Supreme Court Rules Against Patenting Of Human Genes

220px-Clarence_ThomasDNA_orbit_animated_static_thumbI previously wrote a column opposing the claim of Myriad Genetics over patenting human genes in the case of Pathology v. Myriad Genetics, No. 12-398. The Supreme Court appears to have the same concerns. The Court unanimously ruled this afternoon against the Utah company and by extension of the Federal Circuit in claiming such property rights.

At issue is the patent by Myriad Genetics to genes (BRCA1 and BRCA2) that it found correlate with increased risk of hereditary breast and ovarian cancer. This test was recently made famous by Angelina Jolie who had a preventive double mastectomy after taking the Myriad test (which costs more than $3000). The company has been trying to stop other companies from offering the test at a lower cost.

Thomas drew a bright line that “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” Despite the ruling of the Federal Circuit (which has been in a series of sharp disagreement with the Supreme Court over the scope of patents, Thomas saw the question in simple terms: “It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes.”

Notably, the Court acknowledged that the company “found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention. Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the [patent law] inquiry.” There was interest in how the Court would define the applicability of patent law to synthesized DNA, or “complementary DNA,” or cDNA. Yet in a footnote the Court expressly stated that it was not ruling or indicating that even cDNA is specifically entitled to a composition patent.

We have been following the increasingly draconian copyright and trademark laws used against citizens and companies — laws secured by an army of lobbyists, lawyers, and an obedient Congress and White House.

This specific patent issue is different but raises many of overall issues. The Court has been pushing back on the expansion of patent law into areas considered part of the “law of nature.” What is key about this decision is that it is based on 35 U. S. C. §101. This has been in the past treated as a highly generalized provision that does not seriously narrow the scope of patents. It was the later section that has been used to narrow the scope until now. This creates a threshold determination on patents that a wide array of academic and public interest groups have long advocated.

Here is the decision: Myriad Decision

102 thoughts on “Supreme Court Rules Against Patenting Of Human Genes

  1. I couldn’t agree any more with this unanimous decision. To me it is rather a simple issue, in what Justice Thomas’ quoted opinion.

  2. It took comment # 10 for someone to say something negative about a very good, unanimous decision. P Smith, You win the Andy Rooney Curmudgeon Award. It’s 5lbs. of eyebrow hair you can paste on, and a deep yellowing agent for your teeth.

  3. My hope is that this decision sets a strong precedent that will continue to reap benefits to society through the years!! And that the BRCA test will become cheap enough that insurance companies will cover the cost completely, and will thus save lives and give women with negative results and their families much comfort.

  4. Prof. Turley? please fix the link to the decision, it isn’t working… at least, I can’t get it to give me anything but a blank screen. thx

  5. LOL, they voted the way I hoped they would and thought was appropriate. Thing is, I’m so jaded by this court and suspicious of their decisions/motives that now I’m thinking that I missed something, I well may have been wrong about the issue:-)

    Oro Lee, I saw that, hilarious!

  6. As usual, most posters and Prof. Turley miss the point of the SCOTUS decision. And it is NOT a good decision, nor the right one. As I’ve explained many times, the SCOTUS exists today solely to protect and promote big business and to hurt the individual. Period. End of story. All decisions, regardless of the combination of justices siding one way or the other, ultimately are made strictly with this principle in mind. In this particular case, we have a very small company trying to obtain a patent that was already approved.

    So, who would the SCOTUS decide with? A little company,Myriad? Or the big pharmaceutical companies?

    Hmmmmmmmm, let us ponder this very difficult and intellectually challenging dilemma for the SCOTUS, keeping the REAL operating principle behind the SCOTUS in mind, if we can.

    Are we catching on to the principle of the SCOTUS? The little guy, or the little company, ALWAYS loses to the Big Power Money and Industry Interests. Period!

    Thomas, in his opinion, seized upon the fact that Myriad’s patents covered sequences of proteins exactly analogous to ones found in nature. The patent covers any genes that contain strands as small as 15 nucleotides long identified as belonging to the BRCA gene. The decision comes down to what one commentator has said should be the guiding question for patent examiners: “What did you do with your hands?” In identifying specific gene sequences, Myriad didn’t actually create anything, Thomas said. “The location and order of the nucleotides existed in nature before Myriad found them,” he wrote. “Groundbreaking, innovative, or even brilliant discovery,” doesn’t satisfy the requirement that inventors invent something, he said. Wrong, Thomas.

    Let’s turn to someone who actually knows something about invention and biology, rather than paper-shuffling ideologue: Brenda Jarrell, a Ph.D biochemist and partner with at Choate, Hall & Stewart in Boston. “It’s one of these situations where candidly, it just makes me sad there isn’t a higher level of basic biology knowledge in the world,” she said. “Unfortunately, this is the Supreme Court.”

    In Myriad, the high court held cDNA is patentable, because it involves actual work in the laboratory and inverts the normal process found in nature. The synthetic DNA is an edited version of a gene, stripped of non-coding regions that the court said makes it “not naturally occurring.”

    Critics say even the edited sequences are directly analogous to naturally occurring DNA. “That may be so,” Thomas wrote, “but the lab technician unquestionably creates something new when cDNA is made.”

    But Jarrell, who has a doctorate in biochemistry from the University of California in addition to a Harvard Law degree, said Thomas is wrong. Not only do researchers make cDNA with naturally occurring tools, but the exact same process can occur naturally in the body. “It’s not actually correct to say cDNA is not a product of nature,” she said. “There’s nothing more inventive about making cDNA than isolating DNA.”

    Note: Certain material was taken from “Supreme Court Rejects Human-Gene Patents — Sort Of,” by Daniel Fisher, published in Forbes Magazine.

  7. Ralph Adamo:

    they still have their test intact right? Or does this just let anyone make a tester?

    Read that link above I posted by Adam Mossof, he is pretty good on patents.

  8. Ralph Adamo:

    from that article:

    “However, you can get a patent for identifying, isolating and purifying something that already exists in the world. For example, the inventor of aspirin at the turn of the 20th century isolated and synthesized the active ingredient in willow bark, which people had chewed for thousands of years to relieve pain and fever.

    The greatest confusion in the debate about the Myriad case stems from failing to understand this distinction. Unfortunately, the Supreme Court contributed to the confusion when it took the case to answer: “Are human genes patentable?” Patent experts scratched their heads, because the answer is undisputed: No, human genes in their naturally occurring form are not patentable.

    But Myriad’s patents don’t cover genes in their naturally occurring, unisolated form, just as the aspirin patent did not cover chewable bark. Rather, the BRCA1 and BRCA2 patents claim the genes as isolated, purified and used in a scientific or medical context.

    Thus, Myriad’s patents cover the same “composition of matter” that these patents have always covered, and which built the modern pharmaceutical industry in the early 20th century.”

  9. You mean business did not win this one…. I’m glad… Surprised by Thomas though…very… Thought he could be bought and paid for…. Guess…. Miracles can happen….. Nifty cool….

  10. Yes, Bron, that’s very informative. Although Adam Mossof is not a scientist, he is a highly regarded legal scholar in the area of intellectual property, and his explanations make perfect sense to me.

