4 ms·

Supreme Court’s Myriad decision is deeply confused over cDNA

26 points by carbocation 13y ago

aroch 13y ago
These are exactly the concerns I had[1]...I don't understand why the Court is under the impression that cDNA is something magical and patent worthy. Its ubiquitous in Nature and is no different than any other DNA. The Court seems hung up on the fact that it's "exons only" based on my reading of the Majority opinion and that somehow makes it unique _____ [1] https://news.ycombinator.com/item?id=5874506 https://news.ycombinator.com/item?id=5874506
- carbocation 13y ago
  I agree with you, in particular because of logic similar to that in JosephBrown's post [1]: > The justices seemed to argue that removing the introns was the step that makes cDNA patentable, but the introns are already removed from an mRNA molecule If we take this decision at face value, then scientists simply have to decrease reliance on cDNA intermediates. But I worry that we will have to deal with fallout from analogies to the cDNA logic for decades to come. 1 = https://news.ycombinator.com/item?id=5874580 https://news.ycombinator.com/item?id=5874580
  - aroch 13y ago
    I do too, especially since I work with mRNA's and cDNA's on an almost daily basis.
- dnautics 13y ago
  Disclaimer - I don't believe in patents generally. I would rather this whole problem go away. But since we have patents: cDNA is magical because it's created deliberately by the action of human hands to a specific, useful purpose. It's irrelevant that it's made in vanishingly small quantities by accident[1] by RTs on retrovirii in the human body. The same holds true for PCR products, sanger reads, etc. Barring a specific recategorization of nucleic acid products by congress, all of these SHOULD be patentable by the same standards that molecule patents in general should be patented. [1]if you remember your molecular biology - the way that in vivo RTs are primed on the viral RNA template is by having a recognition site that hijacks an endogenous tRNA for use as a primer. As you can imagine, it's highly unlikely that any given gene (e.g. BRCA2) just happens to have a tRNA binding domane upstream of it - you can imagine the problems a virus would have if it just willy-nilly RT'd the heck out of the entire transcriptome. Although it probably happens stochastically at a very, very, very low rate.
  - harshreality 13y ago
    The same reasoning could be used to decide that synthesized diamonds are patentable (not merely the process, but the synthetic diamonds themselves). The decision should have been very straightforward, and against patentability of cDNA of naturally occurring genes. Introns are already removed (according to well-accepted modern theory) between the pre-mRNA and mRNA stages in the naturally occurring process of protein synthesis from DNA. Therefore, intron removal is not novel. Furthermore, constructing cDNA from mRNA is not novel because the process is straightforward given observation of retroviruses. cDNA is informationally identical to mRNA which is naturally occurring. The fact that BRCA cDNA has not occurred in nature (to our knowledge) because no retroviruses (that we know of) carry RNA for it is irrelevant. How does any of that add up to the conclusion that cDNA is patentable? For that matter, how does that add up to the cDNA creation process being patentable?
    - dnautics 13y ago
      Did you actually read the patents? For the most part, they are molecule patent, not a method patent[1]. And you can't patent information, so your argument that "they are informationally identical" means very little, legally. A DNA molecule is not an RNA molecule, so they would have to be covered under different claims in a molecule patent. However, it is the use context which determines novelness of the molecule, which is why the myriad DNA is novel - in the absence of any of the research, how would you have picked that segment of DNA to amplify by PCR in order to test for an enhanced risk for breast cancer? So, that particular class of double stranded DNA molecule has a non-obvious use as a diagnostic tool. It doesn't matter how you made it, or that how to make it is 'obvious'. Let's say you make a wooden machine that does something impressive that no one has thought of before. Does it matter, that just by looking at it, the process to make it (say with a six-axis cutting tool) is obvious? Of course not. Your argument that the "process" is not novel is irrelevant, because molecule patents don't care about the process. Just as plant patents don't care about the process (which for a long time was always the same, plant husbandry, crossing, and grafting). So you shouldn't conflate the requirements for a method patent with the requirements for a molecule patent. The Myriad lawyers weren't idiots - there was a reason why they filed these patents as a molecule patent. That said, I happen to think the claims are overbroad, and that a molecule patent should probably adhere to some more careful standards as to what molecules, exactly, are and are not claimed, but the court case didn't address that at all. Finally, I don't agree that genes should be patented, but only in the context that I don't believe in patents at all. But, if we have a patent system with the laws as they are now, I think the myriad patents are valid. Moreover, I think that the supreme court is overstepping its bounds in its declaration because what it is doing (determining patentable classes) is the function of Congress. However, I don't think what the supreme court is doing is wrong (beyond my general moral objection to patents) because if their faulty understanding of the underlying science were to be correct, then what they did would NOT be determining patentable classes outside of the already-established rubric. [1] there is a method in there, which amounts to "take a patient sequence and compare it to Craig Venter (reference sequence)". IIRC, because this method of diagnosis is clearly obvious, this is not at issue in this case, as it has been rejected and unchallenged.
daughart 13y ago
It seems clear to me that such a confusing and scientifically-confused decision will not last long. Hopefully this decision paves the way for a more reasonable standard in a few years. Meaningful modification should be the standard. Removing introns, which is done naturally, is clearly not such a modification.
- carbocation 13y ago
  > Meaningful modification should be the standard. This would have been a much more useful and realistic ruling. They explicitly don't address meaningful modification (they mention it to say that they intentionally do not address it), so I suppose we shall see where they stand on that eventually.
come2gether 13y ago
herein lies the problem with allowing 80+ year olds with no scientific training to rule on complex scientific questions.
- waterlesscloud 13y ago
  If only they had young clerks working for them.

