From Creator To Object: The Supreme Court To Consider Patent Claim To Human Genes

The U.S. Supreme Court
The U.S. Supreme Court
DNA_orbit_animated_static_thumbBelow is my column this week in USA Today (the print version will run Wednesday while the web-version ran today). 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. The impetus of the piece is the Myriad case to be heard on Monday, where the Supreme Court will have to decide whether a company can patent human genes. The company argues that it took considerable research to isolate the genes associated with breast cancer and that patent protection gives companies like Myriad to do such extensive research and development. For many others, the patent claim represents a virtual franchising of the human body – giving companies claim to something that exists in nature. It also gives these companies a critical gatekeeper control on research into key components of cancer, Alzheimer’s disease, asthma, and other health threats. While this column deals with statutory expansions of private property claims over genes, common phrases and images, there is an equal expansion occurring in the common law, including the “misappropriation of name or likeness.” Perhaps the most infamous such authority can be found in the case of White v. Samsung. In this case, Vanna White sued Samsung over a commercial that showed a robot with a blonde wig turning cards in a game show. It was an obvious parody but the federal court found the image of a blonde who did nothing but smile and turn large cards belongs exclusively to White.

This column is meant to show that there is a broader problem in the rush to claim common material, images, and terms. Perhaps it was inevitable that with the ever expanding patent, copyright, and trademark laws, mankind itself would become a form of property: the ultimate evolution from creator to object.

This week, the Supreme Court will consider whether a company can claim ownership of two human genes under a patent. Myriad Genetics currently holds a patent to two genes associated with breast cancer. The case challenges the long-held position of Congress that people can patent “anything under the sun that is made by man.” The case raises significant moral and legal issues as companies claim parts of the human genome as their property. Currently twenty percent of your genes are now claimed as private property. This case is part of an overall trend of claims over virtually every basic term, symbol, and now human genes under the sun. Human existence is being privatized to the point that a creative existence seems to require the consent of a new class of property overloads.

While Myriad Genetics argues that is only seeking to reap the rewards of its extensive research and development, others view its claim as a virtual franchising of the human body. The Myriad case raises fundamental questions on the meaning of property, including the treatment of the human genome as akin to a Hoover vacuum. Jonas Salk, the developer of the polio vaccine, was once asked if he owned the patent on this valuable vaccine. Salk famously replied in disbelief by asking “Could you patent the sun?” He said such things must belong “to the people.”

Today, most things under the sun (including images of the sun) seem claimed by patent, copyright, or trademark holders. Apple Computers even sued a grocery chain for using an apple as its symbol. While God may have created the apple, he failed to trademark it.

It has triggered a type of land rush as everyone grabs objects, expressions, and names like settlers carving up free land. This year, the Prince George’s County Board of Education moved to claim copyright to work created by staff and students that would include everything from a teacher’s lesson plan to a toddler’s finger painting project. Then there is Robert and Diane Maresca of Long Island who claimed “Occupy Wall Street” as a trademark as soon as the protest began. They were not part of the protests, mind you. They just wanted to make money off it and Robert Maresca insisted “if I didn’t buy it and use it, someone else will.”

Other terms from “Linsanity” to “Who Dat?” to the word “Yuuup” have been claimed. This often results in fights over the spoils of common terms. Last year, Roy Fox secured a copyright to the term “Harbowl” last year to make money off a Superbowl between the Baltimore Ravens coach John Harbaugh and San Francisco 49ers coach Jim Harbaugh. He was then muscled out by NFL lawyers insisting that no one can use the term “Bowl” but them.

As terms and images are grabbed in this mad rush, the laws have become the very inverse of their intended use. Rather than protecting inventions to encourage and reward creativity, these laws now restrict creative thought and invention with layers copyright, trademark, and patent claims. Interestingly, citizens find themselves traveling through a world where everything they see has a TM or © sign to signify the owner of items and expressions around them. The Susan G. Komen charity fund has repeatedly threatened lawsuits against other charities seeking to raise money with the words “for the cure.”

The Obama Administration has been criticized for yielding to the demands of lobbyists for higher and higher penalties, including criminal penalties, over such infringements. The Administration recently intervened in the Supreme Court to defend the ruinous fine of $222,000 imposed on a young Minnesota mother for sharing 24 songs. The Court refused to review a $675,000 fine against former college student Joel Tenenbaum for downloading and sharing 30 songs.