    And just to make my point about the REAL principle behind the SCOTUS– so there can be no mistake about it–if it had been PFIZER, instead of Myriad, that was seeking to obtain patent protection, the SCOTUS would have IGNORED the writ of certiorari altogether, clearing the way for Pfizer to have its way. The SCOTUS would NEVER interfere with the desires or plans of such a major big business force like Pfizer, which engages in fraud, tax evasion, and worse, every single day of the year. But Myriad, a small innovator, with no claim whatsoever to being part of the power-player global “elite”? In their case, of course, the pseudo-intellectual dishonesty of the “high court” dispatched with them, as the SCOTUS follows their real masters with strict obedience.

  11. Anonymously Yours, you appear to be a very slow learner. Yes, SMALL business lost, but BIG BUSINESS won.

    I realize that some of my concepts are difficult to comprehend or accept, much as people once had a difficult time understanding or accepting that the Universe doesn’t revolve around the Earth. But perhaps in time, or by repeated examples, hammered over and over and over, some learning, at some remote level, might actually take place.

  12. Oh… And since when is pharmacology small business…. What big business won… I’m curious…. Maybe I am slow… You can help educate me…. A fool that suffers from the lack of knowledge you seem to posses…. Impart your pearls of wisdom…

  13. Gene,

    Leftist of what…..seems like someone wanted an exclusive on the human already evolving body….

  14. Of course, big business wins here. They are now in a position to make the serious money that Myriad would’ve made otherwise. I think I’ll have to apologize to the slow learners. They should not have been denigrated by comparing them to some of the deeper “thinkers” on this board.

  15. AY,

    A little joke about Ralph’s usual bad guys of choice. FWIW, I agree with you and the other posters noting this is an unusually sane decision from a Court that has made some very questionable calls in the recent past. The idea that a company could patent a naturally occurring DNA segment merely because it has been isolated is lunacy. The reductio ad absurdum for that is a company could patent blue eyes and seek licensing fees from every blue eyed devil on the planet. But I’m not shocked that it was unanimous nor that they let Thomas write one for a change. The argument is against the patent is fairly self-evident.

  16. Ralph,

    It appears that you don’t understand the nature of what patents are used for. There was no innovation involved in isolating these genes. These genes have been active in humans since there have been humans. Could Myriad have a possible patent claim on the methodology of their testing? Sure. But the genes involved are public domain by the very fact that Myriad didn’t build them and insert them into the human genome. They are naturally occurring and once identified there is nothing preventing other companies from detecting the genes using other possibly patentable technologies. To grant a patent on these genes would be like granting Carl Wilhelm Scheele a patent on oxygen. Utter nonsense with possibly horrific legal consequences.

  17. Wrong analogy. Bron referred to the correct analogy. This case is like aspirin. Aspirin was patented on February 27, 1900. Aspirin was derived from willow bark, And general use of that product had been in effect for centuries before the patent. However, for this patent, Scientists synthesized The compound that we call aspirin today as acetylsalicytic acid. As a result of this new decision, the big pharmaceutical companies Effectively steal the patent without having to pay any royalties. But you can rest assured that if any of the major big pharmaceutical companies develop their own invention That would match exactly the circumstances of this case, The Congress or the Scotus Would come to their rescue to make their invention patentable. I understand, you do not want to accept the principle that I have made clear to you. Your mind is not trained to see things as they are but only as you have been programmed to see them.

  18. This is a horrible decision. The patent did not try to claim naturally-occurring DNA. The media campaign has spun this case all out of proportion. It tried to claim isolated, purified, concentrated forms of DNA. If someone claims that these are naturally occurring, well I say:

    Can you show me where I can get some of this stuff for free, ’cause I have some experiments to run asap. Thx.

    Also, an effect of this decision will be that artificially created hearts and lungs will no longer be eligible for a patent, because they mimic a naturally occurring heart. !!!

    Who would spend the R&D $ to make artificial organs now, after this travesty?

  19. No, Ralph. The analogy was perfect. The manufacture of aspirin on a mass scale was enable by scientists figuring out how to synthesize acetylsalicylic acid (containing aspirin’s active ingredient salicin) – a patentable process. The compound itself is naturally occurring and is not what Bayer patented. Charles Frederic Gerhardt was the first to prepare acetylsalicylic acid in 1853 as an isolate but the properties of willow bark as an analgesic were known to the ancients (including Hippocrates). In 1897, chemists working for Bayer created a synthetically altered version of salicin that was easier on the digestive system than the naturally occurring compound. A technical innovation based on a novel manufacturing process like synthesizing acetysalicylic acid is patentable. A naturally occurring compound like salicin isn’t. Bayer was making something not found in nature.

  20. I agree with the decision, and Gene.

    If Myriad wanted to patent their discovery, they should have kept their knowledge of the effect of the variant BRCA1 / BRCA2 as a trade secret, and marketed their test instead as a “black box” that, in double blind clinical trials, separated those at high risk of breast cancer from those at lower risk of breast cancer with a high probability of success.

    That is a more difficult route, but with money it can be done. Trade secrets (like the formula for Coca Cola or the spices in KFC) last forever; but because they have no legal protection, are at risk of reverse-engineering.

    Even so, if we are talking about a pharmaceutical, then even if reverse-engineered, Myriad would have no obligation to acknowledge the success of that effort, so a competitor would have to build their own justification from scratch, re-executing the double-blind clinical trials, marketing, and so on. That is a steep hill to climb, and in the lore of marketing, those that have tried that feat in the past almost always find the first to market remains king of the hill forever, even if the competitor’s product is better. (e.g. the QWERTY keyboard vs many superior layouts).

    Even though willow bark was used by many cultures for thousands of years as an analgesic, that is NOT how it was introduced to Western Medicine; it was independently rediscovered in England while searching for an alternative to (very expensive) quinine as a treatment for Malaria, and mistakenly thought to be an inexpensive and more available cure because it relieved the fever and aching symptoms of Malaria. Which it is not.

    What made powdered willow bark popular and widespread was this independent beginning, not as a general analgesic but as a medicine, and its other properties were then rediscovered. The use by non-Englanders was discovered later, it was not the impetus in any way for the English usage of willow bark.

    In fact the impetus for the English usage of willow bark was a belief in sympathetic magic; because Malaria was thought to be caused by smelling the fumes of stagnant water, and quinine bark was known to be bitter and grow near stagnant water, a magical thinking pastor decided to look (in England) for trees with bitter tasting bark, growing near stagnant water, and bumbled into the willow. Forming a tea of the dried, ground bark, he found it seemed to relieve malaria. Success! (well, not really.)

  21. Oops. I said “If Myriad wanted to patent…” when what I meant to write was “If Myriad wanted to protect…”.

  22. “But you can rest assured that if any of the major big pharmaceutical companies develop their own invention That would match exactly the circumstances of this case, The Congress or the Scotus Would come to their rescue to make their invention patentable.”


