+ / 0-)
    Since the overwhelming majority of breast cancer incidences are caused by mutations in BRCA1 (and it's cousin, BRCA2), the main test that physicians will do for individuals with a family history of breast cancer is sequencing of those two genes
    Actually, BRCA-related breast cancer is less than 10% of all breast cancer cases. It might even be closer to five percent.  A higher percentage of ovarian cancers (but still under 20%) have the BRCA mutation(s).  Having a BRCA mutation is not a death warrant either.  Increases likelihood but it is not 100%

    There are many other paths to breast cancer and just because you don't have a BRCA mutation doesn't mean you are free and clear.  The BRCA mutations are actually uncommon and the test is not routinely performed on women unless there is a strong family history.

    The sequester is the new Republican immigration reform plan. Make things so bad here in the US that no one will want to live here.

    by Mote Dai on Thu Jun 13, 2013 at 09:23:29 AM PDT

    •  Noted and edited (2+ / 0-)
      Recommended by:
      Mote Dai, Cassandra Waites

      I meant to emphasize the fact that individuals with BRCA1 and BRCA2 mutations are at a vastly higher risk for developing cancer.  There is also the well-studied HER2/neu oncogene that can cause breast cancer, among others.

      It is done. Four More Years.

      by mconvente on Thu Jun 13, 2013 at 09:50:28 AM PDT

      [ Parent ]

      •  Yep, that is true (3+ / 0-)

        I think many scientists and doctors were so very disappointed when they realized how low of a frequency the mutations were in the population.  If it were a majority, it would have given a great hope to some sort of simplified treatment and diagnosis.  Unfortunately not.  We use the term "breast cancer" so loosely to describe what is actually a very complex collection of cancers with no one cause or treatment.   Unfortunately, as you correctly noted, the BRCA mutations are particular aggressive.  Just shows there is soooo much more to do to understand this.  BRCA itself is such an interesting protein and it isn't really clear why it is tied to breast and ovarian cancers and not in other tissue types.   What about those tissues make them such a target?

        The sequester is the new Republican immigration reform plan. Make things so bad here in the US that no one will want to live here.

        by Mote Dai on Thu Jun 13, 2013 at 10:16:48 AM PDT

        [ Parent ]

        •  I dislike the phrase "curing cancer" (1+ / 0-)
          Recommended by:
          deep info

          for the very reasons you outline.

          But yeah, it's odd that a general DNA repair gene, when malfunctioning, would lead to uncontrolled cell growth of certain types of cells, but not others.  A lot of this is expression levels, plus all the newly-discovered results regarding the importance of our epigenome.

          It is done. Four More Years.

          by mconvente on Thu Jun 13, 2013 at 10:20:34 AM PDT

          [ Parent ]

        •  It's not my area, but chances are (1+ / 0-)
          Recommended by:
          deep info

          that there's a DNA damage correction pathway largely redundant with the BRCA-based pathway that does very similar DNA repair work in all other human cell types prone to cancers.

          The BRCA-based pathway then operates solo in these breast and ovarian cell types.  When the BRCA-based pathway becomes dysfunctional there's no backup or alternative means of correcting particular kinds of DNA damage.  These forms of damage are very low in rate, but the numbers of cells and the amount of molecular activities in which they potentially occur are very high in aggregate.  Significant numbers of mutations due to these types of DNA damage form and, the substrate being DNA, accumulate.

          I did work on a bacterial DNA mutation correction system a long time ago, and the strains with dysfunction in these systems are called "mutator" strains.  They get additional mutations willy nilly, more or less.  The gene I worked with/on, called mutL, turns out to have a human equivalent (MLH) which when lost leads to cancers- most usually intestinal cancers.

          •  I think that is correct. (0+ / 0-)

            To also address the second part of your comment, there is a reason why some of the very early American Cancer Society grants went to bacterial geneticists!  I am glad you mentioned that is this thread.  Bacterial systems are powerful models for mutation and DNA repair.  I can remember doing Ames tests as lab demonstrations to determine the mutagenicity of chemicals.  Fun!  This is why model organisms and basic research are so critical to future medical discoveries.

            The sequester is the new Republican immigration reform plan. Make things so bad here in the US that no one will want to live here.

            by Mote Dai on Thu Jun 13, 2013 at 04:49:15 PM PDT

            [ Parent ]

            •  Bacteria are too different from eukaryotes (0+ / 0-)

              to make really good generalizations from them to humans, unfortunately.  A bunch of the same basic mechanisms are there (methylation, etc), but eukaryotes have such a complex overlay on top of them.  

              But we're better at the care and feeding of bacteria than we are at that of protists, and after all, bacteria are supremely important to the world ecology, so they're well worth studying.

              I hope eventually we get better at doing basic research on single-celled eukaryotes, which I think will start unlocking a real understanding of how things work in humans.

