The Questionable Authority

Federal Judge Strikes Down BRCA1/BRCA2 Patents.

Posted by Mike Dunford on March 29, 2010
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As of this morning, at least 20% of your genes were patented by someone other than you. The holders of the patents could quite literally forbid you to investigate large portions of your own personal genome. This afternoon, a federal judge in New York handed down a broad ruling that calls into question – thankfully – the entire idea that naturally occurring genes are patentable.

The ruling in question most directly affects the BRCA1 and BRCA2 genes, which have been implicated in hereditary breast cancer. Myriad Genetics patented those two genes, and has been jealously guarding those patents. This has restricted research into those genes, and has prevented the development of any alternative methods for tests involving those genes. The ACLU filed suit challenging the patents last year, and the ruling in question came in response to their request for summary judgement.

I’m still reading through the 156-page ruling, which can be downloaded from the ACLU’s website (pdf), but I think I may have already found one of the quotes that – if the ruling survives the appeals process – is likely to have extremely wide-ranging effects on genetic research in the future:

Because the claimed isolated DNA is not markedly different from native DNA as it exists in nature, it constitutes unpatentable subject matter under 35 U.S.C. 101.

Myriad is sure to appeal the ruling, so the case is most likely far from over. But it at least gives cause for hope that research into human genetics will not be restricted by firms that claim patents on part of our very physical makeup.

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  1. #1 RodM
    March 29, 2010

    Wow, I had no Idea that Genes were being patented. This is ridiculous, talk about stifling research.

  2. #2 Travis
    March 29, 2010

    Neat, I was just reading about this yesterday in Rebecca Skloot’s book about Henrietta Lacks. Good timing!

  3. #3 Paul
    March 29, 2010

    This is excellent news! James Watson co-discoverer of DNA was opposed to such patents and when NIH overuled him he left, or was forced out, in 1992. As the judge correctly notes these are products of nature not intellectual products. Now we are in the absurd position of being able to cheaply and rapidly sequence a persons entire genome. Is every single nucleotide polymorphism found in the individual by the testing company open to being patented. It is to my mind akin to buying a microscope and then claiming a patent on whatever components of life I find there. What about, again as the judge noted, the problem with stifling scientific advance by not being able to openly study the gene in question. I would go one further and say that no DNA sequence whether created artificially or found through sequencing may be patented. Quite often these sequences end up in self replicating or potentially self replicating organisms. There is an interesting story http://healthjournalclub.blogspot.com/2010/03/astonishing-court-case-of-becky-mcclain.html of a microbiologist who is claiming she was inadvertently infected by a genetically engineered virus. The company however, is refusing to release the sequence of the virus in question. Well what if that virus or a future one turned out to be contagious? Can you even place a patent on a computer virus? How much more foolish to claim there is patent protection on a virus that might someday be able to kill you. At the very least, requests by health practitioners or public health officials should over rule patent claims, whether a sequenced part of a genome or one made from scratch. Glad to see this ruling.
    Paul
    http://healthjournalclub.blogspot.com/

  4. #4 The Gregarious Misanthrope
    March 30, 2010

    I agree that patenting extant genes is ludicrous. How can someone patent a part of me without my permission?

    Novel, lab-created organisms or even genes are a different matter. If the heart of this ruling is about whether the thing existed in nature, then anything you create that is novel is patentable.

    A computer virus is simply computer code; written instructions. As such it would be treated as computer software is today, not as patentable, generally, but subject to copywright. No one would copywright a virus, of course, because then the authorities would be able to find you and people would see how the thing is written and be able to defeat it.

  5. #5 JohnW
    March 30, 2010

    I think many misunderstand the notion of patenting genes. The interpretation has been, until now it appears, that the description of a gene by someome constitutes intellectual property. That makes some sense, as no one just stumbles across a DNA sequence and says “Oh, it’s the so-and-so gene”. A lot of work and interpretation goes into establishing that DNA sequence A encodes protein B. BTW, I’m pretty sure Myriad Genetics did not discover the BRCA genes. They purchased the patents from the academic institutions were the discovery research was done. Happens all the time.

    Not sure where I come out on this one though. I totally get the absurdity argument against the patenting of genes. But think about this, if someone does a couple years worth of work, conducting linkage studies to home in on a putative gene’s location, slogs through the bioinformatics work to delineate the coding sequence (exons and introns), perhaps conducts animal or cell culture modeling to establish function and to be able to say this stretch of DNA creates this protein, and then does some population studies for disease-associated genes, how is that different from working a couple of years on a project that creates a new process for, say, storing energy? Energy occurs in nature and the chemistry or physics involved to store it come from nature, but who would say a new technology for energy storage is not patentable? It’s the inventor’s/discoverer’s intellectual property, right? How is describing a gene different?

  6. #6 Jesse
    March 30, 2010

    JohnW–

    In the example you bring up, I could spend a long time coming up with a new engine to burn wood in a steam engine. I can patent the engine. But I can’t patent the wood, I can’t patent the metal the engine is made of (unless I invented it) and I can’t tell everyone else “you can’t study anything that burns wood, uses metal, or steam without paying me.”

    That’s the problem with gene patents. Yes, it takes a lot of study to find out which gene does what. But it takes a lot of time to find a new way to process oil into gasoline too. I can patent the process but I can’t patent gasoline itself, or crude oil, and forbid anyone from investigating other methods of making the same stuff. If I use process A to make gasoline from oil and another guy uses process B, that’s okay. But neither of us can patent crude oil.

