ADDED: First up is American Trucking v. LA, a Kagan opinion. They announce opinions in order of seniority, and Kagan is least senior. Something about trucks... and preemption. [ALSO: This case has a concurring opinion from Justice Thomas saying Congress's statute is not supported by the Commerce Clause, "at least in certain contexts."]
AND: A second opinion, Tarrant Regional Water Dist. V. Herrmann, from Sotomayor, the second-least senior. Something about water... and preemption.
NEXT: Third: Ginsburg's opinion, U.S. v. Davila. "This was a case in which the issue was whether there must be an automatic reversal if the judge played any role in the plea bargaining... Federal Rule of Criminal Procedure 11 prohibits judges from participating in plea agreements, but another subsection of the rule also provides that a 'variance from the requirements' of Rule 11 is 'harmless if it does not affect substantial rights,' so this one did not come as a huge surprise."
ALSO: "We have gene patenting. The Court holds that natural isolated DNA is not patentable. Synthetic DNA is patentable." This is a very important case. Unanimous. Thomas wrote the opinion, so that means only Kennedy, Scalia, and Roberts are left to have opinions that might come out today. Here's the PDF of the case, Myriad Genetics. It's a unanimous opinion but Scalia concurs to say:
I join the judgment of the Court, and all of its opinion except Part I–A and some portions of the rest of the opinion going into fine details of molecular biology. I am unable to affirm those details on my own knowledge or even my own belief. It suffices for me to affirm, having studied the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA (cDNA) is a synthetic creation not normally present in nature.AND: That's it for today.
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22 comments:
Someone needs to tell Kennedy to Fisher cut bait.
I'm still here.....doe-si-do.....yep....waiting......
In the meantime, enjoy this dissent posted over at Volokh
Wonderful Scalia concurrence in the gene case... "I join the judgment of the Court, and all of its opinion except Part I–A and some portions of the rest of the opinion going into fine details of molecular biology. I am unable to affirm those details on my own knowledge or even my own belief. It suffices for me to affirm, having studied the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA (cDNA) is a synthetic creation not normally present in nature." Ad multos annos!
The DNA patent case was very straightforward. It is hard to understand how this case could have taken so long to make its way through the courts.
There have been significant financial and social costs associated with this failing by the law system.
I'm shooting from the hip here, but if I understand your post correctly, then they have apparently ruled that DNA actually isolated from a natural source (even "synthetic" DNA is "natural," though) is not patentable, but cDNAs made from that DNA are. "Patenting" DNA sequences was only ever going to occur through materials obtained by such methods as generating cDNAs. Holding the "patent" for a cDNA is effectively the same thing as holding the patent on the natural DNA, since most practial applications from the natural DNA will involve first generating a cDNA (and what if I make an RNA transcript from the natural DNA, then a cDNA from the RNA using RT?). If I use PCR to make the cDNA, and include added sequence on the primers that were not on the original patent holder's cDNA, is it still an infringement?
Sorry for the jargon, but I'm sure somebody here follows it as well as the law and can maybe clarify this for me. My initial impression is that when you talk about "patenting genes," they have drawn a line that is a distinction without a difference. I'm going to start cranking out and filing patents on every cDNA I can think of from every organism I can get my hands on, especially for genes of unknown function.
Crimso said...
I'm going to start cranking out and filing patents on every cDNA I can think of from every organism I can get my hands on, especially for genes of unknown function.
This has already been done.
I think you are misunderstanding the ruling, although I am not a lawyer so I may be misunderstanding the law. As I understand it they ruled against the patent. Your argument regarding the cDNA is irrelevant because it is technically possible to directly sequence the genomic DNA. I think they bring up the cDNA so that their ruling doesn't infringe on true synthetic genes as opposed to simple copies of naturally occurring genes.
"Your argument regarding the cDNA is irrelevant because it is technically possible to directly sequence the genomic DNA."
But in so doing you are making a synthetic copy of the genomic DNA, and if someone has already patented that...
"I think they bring up the cDNA so that their ruling doesn't infringe on true synthetic genes as opposed to simple copies of naturally occurring genes."
That sounds sensible.
AReasonableMan,
They ruled against the patents on the original genes, just split off from the remainder of the genome. But they upheld the patentability of the same genes modified so as to remove the introns. Myriad lost some of its patents, but kept others.
The logic (which seems to me perfectly sound) is that the original genes are natural phenomena; the cDNA is not. (Weird: "cDNA" is glossed as "composite DNA" in the "executive summary" at the top of the opinion, but "complementary DNA" in the opinion proper. There's also a strange editing glitch at the bottom of p. 20 -- you can tell what was meant, but it's distracting.)
I can't wait to see what my Dad, the retired biotech patent attorney, has to say about this. To me it certainly looks rightly decided, but then I don't have Dad's biochem Ph.D. Or his J.D. either :-)
"Myriad's shares soared after the court's ruling."
That's the real measure of their "loss" of the case. The DNA of real practical value IS patentable.
Patrick,
Amen to the Volokh link. If ever there was a case for the Rule of Lenity, that was it. I would love to see everyone who voted for that statute explain publicly what they think it actually says. Ye Gods.
Michelle:
Do please pass on his thoughts, since he would have a full grasp of what this actually means.