          •  The reasons for that pathway to be shut down in (1+ / 0-)
            Recommended by:
            mconvente

            breast and ovarian tissue are mysterious.  (I mean the "ordinary" DNA damage correction pathway.)  

            Now, there may be some logic to it for breasts, because of the really weird process of producing milk, which seems to be derived evolutionarily from breaking some of the cell-reproduction limits on sweat glands, and would therefore plausibly involve turning off some of the anti-cancer mechanisms.

            For ovaries, it makes no sense at all, and is probably one of those evolutionary accidents.

            •  Not at all (0+ / 0-)

              It is a reductionist system for DNA repair, homologous recombination, and tons of other pathways involved in all aspects of DNA replication, transcription, etc.  There are many kinds of DNA repair pathways and bacterial systems are easily generalizable to mammalian systems.  True that bacterial lack certain other aspects of oncogenesis but still a quite useful model.

              The sequester is the new Republican immigration reform plan. Make things so bad here in the US that no one will want to live here.

              by Mote Dai on Fri Jun 14, 2013 at 07:29:10 PM PDT

              [ Parent ]

  •  Wow! Really GOOD news for a change! (5+ / 0-)

    The potential for massive abuse, even something resembling high-tech slavery that was built into the confluence of "intellectual property rights" and the human genome research was scary as hell.  Glad to see that the most pro-"intellectual property rights" judicial body in the world just swatted this down so decisively.

    "You may very well think so, I could not possibly comment." ~ Francis Urquhart, pragmatic political philosopher

    by ActivistGuy on Thu Jun 13, 2013 at 09:29:57 AM PDT

  •  No, the overwhelming majority of breast cancer... (8+ / 0-)

    incidences are NOT caused by mutations in BRCA1 or BRCA2.

    If you have BRCA1 or BRCA2 mutations, your risk of breast cancer are extremely high.

    But most people who develop breast cancer do not have BRCA1 or BRCA2 mutations. These mutations only account for about 10% of breast cancers.

    ~Doc~

    -7.88 -8,77 Just a wine sipping, brie eating, $6 coffee drinking, Prius driving, over educated, liberal, white, activist, male New Englander for Barack Obama.

    by EquationDoc on Thu Jun 13, 2013 at 09:30:37 AM PDT

    •  In my haste, I miswrote (0+ / 0-)
      If you have BRCA1 or BRCA2 mutations, your risk of breast cancer are extremely high.
      That's what I intended to emphasize.

      Yes, there are other mutations that can cause breast cancer, notably the Her2/Neu oncogene for example.

      It is done. Four More Years.

      by mconvente on Thu Jun 13, 2013 at 09:36:53 AM PDT

      [ Parent ]

    •  THANK YOU - only 1% at risk for BRCA1 (0+ / 0-)

      Gil Welch at the Dartmouth Institute for Health Policy went into some detail about this issue in his recent CNN op-ed

      ....Why? Because more than 99% of women do not have the BRCA1 mutation -- or the BRCA2 mutation, for that matter.

      Let's be clear, the BRCA1 mutation is a bad thing. Although I might quibble with the exact numbers in the piece, the big picture is this: the mutation increases the risk of developing breast cancer about five fold and increases the risk of ovarian cancer more than

      99% of women don't have a BRCA 1 or 2 genetic mutation that causes breast cancer.  Most breast cancer is sporadic.
      Population-wide screening raises complex issues. We would want to know more about how often the test is wrong, particularly how often the test is falsely positive. That's important because women falsely diagnosed as a mutation carrier might undergo prophylactic mastectomy unnecessarily. Then there are the psychological effects, not only for the patient but also for her siblings and offspring.

      We'd also need to know more about what a BRCA1 mutation means in the absence of family history. Ms. Jolie's mother died of ovarian cancer at age 56. I'm no geneticist, but I can guess that puts her at higher risk -- both for having the mutation and for developing a bad cancer.

      "If you can't take their money, eat their food, drink their booze and then vote against them, you have no business being in DC."

      by Betty Pinson on Thu Jun 13, 2013 at 12:39:39 PM PDT

      [ Parent ]

  •  One or more of the conservative majority (0+ / 0-)

    must be directly affected or have a family member who is for them to have voted against corporate profit.

    48forEastAfrica - Donate to Oxfam> "It is better to light a candle than to curse the darkness." Edna St.V. Millay

    by slouching on Thu Jun 13, 2013 at 09:32:25 AM PDT

  •  You mean Clarence Thomas and Antonin Scalia (0+ / 0-)

    didn't want to patent and copyright-protect their DNA?

  •  this is a great discussion (2+ / 0-)
    Recommended by:
    mconvente, buddabelly

    My piece, which'll get to the FP at some point today, is now up.

  •  This sounds like really good news. (1+ / 0-)
    Recommended by:
    mconvente

    It seems like it would be wrong to patent this anyway, kind of sad that we would be surprised for them to come through.  Maybe there is hope after all.

