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. Bron,

    “So you take some cells from an individual and mix them with the synthetic Myriad DNA and that DNA attaches to the BRCA genes and then they are easily identifiable. That is a phenomenal advancement and should be given a patent to protect their intellectual work.”

    Whose cells were used in the research? You “mix” cells with DNA? How is that done?

  2. P Smith,
    In response to your rainwater comment. Recall Gandhi broke the law by making salt. Put seawater in a shallow pan, let the hot sun do its thing evaporating the water, and you have salt. But that was illegal. The government wanted citizens to BUY salt, when there was an ocean full of it right on their doorstep.

  3. #2 FYI

    The UofU Technology Commercialization Office page is a great page to explore and is probably a template for university research commercialization as it is practiced in most universities. Below is the link to their start-up success page, that’s interesting reading as is their Faculty, Startups, Students and Partners pages (in the right hand box). Federal money, from NIH and programs (interest-free and you don’t have to pay the money back- it’s a grant more than a loan) to funnel federal money into start-ups to commercialize research success’ is touted, encouraged, explained and e-forms for filing requests are available.

    http://www.tco.utah.edu/

    The Office of Sponsered Projects is a page that discusses the NIH grants but that’s a ink too far for WordPress, the h thing osp dot utah dot edu forward slash will get you there.
    **
    U of U commercialization successes (Myriad is there along with other names you might know.)

    http://www.tco.utah.edu/tco/successes.php

  4. #1
    A couple of points that are overlooked in the debate:

    From Genomics Law Report (r) / A publication of the law firm Robinson Bradshaw & Hinson

    “By now everyone has heard of the ACLU-instigated suit against Myriad’s patents on the breast cancer susceptibility genes BRCA1 and BRCA2. …. These patents emerged from research at the University of Utah and were assigned to Myriad, a private spinoff.” (my emphasis)

    http://www.genomicslawreport.com/index.php/2009/06/04/aclu-v-myriad-genetics-suit-legitimate-challenge-or-publicity-stunt/

    Also;

    From Congressional Research Service, Federal Support for Academic Research
    Christine M. Matthews, Specialist in Science and Technology Policy, Oct. 2012:

    “Historically, the federal government has been the primary source of funding for basic research at
    colleges and universities. In FY2008, the federal government provided approximately 60% of an
    estimated $51.9 billion of R&D funds expended by academic institutions.31 In current dollars,
    federal support for academic research increased by 2.5% between FY2007 and FY2008. When
    inflation is taken into account, federal funding increased 0.2% from FY2007 to FY2008
    following two years of decline in constant dollars since FY2005.” ….

    “There has been an increase in the patenting and licensing by the academic sector as a result of their research. According to the NSF, one factor in this increase was the enactment of the Bayh-Dole Act, 1980, which allowed institutions to retain title to inventions as a result of federal
    research support.27 Patenting by academic institutions is highly concentrated among a select number of colleges and universities. NSF reports that the number of patents received by academic institutions ranged from 2,950 to 3,700 for the period 1998-2008.28 Two hundred academic research institutions, less than 10% of the total number of institutions that received patents from 1998-2008, accounted for 96% of all patents awarded to academic institutions. Nineteen institutions alone received more than half of all patents awarded. NSF reports that patent activity differed by field of science. Of those patents awarded, approximately half were granted in the areas of biotechnology, chemicals, and pharmaceuticals.”

    http://www.fas.org/sgp/crs/misc/R41895.pdf

    ******************

    If there is one thing the debate over big-pharma revealed it is that public money in large amounts fund the majority of research into new medicines, not reworkings of old medicines as a ploy to extend by innovation existing patents, but new medicines. Tax dollars go to industry labs, university labs and hospitals for research. When something new and potentially profitable is turned up in research funded in whole or part by tax dollars there are patent opportunities for the researchers. I read a few years ago that patents were assigned based on the level of salient work and as a means of keeping all relevant players in a particular research endeavor profitable. How that works exactly I don’t know and it wasn’t explained in the brief reference I read.

    The first quote in this comment indicates that Myriad is a private spin-off to capitalize on the research performed by University of Utah. I have not been able to find out by searching (My fault probably, I’m asking the question with the wrong search terms no doubt.) if this particular program got federal funds but I’m betting that it did, nor in what amount. I’m wondering how much of the research that made this diagnostic breakthrough possible was funded by taxpayers? More broadly and even if this particular breakthrough was not at all funded with some measure of taxpayer funds (unlikely IMO) how can decades long protection be morally granted to any corporation or legal entity for advances in medicine or science funded at even a small percentage by taxpayer funds? I think there’s something wrong with a patent system that does that.

