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Supreme Court Gene Patents Ruling Opens Genetic Test Options

vinces99 writes "The Supreme Court's unanimous decision to bar the patenting of naturally occurring genes opens up important clinical testing options for a variety of diseases, which University of Washington medical geneticists and laboratory medicine experts say will benefit patients. Mary-Claire King, a UW geneticist who was instrumental in identifying the breast cancer-causing genes at the heart of the court case, hailed the ruling as 'a victory for patients, their families, their physicians and common sense.' She noted that within 24 hours after the decision was announced on June 13, UW Laboratory Medicine was offering tests for all known breast cancer genes."

22 comments

  1. It is a hopeful, small step in the right direction by rts008 · · Score: 4, Insightful

    "... within 24 hours after the decision was announced on June 13, UW Laboratory Medicine was offering tests for all known breast cancer genes."

    A prime example of how current IP law and mentality have hindered usefulness and innovation of technology.

    Hopefully this will serve as a wake-up call to much needed IP law reform.

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  2. Re:It is a hopeful, small step in the right direct by Anonymous Coward · · Score: 0

    +1 Naive.

  3. Re:It is a hopeful, small step in the right direct by Mordok-DestroyerOfWo · · Score: 1, Funny

    "... within 24 hours after the decision was announced on June 13, UW Laboratory Medicine was offering tests for all known breast cancer genes."

    A prime example of how current IP law and mentality have hindered usefulness and innovation of technology.

    Hopefully this will serve as a wake-up call to much needed IP law reform.

    This is nothing more than a slap in the face of Capitalism. I say let the free market decide who lives and who dies!

    --
    "Never let your sense of morals prevent you from doing what is right" - Salvor Hardin
  4. Re:It is a hopeful, small step in the right direct by interkin3tic · · Score: 4, Interesting

    The fact that the supreme court said genomic DNA was not patentable but cDNA was means that the issue isn't resolved, but momentum is on the side of sanity. Had the supreme court said "No, neither are patentable because you didn't fucking make those sequences, and cDNA is just genomic DNA with parts taken out," then the issue would have been resolved, which would have been good, but we couldn't say "See, IP laws are holding back cancer research and are STILL not fixed."

    Perhaps the SC's incompetence to realize that reverse transcriptase is a naturally occouring enzyme, and viruses make cDNA all the time, and your cells remove introns all the time, so there is absofuckinglutely nothing patentable about cDNA... perhaps that will actually be useful in the larger battle.

  5. Re:It is a hopeful, small step in the right direct by Anonymous Coward · · Score: 0

    So if the argument was anything like your post, there was the problem. You used a lot of big fucking words. Thats good. However, they are not lawyer big words so they did not understand and went with a coin toss.

  6. Re:It is a hopeful, small step in the right direct by Anonymous Coward · · Score: 0

    To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries

    The reason you should worry, is that why the above words do say "Inventors" and nobody can claim to have invented naturally occuring genes, the above words also say "Discoveries." If I'm an inventor who discovers a gene, do the words apply to me or not?

    I'm not asking about right and wrong, I'm asking what the law is.

    It's hard.

  7. Naturally occurring? by Anonymous Coward · · Score: 1

    What do they mean by naturally occurring? Aren't all configurations of genetics potentially naturally occurring?

    1. Re:Naturally occurring? by skywire · · Score: 1

      They meant the actual occurrence of these particular genes in cDNA form in nature.

      --
      Those who would give up essential liberty to purchase a little temporary safety, deserve neither liberty nor safety.
  8. Re:It is a hopeful, small step in the right direct by the+gnat · · Score: 4, Informative

    reverse transcriptase is a naturally occouring enzyme, and viruses make cDNA all the time, and your cells remove introns all the time, so there is absofuckinglutely nothing patentable about cDNA

    But the cDNAs that people would like to patent is not simply endogenously present - it has to be created using an entirely artificial process. And reverse transcriptase isn't a naturally occurring enzyme in humans, or at least not the kind that's used to make cDNA*. And our cells remove introns only to make mRNA, not cDNA. So it's a little deceptive to say that cDNA is a natural product and therefore not patentable. If your rather simplistic argument were valid, a vast number of forms of gene manipulation and genetic engineering would become unpatentable, because organisms undergo gene manipulation all the time. (The most extreme example is probably horizontal gene transfer, but there are plenty of other weird things going on, many involving viruses.)

    Now, my personal preference (as both a scientist and a consumer) is for as few patents as possible on any genetic material, and I was relieved to see Myriad get slapped down by all nine justices. But what I prefer isn't always in line with what current case law decrees is allowable, and I wouldn't call the Supreme Court incompetent just because they didn't reach the conclusion I personally favor.