  •  $1000 a test? (2+ / 0-)
    Recommended by:
    mconvente, Cassandra Waites

    Perhaps I'm not as knowledgeable about eukaryotic genetics as I thought I was ... but a PCR reaction costs a few dollars, and a sequencing costs between $10-20 per 1000 base pairs, lets say paying a tech to do the work makes it an even $100, so ...

    ... where is this $1,000 number coming from?  That would give them like a profit margin of maybe, $900 on a $100 dollar test??

    •  The price of monopoly and patents (4+ / 0-)

      OK, so back when Myriad originally patented everything to do with BRCA1, sequencing even one gene was costly (maybe a few hundred dollars).

      But today?  You're right, no more than $100 tops, and probably more like $50.

      But when you're the sole company that holds the patents for this gene (and BRCA2), you have all the leverage in the world to charge whatever you want.

      Healthcare is probably the most price inelastic commodities in existence.  In classic economics, as prices increase demand falls.  But this is not equal for all things.  Demand for healthcare doesn't change much at all no matter what the price is, because we like staying healthy and alive.

      So that's how Myriad could get away with charging so much.  It's because people have no other choice - it's their lives at stake.

      It is done. Four More Years.

      by mconvente on Thu Jun 13, 2013 at 09:48:50 AM PDT

      [ Parent ]

  •  Great news. Thank you. (1+ / 0-)
    Recommended by:
    Words In Action

    I wonder if someone could sue a company due to it's gene being her body.
    The argument would be "I didn't want this gene. You own it. Get rid of it."

    (Yes, that's snark, but it demonstrates that this is yet another one sided corporatist ploy. You can own the rights to working with the gene, but not have to do anything about it in the real world)

    I ain't often right, but I've never been wrong. Seldom turns out the way it does in this song.

    by mungley on Thu Jun 13, 2013 at 09:46:04 AM PDT

  •  Myriad just moves the goal post. (1+ / 0-)
    Recommended by:
    mconvente

    Well the Myriad share price is up today ... so maybe not such bad news for them.

    http://finance.yahoo.com/...

    Myriad Genetics said the Supreme Court of the United States upheld its patent claims on complementary DNA, or cDNA. However, the Court ruled that five of Myriad's claims covering isolated DNA were not patent eligible. Following the decision, Myriad has more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis test. Importantly, the Court noted that many of Myriad's unchallenged claims are method claims applying knowledge about the BRCA 1 and BRCA 2 genes. While these method claims were not at issue in this case, the Court highlighted Federal Circuit Judge Bryson's opinion that, "(a)s the first party with knowledge of the (BRCA1 and BRCA2) sequences, Myriad was in an excellent position to claim applications to that knowledge."
    So the gene can't be patented ... but the "applying knowledge" can? So if I come up with a test ... no one else can? Not sure I get this.

    Bloody lawyers ...

    There's room at the top they're telling you still But first you must learn how to smile as you kill If you want to be like the folks on the hill

    by taonow on Thu Jun 13, 2013 at 09:46:46 AM PDT

    •  Basically. (3+ / 0-)

      You can patent the technologies based on the isolated genes.

    •  Well, the court just remained undecided (0+ / 0-)

      regarding those other things at play.  If cases are brought up, they will be decided then.

      They were just ruling on the notion of whether or not naturally occurring DNA can be patented.  They decided no.

      It is done. Four More Years.

      by mconvente on Thu Jun 13, 2013 at 09:52:52 AM PDT

      [ Parent ]

    •  Method patents are an issue. (0+ / 0-)

      But who will pay for the millions in research required to come up with these methods? How will they be protected, or should they? Should it all be done through the government/governments of the world?

      "You can die for Freedom, you just can't exercise it"

      by shmuelman on Thu Jun 13, 2013 at 01:34:07 PM PDT

      [ Parent ]

      •  First Movers (0+ / 0-)

        Even without patents, the first movers into the market often come with fat rewards. Especially the movements that directly copy naturally occuring biochemistry, which are much more likely to widely work.

        If patents were reformed to expire either quickly (a few years) or upon recouping the risked investment (say, revenues double the investment, or the investment divided by the %risk of success plus 50%), then patents would actually "promote progress in science and the useful arts", rather than impede it for everyone else. Which is the only legal justification for intellectual property monopolies created by the state, conflicting with free trade and free expression (and progress).

        "When the going gets weird, the weird turn pro." - HST

        by DocGonzo on Thu Jun 13, 2013 at 07:51:20 PM PDT

        [ Parent ]

    •  Different Tests (0+ / 0-)

      Nobody can patent the gene, though Myriad tried to. That would have prevented any other test.

      If someone makes a different test, that tests that gene in a different way than Myriad does, they are free to do so. And to patent it themself.

      Though any test that patents, say, a protein used in the chemical reaction that is the same protein that occurs naturally, will fail upon challenge to patent that protein. This decision directly prevents patenting naturally occuring DNA sequences, but it also implies that any naturally occurring chemical found in nature cannot be patented. The chemistry that synthesizes it, if different from the naturally occurring chemistry, is patentable.

