Should We Patent Human Genes?

The Supreme Court ponders the intersection of biology and intellectual property

Should human DNA be patentable? That’s the central question in Association for Molecular Pathology v. Myriad Genetics, a case argued before the U.S. Supreme Court in April. The lawsuit was organized by the American Civil Liberties Union on behalf of several professional organizations that have long opposed such patents, which the U.S. Patent and Trademark Office has been granting since the 1980s. 

Patent law is arcane, and arguments about it can sound a lot like squabbling over the number of angels that can dance on the head of a pin. But in this case, it affects tens of billions of dollars in research, products, and profits.

At issue are several patents related to two breast cancer genes, BRCA 1 and BRCA 2. In the 1990s, researchers at Myriad Genetics identified and isolated two genes in which certain mutations dramatically increase the risk of breast and ovarian cancer. The company then offered a product, called BRACAnalysis, which compares patients’ BRCA genetic sequences to the company’s reference sequence to identify the mutations. Armed with the knowledge that they are at greater risk, patients can then engage in protective actions ranging from more frequent mammograms and ultrasound examinations to having their breasts and ovaries surgically removed.

The Supreme Court must decide if Myriad is merely using products that exist in nature (which cannot be patented) or if it has invented a “new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof” (which can). 

Why do the plaintiffs want to invalidate human gene patents? As a matter of policy, mainly because they believe such patents impede rather than speed valuable research and development. The Association for Molecular Pathology, for example, cites estimates that “about 20 percent of the human genome is under patent” and argues that “scientific research has been delayed, limited or even shut down due to concerns about gene patents.”

As a matter of law, the plaintiffs argue that a gene isolated by Myriad conveys the same genetic information as a gene found in a human body and that it thus “represents the same laws of nature as genomic DNA.” Myriad, the ACLU concludes, “is in effect arguing that it may obtain a patent on a product or law of nature itself if it finds a new use for it.”

In its brief, Myriad counters that no one would contest a patent on a new chemical that could be applied to a blood or tissue sample to detect a higher cancer risk. “That is what Myriad’s patented molecules are,” the company claims, “and they were never available to the world until Myriad’s scientists applied their faculties to a previously undistinguished mass of genetic matter in order to identify, define, and create the isolated DNA molecules.”

Who is right? It’s illuminating to consider how the patent office applies the product-of-nature doctrine. In one training example, the office notes that exposure to sunlight is known to affect some people’s moods. If someone tried to patent a method for treating seasonal affective disorder that involved exposing a patient to sunlight, the application would be rejected, since it “is no more than the law of nature plus telling people to ‘apply it.’ ” Nor would the office issue a narrower patent on exposing the patient to a source of white light, since the sun is also a source of white light. But it would patent a treatment in which a patient is precisely positioned for a specified length of time near a white light source from which ultra-violet rays have been filtered. In fact, just such a treatment was patented in 2002.

So are Myriad’s molecules more like advising a patient to sit in the summer sunlight or more like creating a contraption that exposes him to white light in the depths of winter? I am not a patent lawyer, but it seems to me that gene patents are more like the latter—that the isolated DNA molecules are the result of human ingenuity and are composed, manufactured, and improved, not merely discovered or found.

The public policy issue raises a different question: Do gene patents promote progress, or do they impede discovery and invention? In its brief, Myriad makes the uncontested point that since its BRCA patents were issued, 18,000 researchers have conducted studies involving those genes, published more than 8,000 scientific papers, and conducted more than 130 clinical trials. That’s a lot of progress, and the evidence that the patents have prevented still more progress from occurring is slim. In a recent, comprehensive analysis, Christopher Holman, a professor at the University of Missouri–Kansas City Law School, deflates the claim that 20 percent of human genes are patented and that this constitutes a roadblock to newer genetic technologies, such as testing based on whole genome sequencing. 

The claim that 20 percent of human genes are patented comes from a 2005 article in Science magazine. The Science authors assumed that the mention of a gene’s DNA sequence in a patent claim was equivalent to patenting the gene, but in most cases that isn’t so. What’s more, sequencing a whole genome does not require the use of isolated genes. It involves running a person’s DNA through a detection device to determine the specific order of DNA base pairs; these data are then compared with publicly available studies describing the various effects of the identified sequences on an individual’s health and well-being. In very few instances would pre-existing patents prevent this. 

Holman concludes that “there is no empirical support for the widespread notion that 20 percent of human genes are patented in a manner that would be inevitably infringed” by modern genetic testing technologies. In fact, whole genome sequencing will soon be cheaper than diagnostic tests, such as Myriad’s, that depend on patented genes. 

In the meantime, declaring human gene patents invalid likely would slow progress in the creation of new medical treatments. As Holman notes, the “biotechnology industry has invested heavily in life-saving products based on the expectation that effective patent protections are available for innovations in this field.” During oral arguments, Justice Antonin Scalia asked this highly relevant question of the ACLU attorney: “Why would a company incur massive investment if it cannot patent?” The lawyer lamely responded that scientists might do such work “because they’re curious,” “because they want a Nobel Prize,” and because they would “get enormous recognition.” Scalia drily replied, “Well, that’s lovely.” Scalia asked the right question; for the sake of future patients’ well-being, let’s hope a majority of the Court comes up with the right answer.  

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  • Dweebston||

    Short answer: no.

    Long answer: noooooooooooooooooooooooo.