    (* In fact, the polymerases used in molecular biology labs are often heavily engineered for greater stability and control, and of course they're not endogenously produced but rather purified from a [heavily modified] recombinant organism expressing the protein on a [human-designed] plasmid, so the connection to the naturally occurring proteins is tenuous.)

  9. 23&Me tests are $99, vs. Myriad's $3000+ by billstewart · · Score: 1

    23&Me's tests say they're not for diagnostic use, but as far as I can tell from most of the articles on the topic, they have a bit more detail on breast cancer related genes than Myriad's, as well as telling you about a lot more disease traits, general physical traits, ancestry data, percentage of Neanderthal DNA, etc. For a couple of the scarier traits (I think it was breast cancer and Huntington's), they do ask you to confirm that you really do want to see them. Many of the genes they're testing for are specific ones that you do or don't have (e.g. Tay-Sachs), while many others are general risks (e.g. lots of genes affect diabetes or heart disease, or strict correlation hasn't been proven) so you only get a "N times more/less likely than average" level of granularity on some of those, but they do give you the best results they've got.

    Apparently I've got a lower-than-average risk of diabetes but a higher risk of male pattern baldness, my ancestors seem to come from the areas I'd expect and more of them were Neanderthals than the average western European, and a hundred or two other details like that.

    --

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    New Fast-Compression-only CPR http://preview.tinyurl.com/dy575ks
    1. Re:23&Me tests are $99, vs. Myriad's $3000+ by pepty · · Score: 1

      23&Me's tests say they're not for diagnostic use, but as far as I can tell from most of the articles on the topic, they have a bit more detail on breast cancer related genes than Myriad's,

      For BRCA1 and 2 the real value add right now for Myriad's test is that they have spent the last fifteen years collecting variants and correlating them with cancer occurrence. No one else has that data right now. ClinVar (a public database) has about 1000 of the most common variants, but that's estimated to be about only 1% of Myriad's.

  10. Re:It is a hopeful, small step in the right direct by interkin3tic · · Score: 1
    I'm not enough of a virologist to say "Retroviruses accidentally reverse transcribe human mRNAs often when we get a retroviral infection," but I'm willing to bet money they do.

    Either way, the sequences of cDNA are fundamentally natural. All of the cDNA sequence is found in the genomic sequence. I can't retype a popular book on a typewriter, exclude a boring chapter or two, and claim it's novel and claim exclusive rights to it based on the fact that no one had previously typed it out on a typewriter. Transcribing and editing is all cDNA is.

    If some biotech company comes up with a completely novel protein designed by a computer, they should be able to COPYRIGHT it. That's creating something, not simply copying something that's natural.

    If your rather simplistic argument were valid, a vast number of forms of gene manipulation and genetic engineering would become unpatentable, because organisms undergo gene manipulation all the time. (The most extreme example is probably horizontal gene transfer, but there are plenty of other weird things going on, many involving viruses.)

    I don't take it as a given that such things SHOULD be patentable. I am especially wary of techniques for manipulating genes and putting those genes into other things being patentable. But it would depend on the specifics. If you invent a completely novel retrovirus, you again should be able to apply copyright to the viral proteins you made to do genetic engineering and get exclusive rights to it, but you can't patent the idea of a retrovirus transfecting genes, nor should you be able to modify an existing virus and patent that. Maybe you should be able to copyright the modifications.

    But what I prefer isn't always in line with what current case law decrees is allowable, and I wouldn't call the Supreme Court incompetent just because they didn't reach the conclusion I personally favor.

    I was a little hot under the collar, they're not stupid people even when I disagree with them. And you're right, the decision was a win even if it was contradictory. But it was contradictory, and the only way I could see them making that contradiction is if they failed to realize that cDNA is fundamentally the same thing as DNA.

  11. Re:It is a hopeful, small step in the right direct by skywire · · Score: 1

    Yours is the simplistic argument. Yes, the cDNA is 'created' using an artificial process, like copying a book with a photocopier. Copying a book doesn't make you the author, and copying the naturally occurring gene embodied in mRNA into the cDNA form doesn't make you its inventor. Or its discoverer, for that matter, despite the fact that in this case, Myriad was the discoverer of the gene. That discovery was not the rationale offered by the court for their second holding. Their shaky rationale was that Myriad did in fact invent the cDNA form of the gene.

    --
    Those who would give up essential liberty to purchase a little temporary safety, deserve neither liberty nor safety.
  12. Re:It is a hopeful, small step in the right direct by the+gnat · · Score: 1

    I'm not enough of a virologist to say "Retroviruses accidentally reverse transcribe human mRNAs often when we get a retroviral infection," but I'm willing to bet money they do.

    It's quite possible, but largely irrelevant - you would first have to prove that a specific cDNA under question did actually occur naturally. And in any case, a controlled process that produces large amounts of a cDNA is very different from a freak accident like this. Technically speaking, it's also possible that many patented synthetic molecules do actually occur in nature due to biological or spontaneous chemical processes. That doesn't make them unpatentable.