We have come a long way from men like Salk who viewed most things as properly owned in common by the people. It was only a matter of time that with people claiming everything under the Sun, they would soon direct their interest to people themselves as a type of chattel to be claimed. As the Supreme Court deliberates over the very ownership of our genes, there has never been a national debate over the commoditization of American life. If we do not want to live by the leave of a new property class, we have fight for our rights. Just be careful in how you say it. “Fight for your rights” is trademarked.

Jonathan Turley is the Shapiro Professor of Public Interest Law at George Washington University and a member of USA TODAY’s board of contributors.

68 thoughts on “From Creator To Object: The Supreme Court To Consider Patent Claim To Human Genes”

  1. the wright brothers in some ways put the US behind in early aviation. we entered ww1 with almost no aircraft or aircraft industry because the wright brothers claimed to own the idea of controlling aircraft roll.

    http://en.wikipedia.org/wiki/Wright_brothers_patent_war

    the best we could do at the start of ww1 was to build an aircraft engine that was too powerful to use in existing aircraft.

    http://en.wikipedia.org/wiki/Liberty_engine

    they worked great for prohibition rumrunners on the great lakes though.

  2. And now a word from our sponsor (in the year 2059)

    Parents, do you wish to have the perfect child, one with perfect intelligence and the looks of a model? Synthesize your child at your local Chrome-a-zone(R) Genetics Solution Center (TM) where we offer our patented system of augmentations and most importantly we deliver your baby. After all who has time in this busy world, who has time to gestate your next baby? Step up in the world to Chrome-a-Zone, you’ve come a long way BABY!.

    (Plans start at $117,000 and does not include augmentation tax. While we our professionals work hard to ensure the most healthy genetic sequence, we are not responsible for replication errors. A bio-mechanic’s lien will be placed on children for all accounts 90 days over due.)

  3. Bron, They are shading the truth to the point that it is a different color entirely. It is a replica of the gene without the attendant detritus and/or surrounding material inherent in the original, naturally occurring gene in your body. They are telling the truth that their product is not something that occurs in nature- in nature the gene is not separated from its matrix- matrix for lack of a more precise word. But the isolated replica is the gene, it is a bit of DNA with the same recipe, the same amino acids arranged exactly the same as occurs in the human body. What they are saying in their site is their argument for why it is patentable, they are not going to be inconsistent between their argument and their description. LOL, where is a scientist when you need one?

  4. Utah company Myriad’s gene patents go before Supreme Court
    Lawsuit » Sides with plenty at stake will argue whether Myriad Genetics can maintain control of cancer tests.
    By Tom Harvey
    The Salt Lake Tribune
    First Published Apr 12 2013
    http://www.sltrib.com/sltrib/money/56143620-79/myriad-genes-patents-court.html.csp

    Excerpt:
    Myriad argues that it is not patenting a gene from a human body but rather from chemicals isolated from the body that are substantially different from those that reside in specific places on the human genome.

    “What we actually created was the sequences for the BRCA1 and 2 genes,” said Capone. “It was created because these don’t exist in nature. They don’t exist in the human body as a separate chemical molecule.”

    Without that separation from the body, the genes could not be tested for mutations, said Richard Marsh, the company’s executive vice president and general counsel.

    “This new chemical entity, not found in nature, has very significant and important new utilities which cannot be accomplished with genomic DNA,” said Marsh.

    But the ACLU, which filed the lawsuit on behalf of cancer patients, medical groups, researchers and women’s health advocates, argues that the isolated genes remain substantially the same as if they still resided in their natural place in the body.

    “Removing the genes from the cell does not create an invention,” said Sandra Park, ACLU co-counsel on the case. “The gene still remains a product of nature, and its connection to disease is a law of nature.”

    The ACLU also is bringing the weight of Joseph Stiglitz, a professor at Columbia University and recipient of the Nobel Prize in economics, to bear on Myriad. Specifically, the advocacy group and Stiglitz are challenging the contention that without patent protection there would not be so much money poured into genetic research, making fewer tests and treatments available. In a conference call earlier this week arranged by the ACLU, Stiglitz said research has shown gene patents hinder innovation and research.

    “The evidence is overwhelming … that these kinds of patents on genes actually are impeding further research into this area,” he said.

    Stiglitz was backed by Ellen T. Matloff, the director of genetic counseling at the Yale Cancer Center, said the patent has meant that Myriad also has been able to prohibit others — such as her center — from offering tests, even when they covered areas beyond those of Myriad’s products.

    “The patents that Myriad Genetics holds have allowed them to have this exclusive monopoly,” she said. “No one else can do testing; no one else can compete; no one else can offer a more comprehensive test.”

  5. Elaine:

    this is what they said:

    “These man-made copies, called “isolated DNA,” are unique chemical compositions not found in nature or the human body.”

    From what they are saying they are not the gene in question. A copy would have the same chemical composition, they are saying it doesnt and that it isnt found in nature. Some one isnt telling the full story. It sounds like the word copy is the problem. But how do you make a copy of a gene if it doesnt have the same chemical composition? Would mimic be a better word?

    Both sides have a monetary incentive and Myriad has already said this:

    “No one can patent anyone’s genes. Genes consist of DNA that is naturally occurring in a person’s body and as products of nature are not patentable.”

    I agree with that statement as well. If you think about it, Myriad has a vested interest in not having human gene patents, it makes their work harder as well and possibly more expensive.

  6. Myriad Genetics CEO Claims He Owns Your Genes
    By Steven Salzberg
    4/13/13
    http://www.forbes.com/sites/stevensalzberg/2013/04/13/myriad-genetics-ceo-owns-your-genes/

    Excerpt:
    With the Supreme Court about to hear a landmark case on gene patents, Myriad Genetics, the company that owns the patents under scrutiny, is going on the offensive. I’ve written about this case before, when the patents were first thrown out by one court, and then restored by another. Now the Supremes will have the final say.

    Just last week, geneticists Jeffrey Rosenfeld and Chris Mason wrote a commentary for the Washington Post that warned about the consequences of companies owning the rights to our gene sequences.

    Today, in a letter filled with non sequiturs and distortions, Myriad Genetics’ CEO Peter Meldrum, worried about whether his company will be able to maintain their monopoly on a test for which they charge $4000, responded. Let’s look at his claims.

    First, though, let me remind readers that the genes in question, BRCA1 and BRCA2, are linked to an increased risk of breast and ovarian cancer, a risk that was first discovered in 1994 by scientists at the University of Utah. Myriad Genetics owns a patent on these genes, and as I wrote last year:

    “Thanks to these patents, you can’t look these genes in your own body without paying a fee to Myriad. Sounds ridiculous, right? Well, that was the state of gene patents until last May [2011], when judge Robert Sweet ruled that the Myriad’s patents were invalid.”

    Myriad appealed the decision, and the appeals court overturned Judge Sweet, buying into the argument by Myriad’s lawyers that “isolated DNA” is not the same as the natural DNA, and that this distinction allows companies to patent it. This is scientific nonsense for many reasons: for one thing, the process of isolating DNA does not create an artificial molecule. The body’s own cells isolate DNA all the time, in the process of turning it into proteins. But the appeals court accepted the argument, so now the Supreme Court will re-examine this scientifically ridiculous claim.

    Now let’s look at CEO Meldrum’s letter. He first claims that Myriad’s patents

    “were essential to developing diagnostic tools that have been used by more than 1 million women to understand their hereditary risks of breast cancer and ovarian cancer.”

    This claim is simply false. Myriad’s patents made no contribution at all (and certainly weren’t “essential”) to the diagnostic tools used to detect mutations. I know something about these tools, which I’ve been using in my own research for over 15 years. Furthermore, academic medical centers were offering their own diagnostic tests on the BRCA genes, at a lower cost than Myriad, until Myriad’s lawyers forced them to stop. So Myriad’s patents have increased costs to patients and, if anything, slowed down progress on making the tests faster and cheaper.

  7. Myriad reasons to block gene patents: Our view
    USA Today Editorial Board
    4/14/13
    http://www.usatoday.com/story/opinion/2013/04/14/genes-patent-supreme-court-editorials-debates/2082565/

    James Watson, the scientist who won the Nobel Prize for co-discovering the double helix structure of human DNA in 1953, was once asked whether he would patent his find. “Out of the question,” he replied. And when Jonas Salk’s polio vaccine electrified the nation by passing its field trials in 1955, Salk said no to a similar question, asking, “Could you patent the sun?”

    That was a different era, when those who made remarkable discoveries that unlocked the secrets of the human body and promised immense benefit to mankind didn’t think first of how to make a buck.

    Since then, the mysteries of human genetics that Watson began to unravel in the 1950s have led to a gold rush, as companies and institutions race to patent elements of the human body in ways that seem perverse. Now there are so many patents on human genes that a study in the journal Genome Medicine says your doctor can’t look at 41% of the human genome without the permission of a patent holder because, in effect, those genes aren’t legally yours.

    This has profound implications for personalized medicine, in which doctors will prescribe individualized cures that could be vastly more effective because they target a person’s makeup. Many researchers, doctors and medical organizations fear that the proliferation of gene patents will limit those treatments because patent holders have locked down genes in ways that discourage research and kill competition.

    Monday, the Supreme Court will consider whether that makes sense, hearing arguments in a challenge to the company that holds the patents on the BRCA1 and BRCA2 genes. Mutations of those genes can reveal whether a woman has a dangerously high risk of developing breast or ovarian cancer.

    The law here seems simple, allowing patents for “anything under the sun that is made by man,” to quote a phrase from an earlier Supreme Court decision. But the question of what’s man-made is much harder.

    Myriad Genetics says its work in isolating the BRCA genes created something man-made and patentable. Myriad’s critics say — correctly, in our view — that’s like patenting elements in the periodic table or claiming that a kidney could be patented once it’s removed from the body for transplant.

    By locking up the BRCA genes and making its $3,340 test the only one doctors can use without the company’s permission, Myriad stifles independent scientific inquiry and the sort of competition that might produce better or cheaper tests. For example, when researchers developed a test to look at 20 genes that could cause breast or ovarian cancer, they had to exclude BRCA1 and BRCA2 because of Myriad’s patents.

    The gene patent also compromises patients’ ability to get a second opinion. Myriad grants permission to some labs to conduct “confirmatory tests,” but Ellen Matloff, director of cancer genetic counseling at the Yale School of Medicine, says the claim is misleading because labs like Yale’s can conduct only limited testing under the agreement with Myriad.

    Myriad says it spent hundreds of millions of dollars developing its test, and no one could reasonably object if the company patented only its test. But the gene patents go too far.

    Double-helix co-discoverer Watson, who at age 85 is still researching the link between cancer and genes, filed a brief in the case to argue against patenting genes. “Scientists should be permitted to experiment on human genes free from any threat of patent infringement,” he said. “Life’s instructions ought not be controlled by legal monopolies created at the whim of Congress or the courts.”

  8. Bron,

    The company isolated a human gene and copied it. Synthetic or not–it is still a copy of a real human gene. How can a copy of an human gene have a different composition from the real gene? Then, it wouldn’t be a copy of the human gene, would it?

  9. Elaine:

    this is what Myriad says:

    “No one can patent anyone’s genes. Genes consist of DNA that is naturally occurring in a person’s body and as products of nature are not patentable. In order to unravel the mysteries of what genes do, researchers have had to separate them from the rest of the DNA by producing man-made copies of only that portion of the gene that provides instructions for making proteins (only about 2% of the total DNA in your body). These man-made copies, called “isolated DNA,” are unique chemical compositions not found in nature or the human body.”

  10. Elaine:

    All I am saying is from the information available, I dont know if they developed something new or just put a new coat of paint on something. From what I can tell it sounds like they developed a synthetic DNA which they use to test for cancer.

    I dont think they are trying to patent an existing gene.

    Nothing you have posted leads me to believe otherwise.

  11. Bron, Not piling on here but it is also my understanding that the gene itself is patented- they first isolated it and the created an isolated replica. It is that replica that is used in all the tests and other applications. But, the replica is the gene.

    If you want a second opinion you an get one as your quote upthread shows but the gene, testing equipment and all attendant means are owned by Myriad so you are getting the same test using the same stuff and the same methodology. Its done by a handful of other labs essentially and no doubt those other labs/hospitals etc are licensed by Myriad. The Myriad site is disingenuous on that point.

    If I want a second opinion I want and independent opinion using different ‘stuff’, you can’t get that now. Without something to compare the testing materials against how does one know that the result is accurate, or as accurate as it could be? Might it be done more cheaply if competition was at work?

    In any event, if I too am misunderstanding the underlying basis of the patent I’d like to be pointed in the right direction.

  12. Human Gene Patentability Case Heads To Supreme Court
    By Sharon Begley
    Reuters
    Posted: 04/14/2013
    http://www.huffingtonpost.com/2013/04/14/human-gene-supreme-court_n_3081399.html

    Excerpt:
    NEW YORK, April 14 (Reuters) – Soon after learning that his son had autism, Hollywood producer Jon Shestack (“Air Force One”) tried to get researchers investigating the genetic causes of the disorder to pool their DNA samples, the better to identify genes most likely to cause that disorder. But his approach to scientists at universities across the country in the late 1990s hit a brick wall: They refused to join forces, much less share the DNA.

    “Each thought they needed to hold on to it to publish and patent,” Shestack said in an interview. “This seemed criminal to us.”

    The U.S. Patent and Trademark Office has granted patents on at least 4,000 human genes to companies, universities and others that have discovered and decoded them. Patents now cover some 40 percent of the human genome, according to a scientific study led by Christopher Mason of Weill Cornell Medical College. But if foes of gene patents have their way, that percentage could be rolled back to zero.

    On Monday, the U.S. Supreme Court will hear oral arguments in a case that calls into question whether human DNA can be claimed as intellectual property, and remain off limits to everyone without the permission of the patent holder.

    The lawsuit, filed in 2009 by the American Civil Liberties Union and the Public Patent Foundation, challenges seven patents held by Myriad Genetics Inc on two human genes linked to breast and ovarian cancer. A federal judge said the patents were invalid. An appeals court overruled that decision, and the case landed in the Supreme Court.

    The legal issues center on whether the genes that Myriad patented, called BRCA1 and BRCA2, are natural phenomena. The ACLU says human DNA is a product of nature, and as such not patentable under the Patent Act. Myriad argues that its patents are for genes that have been “isolated,” which makes them products of human ingenuity and, therefore, patentable.

    As scholars debate the legal questions, two parallel issues have emerged: whether patenting genes thwarts scientific research, and whether it harms patients.

  13. Bron,

    I know about DNA. I studied genetics in college.

    Myriad holds patents on human genes–not DNA. Did you read what I posted in my comment at 5:36 pm?

  14. Elaine:

    there are 4 molecules which make up human DNA:
    Adenine, Thymine, Guanine, and Cytosine.

    If I understand correctly, they manipulated some combination of those 4 molecules which created the synthetic DNA they are using for their tests.

    If they are actually seeking a patent for human DNA, I agree with you and others but that isnt, at least if I understand this correctly, what they are doing.

    I cannot patent the sun but if I could create the power of the sun and confine it in a chamber I can surely patent the process and or the machine itself.

  15. “The genes aren’t synthetic. The company isolated them. They hold patents on genes they isolated.”

    ++youch.

    Q. What happens, upon patenting, say, all isotopes of Carbon, and there is literally nothing left to monetize? Or is the Proton and Neutron market heating up, and I missed that tip sheet?

    It is widely suspected Ungoliant ate herself.

  16. Bron,

    Association for Molecular Pathology, et al. v. Myriad Genetics, Inc.
    http://www.law.cornell.edu/supct/cert/12-398

    in GENES INVENTIONS PATENT PATENTABLE SUBJECT MATTER PRODUCTS OF NATURE

    Oral argument: April 15, 2013

    Court below: United States Court of Appeals for the Federal Circuit

    Myriad Genetics first identified and isolated the BRCA1 and BRCA2 genes responsible for diagnosing an elevated risk of breast and ovarian cancer. Myriad claims patents on the isolated BRCA genes along with cDNA, which is a synthetic product that mirrors the coding sections of the BRCA genes, and “primers” used in diagnostics. The Patent Act defines the scope of patentable subject-matter in 35 U.S.C. § 101; however, the Supreme Court has consistently held that laws of nature, abstract ideas, and natural phenomenon cannot be patented. Myriad claims that the isolated and modified genes that they hold patents for never occur in nature, and subsequently are patentable subject-matter. Conversely, the Association for Molecular Pathologists contends that Myriad only isolated, and did not modify, a gene already existing in nature and that this isolated gene performs a similar function as the gene in natural form. The district court held that naturally-occurring genes were not patentable subject-matter, but the Federal Circuit court reversed. How the Supreme Court decides this case will greatly impact the scope of patentable subject-matter. A narrowing or a broadening of current subject-matter eligibility will have significant effects on the incentives for inventors as well as what information is available for and usable by the general public.

    *****

    The genes aren’t synthetic. The company isolated them. They hold patents on genes they isolated.

Comments are closed.