I’m shocked. Just totally surprised. And it was unanimous — the Supreme Court determined that human genes cannot be patented. This is excellent news.
Why is it a good decision? Because medical DNA analysis was turning into a patchwork of competing landgrabs. Sequencing technology is coming along so nicely that more and more diagnostic tools are available, that can analyze big chunks of the genome for, for instance, known dangerous mutations. But at the same time, many stretches of DNA were ‘owned’, or patented by various companies. A company called Myriad had the patents on the genes BRCA1 and BRCA2 which, when defective, are associated with a higher frequency of breast cancer. Another company which might have a tool for analyzing a piece of chromosome 17, where BRCA1 was located, would have to intentionally mask their analysis, hiding the sequence of the BRCA1 gene, or they’d have to pay royalties to Myriad.
This is an increasingly ridiculous situation. Imagine if 50 competing meteorological forecasting companies each had rights to the weather above a different state, and a weather service in Louisiana had to pay the weather service in Florida for the right to examine clouds and wind and pressure to the east, and you couldn’t have a national or worldwide weather analysis without paying a thousand petty weather barons. That’s where we’ve been in genetics, with an increasingly balkanized genome and a welter of companies expecting payment if you looked at the DNA sequence in an individual patient.
Francis Collins, director of the National Institutes of Health, who has long argued for limiting private control of DNA data, said today that he was pleased with the ruling. “Our position all along has been that patenting DNA in its natural state does not provide any benefit to the public. There have been concerns that you might have a $1000 genome sequence, but a $500,000 royalty fee to use it. We can breathe a big sigh of relief that this will no longer threaten to inhibit the progress of DNA research.”
So, smart move, Supremes. For once they made a decision that didn’t simply back corporate interests.
One complication, though. They made this decision based on the logic that the genetic sequence wasn’t an invention of the company — it was just what they found there — making that unpatentable. But they also made a decision that cDNA was patentable, which is a little weird.
cDNA isn’t exactly an invention by the company. Here’s what it is: the genomic sequence of a messy human gene is a cluttered mess. There are regions called exons which code for the proteins of the gene product, but they’re broken up by intervening sequences called introns. What the cell will do is copy the whole messy DNA sequence into RNA, and then enzymes come along and snip out the introns and splice together the exons into one continuous sequence. It’s like finding an interesting magazine article in which every other paragraph is interrupted by an ad, so you cut it up, throw away the ads, and tape the story together into one complete, uninterrupted flow of text. It’s a tedious exercise, but your cells do it all the time.
So this processed RNA is simply the coding part of the sequence, with all the useless bits cut out. Most of our genes are more intron than exon, so this is a fairly significant task; the BRCA1 gene, for instance is made of 24 exons, so those 24 chunks are splice together to make the final RNA molecule.
Your cells do not naturally produce cDNA, so the judges are sort of right to recognize it as an artificial process. To make cDNA, that spliced-together RNA is processed by a reverse transcriptase in the lab, making a complementary sequence of DNA. It gives you a new chunk of DNA without all the introns cluttering it up, which you can then insert into a bacterium, for instance, and put it to work making the full RNA/protein for you.
I guess it’s a reasonable compromise to say cDNAs are patentable. There is some specificity to it: you might be selecting a particular splicing variant (there are 38 different kinds of RNA produced from different patterns of cutting and splicing BRCA1 RNA, for instance) with a specific mutation, producing a particular molecular construct that is useful for diagnostics or for experiments. In that case, you have used the sequence to build a useful probe or tool — it seems fair to say your tool is a patentable creation, especially since the underlying genetic sequence is not patented, so someone else could come along and build their own tool from scratch.
There’s still one troubling thing about the decision, and it was Scalia who pointed it out.
Although the court’s opinion was unanimous, Justice Antonin Scalia added a divergent view. While he agreed with the decision, he could not personally stand behind the “fine details of molecular technology” cited by his colleagues, he wrote, because “I am unable to affirm those details on my own knowledge or even my own belief.”
