Supreme Court: No Patents For Natural DNA Sequences

ColdWetDog writes "The ongoing story of Myriad Genetics versus the rest of the world has come to an end. In a 9-0 decision, the US Supreme Court has decided that human genes cannot be patented. From a brief Bloomberg article: 'Writing for the court, Justice Clarence Thomas said isolated DNA is a "product of nature and not patent eligible merely because it has been isolated." At the same time, Thomas said synthetic molecules known as complementary DNA, or cDNA, can be patented because they require a significant amount of human manipulation to create.' Seems perfectly sane. Raw genes, the ones you find in nature are, wait for it — natural. Other bits of manipulated DNA / RNA / protein which take skill and time to create are potentially patentable. Oddly, Myriad Genetics stock actually rose on that information." Adds reader the eric conspiracy: "The result for Myriad is that they still have protection for their test, however the decision also allows researchers to work with the DNA sequences that are predecessors to the cDNA used in the test." Here's an AP report on the ruling, as carried by the Washington Post.

Comments

Why is it odd?

[Eskarel]

The court case is over and the result wasn't actually all that bad. Sure Myriad and their stock holders would much rather have complete patent rights to the whole thing, but they kept the protections on their actual asset and the court case is now final and decided. Hell even if they'd lost completely their stock probably would have gone up because at least the risk was gone.

Re:Why is it odd?

[bonehead]

The result wasn't that bad, but the real question is "Why the fuck was this ever even an issue in the first place"?

Patents should be for creations, not discoveries.

The ONLY people who should be entitled to a patent on my genome is my parents, and even that is questionable.

Or, I could see a patent on genes being issued to either "God" or "The Universe", depending upon religous beliefs (or lack thereof).

But this case should have never even been allowed to waste the court's time.

Re:Why is it odd?

[Samantha Wright]

It's disastrous. cDNA is just a direct copy of the most important part of what's in the genome—the actual transcript that gets used to make the final protein. This isn't a victory at all.

Re:Why is it odd?

[Sarten-X]

Wait, you mean the stock market is a complex system that isn't accurately described by a single "good news/bad news" model? But Slashdot has taught me that the easy and simplistic solution is always right!

Next you'll be telling me that a gold standard won't actually fix economic problems, or that Linux won't immediately replace Windows everywhere once it has $FEATURE... What madness is this?

Re: Why is it odd?

[Anonymous Coward]

They said may be patentable. Naturally occuring cDNA falls under the original ruling which stipulated human modification is a requirement for patent eligibility.

Re:Why is it odd?

[NatasRevol]

I wonder how much it costs to sue all the way to the Supreme Court. And lose.

Re:Why is it odd?

[gman003]

Or, I could see a patent on genes being issued to either "God" or "The Universe", depending upon religous beliefs (or lack thereof).

Once again, I see people would rather ignore Pastafarianism than accept the objective evidence of its correctness.

I will note that DNA was obviously made by the Flying Spaghetti Monster, in his image. Why else would the foundation of life be so noodley? Yet more evidence we are correct!

Re:Why is it odd?

[cdrudge]

Patents should be for creations, not discoveries.

Aren't all creations just discoveries on how to do something a particular way?

Re:Why is it odd?

[RDW]

Sure Myriad and their stock holders would much rather have complete patent rights to the whole thing, but they kept the protections on their actual asset

If this is the case (and it probably is, hence the increased stock price), then the BRCA genes effectively remain patented in the US. Anyone 'skilled in the art' (like a grad student or junior technician) can trivially create 'artificial derivatives' of a known gene sequence (e.g. cDNA, as mentioned in the decision) just by 'designing' some primers (there's software to automate this), ordering them in (together with the relevant reagent kits), and following some step by step protocols. If this sort of thing is still patentable (as it seems to be), and Myriad is still the only provider allowed to offer a BRCA testing service, then the SC decision will make little practical difference for the moment - Myriad will still 'own' the genes if they are screened by standard methods. However, the decision might be good news for anyone using a 'next generation' sequencing approach, where relevant mutations are pulled out from (e.g.) a whole genome sequence (which isn't much more expensive than Myriad's price for targeted screening, and will be much cheaper in future):

http://www.genomicslawreport.com/index.php/2010/10/11/a-do-it-yourself-genomic-challenge-to-myriad-the-fda-and-the-future-of-genetic-tests/

Re: Why is it odd?