  5. Elaine:

    Myriad says it isnt a human gene they patented but a synthetic DNA sequence they developed to identify the BRCA gene.

    It seems to me they did nothing more than develop a “stain” to mark the gene they are looking for to make it easier to identify.

    So you take some cells from an individual and mix them with the synthetic Myriad DNA and that DNA attaches to the BRCA genes and then they are easily identifiable. That is a phenomenal advancement and should be given a patent to protect their intellectual work.

    From what I can tell Myriad did not patent a human gene but a synthetic gene they use as a diagnostic tool. It is nothing more than the equivalent of a thermometer. Of course you cannot patent the sun but you can patent a process to change sunlight to electricity or to heat water to run a steam turbine.

  6. Elaine,
    that was a great video of Jonas Salk. I think he could have run for President and won. He was that popular. My brother had a mild case of polio when he was young, but he was able to over come it. My cousin is still in braces today from her case of it.

  7. Attempting to own people (or parts there of) has in the past been called slavery. Your US constitution has something to say about slavery in its 13th amendment.

  8. HumpinDog, that’s because your sperm is not patentable; it’s just a design change.

  9. Nobody should be able to wrangle a patent out of the government over a pair of jeans. The next thing would be some kedds wanting to put a patent on some dumb looking tennis shoes.

  10. I want to obtain a patent on my sperm. I sent a sample into the patent office and they sent it back with a crude note. I told em my name was Gene Egghead.

  11. For those who do not know the procedural history of the case:

    Myriad Genetics, Inc. and the Directors of the University of Utah Research Foundation (collectively, “Myriad”) appeal from the decision of the United States District Court for the Southern District of New York holding that an assortment of medical organizations, researchers,
    genetic counselors, and patients (collectively, “Plaintiffs”) have standing under the Declaratory Judgment Act to challenge Myriad’s patents. Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 669 F. Supp. 2d 365 (S.D.N.Y. 2009) (“DJ Op.”). Myriad also appeals from the district court’s decision granting summary judgment that all of the challenged claims are drawn to non-patentable subject matter under 35 U.S.C. § 101. Ass’n for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F. Supp. 2d 181 (S.D.N.Y. 2010) (“SJ Op.”). We affirm in part and reverse in part.

    This appeal has returned to us as, a petition for certiorari having been filed from our decision of July 29, 2011, the Supreme Court of the United States granted the petition, vacated our decision, and remanded the case to us for further consideration in light of its decision in Mayo Collaborative Services v. Prometheus, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012). Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 132 S. Ct. 1794 (2012). We invited and received briefing by the parties and interested amici and held oral argument on July 20, 2012. Our decision on remand follows. It both decides the issues that were before us in the original appeal and evaluates the effect of Mayo on those issues.

    On the threshold issue of jurisdiction, we affirm the district court’s decision to exercise declaratory judgment jurisdiction because we conclude that at least one plaintiff, Dr. Harry Ostrer, has standing to challenge the validity of Myriad’s patents. On the merits, we reverse the district court’s decision that Myriad’s composition claims to “isolated” DNA molecules cover patent-ineligible products of nature under § 101 because each of the claimed molecules represents a nonnaturally occurring composition of matter. We also reverse the district court’s decision that Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates of
    transformed cells is directed to a patent-ineligible scientific principle. We affirm the court’s decision, however, that Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible; such claims include no transformative steps and cover only patent-ineligible abstract, mental steps.

    (Molecular Pathology v. Myriad Genetics, Inc.). This is the second time this case has been before the supremes following their vacation of the judgment of The Federal Circuit earlier, and remand to The Federal Circuit in light of Mayo.

    The Federal District Court had held the patents invalid, but The Federal Circuit reversed for the most part, and the supremes granted the writ.

    Tomorrow oral argument takes place.

  12. Should Monsanto and Myriad Be Allowed to Patent Life?
    Written by Heather Kathryn Ross
    Published on February 22, 2013
    http://www.healthline.com/health-news/policy-monsanto-myriad-patenting-life-022213

    Excerpt:
    Patents exist to protect inventors (and their investors) from those who would steal their idea for, say, a new cell phone charger and manufacture a cheap knock-off. But what happens when companies patent genes?

    The longest running spat over gene patenting may be between agribusiness giant Monsanto and organic farmers. Monsanto, DuPont, and Syngenta together hold 53 percent of the commercial seed market worldwide, and Monsanto’s genetically modified “Round-up Ready” seeds are the norm on industrial-scale farms.