So the judges came to an acceptable decision in this case, but truth be told, none of them are trained in molecular biology and genetics, so they weren’t actually competent to make that decision. This is a problem that’s only going to grow worse and worse as biology becomes more powerful and more esoteric. It’s also a little worrying that Scalia thinks mere belief might have been a useful barometer in making a decision — but the case was so far beyond the bounds of what he understands that I suspect he and the other judges based their decision entirely on the recommendations of the lawyers presenting briefs for their scientist clients.
Scalia’s language is even more bizarre given that he is an very very very pre-Vatican II conservative Catholic, so he’s plenty experienced at believing things he cannot understand. I guess you scientist types simply don’t have the intellectual weight of the typical Catholic priest.
I know. I couldn’t believe it. This is the same court that decided that corporations are real people.
It’s their smartest move since signing with Barry Gordy.
from wikipedia on Jonas Salk and the Polio vaccine:
take home lesson, even if you get a patent, the survival and health of a fellow human being will never earn you a buck. I should also never cost a dime. It is granted. No brainier. Done.
The war on polio is almost done. One generation if we keep seriously focused on the hot spots and everyone else thoroughly vaccinated and it will be gone.
Next one: Malaria.(please, let’s make it Malaria!)
The fact that you’re shocked and surprised by this decision might be a sign you probably shouldn’t be pontificating off-the-cuff on legal matters, good sir. :)
This holding isn’t that surprising at all. (A decision to the contrary would’ve been far more so.) The fact that it was unanimous is only slightly more surprising–although still not really surprising in any objective sense–and is clear evidence of how straightforward this case really was, from a legal standpoint. (On a relative scale, of course. The SCOTUS doesn’t really deal in cases that are completely straightforward.)
Scalia was wise enough to articulate the limits of his knowledge with respect to technology. Those untrained in the law might want to be conscious of their own when discussing it.
Why the fuck did “I know you can’t patent prior art NORMALLY but this is a really real special case we promise” get all the way to the supreme court?
What’s your opinion on elephants’ wings?
I hope they let people grab lunch halfway through him doing that.
Disagree. It has already been published (in the mature mRNA format by myself and all other human beings) and is therefore not subject to patenting due to the lack of novelty.
Genes are already there. It is nobodies intellectual property.
You can not patent the sun.
You can not patent genes of a plant, an animal a human.
It is already published (by non-human but non the less real standards) and NOT a novelty at all.
Synthesize a novel piece of code and we are talking. Sequencing samples is NOT enough. Generate innovation that you can patent, else, fuck off.
Skeptex
Scalia has a history of asserting his own beliefs to fill in the holes of his knowledge (i.e. he’s often an ignorant ass and proud of it).
It may depress you to know that Accuweather has been lobbying for years to turn weather into exactly that scenario. NOAA is an evil socialist organization that must be stopped!
The really sad part is they want NOAA to keep collecting all their data – because they depend on it. They don’t have the resources or desire to monitor all the stuff NOAA monitors. They just want NOAA banned from making the data public. Tax money paying for Accuweather’s profits.
It’s another of those subjects that shouldn’t be debatable at all.
re:
If only so many people weren’t antti-vaxxers. Sorry to derail, reading too much Respectful Insolense for my own good. Sorry
cDNA shouldn’t be patentable. It’s not naturally occurring and it does involve some work, but it fails the test of obviousness.
In many of my patent applications the examiner responded that the invention would have been obvious to one with normal skill in the art given the teaching of X and Y. An obvious combination of two independent inventions is not itself patentable. There’s always an argument about what’s obvious, of course, and sometimes combining two techniques has a serendipitous, surprising result, but that doesn’t seem to be the case here.
I think this is a pretty weak decision. If we can’t generate an entire gene from scratch yet, we soon will be able to, let alone reconstituting the original gene from cDNA. In that case, what’s the difference between unpatentable ‘natural’ DNA and patentable ‘synthetic’ DNA? It’s been pointed out to me that SCOTUS actually didn’t rule one way or another on cDNA, they call it ‘patent eligible’. If I were a company, I’d call that ‘patentable until SCOTUS rules otherwise’.
