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. Thou Shall Have No Other God Before Pharmacology…..except for insurance companies if they get there first….

  2. Jonathan,

    This is such an important article because the issue mostly flied under the radar of the public and the media. The entire notion of patents and copy-write from a legal standpoint has to be re-thought or we will all become corporate chattel. That it is now being criminalized makes it eve more ominous.

  3. Let’s say they are just insane enough to agree that a company can own the patent to a human gene. Strictly from a legal sense, how would that play out if say the European courts have a different opinion?

    Would you legal professionals please provide us lay folks with some info on how these things are handled currently?

    I am sure there are patent issues in other areas where our “rules” are different than theirs.

  4. Trying to copyright genes is like trying to copyright sunshine. These things exist naturally and ownership cannot be claimed. If someone tried to patent a new antibiotic, sure, because that required discovery of chemical processes to make it. But only an idiot would claim a patent on all the world’s willow trees to try and corner the world’s aspirin market.

    What sort of idiots and jerks would attempt to claim ownership of something they didn’t create or invent, to claim ownership of something that naturally occurs? Large corporations, that’s what sort of idiots and jerks. In 2000 in Bolivia, Bechtel and other companies tried to criminalize the collection of rainwater for the purpose of drinking it. I’m not kidding, look it up.

    What sort of idiot and jerk judge would even hear such a case? A corrupt one, no doubt. This claim should have been thrown out upon filing, never mind going to trial.

  5. The evolution of information technology has overtaken the old world of patents, trademarks, and copyrights. Before long, they will become utterly unenforceable. The FBI would need hundreds of thousands of agents just to post take-down notices, and only then for the material under their jurisdiction.

    For all practical purposes, this has already happened to software, books, music, and movies. There is virtually no restrictions to what you can download if you want it. The hosts that carry them have long ago diversified beyond any warrant. See: King Dot Com.

    These laws serve only the worst in us.

  6. Question for genetic science: A WHOLE gene?!? That’s a lot of information! How many alleles must occur during transcription before it’s not the “same gene” any more? How do you account for the VAST variation among individuals? Are they also copyrighting the “junk sequences” in between? Turns out they aren’t junk after all, but let’s not let evolution, which will eventually make a mockery of any “permanent” gene sequence, get in the way.

    This is a seriously stupid idea that is utterly unenforceable, particularly given our stone knives and cat gut sutures approach, which is where are in comparison to that which must yet be known of genetics to even BEGIN to have this discussion.

    This idea seems to fail on multiple levels.

  7. 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.”

    Well said Mr. Turley.

    This case must have been filed a long time ago.

    Perhaps even before the discoveries that some 98% of “human genes” are actually microbial, and only about 2% are purely human.

    Thus, the case may be about copyrighting genes that are billions of years old by calling them “human” when technically they originated before humans did.

    Here is a female colleague of yours (in the sense of being a professor) explaining some of it in an enjoyable TED talk:

  8. About the case of Henrietta Lacks:

    A New Chapter In The Story Of Henrietta Lacks
    http://www.npr.org/2013/03/26/175335268/immortal-life-of-henrietta-lacks

    Excerpt:
    Henrietta Lacks was an African American tobacco farmer and mother of five. She died in 1951, but her cells were kept and studied by scientists without the knowledge of her family. The cells have been genetically sequenced once again without consent. Renee Montagne talks to Rebecca Skloot, the author of The Immortal Life of Henrietta Lacks, about an Op-Ed she wrote in Sunday’s New York Times examining this development.

    *****
    DAVID GREENE, HOST:

    This is MORNING EDITION from NPR News. I’m David Greene.

    RENEE MONTAGNE, HOST:

    And I’m Renee Montagne. There’s a new chapter in the story of Henrietta Lacks. That name has come to be widely known, mainly because Lacks was the subject of the best-selling book “The Immortal Life of Henrietta Lacks.” Here’s author Rebecca Skloot.

    REBECCA SKLOOT: Henrietta Lacks was a poor black tobacco farmer who grew up in southern Virginia and in 1951 she was diagnosed with cervical cancer. And she went to the doctor and, without telling her, her doctor just took a little piece of her tumor and put that in a dish.

    MONTAGNE: Henrietta Lacks died soon after, but her cells did not. They kept growing and reproducing. It was a huge breakthrough for medicine. Scientists have used those cells, named HeLa cells, to explore cloning, do cancer research, help develop the polio vaccine and much more. The problem?

    SKLOOT: She never knew the cells were live and her family didn’t find out about them until the ’70s so it’s been this long kind of legacy within the family of research without consent. And it had quite a few privacy violations along the way.

    MONTAGNE: Then last week another privacy violation to add to that list. Scientists announced they had sequenced the genome of HeLa cells and published the results on the Web, again without the family’s consent. Rebecca Skloot wrote about it in Sunday’s New York Times. She says the researchers who published the genetic information online claimed that no private medical information about Lacks or her descendants could come from the data.

    SKLOOT: But that’s actually not true and soon after this was published, a lot of scientists on Twitter started saying, whoa, wait a second. You know, yes, the cells have mutated but you can still find her genes in there. And to prove their point, some scientists actually took that genome and turned it into essentially a report on Henrietta and what her genes actually said. To illustrate, yes, you can find very specific information about her.

    MONTAGNE: Give us an example of what one might really be able to find out about Henrietta Lacks.

    SKLOOT: So a lot of people are familiar with companies like 23andMe, you know, where you can send in a little, you know, sample of your cheek cells and they’ll give you a whole report that says you have a risk factor that may mean you’re going to get Alzheimer’s. Or it may mean you are at an increased likelihood of X or Y. But then also normal traits like, you know, what color eyes do you have? What’s your hair color?

    So there’s a lot of specific stuff to health but also just to your personal sort of being.

    MONTAGNE: This family, her descendants, again, have just seen very key information about their genetics be revealed for all to see online. I gather that that is perfectly legal. What kind of privacy protections would you say should be out there?

    SKLOOT: There are a lot of big questions raised by this and people are still trying to figure it out. We have more questions than answers at this point. And one of the questions that comes up is can you hide the parts of this genome that are Henrietta and just do research on the parts that are more related to the cells. And the answer seems to be pretty clearly no.

    And then there’s also just questions of who do you consent? In the case of Henrietta Lacks, you know, she’s obviously gone. Does it go to the next of kin, just like their medical records would? And right now there’s just no clear regulations. There’s not really any clear agreement yet. But given what we know now, it’s very clear that our regulations aren’t covering the privacy questions that come up for people.

  9. The Immortal Life of Henrietta Lacks, the Sequel
    By REBECCA SKLOOT
    Published: March 23, 2013
    http://www.nytimes.com/2013/03/24/opinion/sunday/the-immortal-life-of-henrietta-lacks-the-sequel.html?pagewanted=all&_r=0

    Excerpt:
    LAST week, scientists sequenced the genome of cells taken without consent from a woman named Henrietta Lacks. She was a black tobacco farmer and mother of five, and though she died in 1951, her cells, code-named HeLa, live on. They were used to help develop our most important vaccines and cancer medications, in vitro fertilization, gene mapping, cloning. Now they may finally help create laws to protect her family’s privacy — and yours.

    The family has been through a lot with HeLa: they didn’t learn of the cells until 20 years after Lacks’s death, when scientists began using her children in research without their knowledge. Later their medical records were released to the press and published without consent. Because I wrote a book about Henrietta Lacks and her family, my in-box exploded when news of the genome broke. People wanted to know: did scientists get the family’s permission to publish her genetic information? The answer is no.

    Imagine if someone secretly sent samples of your DNA to one of many companies that promise to tell you what your genes say about you. That report would list the good news (you’ll probably live to be 100) and the not-so-good news (you’ll most likely develop Alzheimer’s, bipolar disorder and maybe alcoholism). Now imagine they posted your genetic information online, with your name on it. Some people may not mind. But I assure you, many do: genetic information can be stigmatizing, and while it’s illegal for employers or health insurance providers to discriminate based on that information, this is not true for life insurance, disability coverage or long-term care.

    “That is private family information,” said Jeri Lacks-Whye, Lacks’s granddaughter. “It shouldn’t have been published without our consent.”

    Some scientists agree: Jonathan Eisen, a genomics researcher at the University of California, Davis, tweeted, “A bit stunned that the people publishing the HeLa genome appear to not have gotten consent from the family.” Another said this was going to further damage public trust in science. A few argued that the cells had changed so much over time, they couldn’t accurately tell us anything about Lacks (to which a geneticist replied, “Your claim is so wrong that I don’t know where to start”). Several noted that consent wasn’t required to publish the HeLa genome (true). But over all, the scientific community was surprisingly silent on the issue.