    Monsanto says that because the company invested a great deal of time and money genetically engineering a seed that is resistant to its weed-killer, Round-up. Because it can produce more food per acre of land, Monsanto says they have the right to patent that seed. The problem is that seeds grow into plants, which create more seeds with the same patented genetic makeup.

    So, Monsanto asserts that even if a farmer pays for Round-up Ready seeds, if he or she saves seeds from that crop to plant the following year without paying Monsanto again for the rights, it amounts to a crime. The company is suing 75-year-old Indiana farmer Vernon Hugh Bowman for buying and planting such second-hand seeds.

    The U.S. Supreme Court is currently hearing arguments from both parties, but is widely expected to side Monsanto.

    “Why in the world,” Chief Justice John G. Roberts Jr. asked, “would anybody spend any money to try to improve the seed if as soon as they sold the first one anybody could grow more and have as many of those seeds as they want?”…

    *

    Myriad Genetics, the company who owns the patent on BRCA1, says that about seven percent of breast cancer cases and 15 percent of ovarian cancer cases are caused by mutations on the BRCA1 or BRCA2 gene (Myriad also owns a patent on BRCA2). According to Myriad, patients with BRCA mutations have “risks of up to 87 percent for breast cancer and up to 44 percent for ovarian cancer by age 70.”

    Women, especially of Ashkenazi Jewish descent, whose close relatives were diagnosed with breast or ovarian cancer before age 50 are often urged to undergo genetic testing for these mutations. By restricting who can test for BRCA mutations, patient advocates worry that women who qualify will not receive the test, and the personalized preventative care they may need.

    Myriad countered that argument by saying they should be allowed to protect the product of techniques they’ve spent millions of dollars to develop. For now, Myriad Genetics is not enforcing their patent protections on BRCA1 and 2, but the U.S. Supreme Court will hear arguments from both sides on April 15.

  13. Gene patent case could impact patients, research
    Promising personalized medicine field could be limited by gene patents
    By Meredith Cohn
    The Baltimore Sun
    September 22, 2012
    http://articles.baltimoresun.com/2012-09-22/health/bs-hs-brca-patents-20120922_1_myriad-genetics-patents-brca

    Excerpt:
    Every time a woman is tested for gene mutations linked to significantly higher rates of breast and ovarian cancer, her blood is sent to a lab in Utah.

    That’s because Salt Lake City-based Myriad Genetics Inc. owns the patents to the BRCA 1 and BRCA 2 mutations, giving it control over all research and testing done nationwide. The company charges thousands of dollars for each set of results.

    The patents have become the subject of a legal fight that could soon head to the U.S. Supreme Court and have sparked a broader discussion about the fast-evolving field of genomics and so-called personalized medicine, in which treatments are tailored based on a patient’s genetic makeup.

    Scientists, lawyers and bioethicists say the outcome of the legal and ethical debate could impact research and patient care.

    Civil libertarians and patent opponents object to companies claiming they have invented what nature has wrought and contend that such patents hinder life-saving research. Corporate patent owners say their scientific ingenuity is needed to isolate the genes and that research could stall without the protection of patents.

    “If I want to look at the data in my genome from the computer in my basement or wherever, I should be able to or my doctor should be able to tell me,” said Jeffrey Kahn, professor of bioethics and public policy at the Johns Hopkins University’s Berman Institute of Bioethics. “But the standard argument is that if we don’t respect patents, there will be less incentive to do research and development. There is a collision course coming.”

    The potential implications are staggering, given that what’s at stake is control over basic biological units of heredity.

    Corporations and scientists hold patents on 20 percent of the human genome and could limit what doctors study and share when it comes to protected gene sequences linked to Alzheimer’s disease, Huntington’s disease and colorectal cancer, among other illnesses. Patents give owners rights to the intellectual property for at least 17 to 20 years.

    The BRCA 1 and BRCA 2 mutations are responsible for most hereditary ovarian and breast cancers. Many women with the mutations take extreme preventive measures, such as breast and ovary removal. While hereditary versions of the disease are a small percentage of total cases, the mutations increase breast cancer risk by 82 percent and ovarian cancer risk by 44 percent.

    The American Civil Liberties Union originally brought a lawsuit against Myriad Genetics in 2009 on behalf of about 20 scientific organizations and patients, and a panel of the U.S. Court of Appeals for the Federal Circuit in Washington upheld the patents earlier this month — the second decision in the company’s favor. The Supreme Court had asked the court to reconsider its initial ruling last year.

    “No one is really enforcing their patents like Myriad, so this is really a landmark case,” said Joann A. Boughman, executive vice president of the American Society of Human Genetics, which was not a plaintiff but which does not support gene patents. She also said that BRCA is “probably the poster child for gene mutations because everyone knows someone with breast cancer and has had the test.”

  14. Association for Molecular Pathology v. Myriad Genetics
    April 12, 2013
    http://www.aclu.org/free-speech-technology-and-liberty-womens-rights/association-molecular-pathology-v-myriad-genetics

    Whether human genes can be patented.

    Excerpt:
    On May 12, 2009, the ACLU and the Public Patent Foundation (PUBPAT) filed a lawsuit charging that patents on two human genes associated with breast and ovarian cancer, BRCA1 and BRCA2, are unconstitutional and invalid. On November 30, 2012, the Supreme Court agreed to hear argument on the patentability of human genes. The Court will hear these arguments on April 15, 2013.

    On behalf of researchers, genetic counselors, women patients, cancer survivors, breast cancer and women’s health groups, and scientific associations representing 150,000 geneticists, pathologists, and laboratory professionals, we have argued that human genes cannot be patented because they are classic products of nature. The suit charges that the gene patents violate the First Amendment and stifle diagnostic testing and research that could lead to cures and that they limit women’s options regarding their medical care.

    The U.S. Patent and Trademark Office (PTO) has granted thousands of patents on human genes – in fact, about 20 percent of our genes are patented. A gene patent holder has the right to prevent anyone from studying, testing or even looking at a gene. As a result, scientific research and genetic testing has been delayed, limited or even shut down due to concerns about gene patents.

    *****

    Gene Patents
    Myles Jackson, Professor of the History of Science, NYU
    11/29/12
    http://www.huffingtonpost.com/myles-jackson/gene-patents_b_2214684.html

    Excerpt;
    When one thinks of patents, one generally thinks of mechanical contraptions, the products of a creative genius, such as Thomas Edison. Rarely does one think of human genes. Alas, since 1982 the United States Patent and Trademark Office has granted patents on human genes. As of 2005 nearly 20 percent of our circa 23,000 genes had been patented. Sixty-three percent of those patented genes are owned by private companies. “How can one patent my genes?” is a query I often hear when I offer lectures on the subject. Even university scientists have interrupted me to explain that natural products are not patentable. Other incredulous statements and queries quickly ensue. “Genes are not inventions, but discoveries.” “How can another person or entity ‘own’ my genes?” “Can I patent my own genes before someone else does?” Eventually, the conversation turns to issues of impact. “How does this affect scientific and medical research?” “Does gene patenting encourage innovative research?” “Does it influence the ‘objectivity’ of science, which [it is claimed] is free from commercial interest?” “Does it foster collaboration or thwart it by means of secrecy?” These questions are crucial ones. As for the answers: in many cases, the proverbial jury is still out.

    In one sense the patenting of genes is the next step in the continued commodification of biological entities. Throughout the twentieth century, purified hormones, vitamins, steroids, antibiotics, and asexually reproduced new varieties of plants (other than tuber-propagated plants) have all been patented. In other respects, gene patenting is actually something very different. First, since one cannot patent around a gene, as one can for example with a chemical, the patent holder can potentially stymie downstream research on diagnostics and therapeutics. Second, recent studies by bioethicists have demonstrated that those working in laboratories interested in patenting genes tend to be much more secretive about their research until after the patent is granted. In addition, a number of laboratories have ceased performed clinical genetic tests as a result of a patent of license. Hence, despite the historical purpose of patents — to render public the knowledge about what the invention is, how it is made, and what its best use is and to promote further research, gene patents can actually enhance secrecy and impede further research.

    The problems with gene patenting took center stage with the ACLU’s lawsuit against Myriad Genetics, The Association for Molecular Pathology, et al. vs. Myriad Genetics, et al. This Utah-based company owns the patents on two genes, BRCA 1 and 2, which code for tumor-suppressing proteins. Mutations in these genes can result in the proteins’ inability to interact with cancer cells, thereby increasing the chance of developing breast cancer. Myriad Genetics also own the patents on all possible mutations of those two genes and on the test for the mutations. Myriad does not permit any biomedical researchers to perform full sequencing testing on those genes. Indeed, the company has sent cease-and-desist letters a number of U.S. laboratories to prevent scientists from offering BRCA testing. It is impossible to get an outside verification of the results. The test can be rather expensive, over $3,000. Many American women cannot afford such a fee, and their insurance might not cover it.

  15. yes I am aware that I am posting from the companies website but that at least gives a person a place to start to determine if they are telling the truth or the Prof is or if the truth is somewhere between.

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