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

  2. 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:

  3. 35 U.S.C. § 101 and the definitions of “invention” and discovery trumps your wishes.

  4. 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.

  5. 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.

  6. 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.

  7. “The lady doth protest too much, methinks, to have sold short”

    Margin Call, m’ Lady !

  8. 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.)

    1. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.”

  13. 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.)

  14. 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?

  15. 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.

  16. 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.

  17. 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.

  18. And there is where the rubber meets the road.

    A discovery is not an invention.

  19. 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.

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