      There's more than one way to skin a cat, and the ones not yet patented remain patentable.

      "When the going gets weird, the weird turn pro." - HST

      by DocGonzo on Thu Jun 13, 2013 at 07:48:06 PM PDT

      [ Parent ]

    •  The cDNA claims are going to have to go down. (1+ / 0-)
      Recommended by:
      mconvente

      I'm not sure how long it's going to take, but application of an absolutely standard lab technique in an absolutely standard way according to the standard textbooks is not going to survive as a patent for very long.

  •  Not so simple. (0+ / 0-)

    Why is Myriad's stock price up more than 7% this morning? Because they've lost all their gene patents? Does that make sense?

    SCOTUS ruled that an isolated segment of DNA cannot be patented, but it upheld the validity of Myriad's cDNA-based patents.  (cDNA is DNA that's the product of an enzymatic reaction that uses RNA as a template to make a DNA copy).

    SALT LAKE CITY, June 13, 2013 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today said the Supreme Court of the United States upheld its patent claims on complementary DNA, or cDNA. However, the Court ruled that five of Myriad's claims covering isolated DNA were not patent eligible. Following today's decision, Myriad has more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis® test.

    Importantly, the Court noted that many of Myriad's unchallenged claims are method claims applying knowledge about the BRCA 1 and BRCA 2 genes. While these method claims were not at issue in this case, the Court highlighted Federal Circuit Judge Bryson's opinion that, "[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications to that knowledge."

    •  Seems like cDNA does occasionally occur in nature (3+ / 0-)
      Recommended by:
      mconvente, DocGonzo, deep info

      cDNA is the version of a gene with introns spliced out.  The court suggested that it does not occur in nature.

      Yes, the typical information flow is DNA->RNA->protein.  But reverse transcriptase (which converts RNA to DNA) in encoded not only by retroviruses but also by mobile genetic elements that reside in our own genome.  Sometimes this enzyme finds a spliced RNA molecule and recreates a "cDNA" version of one of our genes, which might end up inserting somewhere else in the genome.  You can see evidence of this having happened in our genome, where some genes have "retroduplicates" missing the introns.  

      It seems like this occurrence of cDNA in nature could potentially be used to challenge cDNA patents.

      There are thousands hacking at the branches of evil to one who is striking at the root. -Thoreau

      by Frameshift on Thu Jun 13, 2013 at 10:17:28 AM PDT

      [ Parent ]

      •  Right. cDNA is being confused with recombinant DNA (2+ / 0-)
        Recommended by:
        DocGonzo, deep info

        They are not the same.  As I just posted below a bit:

        cDNA is just exomic DNA of a particular gene, plus the 3'UTR and 5'UTR (and maybe promoter regions in the 5' end).  All of the introns (if present in the first place) are spliced out.  You can also get cDNA from reverse transcribing directly from messenger RNA - it's how we do our quantitative PCR reactions.

        However, that is not the same thing as recombinant DNA, like a vector with 25 restriction digest sites nicely aligned to allow for easy cloning of whatever transcript your heart desires.

        The former can occur in nature.  The latter almost certainly does not.

        It is done. Four More Years.

        by mconvente on Thu Jun 13, 2013 at 11:10:05 AM PDT

        [ Parent ]

      •  SCOTUS needs to stop getting facts wrong. (0+ / 0-)

        An awful lot of bad rulings are based on bad facts.  Like this one.  cDNA occurs in nature, but the court suggested that it didn't.  The entire theory of software patents is based on bad facts, including the bogus idea that putting in different software "creates a new machine" (something any computer scientist would laugh at).

  •  Who cares. This work already moved offshore (0+ / 0-)

    to the Island of Dr. Moreau, in 2010.

    Kind of amazing H.G. Wells warned us about this moment in his 1896 book.

    "Work for something because it is good, not just because it stands a chance to succeed." -- Vaclav Havel

    by greendem on Thu Jun 13, 2013 at 10:08:10 AM PDT

  •  Is that decision just for Human Genes or also (0+ / 0-)

    to genes of plants and animals?

    Sorry if the answer is hidden in the text. Can't right now not read the diary, but would like to know the answer.

    Thanks.

  •  This would seem to apply to non-human genes also (1+ / 0-)
    Recommended by:
    mconvente

    since genes from other species would follow an identical argument.  I think that's very important, including for agriculture and biofuel research.

