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The same reasoning could be used to decide that synthesized diamonds are patentable (not merely the process, but the synthetic diamonds themselves). The decisi

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.
- harshreality 13y ago
  I'm aware that the claimed patent was on BRCA1/2 cDNA, and not a process. I can see how my references to process patents might have confused you, but if you ignore those asides, that should take care of your complaints. Your wooden machine is different from cDNA. cDNA is an obvious 1:1 mapping of something that already exists: mRNA. It's obvious because that's exactly what retroviruses do. (Ignoring here the negative vs positive sense distinction in viral RNA because it's irrelevant once the RNA is converted to double-stranded DNA.) If the gene information previously exists in nature, ALL equivalent forms (DNA, mRNA, cDNA, even tRNA) should be excluded from patentability, because they are beyond obvious once you know the nucleotide sequence, and they are equivalent (in terms of information theory). The equivalence (ignoring introns) of all forms of DNA and RNA is universally known (barring strange cases where DNA/RNA structure might interfere with transcription). Novel synthesis methods might be patentable. Novel enzymes that can translate between the forms, also might be patentable. But that's not this case. Often when something obvious or preexisting is patented, a retort is that while the thing may not be patentable, the process to create it might be. I was trying to head off that argument that Myriad might have something patentable here even if the cDNA itself is not patentable.
  - dnautics 13y ago
    wrong. The claimed patent is on BRCA1/2 DNA, not cDNA. Process doesn't matter for a molecule. DNA is DNA is DNA. It doesn't matter if it's made via the cDNA process. It doesn't matter if it's assembled de novo using oligonucleotide assembly. The MOLECULE is patented, not the process. Again. It's the molecule that is patented, not the process. I'm going to say it once more. It's the molecule that is patented. Not the information. Not the process. The MOLECULE. "If the gene information previously exists in nature, ALL equivalent forms (DNA, mRNA, cDNA, even tRNA) should be excluded from patentability, because they are beyond obvious once you know the nucleotide sequence, and they are equivalent (in terms of information theory). " Fine, that's what you believe. However, that is not what the law is. Molecule patents say nothing about information, "equivalent" forms, and have a different definition of 'obvious' than you do. There's a very good reason for them to be defined the way they are, too, because you have to be careful when dealing with legalities. The law has to be (and often fails at being) explicit with these concepts that can be gray, because the way you're treating them is very ill-defined.

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.

harshreality 13y ago
I'm aware that the claimed patent was on BRCA1/2 cDNA, and not a process. I can see how my references to process patents might have confused you, but if you ignore those asides, that should take care of your complaints. Your wooden machine is different from cDNA. cDNA is an obvious 1:1 mapping of something that already exists: mRNA. It's obvious because that's exactly what retroviruses do. (Ignoring here the negative vs positive sense distinction in viral RNA because it's irrelevant once the RNA is converted to double-stranded DNA.) If the gene information previously exists in nature, ALL equivalent forms (DNA, mRNA, cDNA, even tRNA) should be excluded from patentability, because they are beyond obvious once you know the nucleotide sequence, and they are equivalent (in terms of information theory). The equivalence (ignoring introns) of all forms of DNA and RNA is universally known (barring strange cases where DNA/RNA structure might interfere with transcription). Novel synthesis methods might be patentable. Novel enzymes that can translate between the forms, also might be patentable. But that's not this case. Often when something obvious or preexisting is patented, a retort is that while the thing may not be patentable, the process to create it might be. I was trying to head off that argument that Myriad might have something patentable here even if the cDNA itself is not patentable.
- dnautics 13y ago
  wrong. The claimed patent is on BRCA1/2 DNA, not cDNA. Process doesn't matter for a molecule. DNA is DNA is DNA. It doesn't matter if it's made via the cDNA process. It doesn't matter if it's assembled de novo using oligonucleotide assembly. The MOLECULE is patented, not the process. Again. It's the molecule that is patented, not the process. I'm going to say it once more. It's the molecule that is patented. Not the information. Not the process. The MOLECULE. "If the gene information previously exists in nature, ALL equivalent forms (DNA, mRNA, cDNA, even tRNA) should be excluded from patentability, because they are beyond obvious once you know the nucleotide sequence, and they are equivalent (in terms of information theory). " Fine, that's what you believe. However, that is not what the law is. Molecule patents say nothing about information, "equivalent" forms, and have a different definition of 'obvious' than you do. There's a very good reason for them to be defined the way they are, too, because you have to be careful when dealing with legalities. The law has to be (and often fails at being) explicit with these concepts that can be gray, because the way you're treating them is very ill-defined.