    I’ll grant you that would have been a possible, perhaps probable outcome and then assert to you that your argument still fails logically. This question devolves on whether the BRCCA-1 gene is patentable, since it occurs normally in nature and indeed whether any genes should be patented. That SCOTUS has a history of siding with big business is incontrovertible given its overall history, yet that is irrelevant to this discussion, because occasionally SCOTUS rules correctly as in this case. Myriad was in effect trying to stifle competition, was charging unconscionable amounts for its cancer tests and this was what their “patent” was all about. From a capitalist perspective it was stifling research and competition,since no doubt other companies could have developed a test, yielding equal results, through different techniques. By “patenting” the end result Myriad was trying to preclude that, closing the market, eliminating competition and keeping the cost of their test unconscionably high.

  23. Incorrect, Mike. It is the big pharmaceutical companies that are making unconscionable profits. And the FDA actually helps them to do this And will punish those who interfere with this process. Because the reality is that big government and big business work together to ultimately protect both of our interests. The realities of science have nothing to do with this decision whatsoever.

    That was made clear by an expert in the field that I referred to and another Bron referred to.

    And the public interest is the last thing on the minds of the justices on the Scotus. Again, they are simply an extension of the interests of big government and big business.

    When you understand the real principle at work you will never be Surprised by a Scotus decision again. I certainly wasn’t surprised. And some here who were surprised thought that they should doublethink their original position to see if it was wrong. That was in fact a sound instinct. But here there seems to be a sort of cognitive dissonance principle playing out.

  24. Ralph: The proper interpretation of what Thomas is saying is that an invention requires an intellectual component. Yes, the cotton gin was invented with pre-existing materials and tools, but it wasn’t “discovered” as a natural product of evolution or nature in a field somewhere by clearing away some brush. The cotton gin was intellectually conceived and then brought to realization.

    The BRCA genes were not, and cDNA genes are not. Obviously anything that exists is a “product of nature” if brought about by natural processes, but the key question is whether the particular combination of bolts, levers, and machinery that is the cotton gin ever existed in their configuration before.

    Genes are made of the four base nucleotides, but those are equivalent to the bolts or sheet metal of the cotton gin. The arrangement of parts is what can be patented if it is an original arrangement, and the fact that the BRCA genes exist in humans proves they are not an original arrangement. There was no intellectual input into that arrangement, it was a discovery, like finding a fossil. The fact that Myriad dug for the fossil does not mean they invented it, and they can’t patent it and prevent other people from looking for fossils of the same organism.


    For the rest of your thesis, it is incoherent. The companies best able to sue for patent violation and best able to withstand lawsuits against them for patent violation are clearly the richest corporations on the planet. This ruling does not cover just the BRCA genes, it covers ALL human genes, and that is very damaging to the fortunes of the richest corporations. If they are happy about this outcome they are run by idiots because it is a Pyrrhic victory; being allowed to develop one new product while losing patent protection on their own gene discoveries is a very bad trade indeed, they would have much preferred to just buy up Myriad and retain all gene patent protections.

    To create the motive for your thesis you have to pretend this ruling applies only to the BRCA genes, and that is a false premise, it applies to all naturally occurring human genes. I believe it can be used as a hammer even in cDNA cases, if the critical sequences can be shown to occur naturally, this case and Thomas’ reasoning will relegate them to the realm of discovery instead of invention, and strip such naturally occurring sequences of patent protection too.

  25. Any truth to the rumor that Thomas requested copies of all the mammograms that Myriad use in its research?

  26. “Incorrect, Mike. It is the big pharmaceutical companies that are making unconscionable profits. And the FDA actually helps them to do this And will punish those who interfere with this process. Because the reality is that big government and big business work together to ultimately protect both of our interests.”


    I absolutely agree with your statement, but in this instance it is irrelevant and besides the point. On THIS particular issue, in THIS particular case, SCOTUS made the correct decision. You are letting your political viewpoint dictate your assessment of this case. That Myriad is not Pfizer in size, doesn’t mean that Myriad is being discriminated against by SCOTUS. That Pfizer might have gotten away with what Myriad can’t is speculation that detracts from the verity of this case. I dislike all pharmaceutical companies that gouge the public unfairly for life saving medications and I don’t care whether they are the industry leaders in wealth, or the “little guy” trying to make it. To call Myriad Pharmaceuticals a “small” company is a matter of perspective anyway since they were capitalized by the parent company with $190 million.

  27. I must admit there is something very funny in seeing so many on this board falling over one another to sing the praises of Clarence Thomas. Perhaps it has something to do with the disclosures of rampant government wiretapping. The government tracks and records every phone call or email that you make and closely monitors what everyone is saying, doing, and thinking. Perhaps it’s better to have it put on the “record” that we are all being obedient to the State.

    Okay, I’ll go along with you on that….. It was a very good decision, a REAL good decision……

  28. I judge people and results separately; so I do not judge results by who participated in the making of them. I think Clarence Thomas is a corrupt and bigoted fool. I doubt, with a unanimous decision, there was any lack of clear thinking among the nine Justices for Thomas to draw from, or any ambiguity on why they all agreed upon the same thing.

    If anything, I think letting Clarence write the opinion, with other justices providing input and suggesting clarifications, was probably just a favor to Clarence.

    I will agree with an idiot if they happen to speak the truth, because doing otherwise would require me to lie, and put something else (my ego or how others perceive me) above the truth. You see, that is called being “principled.” Some do not attach much importance to that, but I do.

  29. Myriad Genetics Not Allowed To Play, “GOD”

    Decision! U.S. Supreme Court rules human genes cannot be patented,
    And so the ridiculous request of Myriad Genetics shall not be granted,
    Whereas the High Court said the company cannot patent human genes,
    Now market shares of Myriad fell this thunderous rainy day of June 13.

    Can’t fathom any company of humans are attempting to play, “Yahweh,”
    They want to decide who can and cannot have the right to testing DNA,
    Of who might contract ovarian or breast cancer if you can afford to pay,
    Those who cannot find out too late, unable to see another healthy day.

    What is with a supposed great country where insurance companies deny?
    Life saving testing and or treatments so shareholders profits climb high,
    Therefore, causing less fortunate American citizens to hover in despair,
    Because all are still not united equally in love, war and, “Obama Care.”

    Many industry giants have patents and generic brands are against the law,
    Approved by elected government officials who obviously dropped the ball,
    Then again, with high campaign contributions flowing in like, “Tsunamis,”
    Anybody in politics care if little Tommy or Suzy never again see mommy?

    How were HMO’s able to get many drugs off their lists of covered care?
    Saving $$$ leaving the insured with one option, go without it if you dare,
    Between lights, gas, utilities, mortgage payments or whatever daily need,
    Our health care system is nothing more than, “Good Old American Greed.”

    Why is it that many U.S. Citizens cross the Canadian Border or go online?
    To seek medical attention or order prescriptions, certainly not to save time,
    It is for one reason and one reason only, that of affordable, qualified care,
    Is there any in Washington embarrassed that constituents have to go there?

    Apparently not, since the stream of patients over the years have increased,
    For this to be presented before the Supreme Court means it will not cease,
    Crooked law firms, collection agencies & mortgage companies are not alone,
    Add unscrupulous medical research facilities, they’re all right here at home.