[Samantha Wright]

The only time cDNA occurs naturally is in the reproduction of a retrovirus or the replication of a retrotransposon. Myriad is still using the natural human sequence in their tests. This is like getting ownership of a quote from a book because you copied it into a Notepad window and then into Google, instead of just pasting it directly into Google in the first place, and then claiming it's a good way to find a certain rare edition of the e-book because it contains a typo made by the original author. It's completely and utterly intellectually dishonest.

Re:Why is it odd?

[Anonymous Coward]

The ONLY people who should be entitled to a patent on my genome is my parents, and even that is questionable.

It's probably much too late for your parents to claim a patent. If they're anything like my parents you (the invention) were publicly disclosed long before you were even born. The method used for your creation is also widely known, with an entire industry devoted to educational videos documenting many examples of the process and it's variations.

Re:Why is it odd?

[Anonymous Coward]

Once again, I see people would rather ignore Pastafarianism than accept the objective evidence of its correctness.

I will note that DNA was obviously made by the Flying Spaghetti Monster, in his image. Why else would the foundation of life be so noodley? Yet more evidence we are correct!

Oh, you religious nuts are all the same, twisting the evidence to reinforce your own nonsensical beliefs. If DNA were really the creation of some mythical Pasta, how do you explain the disparity between the portion of double helical pastas and the portion of double helical DNA? Or more to the point, where are the single helix based lifeforms, modeled in His noodley image?

No, if the latest findings from the field of theoretical physics are to be considered, the best evidence is for some form of six sided god with varying numbers of pips on each side depending on your denomination. Einstein was close when he said "God does not play at dice," for God *is* the dice. When you think about it, our youth has really known this for generations, naming the devout religious members of the population "squares."

Re:Why is it odd?

[Impy the Impiuos Imp]

It was an issue because Congress was dragging ass on it. Even if you think such discovery should be protected, I still wouldn't hold my breath. They are inherently cowardly and lose fewer votes to inaction rather than risky action. Whenever a court decides something they should have addressed, or a regulatory agency does, everyone gets to throw up their hands and say, "I didn't do it!"

Re:Why is it odd?

[Impy the Impiuos Imp]

That empowers Congress to create laws defining these things. Whether Congress can grant patents to discoveries is separate. Current law as defined by Congress, does not.

Re:Why is it odd?

[mdmkolbe]

Patents should be for creations, not discoveries. The ONLY people who should be entitled to a patent on my genome is my parents, and even that is questionable.

But what if someone created/discovered a gene you have before your parents did? In patent law (unlike copyright), independent creation/discovery is not a defense. All that matters is who was first. This means that protections against DNA patents need to be based on a stronger line of reasoning.

Re:Why is it odd?

[YalithKBK]

The result wasn't that bad, but the real question is "Why the fuck was this ever even an issue in the first place"?

Patents should be for creations, not discoveries.

Seriously! I've been saying this since we first started sequencing the human genome! Now excuse me, I'm going to go patent all the air in this room so my coworkers have to pay me a fee if they want to breathe.

Re:Why is it odd?

[PRMan]

Yes. But you can't patent a new species of plant or animal just because you are the first to find it. Those are "natural" ie found in nature. Taking those building blocks and making a discovery with them (a tungsten wire will glow when electricity is applied to it) is worthy of patent protection, not "hey, I found this new thing called tungsten and nobody else can use it".

Re:Why is it odd?

[Anonymous Coward]

Ramen brother. Ramen.

