Academia, Constitutional Law, Courts, Science, Society

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. 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.

  2. 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.

  3. 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!

  5. 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

  7. 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.

  9. Thomas pinned down a point that the people of Georgia will approve. No fun intended. I mean pun.

  10. 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.

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

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