  30. My non-legal nor scientific assessment has been this, filtering the dna to leave a clean expression of the gene and then patenting the gene in its clean form was the wrong basis for a claim because the gene was already there. That particular filtering process may be unique and the most efficacious way to filter out the vagrant dna That process is patentable. The clean dna is the first ripple on the water, the filtering process is the pebble that generated the ripple(s). If the filtering process was not already under patent protection that’s where Myriad should have been fighting. Similarly, if the method and technology of testing the clean genes are unique to Myriad’s invention then that is also fair game for a patent.

    From my reading on this case the only second opinion a patient could get under the Myriad patent of the gene led back to Myriad. They owned the gene so the labs they licenced to test it were contractually required to use their testing procedures, standards and any attendant Myriad sanctioned equipment. There was no valid second opinion because if any error or lack of ‘sensitivity’ (for lack of a better word) was built into the Myriad process it wouldn’t show up in the second opinion. It was bad science/medicine. They had a monopoly on the money and the science.

  31. lottakatz: There is no ‘clean’ DNA, it does not have to be ‘filtered’ to leave a ‘clean expression.’ DNA is essentially digital information, base 4 (allowable numerals are 0,1,2,3 corresponding to nucleotides A, T, C, G in some order, which themselves are molecules of fixed shape without variation).

    If you unzip the double-helix of DNA, you end up with two chemical strings, and a segment of one of these strings is a gene that gets processed by a ribosome pretty much digitally, like computer code; literally like a punch-tape being fed into a reader. The ribosome machinery recognizes three-letter sequences (64 of them are possible; since each letter can be any of the four letters, so 4x4x4) which we call “codons” as corresponding to specific amino acids that pervade the cellular fluid. There are 20 amino acids, so in some cases several codons correspond to the same amino acid. One of the 64 codons is almost always used as a signpost to start the Gene, and 3 are almost always used as the sign post to terminate the gene, the are called Start and Stop codons.

    The ribosome feeds in the string of codons, and each selects for a particular amino acid, which gets bound to an output chemical string. Basically a translation of digital selections to make a product. The “STOP” codon, when encountered, causes the ribosome to bind a cap on the end of the chemical string and eject it. The string itself will fold up into a protein, the shape of which can attach to receptors on cells, to block functions, initiate functions, moderate functions or themselves to be used as raw material to be harvested and used or consumed by cells.

    How the chemical string folds up into a protein depends upon the amino acids it contains. So a “mutation” consists of changing one of the letters in the sequence, from whatever it is to some other letter, any of which is legal. but remember there are 64 codons and only 22 functions (20 amino acids plus start/stop), so if that changed letter means the three-letter codon still selects the same function, then no-harm, no foul. But if it does not, then we do not code exactly the same protein, and therefore not exactly the same shape.

    Some substitutions of amino acids will produce nearly the same shape, so the protein can still partially function, but perhaps it binds to cells much more strongly, or much more weakly, and that creates problems analogous to a vitamin deficiency or toxicity. Also, some slightly altered shapes can present binding sites to other proteins, and such bindings can reduce the level of those other proteins in the blood, causing a more indirect deficiency.

    If we look at cancer (as I recommend) as a cellular respiration malfunction, then some slightly altered variant like BRCA1 is presumably, by its binding or failure to bind, increasing the odds of such a respiration malfunction in breast cells due to some particular expression of binding sites unique to breast cells.

    So IMO all Myriad found is that a variant of the BRCA gene, a slightly altered protein shape that still seems to be functional, in the long run produces a side-effect, induced cell respiration failure, that is not produced by the most common version of BRCA. Because it is a long run effect, it is difficult for natural selection to weed it out, because it does not typically kill its victims before they mate and reproduce.

    I’ve gotta run, but I do not believe they invented any new process, once a gene’s digital sequence is known, many standard methods can determine if it is present in a particular person’s DNA.

    What they did was select a sub-population of women with breast cancer and compare their DNA to the general population, and found a relative spike in the expression of this gene. Perhaps that detective work deserves some reward to be protected by the government (like a patent) and therefore incentivized, but I do not think patenting the gene is the way to do that; as you point out, that is not in the best interest of the public.

    Perhaps some new thing like a royalty payment or something would be appropriate.

  32. P.S. by “new thing” I mean a legal standing somewhere between a copyright and the exclusivity of a patent; something that does not prevent other people from relying on the research but does, for some number of years, demand a royalty of some percentage of revenue derived from the research.

  33. Please don’t try to justify the SCOTUS ruling. Those who do sound so foolish after having read some of the views of real scientists and patent lawyers who truly understand Myriad’s invention.

    Rather, just say, “It was a good decision. . . . a mighty good decision . . . a REAL good decision.” Be sure to repeat this often on the telephone and on your emails, and also take the time to commend the US Government on its wiretapping too. This will help you build up a good record on your file. “It’s a good thing they done, a REAL god thing.”

    So keep drinking the Cool Aid. After all, you don’t want to get whisked out into the cornfield, now, do you?

  34. Gene H:

    I dont think it is about money for Ralph. Adam Mossoff, whom I respect, says no one thinks genes can be patented. But the process which Myriad developed should be patentable.

  35. Bron,

    And I stipulated as much earlier. However, if genes are not patentable (and I agree that – unless they are artificially constructed – they are not), then Myriad’s attempt to do so simply because they isolated a set of naturally occurring genes fails on its face.

  36. Most definitely not about money and “no skin in the game” with Myriad at all, except in an ideological sense. (I’m a big supporter of the rights of intellectual and creative property, and have been ever since I learned about how Peter Roberts invented the socket wrench and Sears Roebuck made millions and millions of dollars from his invention, which they stole from him for about $10,000.)

    However, if I had known that the SCOTUS was about to render a decision on the Myriad case, I might have shorted Myriad’s stock. To me, the decision was predictable and for the reasons I’ve explained already many times, so there was no surprise here, once you know the principle at work. The only surprise was when the decision actually came.

    Interestingly, when the SCOTUS was about render its decision on Obamacare, and everyone knew when that decision was coming, I had been asked on my views on what the impact would be on healthcare stocks, especially given that several of the leading healthcare insurers helped to WRITE Obamacare. I had predicated that despite the so-called “conservative” wing of the SCOTUS, they would find a way to give Obamacare the thumbs-up. I would not have guessed that Roberts would have been the necessary “turncoat” for that decision, nor that a “tax” scheme would be used to alibi its passage, but, as I’ve said many times, I KNOW the principle that the SCOTUS operates under, and the SCOTUS’ decisions–particularly on business matters–are relatively easy to predict when you follow that principle. But even though I knew that the SCOTUS would approve Obamacare and that the healthcare insurers helped to write the plan, the initial knee-jerk reaction would be that the plan would be harmful to the insurers.. So I advised those investors to stay clear from healthcare stocks until after the stocks dropped–but then to buy in when the dust settled at the discount price. Healthcare stocks have since done very, very well because THEY are among the biggest beneficiaries of Obamacare.

  37. Ralph: I AM a real scientist (a full time research professor at an accredited university) that has done research on the genome and “truly understands” what Myriad did, and I do not regard it as an invention at all, any more than understanding the ribosome or DNA in the first place (to the level we do understand it) rise to the level of an invention. It is a discovery, not an invention. The processes they used may be patentable but are otherwise immaterial to this case, since those versed in the art of genomic lab work could have easily made the same discovery using standard public domain methods and lab technology.

