The future always advances

By Razib Khan | November 7, 2013 2:56 am

The last week has seen a lot of chatter about the slapping down of the diagnostic patent by Sequenom, Judge Invalidates Patent for a Down Syndrome Test:

A federal judge has invalidated the central patent underlying a noninvasive method of detecting Down syndrome in fetuses without the risk of inducing a miscarriage.

The ruling is a blow to Sequenom, a California company that introduced the first such noninvasive test in 2011 and has been trying to lock out competitors in a fast-growing market by claiming they infringe on the patent.

Sequenom’s stock fell 23 percent on Thursday, to $1.92.

The judge, Susan Illston of the United States District Court in Northern California, issued a ruling on Wednesday that the patent was invalid because it covered a natural phenomenon — the presence of DNA from the fetus in the mother’s blood.

The existence of intellectual property is a utilitarian one. That is, these are institutions which are meant to further the cause of creativity and innovation. Is there going to be an abandonment in this domain of the push toward technological innovation? Coincidentally in the last week of October Sequenom put out a press release which heralded some advances in its panel:

…The MaterniT21 PLUS test will begin reporting additional findings for the presence of subchromosomal microdeletions and autosomal trisomies for chromosomes 16 and 22, in addition to the previously announced additional findings for sex chromosome aneuploidies involving an abnormal number of the X or Y chromosomes. These additional findings complement the MaterniT21 PLUS test core identification of trisomies for chromosome 21, chromosome 18 and chromosome 13. With this expansion, the MaterniT21 PLUS test is the first-of-its-kind noninvasive prenatal technology (NIPT) to provide these comprehensive results from a maternal blood draw.

Sequenom Laboratories will begin reporting on these select, clinically relevant microdeletions, including 22q11.2 deletion syndrome (DiGeorge), Cri-du-chat syndrome, Prader-Willi/Angelman syndrome, 1p36 deletion syndrome, as well as trisomies 16 and 22 the last week of October. Results from a method validation study….

It seems that the firm’s main path to profit and riches is going to be to innovate faster, gain market share, brand recognition, and economies of scale. This seems as if it is a greater good for the public than its rents extracted through intellectual property monopolies.

CATEGORIZED UNDER: Personal Genomics
  • Dmitry Pruss

    Isn’t it the same with generic drugs? Brand recognition, economies of scale, and marketing power give brand-name medications a certain advantage over generics, so by your logic, it serves a greater public good to do away with patent protection for the pharma.

    Do you really think that the advantages of running a better R&D shop & innovating faster will remain worth the price tag of R&D if any lean competitor can just copycat your IP for free?

    Mind you, it’s about health, and the health insurers love lean, cheap products and hate paying more for a fractionally better sensitivity of the test or efficacy of a drug. “Not just trisomy-21 but also Prader-Willi and Cri-du-chat? Too rare and isn’t worth the price of a brand-name product; claim denied”

    • razibkhan

      so by your logic, it serves a greater public good to do away with patent protection for the pharma.

      when you have to translate my logic, which you infer, to another case, that’s usually a clue that you’re setting up your own argument, rather than engaging with mine :-) i’m skeptical of IP, but i can accept a gradation of plausible arguments for such protections. e.g. amazon’s “one-click” != pharm R&D.

      Mind you, it’s about health, and the health insurers love lean, cheap products and hate paying more for a fractionally better sensitivity of the test or efficacy of a drug. “Not just trisomy-21 but also Prader-Willi and Cri-du-chat? Too rare and isn’t worth the price of a brand-name product; claim denied”

      in this specific case i think many potential parents would actually pay out of pocket for this if necessary. more specifically, upper middle couples who are 30+ in age.

      • Dmitry Pruss

        >i can accept a gradation of plausible arguments for such protections.
        >e.g. amazon’s “one-click” != pharm R&D

        It goes w/o saying. It’s just, people outside of the clinical testing industry generally underestimate the costs of innovation in genetic testing, how CLIA compliance affects pre-clinical development of the future clinical products, how expensive is to re-validate the lab after each incremental improvement.

        >in this specific case i think many potential parents
        >would actually pay out of pocket for this if necessary

        Most of them already do, but there is a catch: Sequenom charges patients with or w/o insurance coverage for their test a flat OOP maximum of $235; it may charge the insurance companies up to the list price of $9200. Simply put, the money is where the insurance is; each unfavorable shift in insurance coverage threatens to sound a death knell to the already money-loosing company. SQNM’s stock price lost 2/3rd of its 52 wk high, and it’s extremely difficult for them to budget any R&D effort now, especially if it affords them only a fractional advantage over the competition.

  • http://blogs.discovermagazine.com Apple Pie

    Or some country will wise up and smell the future and begin stringent protection of hi tech (genomic) intellectual property. There is a collective/public interest in providing (for a limited time) state protection for small inventors.

    Otherwise every innovation will be gobbled up by board rooms full of men in suits who are looking to increase market share. Who will chew it up and spit it out after buying another wing for their McMansion or just for a few kudos from shareholders. Yes, evil/stupid big corporations do exist and they are pretty ruthless. Rarely do they bite on something they can’t chew.

    Nature is full of big, dumb sharks. Intelligence can be a fragile thing in an environment of unrestrained competition. True for biology, true for economics, true for human progress.

    • razibkhan

      Otherwise every innovation will be gobbled up by board rooms full of men in suits who are looking to increase market share.

      microsoft’s explicit ‘second mover’ strategy has been a failure since 2000.

  • Karch_Buttreau

    Does anyone have a link to Judge Illstron’s opinion?

  • Anthony_A

    Without reading the opinion, it sounds like the patent falls into the gray area between patenting a method and parenting a naturally-occurring product. Methods for detecting Down’s syndrome have been around a while, and one can’t (I hope) patent the discovery that embryonic DNA exists in the mother’s bloodstream. What should be patentable would be a method of reliably separating embryonic DNA from the mother’s DNA in a sample of the mother’s blood.

    Was that what the patent covered, or did it try to make overbroad or unallowable claims? I don’t know, and I’m not sure reading the judge’s opinion will actually tell me that.

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This blog is about evolution, genetics, genomics and their interstices. Please beware that comments are aggressively moderated. Uncivil or churlish comments will likely get you banned immediately, so make any contribution count!

About Razib Khan

I have degrees in biology and biochemistry, a passion for genetics, history, and philosophy, and shrimp is my favorite food. In relation to nationality I'm a American Northwesterner, in politics I'm a reactionary, and as for religion I have none (I'm an atheist). If you want to know more, see the links at http://www.razib.com

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