    There are thousands hacking at the branches of evil to one who is striking at the root. -Thoreau

    by Frameshift on Thu Jun 13, 2013 at 10:10:10 AM PDT

  •  Another steaming SCotUS load. (1+ / 0-)
    Recommended by:
    deep info

    The decision is hardly a victory. It merely demonstrates that the SCotUS has a weak grasp of science, and of the nature of scientific discovery (its distinguishing between patenting isolated DNA and cDNA was little short of pathetic). Not to mention that they blew the "delicate balance" between fostering innovation and quelling it; what company will be interested in commercializing such a product as Myriad's kits now that there is no patent protection? (And make no mistake, non commercial entities almost always go thru commercial entities to get a product like that to market, and to patients.) And it won't make a difference going forward; companies will simply now know better how to draft claims to avoid the "Myriad problem".

    Rotten decision, for the most part. At least they recognized cDNAs are patentable.

    The road to Hell is paved with pragmatism.

    by TheOrchid on Thu Jun 13, 2013 at 10:17:49 AM PDT

    •  The court's logic on cDNA is highly questionable (3+ / 0-)
      Recommended by:
      mconvente, peachcreek, deep info

      I would argue that it also occurs in nature, if less frequently.  See my comment above.

      You may feel that it's practical to allow companies to patent genes (I don't), but it should be obvious to anyone that they fall under the category of products of nature.

      There are thousands hacking at the branches of evil to one who is striking at the root. -Thoreau

      by Frameshift on Thu Jun 13, 2013 at 10:22:43 AM PDT

      [ Parent ]

      •  They do not. (0+ / 0-)

        You will never find the patented sequences, as they are claimed, in nature. In nature, they have the rest of the chromosome attached to them; good luck using the sequences in that form.

        The road to Hell is paved with pragmatism.

        by TheOrchid on Thu Jun 13, 2013 at 10:34:53 AM PDT

        [ Parent ]

        •  You're confusing cDNA with recombinant DNA (1+ / 0-)
          Recommended by:
          deep info

          They are not the same.

          cDNA is just exomic DNA of a particular gene, plus the 3'UTR and 5'UTR (and maybe promoter regions in the 5' end).  All of the introns (if present in the first place) are spliced out.  You can also get cDNA from reverse transcribing directly from messenger RNA - it's how we do our quantitative PCR reactions.

          However, that is not the same thing as recombinant DNA, like a vector with 25 restriction digest sites nicely aligned to allow for easy cloning of whatever transcript your heart desires.

          The former can occur in nature.  The latter almost certainly does not.

          It is done. Four More Years.

          by mconvente on Thu Jun 13, 2013 at 11:08:23 AM PDT

          [ Parent ]

          •  You're confusing what I'm saying. (0+ / 0-)

            The claimed sequences are not products of nature because you will never find them, in their isolated form, as claimed, in nature. Your distinction between cDNA an recombinant DNA (to the extent it is valid) is irrelevant to that point.

            The road to Hell is paved with pragmatism.

            by TheOrchid on Thu Jun 13, 2013 at 11:30:13 AM PDT

            [ Parent ]

            •  See, this is a nonstarter (2+ / 0-)
              Recommended by:
              DocGonzo, deep info

              You write - "Your distinction between cDNA an recombinant DNA (to the extent it is valid"

              See, you're already being disingenuous because there is no "extent it is valid".  Simply, It IS valid.

              Put another way, all recombinant DNA is cDNA, but not all cDNA is recombinant DNA.  And honestly, even the first statement isn't always true, especially when involving things like Bacterial Artificial Chromosomes and recombinant DNA that requires a lot of intronic enhancer sequences.

              It is done. Four More Years.

              by mconvente on Thu Jun 13, 2013 at 11:42:06 AM PDT

              [ Parent ]

              •  You're still not addressing my point... (0+ / 0-)

                ...and it's the point that shows the decision to be wrong.

                And perhaps cDNA at some point is not recombinant, but if you want to do anything useful with it, such as bacterially propagate it, you need to put it into a vector, at which point it becomes recombinant DNA.

                "To the extent it is valid" is valid here.  And so is my point.

                The road to Hell is paved with pragmatism.

                by TheOrchid on Thu Jun 13, 2013 at 11:50:11 AM PDT

                [ Parent ]

                •  OK, will do my best (0+ / 0-)

                  cDNA stands for "complementary DNA" target="_blank", in that its sequence is the complement of its messenger RNA (mRNA) sequence, following the central dogma of molecular biology, in that DNA --> mRNA --> protein.

                  Scientists usually explain cDNA as being all "exomic" DNA, i.e. - the part of DNA that actual encodes for proteins (some other immediately flanking regions notwithstanding).  As you may be aware, the overwhelming majority of our DNA sequence does not code for proteins, but instead is known as "intronic" DNA, which includes enhancer, silencer, splice-sites, microRNAs, etc. sequences.  They affect expression of gene products, but themselves do not encode for proteins.

                  cDNA, as simply stated as possible, is literally just the reverse transcription product of mRNA - all the coding DNA without all the introns in between that naturally occurs.

                  Reverse Transcriptase, the enzyme that reverse transcribes mRNA into cDNA, is not naturally present in humans.  It's used by RNA viruses (retroviruses) that integrate their RT'd DNA into the host (i.e. - the human) to replicate and produce more viruses - that's why HIV needs a host; it's a retrovirus.