    Your pathetic appeal to the authority of “scientists” and “lawyers” falls flat on this blog, we have both here, and in fact the lawyer this blog belongs to (JT) is one of the lawyers that disagrees with you! I imagine for both disciplines there are some on either side of this debate, so your reliance on those that agree with you is just cherry picking or selective vision; either way it is not a valid argument.

    Myriad did not invent the BRCA gene variants, they discovered them in the process of looking for a genetic basis for breast cancer, or breast cancer risk, probably after observing a statistically significant inheritable component in academic studies of the disease.

    As I said before, it would seem reasonable that doing the legwork and investment it took to commercialize their discovery deserves some sort of protection as intellectual property, but patenting a naturally occurring sequence of nucleotides (it has to be naturally occurring or the test wouldn’t work!) is not a reasonable way of providing that protection. Perhaps some real lawyers on this blog can propose some method of doing that, I am just the real research scientist.

  38. Nope, it may be where the rubber meets the ravine, but not certainly not the road.

    Google “Jarrell” and “Myriad”–and also “Mossoff” and “Myriad” as Bron suggested. Jarrell is not merely a scientist and researcher, but she has all the top credentials that you could imagine to render a meaningful opinion on Myriad’s INVENTION (not discovery). Mossoff is a first-rate patent attorney.

    Here’s a little bio on Jarrell:

    Can you find me a top scientist or similar caliber who argues that Myriad’s invention should not be patentable? Please post if you can.

  39. Her opinion is irrelevant, Ralph.

    The arguments for being able to patent a naturally occurring gene sequence were made at SCOTUS and failed not just a little bit but unanimously.

    Your appeal to her authority is cute though.

    She may be an excellent patent attorney but she doesn’t have the power to adjudicate and render final decisions.

    But let’s look at the basic meanings of the words “discovery” and “invention”.

    discovery /dɪˈskʌv(ə)ri/, n.,

    the action or process of discovering or being discovered:

    Contrast with . . .

    invention /ɪnˈvɛnʃ(ə)n/, n.,

    the action of inventing something, typically a process or device

    You can patent inventions, but not discoveries. As said, their process may be patentable. The isolated gene? Isn’t.

    No lawyer in the world could win that case for Myriad.

  40. I have an open mind and I always research as many sides of a story as I can. I have searched for a view from qualified scientists who are also patent attorneys, so they know how the law applies to a case like Myriad’s. I have found NONE that would support the opinion of the paper-shuffling-ideologue Clarence Thomas.

    If you can’t find anyone with such credentials who can articulate sound reasons that Myriad’s invention is not patentable, perhaps that just might get you thinking.

    As I said, “Can you find me a top scientist or similar caliber who argues that Myriad’s invention should not be patentable? Please post if you can.”

    And again, I remind you, that in the event that Pfizer, SmithKline, Merck, or some other big pharma-powerplayer should develop their own invention in which this SCOTUS ruling would go against, mark my words, the Congress or the SCOTUS at the time will effectively reverse the decision. The principle underlying ALL SCOTUS decisions that I have articulated is ineluctable.

  41. Tony C:

    Since you have the expertise there has been something that I have wondered for a while: Is it possible to eventually create a DNA Printer, a device that can encode an entire DNA strand based upon a pre-defined transcript from a database? This way the complete DNA of an living thing can be pre-designed and customized then grown into a complete organism.

    Is something like this possible?

  42. PS: I should also remind you that the great innovations come from SMALL businesses like Myriad, not BIG BUSINESS (such as companies like Pfizer, Merck, etc.). So the SCOTUS ruling is a direct attack on innovation as well–also part of the ineluctable principle I’ve articulated. (Thus, in the dawn of the new computer age of the 1970s, IBM, Hewlett-Packard, and other big businesses of that period weren’t the innovators.)

  43. Again…. “Can you find me a top scientist or similar caliber who argues that Myriad’s invention should not be patentable? Please post if you can.”

  44. Uh, because Myriad’s discovery is not an invention, Ralph. You don’t even need to be a patent attorney to know this. A basic knowledge of English (and staying awake in Intellectual Property class) is enough to tell you this.

    Myriad invented nothing about the BRCA1 and BRCA2 genes proper. They discovered the genes. They did not make the genes, they are naturally occurring. They invented a process to detect them. That process is patentable. The genes proper are not.

    This is truly the equivalent of a legal slow pitch softball.

    You’d literally have to try to lose this case for the Association of Molecular Pathology. It’s what we used to call a goose case. Guaranteed to lay a golden egg (a victory).

    This decision won’t be reversed.

    It comports perfectly with the legal definitions of discovery versus invention regardless of whether you understand the meanings of those words or not.

  45. Ralph:

    I concur with Gene in that it doesn’t matter what any particular scientist, no matter how credentialled, believes whether or not the discovery of this gene sequence is patentable or not the Supreme Court ruled that it wasn’t. Since patent laws are ultimately statutory in nature and if the supreme court rules the statute declares this as unpatentable then the law will have to be changed. I am not too familiar with any constitutional common law issues with patents, maybe Gene knows this, but outside of that where it would be under the pervious of the SCOTUS anyway the issue is not likely to be changed by the SCOTUS anyway.

    You say that the SCOTUS has reversed itself over the years but I don’t see it in this case. The unanimous decision is surely predictive of whether it would. AlsoI don’t see the issue as having such a social change issue such as was teh case with Plessy v. Ferguson or those types of changes society made.

    Unless congress changes the statutes, I don’t see this reversing any time soon.

  46. True ‘dat, Darren.

    It would require specific legislative changes to patent law to allow naturally occurring genes or any other discoverable natural phenomenon to be patentable.

    Changes that simply aren’t going to happen for a variety of political and economic reasons.

    Right now, the only things patentable in the U.S. are useful process, manufacture, composition of matter or machines under 35 U.S.C. § 101.

  47. Bottom line: You cannot cite anyone of Jarrell’s or Mossoff’s caliber to defend the SCOTUS ruling. I thought so, and for obvious reasons.

    (And the decision WILL be effectively reversed, but ONLY if Pfizer, Merck, or others of the BIG BUSINESS-power group should develop such an invention. The decision is plainly just another pro-big business/big government, anti-little guy/little business ruling. Classic and 100%predictable.)

  48. Bottom line, Ralph, is I don’t have to make a specious appeal to authority simply because it tickles your fancy. I have the law and legal principle on my side. Or was ” useful process, manufacture, composition of matter or machines” are patentable somehow confusing to you? And that naturally occurring genes are not “useful process, manufacture, composition of matter or machines”?

    Myriad didn’t engineer the BRCA1 and BRCA2 ergo they cannot patent them. If they had? They’d be in a boatload of trouble when the wrongful death suits starting rolling in. This ruling leaves open the possibility to patent engineered genes (like gene therapies), just not naturally occurring ones.

    The legal arguments for permitting patenting naturally occurring genes were made by Myriad’s attorneys.