For the sake of argument say I have discovered a gene with 4 exons and multiple splice variants but only 3 are found as expressed proteins. So I create cDNAs for these three sequences. In effect, have I not patented the gene.
But say I discover that the 3 cDNAs have been patented so I decide to just change a single codon in the cDNA I am interested for Leucine from CUC to CUU – everything else the same. Have I violated the patent? If the patent is for the cDNA sequence – no, if the final protein – yes.
For the record, I don’t think that cDNA sequences should be able to be patented.
mikeyb: why not even a synonymous substitution? Or variation in the length of the poly-A tail? Or you could ligate some personalized linker to the end?
I’m so dumb. CUC to CUU is synonymous. But yeah. I’m with you.
@ skeptex #4
I’m sorry, so are you saying that you must be both a legal scholar and molecular biologist to have an opinion on this? I doubt many people are, including yourself, but PZ is at least one of the two, asshat.
Yeah, the cDNA thing is a bit shady. I mean, by that token, are BLAST and GenBank freely displaying what could become proprietary information? If companies can patent cDNA, then what is the future going to look like for those who commonly do in situs and qPCR. Basically, this is saying that research into transcript-related topics (which is a lot of research, including potentially mine) could become incredibly (more) expensive and bureaucratic. I’m also worried about the potential for conflicts of interest arising.
This was my immediate thought when I read that it was possible to patent DNA, so I’m glad that’s the decision they came to. Seriously, patents are for protecting inventions and intellectual property, you can’t patent a perfectly natural thing and then demand royalties from anyone who wants to study it; that just makes no sense. Not to mention it would slow scientific advance immensley.
I’m a little confused by the fact cDNA is patentable. From your explanation it would seem that that too is entirely natural, so surely the same logic applies?
I can see how it would be logical to patent certain gene combinations that don’t naturally occurr in nature. For example if you GM a crop to be insecticidal, it would make sense to patent the gene combination you used to make it insecticidal. But anything beyond that is nonsensical.
@Skeptex
What does that even mean? How can something be “objectively” suprising? Objective in what sense?
So Scalia basically said “I hadn’t made up my mind ahead of time, so I’m incapable of forming an educated opinion and will go along with everything else” ?
“Everything else” = “everyone else on the court”
skeptex:
So now you are going to pint out why it wasn’t in fact surprising using your vast legal knowledge?
Yay, my first blockquote fail!, second try:
skeptex:
So now you are going to point out why it wasn’t in fact surprising, using your vast legal knowledge?
Guess not.
The judges are saying that there’s prior art. Essentially, they are saying that if this could ever have been patentable, the patent would have to have been assigned to nature when the sequence arose and, as such, it could not be granted to anyone else at a later time.
So, continuing with the magazine analogy, you cannot make a copy of that magazine without permission because someone who is not you (the article writer or the publisher, as the case may be) owns the copyright to it. The Supreme Court decision would be analogous to suggesting that if you took that magazine and republished it after having removed the advertisements you would be granted copyright to this “new” advertising free publication.
I don’t have to tell you (or, very likely, anyone else here) that the set of nucleotides used to express the sequence is not what is significant here but rather the sequence itself. That is, in the sense that matters, the sequence is already naturally occurring.
To continue the magazine analogy, the Supreme Court decision is as if copyright was considered on a separate basis depending on the publishing medium so that if this paper based magazine with the ubiquitous advertisements was also published in an advertisement free electronic version the first person to print a copy of it was granted copyright to the paper based advertisement free version.
I’m glad that the SCOTUS ruled that human genes are not patentable but I think that saying that cDNAs are patentable is an utterly absurd compromise rather than reasonable and “a little weird”.
A friend of mine’s wife tested positive for BRCA a while back, had a double mastectomy and now also works for Myriad. I wonder what her thoughts are on all of this. I’d assume she’s for it but I’m gong to have to ask her.
