Supreme Court’s Myriad decision is deeply confused over cDNA
blog.carbocation.com
blog.carbocation.com
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> 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.
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.
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?
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.
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.
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.
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.