Re:Why is it odd?

[blivit42]

It's disastrous. cDNA is just a direct copy of the most important part of what's in the genomeâ"the actual transcript that gets used to make the final protein. This isn't a victory at all.

I agree that this isn't really a victory. The court still got things very wrong. But the above explanation isn't quite correct, either. The transcript that gets used to make the final protein would be mRNA, not cDNA.

It's still just a copy of the original, though. And a trivial copy to produce. Nature already gave us enzymes to do this, which we isolated from various bacteria (which were also patented). We then mix some stuff in a tube, and voila, we have a complementary copy of the DNA. For a not-quite-apt analogy, it would be like taking a page of text and photocopying a mirror image of it. Or, perhaps more appropriate for Slashdot, transcribing it into ROT13. However you look at it, it is a trivial to produce copy, even if it is sort of a mirror image of the original.

So, I feel that cDNA should not be patentable. It's trivial. It's obvious. It's already existing in nature. Little effort went into creating it. You should not be able to patent fragments of cDNA. Now, how you *USE* said fragments, like as a specific collection of cDNA fragments for a test kit, that's another matter, one which I don't want to get into. I don't like method patents, but that isn't the issue we're discussing right now. The court still got this wrong, due to lack of sufficient understanding of biology.

Re:Why is it odd?

[Samantha Wright]

Yes, it's relatively easy to PCR up the sequence from the genome once you know what you're looking for.

Let me make an extended computer metaphor to explain this properly.

The human genome is comprised of many different types of information, which we can liken to pieces of text in different languages. Consider a case where we have a long document written in Russian that discusses source code for a program that was heavily commented—but in Greek. (For those of you following along in the lab, Russian is the untranscribed DNA, Greek is transcribed but noncoding, and the ASCII program itself is the coding sequence.) All of this is in UTF-32.

When the cell functions normally, it uses the program's source as a build script: it copies the code out of the document into CP-1253 (the Windows Greek code page), and then cuts out any remaining "??????" left by the transcription, as well as all of the Greek comments in the middle of the code. There are some comments at the start of the code and at the end, but most of the copy is the code itself.

In the Myriad case, they've found a program that works the other way, called reverse transcriptase. It turns the 8-bit Greek/ASCII mixture back into UTF-32, but the Russian and the intragenic comments are still gone, leaving us with a usable sequence that we can do a bitwise search comparison with. This is very convenient to do because there's already a complete set of such sequences available. These are called cDNA libraries, and we rely on them everyday to tell us where the Greek comments are.

What researchers will be forced to instead is to cut the sequences out by hand directly from the wide Unicode source, using a lab technique called PCR splicing. The stupid thing is that there's no chemical difference between the two—it would be impossible to prove one way or the other where the diagnostic sequence came from, unless you knew the sequence's history. It just means that researchers now have to fumble around with splicing a bit more. Presumably the only reason Myriad isn't crapping their pants is because they think they can litigate based on intent in such cases.

Re:Why is it odd?

[Samantha Wright]

Sorry, that was a bit of confusing language; I meant it to be read as "cDNA is a copy of the transcript."

And I think I have a better way of doing the metaphor than ROT13: different codepages. (Although the idea of ROT13 is apt to the physical reality, it's not really that important to the explanation.) Unicode genome, 8-bit transcripts, 7-bit ASCII proteins. Intergenic DNA is in Russian, transcribed RNA is in Greek, and RNA polymerase converts things to a Greek codepage.

...the art of the car analogy is definitely dead.

Re:Why is it odd?

[nmr_andrew]

Of all the days not to have mod points. Pretty much any genetic research starts by making a cDNA library. It's not that difficult; I think you can probably buy a kit to do it these days.

It's only a matter of time now until some researcher comes up with a different test for, or treatment of cancer linked to, this particular gene and Myriad's lawyers sue because they "must have" made use of the patented cDNA sequence in their research.

Re:Why is it odd?

