Tech | May 16, 2009 | 24 comments

How human genes become patented

source: http://www.cnn.com/2009/HEALTH/05/13/genes.patent.myriad/index.html

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JanforGore
Here's a little-known fact: Under current law, it's possible to hold a patent on a piece of human DNA, otherwise known as a gene.

Some breast cancers, shown here, are linked with the genes BRCA1 and BRCA2.

Companies that have acquired patents for genes have specific rights to their use, which may include diagnostic tests based on those genes, as well as future mutations that are discovered.

In a new lawsuit, the American Civil Liberties Union alleges that the policy is unconstitutional.

The targets of the lawsuit, Myriad Genetics and the University of Utah Research Foundation, hold patents to BRCA1 and BRCA2, the genes responsible for many cases of hereditary breast and ovarian cancers.

The U.S. Patent and Trademark Office is also named in the suit.

The lawsuit asserts that the patents prevent some people from accessing medical screening for BRCA1 and BRCA2. It also challenges the general patentability of genes, which has been legal since 1980. That year, in Diamond v. Chakrabarty, the Supreme Court found in favor of Ananda Mohan Chakrabarty, who used bacteria to engineer a microbe that dissolves oil.

Genes form the basic unit of heredity. With modern technology, researchers have determined that particular genes carry an associated risk of illness.

A striking 20 percent of all human genes have been patented. However, now that all 20,000 to 25,000 human genes have been mapped and sequenced through the Human Genome Project, they are in the public domain, meaning they would no longer be considered "new" for the purposes of patents, said Lee Silver, professor of molecular biology and public policy at Princeton University. Now, patents on human genes must specify a new use, such as a diagnostic test.

If a company wants to patent the purified form of an antibiotic that exists in nature in a fungus, no one challenges that, Silver said. Plant DNA, as well as human DNA, can be synthesized in a laboratory. Distinguishing this case from a patented human gene that is useful in diagnostics would require the ethical argument that the human genome is sacred -- and even then, things get murky, considering that about 25 percent of human genes are shared by chimpanzees, he said.

"The patent law says nothing about ethics," he said.

But Josephine Johnston, bioethicist at the nonpartisan Hastings Institute, said she thinks that allowing patents for human genes was probably a mistake. She said she would draw the line at modified genes being acceptable as intellectual property, but not genes in pure form. From a legal point of view, that would mean unmodified plant and animal genes would also be off-limits.

In a moral argument, however, one could say that there is a "common humanity" -- that human genetic material belongs to all humans -- or agree that no plant or animal genes should be patented.

"I think that legal arguments about why this kind of thing isn't really something that should be patentable are really strong at a theoretical level," she said. "I wouldn't be that confident that the American court system would agree."

Patents protect inventors and spur innovation by giving companies an incentive to create new things. The invention must be "useful," "novel" and "nonobvious" and carry a description that enables someone to use it for the stated purpose, according to U.S. patent law.

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Is it ethical to patent human genes and just how far do you think this will go?
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24 comments // How human genes become patented

  • poptart_invasion
    • 0
      poptart_invasion  

    • ...i fail to see whats wrong with this. like it said, certain advocates are trying to get a line drawn between pure and engineered genes. thats good. other than that, its information on which they build something. two cookies goes to the person who can convince me that its any different than getting a patent for a car part. so its a human part instead, big woop. one can patent prostetics. do we not have some flower-child, tree-huggy right of humanity to all four limbs even more than a entirely artificial gene used to combat a certain disease?
      nothing has changed but the technology.

    • 3 years ago
  • Hakunamatata420
  • lucidstone
    • 0
      lucidstone  
    • Hakunamatata420:

      First you have to file in triplicate Form H-3B under the clause for "Spawn of Satan".

      Then you have to get the form notarized in triplicate by your local anti-christ . . .

      I'm just kidding, I love redheads and I don't really think they are "god's little hellspawns". =)

    • 3 years ago
  • nursediesel
    • 0
      nursediesel  

    • Yeah, I took some ethic classes that addressed this way back in the late 80's & early 90's regarding new research/treatment prodical for different kinds of cancers.

    • 3 years ago
  • 23485768934756
    • 0
      23485768934756  

    • Way to follow along. Again, your spending allot of time on this. I’m very impressed too.

      They don't own your DNA physically. They own the mapping sequence. Or that is what they are trying to achieve.

