Genetiks and Human Gene Patents

(This post was the subject of Retcon #6, which addressed the Supreme Court’s decision in the Association for Molecular Pathology v. Myriad case.)

No, that’s not a typo in the title.  I’m referring to Genetiks, the graphic novel from Archaia Entertainment.  The protagonist of the book works for a genetic research company (the titular Genetiks), which requires each of its employees to submit a symbolic cell to the company.  The protagonist’s cell is used in a human DNA sequencing project, reminiscent of Celera Genomics’s private competitor to the Human Genome Project.  Apparently it is the first of its kind in the fictional world of the book, and after the protagonist’s DNA is completely sequenced he is told that, because the company now owns his genetic sequence, it now effectively owns him and everything he will ever do or produce.

This immediately raises a host of questions.  Can an employer commercially exploit the genetic information of its employees without further compensation?  Does sequencing someone’s DNA mean that you own it, in some sense?  Does owning that DNA sequence confer any rights over the person?  And can DNA sequences be owned in the first place?

I. Commercial Exploitation

The answer to the first question is a pretty straightforward yes.  To begin with, people don’t have a property right in their own body parts.  Moore v. Regents of Univ. of Cal., 51 Cal.3d 120 (1990).  Once an employee gives up a cell to the employer, that employer can pretty well do what they want with it, including exploit it for commercial gain, and the employee is not entitled to a cut.  But what’s more, the employee almost certainly signed a contract indicating that the cell and any resulting intellectual property rights or income were being exchanged for employment with the company.  Similar contracts are signed all the time, whereby employees agree to assign rights in creative works or inventions to their employers in exchange for employment.

II. Gene Patents

Genetiks makes a pretty broad leap from “sequenced DNA” to “ownership.”  In reality, there’s a bit more to it than that.  There is no property right in a bare DNA sequence.  Such a sequence is simply a fact.  But if a sequence is observed to be new, useful, and nonobvious, then it may qualify as a patentable invention (NB: in the United States inventions are defined as both inventions and discoveries under 35 U.S.C. § 100(a)).  This might be the case if, for example, the sequence is the sequence for a particular gene, which is what so-called “gene patents” are about.  But that still requires applying for a patent; it’s not automatic the way copyright protection is.

III. The Scope of Gene Patents

What gene patents definitely don’t do, however, is confer any inherent rights over the person that the gene was originally sequenced from or any person that the gene is found in.  First, such patents typically claim isolated DNA molecules with a particular sequence, which don’t exist in human beings, even humans with the genes in question.  Second, it has long been Patent Office policy—now codified in the law—that no patent may claim an invention “directed to or encompassing a human organism.”  Third, even if all that failed, the 13th Amendment would almost certainly have something to say about it.

IV. Are Human Genes Patentable?

But all of this may be a moot point.  The Supreme Court is current considering that question (“are human genes patentable?”) in the case of Association for Molecular Pathology v. Myriad Genetics, Inc.  The oral arguments were heard earlier this month, and the case has the potential to upend the biotechnology sector in the United States.  I won’t try to read the oral argument tealeaves, but I will say that—in general—recent Supreme Court patent cases have not been especially favorable to inventors and patent owners.

V. Conclusion

Genetiks is a good read, even though it rests on an extremely shaky legal premise.  You pretty much have to assume that it takes place in an alternate universe with a very different legal system, despite its apparent similarity to our own world and overall realistic tone.

8 responses to “Genetiks and Human Gene Patents

  1. I seem to remember a short story based on a similar premise, but where the parents claimed Prior Art.

  2. Melanie Koleini

    Great post. I don’t disagree with your analysis but you missed the chance to explain how patents on natural ‘products’ work. Personally, I hope the Supreme Court invalidates all patents of genes sequences found in nature (not originally created in the lab). But even if it doesn’t, owning the patent for a particular gene doesn’t automatically give you control of every organism that has the gene. If the gene occurs in nature, organisms born with the gene can keep using it without paying royalties.

    I can think of a lot of real world examples, but no good comic book examples come to mind. Let’s say someone sequences and patents the X gene. Until the Supreme Court says otherwise, the patent holder could demand a licensing fee for anyone testing for the gene and might be able to block others from researching the gene. They could certainly either block or demand some of the profits from anyone developing a commercial product that used the X gene. But none of the X-Men would owe the patient owner a dime.

    Similar rules apply when dealing with non-humans. I think the gene that creates a spider’s web has been patented. If someone wants to start a spider farm and collect spider silk they wouldn’t have to pay a licensing fee.

  3. Terry Washington

    Erm- didn’t owning people go out with the end of the US Civil War back in 1865?

    Terry

  4. If a human gene is patented, does that make children born with that derivative works?

    Per the constitution, the purpose of patents is “To promote the progress of science and useful arts”. That phrase came immediately into mind when I first heard about the BRCA gene patent. A very promising lead in cancer reasearch is now off limits unless you buy a license to work with it.

    • If a human gene is patented, does that make children born with that derivative works?

      No, because that’s not how gene patents work. Such patents don’t cover genes that are parts of chromosomes in human cells in humans. They cover isolated DNA molecules with a particular sequence (i.e. a relatively short piece of DNA). Or they cover diagnostic or therapeutic methods involving those molecules or sequences. But nobody infringes a gene patent simply by existing. Also, “derivative work” is a term from copyright law; it doesn’t have much meaning in patent law.

      A very promising lead in cancer reasearch is now off limits unless you buy a license to work with it.

      But the availability of patent protection arguably promoted the progress of the useful arts by encouraging the University of Utah to perform the research in the early and mid 1990s that found the BRCA1 and 2 genes and their significance. This research was then commercialized by Myriad.

      Also, bear in mind that the Myriad case is not about Myriad suing cancer researchers doing basic research on genetics or cancer. It’s about doctors and hospitals that want to offer competing cancer screening tests, for which they would be paid money. They’re preemptively suing to invalidate Myriad’s patents.

      The available empirical evidence suggests that gene patents have little to no negative effect on biotech research (where, after all, do you think most biotech companies get their ideas?), though of course a company with a patent will tend to use it to prevent commercial competition.

      But even if Myriad were using its patent to stifle research in that area, that same criticism could be leveled at any patented invention, medical or otherwise. It’s not specific to gene patents. Maybe the argument then becomes “then we shouldn’t have a patent system at all”, but that’s not up to the Supreme Court to decide, and it’s certainly beyond the scope of this blog and its comment section.

      • Melanie Koleini

        For human genes, your contention that patients aren’t hurting basic research may be true. (However, patients have interfered with basic research and translational research into diseases like Hepatitis C.

        A few years ago, the owner of the Hep C gene patient refused to allow researchers testing possible treatments for Hep C from testing for the virus (without paying full price). In this case, it made the study unaffordable and also delayed research into a deadly disease. Also, a lot of virologists stopped studying Hep C because they were afraid the patent holder would block the publican and utilization of their findings. (If they developed a vaccine, they’d be sued for patent infringement and there is very little money in vaccines to begin with.)

        In the grand schemed of things I don’t know if allowing patients on natural discoveries helps or hurts science. But when the public good and private profits are in conflict, who wins? Vaccines are almost always less profitable then treating the disease. The government props up the vaccine industry because in a free market, no company would make vaccines. Should companies be allowed to use their patents to prevent others from developing products they don’t want to exist?

  5. Pingback: Law and the Multiverse Retcon #6: Genetiks and Human Gene Patents | Law and the Multiverse

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