While there are usually matters to worry about with Justice Scalia, the “without information or belief” language is a typical filler reference in response to legal complaints, when you have to admit or deny something without making a representation. He probably didn’t want to be saddled with ridicule if the main opinion got something wrong (I know…), or he was worried that the scientific interpretations might change in 10-20 years, and the Judges who approved that statement of the science would look silly. It has certainly happened before.
The issue that cDNA is not produced naturally is simply incorrect. Human cells contain endogenous reverse transcriptase activity (it’s one of the steps involved in the creation of processed pseudogenes), so are able to make cDNA from mRNA. I’d bet that you could detect naturally occurring, low abundance BRCA1 cDNA in human cells if you went looking by PCR.
Mormons are strongly represented in the Myriad Genetics hierarchy. I think maybe they got a little confused and tried to set us a multi-level marketing scheme.
At any rate, the fees they were charging for testing were too high.
https://proxy.freethought.online/pharyngula/2013/06/11/lounge-422/comment-page-1/#comment-636466
Most of the management team, many of the members of the Board of Directors, a most of the hung-ho supporters of Myriad Genetics are mormons.
Here are a few of them:
Peter Meldrum, President and CEO
James Evans, Chief Financial Officer
Richard Marsh, Executive VP, General counsel and Secretary
Roger R. Williams, assistant professor of internal medicine at the University of Utah College of Medicine
Dr. Willford E. Smith, Dr. Wilford E. Smith of BYU’s Sociology Department
More on the connections between the LDS Church and genetics research in Utah:
http://learn.genetics.utah.edu/gslc/utah.html
@augustpamplona
#35
Copyright is different from patent, so the analogy might not be that applicable.
A better analogy might be that the magazine and its content (human DNA) is not patent-able. But the algorithm used to parse (or the machine used to read) the content of that magazine is patent-able (cDNA).
Maybe another example. You cannot patent bolts (human DNA, due to prior art). But you CAN patent a better bolt-cutter/pliers/tool (cDNA) to work with the bolt even if there’re already existing bolt-cutter/pliers/tool to work with said bolt.
@ Azkyroth #6
I have no reason to believe such things exist, of course.
@ Jacob Schmidt # 8
Here, at least, he recognized his lack thereof. That is better than never, is it not?
@ erikthebassist #17
Not at all, although after reviewing my original comment, I certainly understand it giving that impression. I am saying that being a molecular biologist is important for understanding the facts and biological mechanisms in play here, but being a legal scholar is important for understanding why the Court does what it does and the basis or bases for its ruling. I am not both of these, but I am at least one of the two as well.
I deeply appreciate PZ’s discussion of the scientific side of this issue, and I regret that my original comment failed to acknowledge that. I am glad he is calling attention to this decision and that he has explained some of the science at issue. I just think the discussion went a step or two too far when it started to discuss the Court’s motives and intent in general (e.g., “For once they made a decision that didn’t simply back corporate interests” and ” It’s also a little worrying that Scalia thinks mere belief might have been a useful barometer in making a decision”), which gets more into the detail of law in a broader sense.
The post also suggests that he based his discussion primarily on the story he linked, which is helpful, but does gloss over a couple of details discussed in the actual holding. This is true of most legal journalism, frankly, which is why I generally find it difficult to trust most legal journalism without reviewing the original source material (i.e., the Court’s opinion).
@ Thumper # 20
A fair point, and I apologize for the lack of clarity in my earlier post. Please allow me to clarify: The unanimity of the decision was only slightly more surprising than the decision itself, but I would not call either fact especially surprising. On a Surprise Scale of 0 to 100, for example, the decision itself might be a 2, and the unanimity might be a 5, but they’re both still on the very low end of the scale.
@ zenlike #23
You’re right, I probably should have done that, and I shouldn’t have raised the point without doing so. At this point, though, we already have solid explanations from Thumper (“patents are for protecting inventions and intellectual property, you can’t patent a perfectly natural thing and then demand royalties from anyone who wants to study it”), augustpamplona (“The judges are saying that there’s prior art . . . that if this could ever have been patentable, the patent would have to have been assigned to nature when the sequence arose and, as such, it could not be granted to anyone else at a later time”), and Nicholas Ackerman (“the ‘without information or belief’ language is a typical filler reference in response to legal complaints, when you have to admit or deny something without making a representation”). Anything I say in the short amount of time I have now would be duplicative of those observations, and therefore redundant. My apologies for failing to do so originally, though.