      So what? Your only advantage here is money. If there is a patent right issue you can sue for damages because they didn’t pay you for that information. That information being your DNA mapping sequence. Basically there is a theft involved.

      Outside of that. Nothing

    • 3 years ago
  • nursediesel
    • 0
      nursediesel  

    • On May 14 someone posted a site:"Can corporations own your DNA?" Check it out ,also.
      This has to be clarified, in an ethically acceptable way. This could be a slippery slope to a huge moral and ethical debacle, and must be correctly nipped in the bud.
      No one should be able to own anyones DNA.
      Owning the patent to testing for cancers is a different story. The wording must be specific and succinct to what is and is not allowed. No vague legalize that allows loopholes.
      It's got to be stopped now!

    • 3 years ago
  • lucidstone
  • Tygerian
    • 0
      Tygerian  

    • As for the topic, I'm getting more and more convinced we do not need patents AT ALL, let alone when it comes to DNA. Or at least they should not last more than a year - then it's public domain.

      I argue that that would not prevent innovation, since most people who invent things will be more than happy to do it for the benefit of everyone. The only losers would be corporations, and that's OK in my book.

      Same with copyright. Just look at the size of open source community. People want IP to be public domain. Publishers don't.

      Good luck changing the status quo without a revolution though.

    • 3 years ago
  • lucidstone
    • 0
      lucidstone  
    • Tygerian:

      "I argue that that would not prevent innovation, since most people who invent things will be more than happy to do it for the benefit of everyone."

      . . .

      " But Justin Rattner, the senior fellow who helps oversee Intel's $5.4 billion research-and-development budget, said he..."
      http://www.accessmylibrary.com/coms2/summary_0286-31336383_ITM

      "Apple hasn't cut R&D spending. The company spent $534 million on development in fiscal 2005, which was 24% more than it spent in fiscal 2001."
      http://www.thestreet.com/story/10273658/2/apple-frugal-to-a-fault.html

      "Microsoft is spending over $9 billlion in R&D over the next year,"
      http://windowsitpro.com/article/articleid/102121/wininfo-short-takes-week-of-may...

      "When the companies entered into their partnership in 2001, Sony, Toshiba and IBM committed themselves to spending $400 million over five years to design the . . . "
      http://online.wsj.com/article/SB123069467545545011.html

      People will NOT invest billions of dollars or work 40 hours a week for years on end without compensation just to be "happy to do it for the benefit of everyone."

      There may be swell group of guys that contribute to open source in their spare time, but they are hardly up to the challenge to develop next-gen technology chips, global communication satellites, or cancer medicines out of their own pocket of resources . . .

      And if you know someone who is willing to work 40 hours a week solely "for the benefit of everyone" without any pay, then send him my way . . . I know people that could use another lab technician, but are out of resources to compensate.

      It's only morning, but I'm awarding you the Daily Red Ribbon Of Communism for the day, you deserve it.

    • 3 years ago
  • Tygerian
    • 0
      Tygerian  
    • Tygerian:

      Hey, thanks, but I'm afraid ribbons don't go that well with my current attire :P

      It was my bad, however, that I forgot to mention that I had in mind a different society than the one we have now. You're right - the current system is practically build upon the notion of sellable rights to IP. However, like many things eventually, this notion has led to extreme absurdity in some cases, i.e.

      "For thousands of years farmers have saved seeds for replanting. That used to be the only way to get the next crop. Now this ancient practice has come into conflict with modern seed sellers and their patents. Schmeiser grew patented seeds. But he did not steal them from the seed store. Whose fault is it that Monsanto's seeds grew on Schmeiser's farm?"
      http://www.sfgate.com/cgi-bin/article/article?f=/c/a/2002/12/23/BU203042.DTL

      "In essence, Worlds claims it has a patent ("System and method for enabling users to interact in a virtual space," 7,181,690 ('690)) on the technology underlying MMOs, a patent that was granted in 2007 but is actually a continuation of a 1996 patent, "Scalable virtual world chat client-server system"
      http://www.macobserver.com/tmo/article/oh_the_games_youll_play_a_deeper_look_at_...

      As I said, these are extreme cases, but when you start thinking about it more, you can't help but wonder if there isn't a better way to deal with this stuff.

      Oh, and DRM. More to think about.

    • 3 years ago
  • lucidstone
    • 0
      lucidstone  
    • Tygerian:

      "Hey, thanks, but I'm afraid ribbons don't go that well with my current attire :P"

      lol, touche!