    On its own, the HeLa genome doesn’t say anything specific about Lacks: it’s a string of billions of letters that detail the genetic information that makes up a HeLa cell, which is useful for science. A news release from the European Molecular Biology Laboratory, where the HeLa genome was sequenced, said, “We cannot infer anything about Henrietta Lacks’s genome, or of her descendants, from the data generated in this study.”

    But that’s not true. And a few scientists decided to prove it. One uploaded HeLa’s genome to a public Web site called SNPedia, a Wikipedia-like site for translating genetic information. Minutes later, it produced a report full of personal information about Henrietta Lacks, and her family. (The scientist kept that report confidential, sharing it only with me.) Until recently, few people had the ability to process raw genome data like this. Now anyone who can send an e-mail can do it. No one knows what we may someday learn about Lacks’s great-grandchildren from her genome, but we know this: the view we have today of genomes is like a world map, but Google Street View is coming very soon.

  10. In my view if the gene was 100% natural, it is not patentable. Where was the “creative process” of Myriad? All the did (from what I understand in the article) was identify a strand of DNA that had existed in nature for thousands or maybe millions of years. This was not a drug or a substance created to perform a function, it is an observation.

    Furthermore, I suspect the courts have at least prohibited the patenting of a mollusk that has existed in nature for millions of years, since there was no invention involved in the patent, but strands of DNA are. Yet, a virus existing in nature is essentially a strand of genetic material surrounded by a protein casing and sometimes a lipid coating.

    Also, would inheritance of DNA become cause for a copyright infringement? What is the notion of ownership rights with this? Are these companies going after mothers for illegally copying these property of this company by simply giving birth? And what next a conspiracy against the father for aiding in the conception and subsequent birth. Why not even charge anyone for possession of DNA Polymerase enzymes because they can be instruments to facilitate illegal copying of patented genes.

    I would hate to see the end game in this:

    Myriad: “All your Genes are belong to us”

  11. Great article. I guess if the public domain owns my genes, why shouldn’t that same public/private company be responsible for my bills, mortgage, etc? :) When I no longer have rights to my own body parts, it is time to make a change in the system.

  12. “Perhaps even before the discoveries that some 98% of “human genes” are actually microbial, and only about 2% are purely human.”

    This news is really “too big,” if you will. It makes a complete mockery of the lawsuit in question, and raises questions among those who have been controlling our debate for so long that elicit only blank stares, as if Dredd had grown and extra head. Well, many of them, actually. I’d say that particular Ted talk ranks among the most important of those so far assembled, a veritable banquet of meaty questions that absolutely must be tackled. It’s a real field-leveler.

    For many, though, the news will remain “too big.” That’s just too many peg holes to fall down all at once.

  13. Fascinating stuff, Elaine! What law enforcement could do with this information in the Era of the Nod and Wink to Torture is especially chilling.

  14. Here is a brief discussion of the case by a lawyer who filed an amicus brief for the medical profession. They oppose granting the patent:

  15. I don’t understand why “prior art” does not apply here.

    In my business experience with patents (and I have provided the tech to defeat one), if an invention already existed and the “innovation” claimed was already available to the public then the patent was invalidated; that was true even if the “innovation” was not explained or detailed in any way. The proof of pre-existence meant the innovation was apparent to those versed in the “art” of the profession.

    Well, the genes exist in humans already, even the “faulty” genes. If they have not invented a NEW gene, then the prior art exists. It may have been detailed in the human genome project; and certainly just describing WHY the gene is important is not an “invention.”

    You cannot patent an herb that already exists, or even a vitamin that already exists. You cannot patent the idea of a plow, or the idea of a farm, or a letter of the alphabet, or a compound that occurs in nature like, say, “coconut oil”. I do not understand why the law that prevents those ludicrous patent attempts should not apply equally to genes.

  16. “No organization, including Myriad, has ever sought to patent genes in anyone’s body. Rather, Myriad created synthetic molecules of DNA in the laboratory that are used to test patients for increased risk of breast cancer and ovarian cancer. Those synthetic molecules are different from what is found in nature or the human body. Mutations in two genes, known as BRCA1 and BRCA2, have been found to signal that patients are at increased risk for hereditary breast and ovarian cancer.”

    http://www.myriad.com/about-myriad/media-center/myriad-supports-upholding-genetic-patents-for-life-saving-tools/

  17. “Testing by Myriad, called BRACAnalysis®, helps women to determine if they have BRCA1 or BRCA2 gene mutations and is helpful in determining preventative measures and guiding therapy. More than 95 percent of patients in the U.S. have access to BRACAnalysis through private insurance or other coverage. The average out-of-pocket expense for patients is $100. The company also offers a financial assistance program that provides reduced charge or free testing to low-income, uninsured women. More than 5,000 women have received free testing from Myriad during the past three years.”

