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    The Ongoing Gene Patenting Debate (And Why You Are Probably Wrong)
    By Randall Mayes | August 20th 2012 01:47 PM | 29 comments | Print | E-mail | Track Comments
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    Randall Mayes is a policy analyst specializing in biotechnology. His areas of expertise include technology based economic development and public...

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    An ongoing legal battle regarding gene patents began in 2009 when the ACLU representing numerous clients sued Myriad Genetics and the USPTO. The dispute is over patents on two genes, BRCA1 and BRCA2, discovered in the 1990s which have a correlation to increased rates of breast and ovarian cancer.

    The case subsequently went to the Federal Appeals Court that handles biotechnology patents, the Supreme Court, and was earlier this year remanded back to the Federal Appeals Court. On August 16, 2012 the Federal Appeals Court reaffirmed that gene patents are legal. So, why did the activists lose the legal battle?

    Whether you are conservative, liberal, or libertarian, or an expert or amateur patent attorney or molecular biologist; the odds are that you have objections to gene patents and made up your mind based on uniformed opinions. The Federal Appeals Court decided that these arguments are misconceptions and consequently were not very convincing. If you are an activist, do you know what a gene patent actually means? Do you know what actually receives patent protection?

    In the law suit, the plaintiffs argued that gene patents violate the First Amendment and are therefore invalid and unconstitutional, because genes are products of nature. The court wisely determined everything is a product of nature, but is not always natural. Man derives baseball bats from the wood of ash trees, then carves them in to a desired shape and receives patent protection.

    Similarly, isolated BRCA genes are chemically distinct from natural DNA. In nature, BRCA genes are covalently bonded and from a chemist’s perspective they are different molecules than the isolated version. Although the information in both versions of the genes is identical, the patents are on a physical entity. That entity is a molecule, similar to the naturally occurring molecules insulin, EPO, and penicillin produced by man which have also received patent protection.  

    Activists routinely refer to ownership of genes which they perceive as immoral. In patent law, however, gene patents do not convey ownership of a gene, rather are a property right guaranteed by the Constitution which temporarily excludes others from receiving financial rewards from a patent holder’s work. In addition, the Thirteenth Amendment which abolished slavery prohibits owning genes.

    The plaintiffs also argued that the gene patents restrict scientific research. However, the evidence does not support this claim. A National Academy of Sciences study (2003) conducted by Walsh, Arora, and Cohen found:

    "Changes in technology and policy over the last several decades have led to concerns that the patent system may be creating difficulties for those trying to perform research in biomedical fields. However, we find that drug discovery has not been substantially impeded by these changes. We also find little evidence that university research has been impeded by concerns about patents on research tools. Rather researchers managed to adopt solutions or work around the problems through licensing, going offshore, using public data, legal action, and infringement."

    Furthermore, according to statistics compiled by Bloomberg News more than 18,000 scientists have researched the BRCA genes publishing more than 9,000 research papers. 

    The second major dispute of the lawsuit alleges that Myriad’s $3000 screening test for mutations on the BRCA genes is too expensive and restricts access to medical care although it is covered by health insurance. However, a study conducted by Duke University researchers found that contrary to expectations, the BRCA screening test is not particularly costly relative to other tests.

    The Duke study found that systemic transaction costs that exist within the medical industry are responsible for high medical costs. According to Genomics Law Report, Myriad’s revenues for the diagnostic test reached over $400 million during the company’s most recent fiscal year. Myriad’s BRCA patents are set to expire in 2015.