                  The Supreme Court has stated that cDNA is patentable.  Even though cDNA does not naturally exists in humans, it can exist naturally in other organisms - take a bacterial plasmid for example.

                  cDNA, I argue, is thus different from recombinant DNA, which by definition is "sequences that would not otherwise be found in biological organisms"

                  For example - if scientists take a cDNA plasmid and engineer it to have 25 different restriction enzyme sequences in precise order to facilitate molecular cloning, we'd say that is NOT a naturally occurring sequence, at least in the realm of statistical probability.

                  Therefore, I think if the Supreme Court is going to rule that naturally occurring sequences can not be patented, it must include cDNA sequences and explicitly mention and exclude engineered recombinant DNA sequences.

                  In essence, all recombinant DNA sequences are cDNA, but not all cDNA are recombinant DNA.

                  It is done. Four More Years.

                  by mconvente on Thu Jun 13, 2013 at 02:01:00 PM PDT

                  [ Parent ]

                  •  a little bit of messed up HTML up there at top (0+ / 0-)

                    but you can read around it.

                    It is done. Four More Years.

                    by mconvente on Thu Jun 13, 2013 at 02:03:18 PM PDT

                    [ Parent ]

                  •  I guess what I want to know is this (0+ / 0-)

                    How does this question matter in terms of health innovations we'd like to encourage?

                    •  It likely doesn't matter as much (1+ / 0-)
                      Recommended by:
                      Adam B

                      particularly because cDNA doesn't exist naturally in humans.

                      But take for example a pharmaceutical company that utilizes a naturally occurring cDNA plasmid from a bacteria to harvest a drug.  The most likely example I can see is the purification of some restriction enzyme used for biotechnology purposes.

                      Even though the company did no genetic engineering modification of that naturally occurring bacterial cDNA sequence, based on the ruling today, that bacterial cDNA is patentable.  

                      Contrast that with a situation where a company engineers a bacterial anti-biotic resistance gene into a broader plasmid for mouse model generation purposes (this is how it starts, btw - you need a method to select cells that have taken up whatever engineered piece of DNA you want).  Even though that anti-biotic gene has evolved naturally, it was chopped out of its original bacterial genome into an engineered plasmid.  So that should be patentable.

                      Honestly, it's more about the letter of the law and staying consistent with science than any likely test cases that may come up from it.  The important part is clearly the ruling about naturally occurring DNA.

                      It is done. Four More Years.

                      by mconvente on Thu Jun 13, 2013 at 02:53:21 PM PDT

                      [ Parent ]

                      •  The Supreme Court ruling is not binding precedent (2+ / 0-)
                        Recommended by:
                        mconvente, TheOrchid

                        on the matter of cDNA.

                        Why?  Because it was a ruling of fact and they got the facts wrong.  Court rulings only have precedent if they are rulings of law.  If a court declares that the sun rises in the west, it has no value as precedent.

                        Unfortunately, very few judges seem to understand the distinction between facts and law.

                  •  Reverse Transcriptase is in retroviruses (2+ / 0-)
                    Recommended by:
                    mconvente, TheOrchid

                    And lots of them.  They include HIV.  It occurs in nature.  There is lots of naturally occuring "cDNA" for this reason; every AIDS patient is full of it.

                    The Supreme Court ruling is wrong about cDNA.  

                    Actually, it's not only wrong, it's also not binding, because the Supreme Court does not have the power to set precedent on matters of fact, only on matters of law.  This has not been sufficiently well recognized by most judges, who don't know enough about matters of fact to spot when the Supreme Court gets its facts wrong.

                    •  Thank you (0+ / 0-)

                      I'm glad at least one person here is consistently understanding that cDNA and recombinant DNA are not the same thing, particularly in regard to this ruling on "naturally occurring" DNA sequences.

                      You've made really good comments through the diary, thanks for that.

                      "Give me a lever long enough... and I shall move the world." - Archimedes

                      by mconvente on Thu Jun 13, 2013 at 09:53:21 PM PDT

                      [ Parent ]

                •  mcovente's explanation is OK to a point... (0+ / 0-)

                  ...but recombinant DNA is, more broadly, any DNA sequences that have been recombined by a person (that's why they call it recombinant), for example, when two DNA molecules from different sources are linked in a laboratory. For example, when a cDNA is made double-stranded and inserted into a vector (as it almost always is), it becomes recombinant DNA.

                  In any event, the Court was absolutely incorrect to say at the claimed DNA molecules existed in nature; as claimed, they do not, and no commenter in this diary has demonstrated that they do.  They were created by people, and, as such, should have been deemed patentable subject matter under 35 USC 101.