  18. Common Myths and Facts About Gene Patents

    Myth #1: I heard that someone could patent my genes.

    Fact: 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. The U.S. Patent and Trademark Office has been granting patents on “isolated DNA” to universities, hospitals, patient advocacy groups and companies for over 30 years. In fact, most isolated DNA patents were granted to research institutions rather than companies. These patents provide incentive for pharmaceutical, biotechnology and diagnostic companies to invest the hundreds of millions of dollars and decades of time to develop ground-breaking medicines and diagnostics that have saved and enhanced countless lives.

    Myth #2: I can’t get a second opinion because of gene patents.

    Fact: Since 1999, many laboratories have performed genetic testing to confirm breast cancer hereditary risk results. Today, you can get second opinion testing from the UCLA Diagnostic Molecular Pathology Laboratory, University of Pittsburgh Medical Center, University of Chicago Genetic Services Laboratory, University of California San Francisco Molecular Diagnostic Laboratory, Fox Chase Cancer Center, and University of North Carolina Hospitals.\

    Myth #3: Gene patents restrict access to genetic testing.

    Fact: Because of the incentives provided by patents, companies invest millions of dollars in clinical studies that are essential for obtaining insurance coverage. For Myriad tests, approximately 95% of all appropriate patients have access to breast cancer susceptibility testing through private insurance, Medicare, Medicaid or Myriad’s Financial Assistance Program. Under our Financial Assistance Program, we test low-income, uninsured patients at no charge and have provided free testing to over 5,000 patients just in the past 3 years.

    Myth #4: Patented products are more expensive.

    Fact: No, not according to scientific studies conducted by independent researchers. A study published in Genetics in Medicine found that, “Prices for BRCA1 and BRCA2 testing do not reflect an obvious price premium attributable to exclusive patent rights.” The Health and Human Services SACGHS’ Committee released its report on gene patents clearly stating: “The per-unit price of the full-sequenced BRAC test, which often is cited as being priced very high, was actually quite comparable to the price of full-sequence tests done on colon cancer for which associated patents are non-exclusively licensed.” Additionally, the total average out-of-pocket cost for patients taking a Myriad test is less than $100.

    Myth #5: Gene patents hinder research.

    Fact: Actually patents do just the opposite; they facilitate research and ensure that there is full disclosure of new discoveries. Since the discovery of the BRCA genes more than 18,000 scientists have studied them, publishing more than 9,000 research papers. This makes the BRCA genes some of the most widely studied genes in the world. Myriad actually fostered and encouraged research around the BRCA genes by providing testing at cost to any researcher funded by the National Cancer Institute.

    https://www.myriad.com/common-myths-about-gene-patents/

  19. I heard an interesting dicussion on NPR yesterday driving through Wyoming. Thank God for satellite radio. And yes Mr. Turley, we have certainly come a long way[??] since Jonas Salk!

  20. 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.

  21. 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.

  22. 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.”

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. #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.

  31. #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

  32. 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.

  33. 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?

  34. 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.

  35. “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.

  36. 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.

  37. 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?

  38. 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.

  39. 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.

  40. 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.

  41. 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.”

  42. 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?

  43. 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.”

  44. 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.

  45. 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.

  46. 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.”

  47. 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?

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

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  49. 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.

  50. Because there is the potential for REALLY big money to be made from genetically modified organisms, I predict with high confidence that the court will decide that genes are patentable.

    I think it will have to be up to Congress to distinguish between genetic sequences that are developed (new combinations) and those that are isolated/discovered, allowing only the former to be patentable.

  51. Bron,

    Supreme Court Asks: Can Human Genes Be Patented?
    by Nina Totenberg
    April 15, 2013
    http://www.npr.org/blogs/health/2013/04/15/177035299/supreme-court-asks-can-human-genes-be-patented

    Excerpt:
    ‘Could You Patent The Sun?’

    Until relatively recently, much of the medical profession disdained patents, except as a means to ensure quality. When Dr. Jonas Salk, the inventor of the revolutionary polio vaccine, was asked in 1955 whether he had a patent on the vaccine, he replied, “There is no patent … could you patent the sun?”