    Front page image: Shutterstock.com

    Comments

    vongehr
    In nature, BRCA genes are covalently bonded and from a chemist’s perspective they are different molecules than the isolated version.
    ??? The isolated ones are bonded by gravity and the weak force?
    randallmayes
    When the BRCA gene is separate from the rest of the chromosome the covalent bonds are broken giving the molecule a different composition. The bonds that hold the BRCA gene itself together are not changed.
    Randall Mayes
    Additionally, the gene isn't technically separated from the chromosome. Specifically, enzymes unwind the chromosome and attach to the starting sequence of the gene in question. Polymerase then makes a s anti-sense copy of the single stranded DNA sequence. So at the very base of it, the people who own patents on these genes never created anything new, but made a copy of a gene through transcriptional machinery already present in the cell. This bullshit is ludicrous. Now, personally, I could see something like lab-made or engineered point-mutations or insertions and deletions being proprietary. But merely duplicating something from a natural source should not be subject to a patent. It's common sense.

    randallmayes
    But what about PCR copies or cDNA? These are thoroughly discussed in the judge's opinions.
    Randall Mayes
    Your judge is in someone's pocket!

    randallmayes
    You lose a law suit, make malicious claims, and resort to anonymous postings all in one week; your mother must be proud.
    Randall Mayes
    How is it malicious, if it's true?

    So by this logic, if I were to take my very own cells and sequence by very own BRCA genes, that I would be violating Myriad Genetics property rights. Even though I'm not use any materials they have produced themselves, but using natural translational mechanisms to produce molecules which by means could and are produced invivo. For instance, plasmids ad siRNA!

    And yes, my mother is very proud. Not sure what yours would say about her son the blogger.

    randallmayes
    If collusion ls true let's here more about it. Logically, do you know how many human genomes have been sequenced? Each one contains the BRCA genes. Let's also here where Myriad objected to sequencing genomes (or any other gene patent holders). Now you have two unsubtantiated claims.
    Randall Mayes
    You're the one claiming that I slandered the judge. It's not my legal burden to prove my innocence. At-least not in a democracy. Maybe you're right, its possible that the judge is merely incompetent.

    Also for the number of humans genomes, I believe the answer is 3. Not positive though.

    But more to the point. Myriad is claiming property rights over the sequence to the wildtype gene, and the processes for isolating and using said constructs. However, if i were to sequence my own genes, I would be in would be in possession of the BRCA sequence without their express consent. Yet, it's my property because my cells are the things producing it. And this is what makes your kinds argument so odd to scientists like myself and for the most part shows your inane understanding of molecular biology, the only way to determine the sequence of BRCA is by mapping naturally occurring genes. So by definition, the gene (exons and or introns) is common. So presume you agree here, but say that the isolated sequence is different than the wild-type gene. Then why claim ownership over the sequence of wild-type BRCA? Then you get into the questions of how you license the using methods which employ common transcriptional mechanisms that are not in the least bit proprietary. Now please tell me, what legal reason should there be to stop me from using the natural methods to isolate and manipulate my own genes, or the genes of other? If you think the Myriad wins out here, then you're committed to the peculiar argument that Myriad Genetics has partial ownership of MY genome.

    It would be your legal burden to prove your accusations against the judge. Accusations that are so far baseless, and stink of ad hominem attack rather than substantive argument.

    Here's a question: any copy of a gene that is isolated from the chromosome is just a copy right? It is made from nucleotides that did not come from your body. It is no more yours than insulin that is identical to the insulin you make in your pancrease.

    I'm not sure you have the grasp on either molecular biology or this situtation that you claim to. The patent is not for the BRCA gene and all of it's versions. It is for two specific versions. All the "sequence differing from the wild type" stuff is irrelavant. They don't own your gene, they own the ability to make money off two versions of the gene. Analysis of those versions of the gene are not part of the patent.

    How about this, say I take your article, copy it, and then publish it under my name.

    Additionally, you're assuming that I think insulin should be patentable, and not sold under generic licensing.

    And yes, in a very peculiar sense they own these genes, because they can stipulate when, where, and who works them. If i were to sequence it myself, then the patent gods would rain down fire and brimstone.

    There is not a direct comparison to the wriitten word and sequence-specific polymers.

    If you're arguing that no naturally occuring biological molecule can be patented for sale then you are in an upstream battle. One that prevents an awful lot of good discoveries from being made. It's expensive to do this work, and if we want it done there has to be a pay off for the people doing it.

    No, their is a direct comparison. Thousands of years in evolution produced these genes ... not Myriad. And i specifically said that naturally occurring, and even bio-similar molecules, should be sold as patentable formulations.

    randallmayes
    You are saying things that indicate you do not understand the case. There were specifics debated. There were three judges and Myriad does not own genes. To my knowledge there is no collusion and scientists sequence BRCA genes everyday despite your accusation. Under the law, molecules are patentable. The courts said Congress is the one that would have to change the law in Section 101 of the code.
    Randall Mayes
    The conditions of BRCA patent require that the only laboratories legally allowed to test and sequence the genes are ones affiliated with Myriad. This exclusive control over BRCA testing has hindered peer-review0. Please, show me how peer-review is not at the heart of the scientific method?

    Under the law, molecules are patentable if and only if they are atleast semi-synthetic. A copy of someones gene, in my mind, is a natural product which under the right circumstance can occur invivo.

    randallmayes
    I do not need to do anything my side is winning the legal battle.

    Myriad does not need to do anything. They legally obtained a patent and arguably created the greatest success in personalized medicine ( and were rewarded based on market demand).

    Regarding peer review, what does this have to do with this particular lawsuit? They have a temporary legal monopoly like other pharma companies do. Mono means one. This is a generic FDA issue. Under Bayh-Dole, the government can March-In, in the cases where researchers received public money, if they feel that a drug company is not serving the public well and rectify the situation (which they chose not to do). It appears activists haven't articulated a coherent argument to the FDA worth pursuing. Perhaps it's you that needs to do something.
    Randall Mayes
    "They legally obtained a patent and arguably created the greatest success in personalized medicine ( and were rewarded based on market demand)."

    Man, you're just a straight up shill.

    "Regarding peer review, what does this have to do with this particular lawsuit? "
    It has everything to do with this issue, you pompous ... Jesus, you must not speak with many oncologists.

    Isolated genes are always completely synthetic unless diretly taken from a chromosome which may even count as semi-synthetic.

    Under what circumstance do isolated genes occur invivo?

    randallmayes
    I'm not sure how this relates to the legal battle.

    I assume never since regulatory DNA is needed.
    Randall Mayes
    I was using synthetic as meaning ... not-occurring in nature. The gene in question occurs in nature, not really sure what right Myriad thinks they have to claim that it's theirs. Additionally, truncated DNA and RNA fragments are produced invivo all the time.

    randallmayes
    The patent is on a "molecule" with a slighly different chemistry that happens to be a gene .

    I did not get the memo that someone determined that a patented product doesn't exist in nature.
    For example insulin and EPO exist in nature and were patented. Does the law say this or does Michael White?
    Randall Mayes
    Yes, I know what a molecule is. And i know that this gene your speaking of is naturally occuring.

    i'm sorry crazy dude, I have no idea who Michael White is. Additionally, I plainly said that I think insulin should be sold as generic formulations.

    "I did not get the memo that someone determined that a patented product doesn't exist in nature."

    You can't patent things which are naturally occurring. Otherwise, you could patent things like trees, the sky, the moon.

    "( and were rewarded based on market demand)."

    By market demand, you must be callously referring to the ~250,000 new cases of invasive breast cancer in the US per year. It's great to know that when these people are at rock bottom, all your company can think about is their bottom line. All of this is fundamentally opposed to furthering research, which would imply making the disease model public, so that researchers could openly collaborate and review each others work.

    randallmayes
    I can not keep all the anonymous posters straight. I assume that Mike is the Michael White who posted the related links that appear right before the comments. Crazy or resourceful?
    Randall Mayes
    I sticking with crazy.

    No, not Micheal White. Must be a different poster/person?

    randallmayes
    Why am I crazy?
    Randall Mayes
    Because you have to ask?

    But don't take it personally, it's more a turn of phrase.