[flarez]

Great analogy. Might I add a direct quote from Thomas' opinion: "[Myriad's] claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule." Pretty much saying the code matters, not the encoding.

Re:Why is it odd?

[Samantha Wright]

Yeah, it's one of the easiest things to kit since it's just an extra step on top of PCR. All of the big vendors supply it.

Given that the patented sequence is literally a PCR assay for a handful of single-nucleotide mutations, it would be technically impossible to not use the sequence in question, so they can be certain that such a case would go forward. From the patent:

All four sequence variants are heterozygous and each appears in only one of the kindreds. Kinderd 2082 contains a nonsense mutation in exon 11 (FIG. 9A), Kindred 1910 contains a single nucleoting insertion in exon 20 (FIG. 9B), and Kindred 2099 contains a missense mutation in exon 21, resulting in a Met.fwdarw.Arg substitution. The frameshift and nonsense mutations are likely disruptive to the function of the BRCA1 product.

Re:Why is it odd?

[c 0xFF]

Discovering a new way of putting things together == patentable
Discovering something that already exists == not patentable

It doesn't matter if it's nature or prior art: if it already exists, is shouldn't be covered by a patent.

Re:Why is it odd?

[Samantha Wright]

Which is even more horrific, because that's literally a software patent.

Re:Why is it odd?

[idunham]

You seem to be missing something:
"A gene you have" is preexisting and natural (at least for anyone who can post now...); hence, it is not patentable.
"My genome" refers to the genes and alleles I have collectively.
Genes do not spring into existence as a result of sex.
Rather, sexual reproduction takes preexisting genes and recombines them to create a new collection of genes.

Unless someone other than one's parents gave birth to a person as genetically equivalent to you as an identical twin and patented the genome before one's birth (otherwise, prior art comes into play), the situation you refer to could not happen.
In other words: The probability of the first happening is approximately null, with a potential variation less than one quadrillionth (I don't know the real number off the top of my head, but one quadrillion is what 50 genes having two alleles would result in. That's probably a tremendous underestimate of the variation.)
Also, any offspring one had would not be covered by the patent, because they would have a different set of genes.

And finally, one could argue that any given combination of preexisting genes is obvious in light of prior art.

Re:Why is it odd?

[rahvin112]

Myriad was claiming ownership of the entire Gene, any new tests to identify it using different methods or cDNA would be, according to Myriad, covered by the patent. What the supreme court decisions does is says that Myriad owns the specific cDNA they came up with. It may be even possible that different cDNA that accomplishes the same purpose would not run afoul of the patent and tests that didn't rely on the cDNA would be immune as well. This was an important decision because Myriad's claims had basically shut down research on this genetic sequence. The ruling opens that research back up and restricts Myriad's patent only to the specific test they have created.

This does two things, research can continue while allowing research to continue and it preserves the billions being pushed into Genetic research by providing payoffs for patentable tests using human created testing sequences. (I know it's not quite that simple). The thing here is a decision that had been all one side would have damaged the industry regardless of what direction it went. A decision invalidating any patents would have devastated independent research and a decision allowing Myriad to patent genes would have devastated competition and significant amounts of new research on existing identified genes. This is a good middle of the road decision which preserves the open access, lays down a precedent that you can't patent natural creations while preserving investment streams in a very important area of the biological sciences.

Re:Why is it odd?

[thunderclap]

The result wasn't that bad, but the real question is "Why the fuck was this ever even an issue in the first place"?

Because the system is broken and people want to take advantage of that system to make money for themselves and damn the consequences. Shame they couldn't invalidate all their patents simply because they wasted the courts time with an obvious answer. How often do you get 9-0? Thats a what the F### is wrong with you question.

Re:Why is it odd?

[icebike]

That empowers Congress to create laws defining these things. Whether Congress can grant patents to discoveries is separate. Current law as defined by Congress, does not.

That's not exactly true.