And "cDNA" is "complementary." It is usually defined as a DNA copy made from an RNA transcript of a gene, although I would argue that the term could also be applied to any DNA "synthetically" copied from another DNA (in that it is "complementary" to its template DNA) by any mechanism. If you know the DNA sequence in question, you can generate a "cDNA" by other means. It might not be easy or straightforward, but it most certainly can be done. Would such a "cDNA" be covered by a patent? Or only those made specifically via reverse transcribing RNA?
Crimso,
I described the case to him in email just now, and he asked for a link to the decision (which I sent). But he added that if what he gathered from my description of the ruling -- that Myriad was trying to claim patent in isolated segments of the human genome -- was correct, then he agreed absolutely with that part of the opinion.
I pointed out in reply that Myriad hadn't merely sought patent here, it had gotten it, until this morning. But, then, you don't want to get Dad started on the subject of the quality of patent examiners in this area :-)
Crimso said...
"Myriad's shares soared after the court's ruling."
That's the real measure of their "loss" of the case. The DNA of real practical value IS patentable.
I am not sure this is right. They clearly ruled against the patentability of the natural gene sequence. This sequence is all that is required for any diagnostic tests to be developed by rival firms.
If I understand it correctly, the ruling that unmodified cDNAs can be patent eligible seems wrong to me. cDNA is just a copy of naturally occurring mRNA, there is no novelty other than the underlying technology, which is commonplace.
Crimso,
And "cDNA" is "complementary." It is usually defined as a DNA copy made from an RNA transcript of a gene, although I would argue that the term could also be applied to any DNA "synthetically" copied from another DNA (in that it is "complementary" to its template DNA) by any mechanism. If you know the DNA sequence in question, you can generate a "cDNA" by other means. It might not be easy or straightforward, but it most certainly can be done. Would such a "cDNA" be covered by a patent? Or only those made specifically via reverse transcribing RNA?
Judging by the opinion, Myriad wasn't trying to patent means, only the finished product, as it were. So if you were to synthesize the whole thing the hard way, base pair by base pair, you'd still be violating the patent if the results were identical.
Could someone please give a link to the Myriad opinion? Thanks
El Pollo Raylan,
It's in the OP, but PDF is here:
http://www.supremecourt.gov/opinions/12pdf/12-398_8njq.pdf
Michelle Dulak Thomson said: "Amen to the Volokh link. If ever there was a case for the Rule of Lenity, that was it. I would love to see everyone who voted for that statute explain publicly what they think it actually says. Ye Gods.
The sentence runs on and on, but when you break it down, it doesn't seem that complicated:
"Except when an offender commits a violation of section 2903.01 or 2907.02 of the Revised Code and the penalty imposed for the violation is life imprisonment or commits a violation of section 2903.02 of the Revised Code,
[I]
if the offender commits a violation of section 2925.03 or 2925.11 of the Revised Code and that section classifies the offender as a major drug offender and requires the imposition of a ten-year prison term on the offender,
[II]
[OR] if the offender commits a felony violation of section 2925.02, 2925.04, 2925.05, 2925.36, 3719.07, 3719.08, 3719.16, 3719.161, 4729.37, or 4729.61, division (C) or (D) of section 3719.172, division (C) of section 4729.51, or division (J) of section 4729.54 of the Revised Code that includes the sale, offer to sell, or possession of a schedule I or II controlled substance, with the exception of marihuana, and the court imposing sentence upon the offender finds that the offender is guilty of a specification of the type described in section 2941.1410 of the Revised Code charging that the offender is a major drug offender,
[III]
[OR] if the court imposing sentence upon an offender for a felony finds that the offender is guilty of corrupt activity with the most serious offense in the pattern of corrupt activity being a felony of the first degree,
[IV]
or if the offender is guilty of an attempted violation of section 2907.02 of the Revised Code and, had the offender completed the violation of section 2907.02 of the Revised Code that was attempted, the offender would have been subject to a sentence of life imprisonment or life imprisonment without parole for the violation of section 2907.02 of the Revised Code,
[THEN]
the court shall impose upon the offender for the felony violation a ten-year prison term that cannot be reduced pursuant to section 2929.20 or Chapter 2967. or 5120. of the Revised Code."
So there's a laundry list of crimes or attempted crimes for which the sentence is ten years, but there are a couple of exceptions for which the sentence should be life. (And then there's "commits a violation of section 2903.02" for which no sentence is apparently specified.)
Bill,
So you could parse it, and I could parse it (though I hate machete-ing my way through verbiage like that). Do you think the average defendant under the statute could do the same? One part of the rule of law is that people should have some rough idea what the law is.
By the way, PPACA is that times 2,000. It's no wonder that no one who voted for the thing has so far claimed to have read all of it, let alone followed up the changes it makes in existing statutes.
"If I understand it correctly, the ruling that unmodified cDNAs can be patent eligible seems wrong to me."
I agree, but the question is whether SCOTUS just made any "synthetic" DNA patentable, which is a real can of worms. I'm not a lawyer, so I don't know whether they really effectively did that, or if the only legally binding part of the decision was that naturally-occurring DNA can't be patented.
FWIW, Derek Lowe doesn't think the ruling has changed anything other than whether or not genomic DNA is patentable. Apparently the patentability of cDNAs is (and has been) well-established. So I can quit fretting and go back to procrastinating.
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