    No company or person created the BRCA genes. They were there already. They just discovered what they did.

    Know what the problem with patenting genes is? Taken to absurd lengths, if I patent a gene sequence from you, and you have children who also carry it, did you just violate my patent? Under the law the answer was yes, until now. Thankfully nobody filed that kind of suit. But it was possible.

  7. #7 Erin
    March 30, 2010

    YES! Score one for science and nature! I can understand wanting to protect something you made from being copied, but not my goddamn BODY! Sheesh!! And hopefully this will open up more research into these genes without fear of frivolous litigation, moving cancer research in a better direction.

  8. #8 Luther
    March 30, 2010

    “35 U.S.C. 101 Inventions patentable. Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter….”

    The law says discoveries can be patentable. I don’t know enough about genes myself to make a judgement whether or not a gene should be patentable, but it certainly doesn’t seem horribly non-analogous to other undisputed subject matter, such as discovering that a natural product from nature like penicillin, curare, or aspirin. In any event, the Supreme Court has ruled, and the Supreme Court has supreme egos.

    http://www.webmd.com/news/20070316/most-new-drugs-tapped-from-nature
    “March 16, 2007 — Nature has been the source or inspiration of most new drugs created in the last quarter century.

    That’s according to David Newman, DPhil, and Gordon Cragg, PhD. They work in the natural products branch of the National Cancer Institute (NCI).

    Newman and Cragg reviewed all new drugs approved from January 1981 through June 2006 for all diseases worldwide. The list included 1,184 new drugs for a wide range of conditions.

    Thirty percent of the new drugs were totally synthetic in origin. The other 70% were derived from or similar to chemicals found in nature, according to the researchers

  9. #9 Paul
    April 1, 2010

    Luther the more I think about it that is the best argument for gene patenting I’ve yet considered. Namely, if the protein products of genes are patentable, i.e. penicillin, why aren’t the genes themselves? I’ll give two takes on why I see this becoming an issue. 1) on the more cynical end, there ain’t much money in genes, all the useful therapies that have been developed, for the greatest part have been developed down stream at the protein end.
    2) And this really gets at the heart of the issue. Proteins are not heritable traits, genes are. Can someone patent those particular physical expressions and characteristics unique to you and your family and your heritage. There is something in laying legal claim over this, especially when one considers it is not an intellectual innovation but just a description of nature, in this case heritable traits of nature, that strikes me as profoundly wrong and racist in the most elemental sense of the term. After considering your post I see the other side of the argument, but I still profoundly disagree with it.

    As for John W’s point about the difficulty in research involved in pinpointing and characterizing a particular gene, I would just argue that this alone doesn’t necessitate granting a patent, I would say the research was more intense, the fundamental science and bench work such as x-ray crystallography studies of DNA more difficult, to simply characterize DNA, but Watson and Crick didn’t receive a patent on the molecule. This may sound like I am being a wise guy but if you consider if for a bit, yes DNA through the variability of bases encodes information, but as they discovered DNA,really why couldn’t they have patented “DNA”?

    Paul
    http://healthjournalclub.blogspot.com

  10. #10 Dov Henis
    April 2, 2010

    Wives May Patent Husbands?
    RNA Or DNA Genes, Organisms, Should Not Be Patentable
    Organisms Should Not Be Patentable

    Key Cancer Patents Killed
    http://www.the-scientist.com/blog/display/57265/

    All organisms, regardless of size, natural or modified by humans, should not be patentable.

    Otherwise where is the limit???

    My wife of few years might yet apply to patent me…?!

    Dov Henis
    (Comments From The 22nd Century)
    03.2010 Updated Life Manifest
    http://www.the-scientist.com/community/posts/list/54.page#5065

  11. #11 Ginger Yellow
    April 5, 2010

    I have a forlorn hope that this case (or another like it), will lead to a fundamental rethink of patent law. It’s come to an absurd situation where a simple sequence of naturally occurring nucleotides – not a technique for isolating or producing them – can be patented, whereas a piece of software can’t. In theory, patentable items need to be new, useful and inventive/non-obvious. Countless software designs meet these criteria, and yet they can’t be patented, only copyrighted, which is more or less useless as IP protection other than for outright piracy. Other designers are free to rip off the actual innovation, just using slightly different code. On the other hand, what’s new or inventive about a (naturally occurring) gene’s sequence? It’s utterly nonsensical. Maybe mother nature should be granted the patent.

  12. #12 eric
    April 6, 2010

    Luther: “35 U.S.C. 101 Inventions patentable. Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter….”

    The law says discoveries can be patentable.

    The composition of my matter is certainly not new. Phylogenetic analysis makes it pretty clear that practically every gene is thousands, millions, or even billions of years old.

    My wife might also be tempted to argue that the composition of my matter is not useful…thankfully, since the law uses an “and” clause, my DNA is unpatentable regardless of whether she’s right about that or not. :)

  13. #13 deadatheists
    April 10, 2010

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    DOES ATHEISM HAVE A FUTURE?

    AND THE ANSWER – NO!

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    GET OUT OF MY UNIVERSE…

    you little liars do nothing but antagonize…

    and you try to eliminate all the dreams and hopes of humanity…

    but you LOST…

    THE DEATH OF ATH*ISM – SCIENTIFIC PROOF OF GOD

    engforum.pravda.ru/showthread.php?t=280780

    Einstein puts the final nail in the coffin of atheism…

    youtube.com/watch?v=V7vpw4AH8QQ

    atheists deny their own life element…

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