Discoveries can be and are patented all the time. And its perfectly legal according to the constitution and current law.
You may not thinks so, but that is just a testament to how few novel discoveries are actually made in the modern world, and how few of them can actually be incorporated into new and novel inventions. The most common discoveries patented today deal with process patents, ways of doing or making something.

The issue in the present case, is that Myriad tried to not only patent their process and the resultant treatment, but to claim ownership of something that is in every persons's body. You can patent false teeth, or the method of making them. You can't patent MY teeth. Myriad simply over-reached.

Re:Why is it odd?

[shentino]

Anyone thinking DNA should be patentable has a twisted mind.

Re:Why is it odd?

[shentino]

To the mods:

"Ramen" is pastafarian version of "amen"

Get a sense of humor.

Re:Why is it odd?

[bmk67]

It's roughly a metric shit ton of megabucks.

Re:Why is it odd?

[Albanach]

The court case is over and the result wasn't actually all that bad. Sure Myriad and their stock holders would much rather have complete patent rights to the whole thing, but they kept the protections on their actual asset and the court case is now final and decided. Hell even if they'd lost completely their stock probably would have gone up because at least the risk was gone.

Not that bad? Ambry Genetics are, as of this afternoon, offering BRCA testing at half the cost Myriad were charging yesterday. other firms have already announced they'll be offering the test later this year.

Take a look at the front page of Ambry's website. If I were a Myriad stock holder, I'd think this was pretty bad.

Re:Why is it odd?

[AthanasiusKircher]

Yes, it's relatively easy to PCR up the sequence from the genome once you know what you're looking for.

When I hear some sort of detailed computer analogy about some application of PCR, somehow all can think of is this video.

Re:Why is it odd?

[0xdeadbeef]

I'm sorry, I'm going to need a car analogy to make sense of this.

Re:Why is it odd?

[Samantha Wright]

Remember the music videos at the end of Bill Nye episodes? That Bio-Rad commercial is like that for adults. Unfortunately, none of my professors sang along when they brought it up in class.

If it helps, there's a sequel, although it's not as generic.

Re:Why is it odd?

[kaliann]

I didn't follow the coding analogy, but I'm much more biogeek than computer nerd.

I'm in the camp that thinks cDNA, the production of which is prior art, is not patentable just because someone was the first person to identify the gene the the cDNA is encoding.

If you can't patent the sequence, and copying genetic material in that fashion is already well known and widely used, copying your identified sequence is an obvious (in the legal, patent-relevant sense) step.

My analogy is: If you discover a crystal that exists in nature, that isn't patentable. If you use your Crystal Maker 5000 3-D printer to make copies of your crystal, just as everyone else uses their CM 5000 to make theirs, you can't patent the copy either. Not innovative.

Re:Why is it odd?

[Artagel]

Some people have the idea that discoveries can be patented because of the U.S. Constitution. Article I, Section 8, clause 8 reads:

"To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries;"

  So inventors can be given exclusive rights for a limited time for their discoveries. Or at least, that is what English grammar says.

Re:Why is it odd?

[Daniel Dvorkin]

It's disastrous. cDNA is just a direct copy of the most important part of what's in the genomeâ"the actual transcript that gets used to make the final protein. This isn't a victory at all.

It's bad. cDNA just copies the most important part of the genome: the actual transcript used to make the protein. This is no victory.

(c)(r)(tm)(pat. pending) 2013, Daniel Dvorkin. All rights reserved. By reading this post, you grant me all rights to anything you write, say, or think, in perpetuity.

Re:Why is it odd?

[Samantha Wright]

I was trying to come up with one earlier, but I could only think of a car manufacturing analogy. We'll try it anyway:

There's this really good car design that's in the public domain, and it's really popular. Unfortunately, some of the factories that make the car have screwed up molds in some of the ducting that cause the airbags to fill up with motor oil at random. (Sophisticated, I know. Bear with me.) The loss of motor oil eventually causes the engine to overheat and the pistons to fuse, destroying the car. (Okay, so it's not a really good car design. It's a Lada. But still.)

To fix the car, you have to remove the airbags, but this is an obvious safety hazard and wildly undesirable, so no one wants to remove them if it's unnecessary. Determining whether or not they need to be removed depends on knowing the shape of the gasket that causes the leak: a tiny, hard-to-reach component buried deep in the gearbox that can't be checked without disassembling the car.

Aha, says Myriad, but we have a solution—our experts took a mold of the gasket, and if the mold fits on the gasket, you'll be able to tell if your car's at risk! You just stick the mold on the end of a crowbar and put it in a maintenance port that's normally too small for someone to reach inside. If the mold clicks on, then you know it's a match; otherwise, you're fine.

Brilliant! says every mechanic in the world, and they go out to make the mold, because a lot of them have seen these terrible cars and they have examples of the malformed gasket on hand.

But no! says Myriad, who has patented the mold. This is our invention, and you can't use it! Here is our patent.

But it's just a copy of a broken version of something in the public domain! The gasket's shape is already in our cars! says everyone else. In fact, there are molds just like the one you made in the factory! So they take Myriad to court, and the judge says:

1. Since the original mold that made the screwed up gaskets is in the public domain, you can't patent it.

2. But Myriad did work by making the mold and they're very clever, so I want them to be able to patent their invention. (Their lawyers convinced me of this.)

3. What really matters is the shape of the mold, though, not the mold itself. Myriad may not own the factory molds, but they own the shape. If you can cut up one of the factory molds and put it on your crowbars you're fine, and you can make copies of it too, but if you make your own the same way Myriad did, you're infringing on their patent.

4. In fact, we're just going to write this judgement in such an ambiguous way that you're infringing even if you use the original mold, because a copy of it is physically indistinguishable from Myriad's molds.

And that's how fucked up the patent system is.

Re:Why is it odd?

[Samantha Wright]

Maybe this car analogy will work better? :)

Re:Why is it odd?

[ebno-10db]

To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries; [emphasis changed]

You need an expert in 18th century English to really sort that out. In modern English it's a contradiction because inventors invent things, they don't make scientific discoveries. I suspect "science" means something other than our common modern usage (which is more a matter of convention than definition anyway). In the 18th century what we call science might have more likely been called natural philosophy.

Re:Why is it odd?

[ebno-10db]

The most common discoveries patented today deal with process patents, ways of doing or making something.

You're playing with philosophy and word games. I'd argue that process patents are about inventions rather than discoveries because they deal with things that were created by people rather than things which already existed in nature. That's the way it's commonly understood and used today, Plato might have disagreed.

Re:Why is it odd?

[MobyDisk]

Patents should be for creations, not discoveries.

No. Patents should be for inventions. Creations, such as a string of the letters ATGC in any particular order, should be covered by copyright.

Re:Why is it odd?

[mdmkolbe]

Keeping in mind, of course, that this is just a thought exercise (IIUC, the court ruling does not rely on this line of reasoning), you are right that I overlooked the fact that usually "genes do not spring into existence as a result of sex". (Though we still have to consider novel gene mutations regardless of where they come from.)

Since the patent under discussion does not apply to a genome (I doubt any DNA patent does) but rather to particular mutations of the BRCA1 and BRCA2 genes, if the patenter created/discovered the mutation before it's first occurrence "in the wild", then the defense of the original poster would fail. ("First to file" instead of "first to invent" complicates this, but prior art may get us back to the same place.)

That then leaves two potential loopholes (though they do not apply in this case). First, just as pharmaceutical companies can breathe new life into old drug patents by tweaking an "irrelevant" part of the molecule, it is conceivable that companies could patent variations of the mutated BRCA1 and BRCA2 genes that have not yet occurred in the wild. Second, companies could proactively patent gene mutations that have not yet occurred, but that they think will become important (e.g. some other mutation of BRCA1 that they think would cause cancer if it eventually occurred).

I don't know enough about gene mutation rates or interactions to know how feasible these loopholes would be, but I might hesitate to rely on this defense because of these loopholes.

Re: Why is it odd?

[Samantha Wright]

They're already effectively patented. This ruling changes little or nothing for coding regions of DNA.

Re: Why is it odd?

[Samantha Wright]

...sorry, for all transcribed DNA, not just coding DNA.

Re:Why is it odd?

[Dahamma]

Yeah, it still doesn't make sense that cDNA *itself* could be patentable based how it patents vs. copyrights, etc work (at least in my flawed understanding).

I would think a method of creating cDNA *should* be patentable, but the result is just a copy of an existing sequence. If someone else comes up with a different method to copy that sequence, it's not infringing. Sort of like how you can patent a fax machine or a photocopier, but not the copy...

Re:Why is it odd?

[Samantha Wright]

In this case, the photocopiers can be found in almost every animal and plant, and a good deal of viruses. There's not much human innovation; it's just a matter of knowing what to make a copy of and how to use the photocopier.

Re:Why is it odd?

[Dahamma]

Well, technically patents are *supposed* to be about a method or process (which is why most software patents that just talk about user-facing design or look should be invalid). That's why you can get a patent that just modifies an existing process that you don't have a patent on - in which case you'd actually still have to license the original (assuming it's not expired) to use yours.

There are most definitely plenty of processes and equipment used in genetic testing and creating cDNA in a lab that don't exist in nature, or that combine many things that may already exist in novel ways.

Re: Why is it odd?

[YankeeBoy]

The only time cDNA occurs naturally is in the reproduction of a retrovirus...

Great, so we don't need to look for cures for retrovirus-based diseases - we just sue the retrovirus for patent infringement!

Re: Why is it odd?

[Samantha Wright]

Pretty much. Say goodbye to HIV.

Re:Why is it odd?

[Samantha Wright]

To be honest, you're right; it's extreme given the current climate and how many enzymes are patent-protected. But I do want to make a point here: where should the line be drawn? How much 3D shape does code need before it becomes a blueprint? It seems to me, honestly, that this sort of thing should be protected by copyright, not patent law.

Right now people are getting a lot of low-quality patents for enzymes that would make no sense applied to physical devices; Clontech has one or more patent(s) on reverse transciptase for disabling part of the native enzyme. Knowing to disable that part requires a fair amount of expert knowledge and research, but actually carrying out the work can be done in a number of ways, and their patent lists specific amino acids to knock out. That means someone else can still get a patent for the exact same functionality if they happen to break the enzyme at a different critical point. Because the patents involve sequence-level jargon, they're trivializing themselves instead of focusing purely on functionality, which is why (a) Myriad was allowed to get exclusive ownership of a naturally-occurring (if abnormal) sequence, and (b) there are a lot of competitors in the enzyme market for things like DNA replication.

That competition may be good, but it only exists because the patents are too specific in a lot of cases. It exists in circumvention of the spirit of the patent system, not because the products themselves are really all that patent-worthy. Specifically for domain-disabling, in a lot of cases the critical residues to mutate can be determined systematically with little creative work... this is far, far away from the kind of ingenuity involved in designing a new rubber sole, car engine, or a sophisticated algorithm patent.

In my opinion, the bar for enzyme patents needs to be raised to the level of "novel mechanism of action," like a really fancy chemical reaction patent. If you're just knocking the out teeth of, rearranging, and truncating parts of nature, then what you're really doing is creating a remix of something pre-existing, like some kind of bizarre chemical found poem or (gods forbid) an AMV. It's essentially art, not invention.

Re:Why is it odd?

[cundare]

>The result wasn't that bad, but the real question is "Why the fuck was this ever even an issue in the first place"?