    They lost. Big time. So much so that the Justices let Thomas pen the opinion because it was one even he couldn’t screw up. Get over it.

  49. Common sense tell me that Supreme Court was exercising common sense, something they rarely are capable if doing. To argue against the decision states that one does not have much common sense and profit is more important than a human life. In which the Supreme Court has held many times that a human life is not worth much especially if they have been afforded minimal due process.

  50. Like I said, You do not have any evidence to support your opinion that corresponds to the paper shuffling ideologue. Surely, there must be some scientist who happens also to be a patent attorney who could support your view? Perhaps one could be paid to render such an opinion? Maybe you could pay for an official statement? But until then you have absolutely nothing.

  51. Okay, you can’t name any qualified scientist/patent attorney who can articulate a reason why Myriad’s invention is not patentable. So you try a different tactic. But your misdirection from the facts and lack of evidence won’t work, and lack of evidence, except for those that “think” like Clarence Thomas and his ilk.

    So, yeah, sure. The US Patent Office is wrong. The Federal Circuit is wrong. And all off the top scientists/patent attorneys are wrong. And I’m wrong too. But you and the paper-shuffling-one-note-samba-ideologue Thomas (“big business/giverment good; small business/individual bad”) and other Leftists are correct.

    I know that you only like to read material that reinforces your warped view of reality. But, on the offhand possibility that you might be willing to learn a little, here’s an article for you to read:

  52. Bottom line: you cannot cite any top scientist patent attorneys who agree with this decision. Now, why is that true?

  53. Because I have the law – which describes what is patentable and was cited – and the plain meaning of words in the English language on my side which happens to be the side of logically irrefutable argument, Ralph. Words have meaning and laws such as patent laws include definitions of what they cover. Too bad for you and Myriad, naturally occurring DNA isn’t covered by U.S. patent law. As I said, if it were, whomever isolates the gene for blue eyes could patent it and start demanding licensing fees to every blue eyed devil on the planet. And that’s simply an absurd outcome but inevitable outcome of following the logic that a discovered gene is patentable. That’s why I initially gave the reductio ad absurdum example – it illustrates the absurdity of your logic extrapolated out to it’s logical conclusion.

    I don’t need to appeal to authority to refute your assertion.

    Watching you try to argue is like watching a brain cramp in slow motion having a train smash into it at an intersection.

    Or that dog chasing its tail until it runs into the box.

    However, just to shut you up . . . here’s a patent attorney and a doctor in one package. Note his specialty in medicine is molecular biology and genetics and his sub-specialty in patent law is biotech companies.

    The decision is actually not too disruptive for the industry, as it leaves open many ways for companies to build patent exclusivity around manipulated nucleic acids, methods of using even naturally occurring nucleic acids, etc.,” Cooley LLP patent lawyer Michael S. Tuscan said in an emailed statement. “Much of what this decision pertains to is research and discoveries that took place more than 10 years ago, not what is generally new to the life sciences industry in this day and age.”

    “Michael S. Tuscan is co-chair of the Firm’s Patent Counseling & Prosecution practice group and a member of Cooley’s Litigation department. He joined the Firm in 2005 and is a resident in the Washington DC office.

    Dr. Tuscan specializes in patent issues and has spent his legal career serving the biotechnology industry in the U.S. and abroad in all aspects of intellectual property law. He focuses on the development, execution and enforcement of worldwide market exclusivity strategies for products and technologies that are the core asset of biotechnology companies of all sizes. He is also adept at counseling clients to help turn those assets into business opportunities, such as capital transactions, strategic partnerships, product acquisitions and the like. He has extensive experience in the drafting and prosecution of patent applications, business-focused opinions, due diligence, patent interferences and oppositions.

    Prior to joining Cooley, Dr. Tuscan was a partner at Morgan Lewis. He holds a PhD in Molecular Biology from Emory University, an MS in Genetics, did postdoctoral work in human ion channel biology and served as a patent examiner in the biotechnology group of the United States Patent and Trademark Office. His practice focused on the pharmaceutical and biotechnology arts, including genomics, bioinformatics, micro-array technologies, recombinant antigens and vaccines, gene therapy, genetic engineering, rational drug design, pharmaceutical chemistry and human viruses. He has also published and has been an invited speaker on intellectual property issues facing the genomics and bioinformatics industries.

    Dr. Tuscan is a graduate of the Georgetown University Law Center and is admitted to practice before the United States Patent and Trademark Office and in the jurisdictions of Maryland and the District of Columbia.”

    Now run along, lil’ doggy! I’m sure there’s a box out there waiting for you to beat your head against it some more.

  54. Ralph,

    Myriad was capitalized at its inception with $195 million from its parent company, which hardly qualifies it as a “small business”. Secondly geneticists are hardly qualified to make decisions on payent law. Thirdly Myriads position on this case was anti-capitalistic because it would preclude other companies from using different means, via experimentation, to come up with a competing test.

    My guess id that you’re taking your political disposition and fitting it onto the facts of this case, rather than judging it dispassionately.

  55. Your reference to Dr. Tuscan proves nothing. Dr. Tuscan does not say anywhere that he agrees with the decision or that Thomas is correct in any shape or form. He merely tries to put a more positive spin on a bad decision.

    For example, Dr. Tuscan says: “While a fair number of existing patent claims are now likely invalid, many of these patents are at or near the end of their term” and the “decision will not prove too disruptive for the industry” because it leaves open many ways for companies to build patent exclusivity around manipulated nucleic acids, methods of using even naturally occurring nucleic acids. “Much of what this decision pertains to is research and discoveries that took place more than 10 years ago, not what is generally new to the life sciences industry in this day and age.”

    Others also similarly try to put a positive spin on a bad decision. The Myriad decision is “unlikely to move the needle on biotech investment,” said Edward Reines, partner in Weil, Gotshal & Manges’ technology litigation practice. BUT, Reines adds, “It’s obviously not a good decision to incentivize investment, but it’s not the end of the world.”

    However, patent litigator Timothy Worrall of Dorsey & Whitney predicted the decision would discourage investment in diagnostic and personalized medicine.

    Again, bottom line, you cannot name even one qualified scientist/patent attorney who agrees that Myriad’s invention is not patentable.

    As for the size of Myriad, the company is most definitely a SMALL business. Yes, it’s not like the mom-and-pop neighborhood luncheonette small business, but it IS small business by today’s corporate standards. It is ranked as one of the SMALL-CAP stocks by Morningstar, and its business enterprise value is less than 5% of Pfizer’s. Myriad is actually a victim of its small size. Had it been Pfizer (or any other major big-pharma-player) with the patent, the SCOTUS would not have dared to interfere with their business. It’s strictly a political decision. From a patent law standpoint, the US Patent office and the Federal Circuit, which SPECIALIZES in the application of patent law have properly applied the law, whereas Thomas, who probably was a mediocre student in science, and was not even a particularly good attorney took the opposite stance of the most learned specialists in the field. So no, I am not applying any political views of my own to an interpretation of the law. The REAL experts have already spoken.

    Try again.