All in all, I think the general theme of this post is “So, in my hastily-made previous comment, I was pretty brusque, and more than a little rude–which certainly wasn’t my intention, but that doesn’t change the fact that I did it, and now I see that was pretty annoying. I apologize for not being more thoughtful, more considerate, and more detailed in my explanation, and for not expressing how much I did appreciate the vast majority of the post.” I do still think that specialized knowledge of the law is important in discussions of the law, just like specialized knowledge of molecular biology is important in discussions of molecular biology, but I failed to actually articulate any specialized knowledge I might have when I posted, which was both silly and unproductive. I’ll be less obnoxious (and, hopefully, more helpful) in the future.
Apologies for the double-post, but I missed two points to which I’d like to respond as well.
@ Jonathan Pettitt #28
The Court actually addressed this in one of its footnotes:
I freely admit that I have no idea whether this description is accurate, and would love to hear it evaluated by someone who does.
@ WharGarbl #35
A fantastic point. Or, to put it another way: The human DNA might be analogous to certain naturally occurring elements, like iron and carbon, and the cDNA is analogous to a specific alloy that does not (or does not ordinarily) show up naturally, but is composed entirely of those natural elements.
(Again, my understanding of molecular biology is limited, and my understanding of metallurgy is even more so, so I’m not sure if this is a good analogy or not, but I think it’s probably along the lines of the Court’s thinking.)
Uh… Confuse me, maybe. All data is collected by the government, since they have the actual money to put all the shit out there from which its collected, while companies that merely “report” the weather simply don’t, so.. literally everyone that does weather gets their data from the same source. Hell, they don’t even do their own models, in the strict sense, they take the models, run on a big super computer, which runs like 1,000 different scenarios, with small variations in the data set, then generates a “statistical” data set, based on those, to define what the odds of, say, rain is in a particular place. Groups like Accuweather then take this data, which *everyone* gets the same of, and feeds it into its own, simpler, models, tweaking the numbers a bit (for example, nearly all of them prefer, if the odds are 50% rain, that they inflate that, to like 60%, so that they don’t get a bad reaction from people using their service, if it *does* rain). Worse, nearly all of them do completely stupid shit, like giving you a like 10 day forecast, when the models on those huge assed super computers can’t even give one that is accurate beyond 5-6 days. I.e., they lie about their own reliability, so people think they are buying something better than everyone else’s, including the “free” data, from which all weather forecasters get their information.
So… They basically saying, “We want to be the only people allowed to have this. All of our competition can get their own data, by pulling it out of their asses, or something, because the government weather service, from which *everyone* gets their data, for free, should only give it to us, and no one else.”? I don’t know what drugs they take at Accuweather, but I suspect its never going to be legalized… lol
—
As for the whole cDNA thing.. So, presumably, if/when they have a way to target exactly a faulty gene, and disable/delete it, before/while inserting a fixed one, if the “fix” is cDNA, then.. that would be patented. So, the means to find the disease – not patentable, but the means to repair it – patentable… Not sure if that isn’t just as bad, in some cases. I mean, if you miss a payment, once you get a treatment, do they issue you a cease and desist order, on using your repaired genes? lol Not that, what ever they do pull, based on this, will be all that funny.
Scalia has a long history of not understanding even the basics of junior high science. He asked questions at the hearing on limiting CO2 that he could have gotten by reading the chapter on weather in an eighth grade earth science book the night before, and his dissent to the decision against teaching creationism in public schools showed that he failed to understand the basics of evolution.
No, they didn’t. They said that it fell under the range of patentable subject matter, but just being patentable subject matter is not enough for something to be patentable. There are a number of other tests, and the ruling explicitly stated that they made no statement on whether it satisfied any of these other tests.
Here is the exact quote, from footnote 9 of the ruling: