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. 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!

  2. 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/

  3. The case is before the 5 supremes on petition from the Federal Circuit, which upheld the patents: link to Federal Circuit Opinion (PDF).

    Evidently the supremes have treated the Federal Circuit like they treated the Ninth Circuit for a long time (like a step child).

  4. “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.”

  5. “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/

  6. 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.

  7. 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:

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

  9. “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.

  10. 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.

  11. 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”

  12. 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.

  13. 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.

  14. 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:

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

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

Comments are closed.