      I agree that there must be better ways to do things, but I don't think I would ever go as far as communism (or a close derivative).

      But you have a decent argument and a sense of humor. So even though I might not agree with you, you have my attention if you wanted to elaborate. =)

    • 3 years ago
  • unimatrix0
    • 0
      unimatrix0  

    • Great post Jan

      Important, complex and ethically charged.

      This is but one of many cases where our scientific/technological knowledge outstrips our moral development as a society.

      The brave new world will not wait, and does not care, if we are ready or not.

    • 3 years ago
  • doctorx
    • 0
      doctorx  

    • it's essentially impossible to patent a natural gene sequence these days (due to sequencing projects and changes in the law). Those that were lucky enough to be allowed will expire soon. If you invent a novel, useful, non-obvious gene (i.e., a synthetic fluorescent pigment) then it should be allowed. this does not preclude method patents however.

    • 3 years ago
  • cybexg
    • 0
      cybexg  

    • CORRECTIONS

      [1] "are in the public domain, meaning they would no longer be considered "new" for the purposes of patents"

      [2] "The patent law says nothing about ethics,"

      [3] "but not genes in pure form. From a legal point of view, that would mean unmodified plant and animal genes would also be off-limits. "

      1: Classic misunderstanding of how to use IP law. Could still patent a new use of, new method of creation, etc.

      2: The statute doesn't but the administrative rules (laws) do, says the hurdle is new, useful, nonobivous and enablement. The morality of the invention is not to be considered (I think the original case/prosecution had to deal w/ a sex toy - but could be wrong about that...been a long time since I had to know that)

      3:unmodified, non-purified are non-patentable however, you can patent a new use, etc.

    • 3 years ago
  • current89
  • JanforGore
  • lucidstone
    • 0
      lucidstone  
    • cybexg:

      "There is nothing Irrational about this thread."
      -The two previous comments weren't exactly rational.

      "they just want moeny... therfore i find it unethicle."
      -Talk about a sweeping statement that doesn't take into account that patent rights cover the cost of R&D . . . and the stance that wanting money is inherently unethical is far from rational as well as people should be compensated for the work they do.

      "Corporations taking over our natural liberties."
      -Since you recommended this comment . . . maybe you can explain how patent rights over certain techniques in the lab in regards to genes infringes on anyone's "natural" liberties? I honestly don't understand the rationality behind that statement at all.

      ---------------------------------------------------------------------

      Personally, I think this CNN article is misleading as I believe it's most probably talking about the patents of certain lab "techniques" in regards to the genes themselves.

      "But Silver finds this analogy faulty. Though an individual's eyeball is unique and cannot be made in a laboratory, any given form of any gene is present in many people and can be synthesized. The DNA molecule is defined at the atomic level by a genetic sequence. Scientists can make purefied substances with the same characteristics as human genes, whereas they cannot exactly manufacture any person's eyeball. 'The main problem is that people don't understand what genes are and what they're not,' Silver said."

      This rather vague explanation by CNN doesn't explain Silver's point of view at all and instead goes back to the opposing viewpoint, this entire article is entirely unbalanced by only really explaining one point of view.

      Then we get to the "real" argument in the article towards the end:
      "From Rosenthal's perspective, the main issue in this case is no different from a situation in which a pharmaceutical company, regardless of where the ingredients came from, uses a patent to charge unreasonably high prices for drugs."

      Yes pharmaceuticals charge to much, yes healthcare costs to much, yes health insurance costs to much but it's all the same tune that I've been hearing for a long time now . . . Hopefully this administration changes that though.

      Regardless, the CNN article leaves a lot of unanswered questions in regards to what exactly entails a "gene being patented" and the OP article is quite obviously one sided. Without more information, I can't hold an intelligent opinion one way or the other over exactly what's going on here (and I find it "incredible" that you can).

      However, I really doubt it is as simple and basic as just patenting genes and not more involved in the specific techniques behind them that were developed by an individual team. Either way, I want more info.

    • 3 years ago
  • Tyrannous
  • idealist
  • csmonut
    • 0
      csmonut  

    • Also, there is a question in some circles about the person owning their own genetic make-up, or their DNA for that matter.
      Is it owned by the companies that mapped it? Or is it owned by the pharmacutical that has the best lobbyists?
      Or is it owned by the individual?

    • 3 years ago
  • DeliaTheArtist
  • Tygerian
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