                  The road to Hell is paved with pragmatism.

                  by TheOrchid on Fri Jun 14, 2013 at 06:16:41 AM PDT

                  [ Parent ]

        •  You will find the sequence in nature... (2+ / 0-)
          Recommended by:
          mconvente, deep info

          It is simply the sequence of the mature mRNA.
          Yes, molecular biologist's have to go through a step or two to convert that mRNA into a cDNA in order to sequence it, but this is just a tool. I think the SCOTUS needs to hire a better 'splainer of molecular biology. I don't see how this can stand.

    •  Steaming Load (1+ / 0-)
      Recommended by:
      mconvente

      OK, so naturally occuring chemistry like DNA should be patentable by the first corporation (built on mostly publicly funded research) to grab it. Which will prevent anyone else from using it unless they pay the arbitrary fees the monopoly holder charges its competition.

      And nobody can patent a test that is actually novel and synthetic.

      Wrong on both counts. I expect that your income depends on medical patents.

      "When the going gets weird, the weird turn pro." - HST

      by DocGonzo on Thu Jun 13, 2013 at 07:55:29 PM PDT

      [ Parent ]

  •  This is huge! (1+ / 0-)
    Recommended by:
    mconvente

    making the cost for screening for hereditary ovarian and Breast cancer more affordable in developing countries

  •  I'm shocked (0+ / 0-)

    to see this decision because of the twisted logic that is frequently used to justify their decisions, but I'm very pleased to see this outcome.

    The only trouble with retirement is...I never get a day off!

    by Mr Robert on Thu Jun 13, 2013 at 10:19:48 AM PDT

  •  How refreshing! (1+ / 0-)
    Recommended by:
    mconvente

    I've become so accustomed to 5-4 decisions, often on issues where it seems blindingly obvious to me which way the court should go, that I had about given up on them being able to see any case the same way.
    It's a small thing, but at least for a short little while I can pretend that we have a truly functional, reasoning Supreme Court, trying to dispense justice.
    Might as well savor it now, it certainly won't last, but I'll know that there are at least some limits to the insanity.

    •  In this case... (0+ / 0-)

      ...I think the 9-0 decision reflects either a generally anti-patent drift of recent Courts, or that the Supremes didn't quite understand what they were deciding.

      The road to Hell is paved with pragmatism.

      by TheOrchid on Thu Jun 13, 2013 at 10:42:51 AM PDT

      [ Parent ]

  •  Opinion is by Justice Thomas (0+ / 0-)

    I bet if you read him the first three paragraphs of the opinion he'd say "uh, yeah, whatever."

  •  GMOs? (0+ / 0-)

    What does this mean for Monsanto if anything?

    A working man robs a bank and it's a federal manhunt. A banker robs a working man and gets a bailout.

    by Grassroots Mom on Thu Jun 13, 2013 at 11:07:07 AM PDT

    •  I dunno - I thought about this immediately (1+ / 0-)
      Recommended by:
      deep info

      It will not make things easier for them, though I know things are getting tougher in marketing GMO's, even with all the US government support. They have been roundly rejected in Europe, in spite of WTO courts telling Europeans they MUST buy GMO's.
      http://www.globalresearch.ca/...
      What a bunch of asshole, mid-level bureaucrats. You can only shove so much onto the public, after that, you have to do it at the end of a gun because eventually the hoi-polloi get out their pitchforks and tar and feathers.

      "You can die for Freedom, you just can't exercise it"

      by shmuelman on Thu Jun 13, 2013 at 01:31:00 PM PDT

      [ Parent ]

      •  We're hitting that point in so many areas (0+ / 0-)
        You can only shove so much onto the public, after that, you have to do it at the end of a gun because eventually the hoi-polloi get out their pitchforks and tar and feathers.
        We're hitting this point on everything from copyright law to food stamps.

        What happens next?  It worries me, because the logical outcome is revolution.

  •  Hip Hip Hooray! (1+ / 0-)
    Recommended by:
    mconvente

    Finally we win one.

    What we need is a Democrat in the White House. Elizabeth Warren 2016

    by dkmich on Thu Jun 13, 2013 at 11:16:19 AM PDT

  •  Speaking of Genes - my favorite. (2+ / 0-)
    Recommended by:
    mconvente, DocGonzo

    What would Mothra do?

    by dov12348 on Thu Jun 13, 2013 at 11:21:51 AM PDT

  •  The right decision, and a unanimous one? (2+ / 0-)
    Recommended by:
    angry artist, mconvente

    I'm astounded.  But almost delirious that our current Supreme Court can actually do something like this once in a while.

  •  Any chance of recovery for the victims? (1+ / 0-)
    Recommended by:
    angry artist

    This company has extorted huge piles of money over the years, and no doubt contributed to many preventable deaths.  They did so using an illegal patent scheme.  Can the victims recover anything for Myriad's malfeasance?

    "And the President of the United States - would be seated right here. I would be here. And he would be here. I would turn - and there he’d be. I could pet ‘im." - Lewis Black

    by libdevil on Thu Jun 13, 2013 at 12:43:28 PM PDT

  •  Not just HUMAN genes. (2+ / 0-)
    Recommended by:
    shmuelman, WVUCavalier
    "naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that [synthetic DNA] is patent eligible because it is not naturally occurring.”
    HUGE implications, beyond the obvious ones.

    If it's a naturally occurring genetic sequence, it's not patentable. Period.

    Plants.

    Animals.

    HUGE implications in medicine and beyond.

    And note that it's implicitly broader. You'd have to PROVE that a genetic sequence you're trying to patent is NOT naturally occurring. So you'd have to show that a sequence that could plausibly have mutated somewhere hasn't done so. Damned hard to do... unless you can show WHY it could NOT naturally occur.

    "Be just and good." John Adams to Thomas Jefferson

    by ogre on Thu Jun 13, 2013 at 01:20:41 PM PDT

  •  Who will pay for this kind of research? (0+ / 0-)

    If you can't protect this research, who is going to put up the money to find genes, make clones, modifications, etc, when some gigacorp like Monsanto can just blow you out of the water by using your original research, methods and techniques as a springboard into commercialization?
    This is not an easy issue. Maybe all of this should be done through a government / industry consortium that can put up 10's of millions in grants, and then give a royalty to the inventors. And of course, I am sure that is already in place to some degree. However, this precludes scientists from making huge amounts of money that will go to pharma that can manufacture, market (and lobby) the invention.
    I would love to hear knowledgeable opinions.

    "You can die for Freedom, you just can't exercise it"

    by shmuelman on Thu Jun 13, 2013 at 01:22:46 PM PDT

  •  Thank you for this excellent news. n/t (1+ / 0-)
    Recommended by:
    mconvente

    "Too often we enjoy the comfort of opinion without the discomfort of thought." - John F. Kennedy -7.8., -6.6

    by helpImdrowning on Thu Jun 13, 2013 at 01:26:25 PM PDT

  •  Fantastic news in a month full of bad news (1+ / 0-)
    Recommended by:
    mconvente

    Thanks for addressing this. I heard the announcement on NPR, and was happy to see it addressed here as well.
    :)

  •  I want to thank the people on (1+ / 0-)
    Recommended by:
    mconvente

    this site for keeping this alive and making sure it ended up on the docket. I first heard about this 4 years ago from a TU who is one of the smartest people I have ever known.

    "that others may live"

    by Hooverson on Thu Jun 13, 2013 at 02:30:43 PM PDT

  •  How do you patent a noun phrase anyway? (0+ / 0-)

    Don't you need a verb?

    You copyright things that are described with only nouns and no verbs.

    You patent techniques and methods, not things.

    I don't think you should be able to patent artificial genes either for this reason.  You'd have to copyright them, which is a different set of laws.

  •  that is great news (1+ / 0-)
    Recommended by:
    mconvente

    now can Henrietta Lacks descendants sue for a share of the profit off her DNA?

  •  What are the implications (0+ / 0-)

    for Monsanto's seed patenting? Thank you in advance.

    Why do I have the feeling George W. Bush joined the Stonecutters, ate a mess of ribs, and used the Constitution as a napkin?

    by Matt Z on Thu Jun 13, 2013 at 03:57:49 PM PDT

  •  Leave it to those idiots (0+ / 0-)

    To garner credit for affirming the obvious. Color me a bit surprised though, given this was their opportunity to really, really play god.

    You do realize though that if there was enough $ to be made by the right people this decision would have been different.

    Slap happy is a platform.

    by averageyoungman on Thu Jun 13, 2013 at 04:32:57 PM PDT

  •  I Would Have Lost (0+ / 0-)

    I would have bet against this decision, and it was unanimous.

    They evidently are capable of making the correct decision even when vast corporate property grabs for the entire future lose on their decision. That only makes the Court's other bad decisions inexcusable.

    "When the going gets weird, the weird turn pro." - HST

    by DocGonzo on Thu Jun 13, 2013 at 07:23:40 PM PDT

  •  won't matter that much... (1+ / 0-)
    Recommended by:
    mconvente

    ...to biotech companies.  They will just modify a few base pairs and patent it.

    We Glory in war, in the shedding of human blood. What fools we are.

    by delver rootnose on Thu Jun 13, 2013 at 07:55:10 PM PDT

    •  Heh, good point (0+ / 0-)

      Sorta surprised I haven't seen it brought up until you did.

      The BRCA1 gene is really big, and with all of Myriad's compiled sequence data (you can bet they hold on to every patient's BRCA1 sequence), they can run some tests to assess nucleotide conservation.  Find the base that's least conserved (either in the coding region or a 5'-UTR / 3'-UTR region), alter it, boom it's "synthetic".

      Interesting concept.

      "Give me a lever long enough... and I shall move the world." - Archimedes

      by mconvente on Thu Jun 13, 2013 at 10:01:00 PM PDT

      [ Parent ]

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