    Myriad Genetics, however, contends that the genes it isolated are not like the sun. Mark Capone, president of Myriad Genetics Laboratories, notes that the 20,000 genes in the human body are part of a 6-foot-long molecule that’s “coiled and compacted and stuffed into each cell.” And, he says, “What Myriad was able to do is sort through all those 20,000 genes and find the two that were highly linked to hereditary breast and ovarian cancer.”

    The gene is like “a single grain of sand” hidden in a building the size of the Empire State Building, says Gregory Castanias, Myriad’s lawyer. He will tell the justices that isolating the two genes justifies a patent because “it is the final step in an extraordinarily complicated set of inventive actions that led to the creation of this molecule, which had never been available to the world before.”

    Not so, say those challenging the patent. Human genes are products of nature. They are an essential part of the human body. “All Myriad does is take a part of the body out of the body,” says the challengers’ lawyer, Christopher Hansen of the American Civil Liberties Union. “It is no different than taking a kidney out of the body. Just because you are the [first] person who takes the kidney out of the body doesn’t entitle you to a patent on kidneys.”

    Invention Or Discovery?

    Castanias, however, contends that by locating the gene and isolating it — snipping it out from the rest of the genetic material — Myriad has created a new and patentable thing. He says it’s “no different than allowing a baseball bat or cast iron fence to be patented as a new invention,” even though those items “originated in a tree” or a “rock.” The baseball bat and cast iron fence are still “human inventions” and thus are patent eligible.

    “We do know Myriad did a lot of work,” says New York University law professor Rochelle Dreyfuss, a nationally known patent expert who is not associated with either side in this case. But that’s not enough, she says, because the court still has to answer this question: “Is the thing that’s isolated significantly different from the way that it was when it was in nature?”

    Hansen, representing the patent challengers, contends that Myriad is merely following nature’s instructions about where to snip out the gene.

    “The structure of the gene, the constituent elements of the gene, the significance of the gene … where the gene starts, where the gene ends, all of those are decisions that nature made,” he says. “Myriad just uncovered the fact that nature had made those decisions.”

  52. Elaine:

    I think there is more to this than meets the eye. There is something, we as laymen, do not understand.

    I agree with you that “natural” genetic code should not be patentable but what if I cross a fish with a potato and the result is fish and chips? I should be able to patent that.

    You are suspicious of the Kochs and I am wary of the ACLU (although in the last few years I find myself agreeing with some of their work).

  53. Bron: but what if I cross …

    In patents (for devices) the question of patentability turns on whether what you did would be obvious to an expert versed in the state of the art, and whether what you did is necessary to the novel function you create. In the eyes of others, not yourself. For example, you can’t replace a spring with five coils per inch with another spring that has six coils per inch and claim you have invented a new device; UNLESS you can also show that this replacement produces some significant new change in function, and that would not be obvious to somebody else versed in the state of the art.

    Likewise, you can’t just paint your device red instead of green and claim it is something new. You can’t just change an alloy by 0.1% and claim it is something new, unless you can also show it does something significantly different than the previous alloy (tougher, stronger, smoother, whatever, for shorthand think of it as something new the market would pay for).

    So extending that philosophy to genes, isolating a gene from the human genome is like pulling a spring out of an engine and saying you are patenting it. If you invent a new animal, or hybrid, and in the patent examiner’s expert opinion that would not be obvious to those versed in the state of the art (genetics and hybridization is the “art” in this case) then you have something patentable; which means market protection for 17 years (or whatever it is now).

    Of course, if whatever you did or “invented” was already out there before, that is proof enough it wasn’t original, and was not ‘non-obvious’, it was already done.

    With genes, simply isolating them does not make the gene a novel thing the lab created. The procedures for isolating them or testing for their presence (as opposed to some variation on that gene) might be novel, and that procedure might be patentable, but the gene itself is already out there and those versed in the state of the art (genetics and genetic manipulation) could presumably have isolated it too. Maybe not using the same procedure, but using well known canonical procedures it is possible to isolate and sequence (or create) any given gene in the lab.

  54. Hi, I am Courtnee Lacks, Henrietta’s great-granddaughter. Thank you for bringing up her HeLa cells below. Even though the recent Supreme Court ruling didn’t directly apply to HeLa, our family has followed the case closely and were delighted that the ruling supported an individual’s right to own his or her own microbiological materials.

    If you are interested in learning more about how HeLa has affected the Lacks family, my grandparents have published a short digital memoir, “HeLa Family Stories: Lawrence and Bobbette,” that talks firsthand about their experiences. It is available on Amazon at http://www.amazon.com/HeLa-Family-Stories-Lawrence-ebook/dp/B00COEH2RY,

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