    Either way, the sequences of cDNA are fundamentally natural. All of the cDNA sequence is found in the genomic sequence. I can't retype a popular book on a typewriter, exclude a boring chapter or two, and claim it's novel and claim exclusive rights to it based on the fact that no one had previously typed it out on a typewriter. Transcribing and editing is all cDNA is.

    cDNA is a chemically synthesized product. So is (for instance) an impotence drug. To a chemist there is very little distinction, other than you're using polymerases for the first product, and probably some sort of weird metal catalyst for the second.

    If some biotech company comes up with a completely novel protein designed by a computer, they should be able to COPYRIGHT it. That's creating something, not simply copying something that's natural.

    I'm confused, what does copyright have to do with this?

    nor should you be able to modify an existing virus and patent that

    Why not? If I take a naturally occurring biological entity and modify it to do something completely different and unnatural, how is that not a patentable invention? You are basically demanding that everyone performing any kind of molecular bioengineering start completely from scratch and completely avoid anything that vaguely resembles something natural. We'd also have to avoid using traditional amino acids or nucleic acids, because those are naturally synthesized, which means we couldn't use existing biological systems to replicate our products. This is just insane; it may be an interesting research question but everything we do builds upon prior knowledge, and you are asking that we throw all that out.

  13. Re:It is a hopeful, small step in the right direct by the+gnat · · Score: 1

    Yes, the cDNA is 'created' using an artificial process, like copying a book with a photocopier.

    Maybe, if it's a photocopier that also translates the book into another language. And in that case, even if the book was public domain, the translation would not be. (Although it would be covered under copyright, not patent, but for something like DNA the distinction is difficult to make.)

    Again, I am playing devil's advocate here - I was merely trying to disabuse the parent poster of the notion that any method or product which might vaguely resemble something natural is automatically excluded from patentability. I would strongly prefer that cDNA not have patent protection, but the arguments being given were poorly chosen, and could be used to exclude just about any biological product from being patented based on the presumption that it might occur naturally (by accident).

  14. Re:It is a hopeful, small step in the right direct by the+gnat · · Score: 1

    Just to add to my previous arguments: in my opinion, the reason cDNA shouldn't be patentable is that it doesn't even come close to the threshold of "non-obvious". Especially in an era where whole cell mRNA extracts can be sequenced in bulk and gene synthesis is getting cheaper all the time, giving these patent protection is just a terrible idea, but I would argue that most such patents shouldn't even have passed the test when they were first issued. To anyone skilled in the art, making a cDNA is a bloody obvious thing to do. (Changing the activity of an existing gene/protein so it does something truly novel, on the other hand, I think is not so obvious.)

  15. With all due respect... by Theaetetus · · Score: 1

    Mary-Claire King, a UW geneticist who was instrumental in identifying the breast cancer-causing genes at the heart of the court case, hailed the ruling...

    ... she doesn't seem to be listed on any of the patents that were at issue. She did work in the same field and is listed on other patents, but she doesn't appear to have any relationship to the patents involved in the court case.

    Factually incorrect is par for the course for Slashdot, though.

    1. Re:With all due respect... by the+gnat · · Score: 2

      She did work in the same field and is listed on other patents, but she doesn't appear to have any relationship to the patents involved in the court case.

      From Wikipedia: "While on the faculty at Berkeley, King demonstrated in 1990 that a single gene on chromosome 17, later known as BRCA1, was responsible for many breast and ovarian cancers—as many as 5-10% of all cases of breast cancer may be hereditary."

      The patent is on uses of the sequence, which was what the now-overturned patent covers. Back in the old days, identification of genes was done not through sequencing (the Human Genome Project had just started), but by analysis of how different genotypes were inherited - the relative locations of genes could be determined based on how they segregated during cellular reproduction. As a result, many genes were identified and their approximate chromosomal positions were mapped in multiple organisms, long before the actual sequences had been isolated. This information alone wouldn't be sufficient for a genetic test for breast cancer susceptibility, but neither would the patent holders have been able to sequence the gene in 1994 without King showing them where to look for it.

  16. Re:It is a hopeful, small step in the right direct by pepty · · Score: 1

    Actually the cDNAs are naturally occurring to some extent as pseudogenes. Three minutes on Google found me one for exons 5 and 6 of BRCA1 spliced together without the intron

    So the situation right now is that a cDNA sequence is patentable to the extent it contains splice sites that don't occur naturally. If a sequence derived from a cDNA doesn't overlap one of the splice sites (most short probes do not) it's not patentable. If it overlaps one or more splice sites it may be patentable ... but it may not.

    The big question for me now is whether any courts will extend this precedent to patents on other types of natural products.