  56. This is not the first time the SCOTUS has rejected patenting a natural phenomenon. I don’t have a cite, and it was many decades ago, but back when zoom lenses first came out, somebody tried to get a patent on the physics of the optics of a zoom lens. It was rejected, because the physics of refraction cannot be patented. On the other hand, IIRC, they let the patents for individual lens system through as meeting the standard. If they had allowed a patent on the Laws of Refraction, that would have opened a huge can of worms. It is easy to see that an aggressive legal department of the patent holder would be able to go after royalties on everything from eyeglasses to big telescopes. Overly broad.

    Just a couple of weeks ago, the SCOTUS rejected an overly broad applicant for a patent on a procedure to determine proper dosage of a medication.

    Justice Breyer wrote, “To transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words ‘apply it,'”

  57. I don’t have to try again, Ralph. I didn’t have to provide Tuscan’s statement to refute your assertion.

    35 U.S.C. § 101 describes what is patentable.

    Naturally occurring chemical compounds are not patentable no matter how many times you bang your head on the wall.

    Myriad did not make the genes in question.

    Invalidating their patents on human genes will open competition which drives innovation.

    End of story.

    Also, Dr. Tuscan seems to think the decision will have little impact on the industry. Since he is both patent attorney and an appropriate kind of scientist, that ought to tell you something. However, you seem to be fact proof. Just because he doesn’t agree with you doesn’t mean it is spin. There is no loaded language there or other deceptive language. It’s a straight out opinion that the decision is not a negative factor for biotech businesses by a guy who specializes in both patent law as related to the biotech industry.

    Your frustration is really quite amusing.

    Also, any company capitalized with $195 million dollars is not a small business by any reasonable measure of small business. Most small business are valued at less than a million dollars.

    There are plenty of decaffeinated brands out there that taste just as good as the real thing, Ralph.

  58. So Ralph:

    What is the measure of a business in terms of market capitalization that affords it universal protection by the SCOTUS? Is it over 1 billion dollars to make it generally a large cap stock? Does it need to have a PE ratio of 1:100? What are the fundamentals?

    And, what would happen if a large cap company entered into receivership and its bankruptcy resulted in litigation that went to the SCOTUS. Where would your logic fall into? The company was once a large cap company but now it is bankrupt, what would the automatic judgement be from the SCOTUS in this position?

  59. Did I mention . . .

    [T[he decision is more of a win than a loss for medical device and diagnostics makers, says Jennifer Camacho, partner at international law firm Greenberg Traurig.

    Myriad maintained that its manipulation and identification of the BRCA1 and BRCA2 genes, which suggest a heightened risk of breast or ovarian cancer, had made the genes themselves an patentable invention. The Justices today ruled 9-0 that Myriad’s patents were invalid, setting a landmark precedent for research & development in genetics and diagnostics.

    The decisions closes some doors for industry, but it opens others, Camacho told us. For medical device companies that have relied on patents that are “to the gene” or dependent upon the DNA itself to demonstrate novelty and patentability, the patent portfolio is likely to suffer.

    “However, on the flip side all the other companies’ protection based on the gene itself is also at risk, which means that that opens the door to potentially use more information for screening, but putting on their diagnostic tools, for personalized medicine, those sorts of things,” Camacho said.

    Ultimately the Supreme Court ruling strips back just 1 part of patent protection for gene-based inventions, she added. Patent claims that rely solely on the gene in question, like Myriad’s BRCA1 and BRCA2 patents, are basically out the window, but many companies’ patents also claim novelty for methods of identification and use of the gene in a particular assay or in producing a recombinant protein.

    “We’ve lost 1 layer here, intended in part to open up the field for additional invention and research and work that would be the subject of patent protection,” she said. “There is meaningful patent protection still out there and available for genetic inventions.”

    “Jennifer A. Camacho’s practice is focused on intellectual property counseling. Jennifer has broad experience in intellectual property due diligence, patentability and product clearance studies, licensing and related transactional matters, patent infringement and validity analyses, freedom to operate evaluations, worldwide patent and trademark portfolio development, patent reexamination proceedings, intellectual property litigation, and pre-litigation counseling.

    Jennifer frequently works with clients in the life sciences and chemical industries, including biotechnology companies, pharmaceutical companies, and chemical companies as well as venture capital and institutional investors. Representative clients include a venture-backed gene synthesis company, a publicly-traded biofuels company, a publicly-traded biosynthetic chemistry company, and a publicly-traded regenerative medicine company. Additional representative fields of technology for her clients include synthetic biology, industrial biotechnology, pharmaceuticals, regenerative medicine, protein engineering, metabolic pathway engineering, industrial enzymes, hydrocarbon chemistry, biocatalytic synthesis and biofuels, and nucleic acid synthesis and sequencing.

    Jennifer also works with academic and nonprofit research institutions on patent, licensing and technology transfer matters. Her experience includes patent prosecution for technology that has not yet been licensed, positioning technology for pre-formation academic spin-off companies, and exclusive and non-exclusive licensing transactions.

    Jennifer’s recent experience also includes serving on the litigation team representing a large international pharmaceutical company in an infringement action related to certain biomarkers used in drug discovery. Jennifer has served on the litigation team in multiple ANDA patent litigations representing a large pharmaceutical company seeking to enjoin the defendants from manufacturing and selling generic versions of two of the company’s branded oral contraceptives. Jennifer was also on the litigation team defending a major pharmaceutical company as the plaintiff in a breach of contract suit concerning a licensing agreement for foreign marketing rights for a monoclonal antibody.”

    Really, Ralph.

    Give it up.

  60. The Federal Circuit already applied 35 U.S.C. § 101. THEY know FAR MORE about the application of patent law than Thomas and other SCOTUS paper-shuffling ideologues put together and multiplied by 1,000. Oh, but I’m sorry, I forgot: Gene knows 35 U.S.C. § 101, and the Federal Circuit judges are just amateurs.

    Now, back to reality.

    The best that you could come up with now, is Jennifer Camacho, after doing research all day on the subject. Yet, she says NOTHING to support the SCOTUS ruling. Again, like Dr. Tuscan, she only tries to put a positive spin on a bad decision.

    Brenda Jarrell, on the other hand, whom I have cited–and is a REAL EXPERT in the relevant science field AND patent law says Thomas is flat wrong. Wrong, get it?

    It is very unusual for a lawyer to criticize the SCOTUS is such a direct way. In contrast, it is very common to find lawyers who will publicly state that the SCOTUS made the right call and explain why. Yet, you still cannot cite me anyone. Nonetheless, you still stubbornly cling to the notion that Thomas followed patent law.

    As for finance, you disclose that you don’t know your basics when you say: “Also, any company capitalized with $195 million dollars is not a small business by any reasonable measure of small business. Most small business are valued at less than a million dollars.”

    A market cap of $200 or even $400 million is considered to be a SMALL-CAP COMPANY in the real world. See the following for proof of that:

    As for what market cap would make a Company large enough that it would compel the SCOTUS to defer to that Company’s interests–it is not just a matter of market cap, but of political power. Sure a market cap in excess of $1 billion would probably qualify, but to be a genuine corporate power-player, the company also has to have the political and economic strength to influence, and compel when necessary, government agencies and politicians to do their bidding. That is what really counts.

    Try again.

  61. So if the SCOTUS is only interested in pandering to the large corporations of America, due to their political influence and control of the three branches of gov’t, then why would the SCOTUS even grant certiorari to cases such as these below?

    Adoptive Couple v. Baby Girl, 12-399

    Chafin v. Chafin, 11-1347

    Dan’s City Used Cars v. Pelkey, 12-52

    Trevino v. Thaler, 11-10189

  62. I did not say that the SCOTUS is ONLY interested in pandering to the large and powerful corporations. What I said was that the SCOTUS will always side with Big Business against the rights of Small Business.

    But the SCOTUS very clearly has strong interests in trampling on the civil rights of individuals as well. I’ve made that point before here as well. Thus, if a case comes down to the power of, say, the government vs. an individual whose rights were trampled on by the government, then the SCOTUS, of course, would come down on the side of Big Government.

    Are we getting the principle now? Apparently not.

    Try again.

  63. Speaking of reality, you apparently you have no clue as to how appellate jurisdiction works, Ralph.

    MyrIad lost the original case filed in the U.S. District Court for the Southern District of New York. The Court of Appeals for the Federal Circuit reversed the trial court at which point the plaintiff’s filed for certiorari. It was granted and Myriad lost on the gene patent issue again. They lost based on existing patent law whether you think so or not.

    SCOTUS is the final court of appeal.

    You’re free to be as wrong as to the legal technicalities of this matter as you like.


    And I’ve got some more bad news for you.

    They’re likely to lose their case in Australia later this year when it goes to the Full Bench of the Federal Court as this decision has already been referenced for the upcoming hearing. If it goes to the High Court of Australia? They’ll probably lose there too.


    Because discoveries are not patentable.

    Only processes, products and machines are patentable.

    And the U.S. and Australia both have legal systems based in English common law.

    Sleep tight.

  64. You are good at diversions. But your pseudo-arguments are worthless because you cannot escape the fact that the Federal Circuit is the nation’s leading authority on patent law. The SCOTUS are legal servants working for big government and big corporations, and none of the members or staff of the SCOTUS have any expertise in patent law.

    I have asked you repeatedly to name one individual who is both a scientist and an expert in patent law who would agree that the SCOTUS reached the correct decision. You failed to name anyone, after researching the matter all day and all night. That is the tale of the tape.

    Try again, and try not use misdirection and ipse dixitisms.

    Either admit that you cannot find a qualified scientist and an expert in patent law who would agree that the SCOTUS reached the correct decision, or shut up.

  65. Ralph wrote:
    “because you cannot escape the fact that the Federal Circuit is the nation’s leading authority on patent law. The SCOTUS are legal servants working for big government and big corporations, and none of the members or staff of the SCOTUS have any expertise in patent law”
    You’re delusional.

  66. More to the point, you have no idea how SCOTUS works, Ralph. If any justice hearing a case isn’t familiar with a given area of law, their clerks do extensive research on the matter and brief them and/or prominent experts are consulted. All of this informs their reasoning and decisions. That being said, sometimes personal politics does unduly inform decisions, however, this isn’t one of those instances. The law and legal principles here are both basic and clear and the holding comports with them. If they had ruled the opposite? Given Thomas’ specific history of catering to corporations of any size, such a ruling would have been both suspect and in contravention of laws created by the legislature governing what is permissible to patent.

  67. You have been given ample opportunity to find a qualified scientist and an expert in patent law who would agree that the SCOTUS reached the correct decision. You failed. The argument is over. You lost.

    But perhaps there’s a silver lining for you. With your newfound admiration for Clarence Thomas, perhaps Prof. Turley will set up a subgroup, “The Clarence Thomas Fan Club.” Gene, you could be president and Darren could be vice president of the club.

    I will leave you now so that you may post more irrelevant comments to attempt to distract attention away from your blatant failure to find a qualified scientist and an expert in patent law who would agree that the SCOTUS reached the correct decision.

  68. You seem to not grasp the fact that I don’t need anything more than the plain letter of the law and the plain meanings of words in English to support the logic that naturally occurring genes are not patentable as they are a discovery of a natural phenomenon and not an engineered innovation, Ralph.

    Or that I was providing those quotes simply to humor you.

    The appeals to non-adjudicative authority are the meaningless distraction here and have nothing to do with the legal arguments against the patents.


    “The gene patentability question long predates this decision. Genes are the basic units of heredity in a living organism; each one contains instructions (in the form of its sequence) to build a machine (usually a protein) that does the work of living cells. Clearly, genes in their natural state are products of nature.

    On the other hand, genes that have been isolated from their natural state or have been manipulated by scientists are not products of nature. For example, a rock is a product of nature; a rock carved into a statue is not.

    The patent law has always held that, once a natural product has been manipulated by the hand of man, it is no longer a product of nature and is now available for patenting. The fundamental patent statute, 35 U.S.C. §101, states: “Whoever invents or discovers any new and useful . . . composition of matter . . . may obtain a patent therefore . . .”, and this statute has been broadly interpreted. The Supreme Court’s landmark decision Diamond v. Chakrabarty (1980) held that “Patentable subject matter includes . . . anything under the sun that is made by man.”

    The U.S. Patent and Trademark Office (USPTO) has issued about 35,000 patents reciting a gene sequence in their claims. These gene patents protect isolated or purified DNA sequences (many of which encode to therapeutic proteins including biologic drugs), RNA sequences (many of which relate to therapeutic RNAs such as interfering RNAs, antisense RNAs, and ribozymes), vectors, nucleic acid-based vaccines, cells engineered with gene sequences, and various uses of gene sequences (e.g., methods of treatment, methods of diagnosis, or the use of genes as research tools).”

  70. Darren: Is something like this possible?

    Sorry I am so late answering; but YES, in fact there are services right now that will produce any DNA sequences you desire based on a digital file which you can email them; detailing the letter sequence you want.

    The equipment already exists to construct novel chains, and although it is expensive, there is nothing in principle preventing a “printer” device that can automatically convert an arbitrary sequence of letters, of any length, into a strand of DNA. The trick is that DNA does nothing by itself, just like a computer program does nothing if not loaded into a computer; the DNA has to be inserted into a cellular environment which is the “processor” that dumbly reacts to the code. You cannot form proteins without a soup of amino acids, ribosomes to read the DNA, spliceosomes and other mechanisms that manipulate the DNA to extract and prepare genes that the ribosomes can form around, to translate the code into a protein.

  71. Bron: The problem is that BRCA1 and 2 are NOT manipulated in any way by man, they are still ‘rocks’, unchanged. They are not in any way “statues.”

    That should be obvious from the fact that they exist unchanged in humans, or the very idea of the test would not function. Myriad did not modify these carcinogenic genes and then inject them into women and then offer them a test to see if they had been infected. Human genes are the rocks, trees, and natural material that already exist. Patenting BRCA1 or 2 is like patenting Gold, in its raw, natural form unchanged by man. Or, perhaps more relevantly, Lead: I can devise a novel new test to see if a child is suffering from lead poisoning; but that doesn’t mean I get to patent Lead, or the idea of testing for Lead.

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