26 points by carbocation 13y ago

aroch 13y ago

These are exactly the concerns I had[1]...I don't understand why the Court is under the impression that cDNA is something magical and patent worthy. Its ubiquitous in Nature and is no different than any other DNA. The Court seems hung up on the fact that it's "exons only" based on my reading of the Majority opinion and that somehow makes it unique _____ [1] https://news.ycombinator.com/item?id=5874506 https://news.ycombinator.com/item?id=5874506

carbocation 13y ago
I agree with you, in particular because of logic similar to that in JosephBrown's post [1]: > The justices seemed to argue that removing the introns was the step that makes cDNA patentable, but the introns are already removed from an mRNA molecule If we take this decision at face value, then scientists simply have to decrease reliance on cDNA intermediates. But I worry that we will have to deal with fallout from analogies to the cDNA logic for decades to come. 1 = https://news.ycombinator.com/item?id=5874580 https://news.ycombinator.com/item?id=5874580
- aroch 13y ago
  I do too, especially since I work with mRNA's and cDNA's on an almost daily basis.
dnautics 13y ago
Disclaimer - I don't believe in patents generally. I would rather this whole problem go away. But since we have patents: cDNA is magical because it's created deliberately by the action of human hands to a specific, useful purpose. It's irrelevant that it's made in vanishingly small quantities by accident[1] by RTs on retrovirii in the human body. The same holds true for PCR products, sanger reads, etc. Barring a specific recategorization of nucleic acid products by congress, all of these SHOULD be patentable by the same standards that molecule patents in general should be patented. [1]if you remember your molecular biology - the way that in vivo RTs are primed on the viral RNA template is by having a recognition site that hijacks an endogenous tRNA for use as a primer. As you can imagine, it's highly unlikely that any given gene (e.g. BRCA2) just happens to have a tRNA binding domane upstream of it - you can imagine the problems a virus would have if it just willy-nilly RT'd the heck out of the entire transcriptome. Although it probably happens stochastically at a very, very, very low rate.
- harshreality 13y ago
  The same reasoning could be used to decide that synthesized diamonds are patentable (not merely the process, but the synthetic diamonds themselves). The decision should have been very straightforward, and against patentability of cDNA of naturally occurring genes. Introns are already removed (according to well-accepted modern theory) between the pre-mRNA and mRNA stages in the naturally occurring process of protein synthesis from DNA. Therefore, intron removal is not novel. Furthermore, constructing cDNA from mRNA is not novel because the process is straightforward given observation of retroviruses. cDNA is informationally identical to mRNA which is naturally occurring. The fact that BRCA cDNA has not occurred in nature (to our knowledge) because no retroviruses (that we know of) carry RNA for it is irrelevant. How does any of that add up to the conclusion that cDNA is patentable? For that matter, how does that add up to the cDNA creation process being patentable?
  - dnautics 13y ago
    Did you actually read the patents? For the most part, they are molecule patent, not a method patent[1]. And you can't patent information, so your argument that "they are informationally identical" means very little, legally. A DNA molecule is not an RNA molecule, so they would have to be covered under different claims in a molecule patent. However, it is the use context which determines novelness of the molecule, which is why the myriad DNA is novel - in the absence of any of the research, how would you have picked that segment of DNA to amplify by PCR in order to test for an enhanced risk for breast cancer? So, that particular class of double stranded DNA molecule has a non-obvious use as a diagnostic tool. It doesn't matter how you made it, or that how to make it is 'obvious'. Let's say you make a wooden machine that does something impressive that no one has thought of before. Does it matter, that just by looking at it, the process to make it (say with a six-axis cutting tool) is obvious? Of course not. Your argument that the "process" is not novel is irrelevant, because molecule patents don't care about the process. Just as plant patents don't care about the process (which for a long time was always the same, plant husbandry, crossing, and grafting). So you shouldn't conflate the requirements for a method patent with the requirements for a molecule patent. The Myriad lawyers weren't idiots - there was a reason why they filed these patents as a molecule patent. That said, I happen to think the claims are overbroad, and that a molecule patent should probably adhere to some more careful standards as to what molecules, exactly, are and are not claimed, but the court case didn't address that at all. Finally, I don't agree that genes should be patented, but only in the context that I don't believe in patents at all. But, if we have a patent system with the laws as they are now, I think the myriad patents are valid. Moreover, I think that the supreme court is overstepping its bounds in its declaration because what it is doing (determining patentable classes) is the function of Congress. However, I don't think what the supreme court is doing is wrong (beyond my general moral objection to patents) because if their faulty understanding of the underlying science were to be correct, then what they did would NOT be determining patentable classes outside of the already-established rubric. [1] there is a method in there, which amounts to "take a patient sequence and compare it to Craig Venter (reference sequence)". IIRC, because this method of diagnosis is clearly obvious, this is not at issue in this case, as it has been rejected and unchallenged.

daughart 13y ago

It seems clear to me that such a confusing and scientifically-confused decision will not last long. Hopefully this decision paves the way for a more reasonable standard in a few years. Meaningful modification should be the standard. Removing introns, which is done naturally, is clearly not such a modification.

carbocation 13y ago
> Meaningful modification should be the standard. This would have been a much more useful and realistic ruling. They explicitly don't address meaningful modification (they mention it to say that they intentionally do not address it), so I suppose we shall see where they stand on that eventually.

come2gether 13y ago

herein lies the problem with allowing 80+ year olds with no scientific training to rule on complex scientific questions.

waterlesscloud 13y ago
If only they had young clerks working for them.