  • ATrumse||

    This is certainly the nicest-work I have ever done.. Earn 10 to 80$/hr working from home with Google! On Saturday I got a gorgeous Ariel Atom after earning $6292 this – four weeks past. I began this six months/ago and right away began to make at least $80.. per-hour. I work through this link, www.Bling6.com

  • Xenocles||

    I don't understand how you can patent something that has existed for eons. Sure, you could develop a method of testing for specific genes and patent that, but the genes themselves? No way.

  • ||

    You know, Id almost be willing to grant patents to any group that managed to invent a process to manually replicate the specific base pairs in a gene. But they should have to show that they could make a synthetic, working copy of the protein that could be interchanged with a wild, natural gene and still function properly.

  • Xenocles||

    Sure, and again, that's a new artificial process that makes perfect sense to patent. That's all good.

    On further reflection if they grant the patent for the genes themselves doesn't that introduce liability for the patent-holders? If you suddenly "own" BRCA-1 and -2 who's to say it's not your fault that the carriers have an increased risk of cancer?

  • Acosmist||

    Motion to dismiss

    Motion for Rule 11 violations

    Is that what you had in mind? That is not a valid claim at all, in any world.

  • Xenocles||

    It's an absurd consequence of an absurd idea. Patenting a gene would be like patenting ice.

  • Xenocles||

    And it's hardly a frivolous suit. If it's the defendant's position that he owns the rights to the BRCA genes, that ownership cannot include just the benefits of ownership. It must include the responsibilities. I can't own a dog, use it for hunting and security and companionship, and then suddenly disclaim responsibility if it slips its leash and bites someone. Ownership is two-edged.

    Granting a patent for a gene implies the ability to sue for infringement anyone who has that gene in his or her genome. So if you want to claim the ability to extract a licensing fee from me for an accident of birth, what's so frivolous about holding you accountable for the increased anxiety and health risks your property has caused me?

    Of course, the very idea of owning the IP rights to something that has likely physically existed for as long as our species is completely absurd. Discovery is not the same as invention. So, as I said, you can patent the method of detecting the gene but not the gene itself (which, by the way, avoids the negative consequences liability issue I raised - anyone who took the test would be responsible for the consequences of the knowledge discovered through it).

  • Acosmist||

    The patent right is only the right to exclude others from using it. That's it. That's all. By all means, please make this claim in court, ideally when I am opposing counsel. Rule 11 will get expensive for you.

  • ||

    Exactly. Make any patent holder of a human gene liable for damages. Congress could then introduce "lemon laws" for genes and require gene dealerships to pay damages.

  • ant1sthenes||

    No. Shit, software patents are bad enough.

  • some guy||

    But in this case, it affects tens of billions of dollars in research, products, and profits.

    If we take away patents, those tens of billions of dollars will still probably be spent on research, just allocated differently. Patents, like all forms of intellectual property, are arbitrary and counter-productive.

  • Acosmist||

    :citation needed:

  • some guy||

    I said "probably", so I'm off the hook.

    Besides we didn't have patents for most of human history and we still seemed to do pretty well on the research.

  • Libertarius||

    You losers think property rights and the incentive of man's mind are "arbitrary and counterproductive"?

    Of course you do. Like the leftoids, you have an egalitarian view of production, and you are equally eager to dismiss the incentive of minds much better than yours.

  • epsilon given||

    And you, sir, are a loser who thinks that an idea can only have worth if it's been blessed by the State.

    Patents are vestiges of a time when governments would grant monopolies to artisans, in an effort to attract them to their States. It didn't matter who was doing the work before them--it could be something as simple as mining salt--and the artisan had the full power of the State to coerce others to stop their activities.

    And copyrights are the vestiges of the Crown trying to control what could and could not be published. When the government decided to relinquish this power, publishers insisted it was necessary to "protect" the rights of writers--they wanted to continue to have a monopoly on publishing things.

    To this day, patents have been the bane of individual inventors and small companies (who cannot afford the typical $3M lawsuits), and true to form, publishers have used copyrights to profit at the expense of writers and other artists.

  • epsilon given||

    Perhaps I would have a better view of patents and copyrights, if I worked in a field in which they are prevalent. But I do not. I am a mathematician, and mathematics flourishes just fine without the protection of patents (math is exempted practically by name) and copyrights (you can't copyright an idea, only the expression of it, and mathematics is nothing if it isn't the expression of ideas).

    That, and I've seen how Linux flourishes, despite it's refusal to participate in the copyright and patent regime; indeed, I have seen how copyright law had suppressed the growth of BSD Unix, and how patents do nothing but cast fear over the Linux ecosystem.

    Finally, I would propose that the only way to own an idea--to homestead it, in the Lockean tradition, if you will--is to study it, memorize it, and make use of it, and perhaps even extend it. Such "homesteading" is unbound by time or space; indeed, it is not uncommon for someone to think they are original, to have discovered something that someone had found years before!

  • Adam.||

    I'd say you can patent a process or specific therapy but patent a gene itself, absolutely not.

  • Bryan C||

    "“That is what Myriad’s patented molecules are,” the company claims, “and they were never available to the world until Myriad’s scientists applied their faculties to a previously undistinguished mass of genetic matter in order to identify, define, and create the isolated DNA molecules.”

    That's stupid. It's like inventing a new method of desalination, and using that as a justification for patenting water and salt.

  • some guy||

    This is a perfect comparison.

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