Because, among other things, there was an unresolved question about how closely DNA products might follow the same rules as other types of subject matter. Naturally occurring adrenaline, e.g., can't be patented because it's a product of nature. But extracted and concentrated adrenaline is, famously, patentable, as are methods for creating such a concentration. If there's a chance that a manufacturer can obtain patent protection for a high-value product that falls into even the periphery of a gray area, it may be justifiable to at least try to push the envelope.

So now we have more clearly defined boundaries, which is a win for everybody. Including Myriad, apparently.

Actually, from the perspective of someone who works in the legal profession, the only stupid question being asked here is the one cited above.

Just kidding. There are no stupid questions.

Re:Why is it odd?

[bonehead]

It's not a lack of sense of humor, it's just that the whole flying spaghetti monster thing is WAY too old to be funny anymore, even if it had been in the first place. Which it wasn't, it's always been just plain stupid.

Re:Why is it odd?

[harlequinn]

But human genes aren't currently discovered. Human DNA was discovered in the late 1800s. Its structure was discovered over the next 100 years. Short sections of the human genome were sequenced in the 1980s and 1990s. It was sequenced in its entirety in 2004. Sequencing (mapping) is a string of letters in a particular order to which we assign meaning. This string is viewable to anyone, you just need the right machine. It is entirely akin to mapping a town from an aeroplane. You can't get a patent for it because it's a naturally occurring feature viewable by anyone.

Re:Why is it odd?

[harlequinn]

I disagree. You're using the word discovery in place of invention. They are not interchangeable.

There is a lot of case law surrounding the interpretation of the constitution and invention easily overrides discovery in the criteria you need to satisfy for patent eligibility. You certainly don't discover a process (of the sort in a process patent). You invent it.

http://en.wikipedia.org/wiki/Patentability.

There are a lot of people who think process inventions and software inventions should not receive patent protection and the system at large needs to be overhauled.

Re:Why is it odd?

[harlequinn]

The funniest thing about the Flying Spaghetti Monster is that since he is omnipotent, his image and name is arbitrary. I.e. Flying Spaghetti Monster is just a synonym for God.

Re:Why is it odd?

[harlequinn]

Twisted, I get it...

Re:Why is it odd?

[harlequinn]

"Creations, such as a string of the letters ATGC in any particular order, should be covered by copyright."

Even then there is a requirement for artistic merit, which this would not meet.

A good example is a recent case in Australia that found that the names and numbers from a telephone directory were not copyrightable matter (someone was republishing them and the original publisher took exception to this).

Be still, my heart!

[some old guy]

A breath of IP sanity from SCOTUS? And unanimously at that?

Pinch me. Surely I dream.

Re:Be still, my heart!

[mooingyak]

The unanimous part was the weird bit for me. Partly because they all agreed, and partly because I thought the kind of cases that would have unanimous decisions usually didn't make it to the SCOTUS.

Re:Be still, my heart!

[UnknowingFool]

No, you're not. And don't call me Shirley.

Re:Be still, my heart!

[Anonymous Coward]

A breath of IP sanity from SCOTUS? And unanimously at that?

Indeed.

Even the good recent decisions are uncomfortably often a 5-4 split (meaning that we could be one retirement away from flipping them). That thought disturbs me...

Re:Be still, my heart!

[Hatta]

This isn't good enough. Creating cDNA is not a creative act. Extract RNA, apply a reverse transcriptase. Now you have cDNA. The sequence of the cDNA(and the protein product it codes for) is 100% determined by the sequence of the RNA, which is a natural product.

Re:Be still, my heart!

[OG]

I think it's a bit more complicated than that. Blindly creating cDNA is one thing. Identifying particular cDNA that can be used for therapeutic purposes is a whole other thing and requires a lot of research. I can understand protections for the first researcher/group to identify a particular sequence that can be used for gene therapies. It's fair to address exactly what those protections should be. We need protections from people who want to patent sequences willy-nilly. There needs to be a strong reason for why the particular sequence in question has been identified for protection. Perhaps a form of copyright may be more appropriate there than patent.

Re:Be still, my heart!

[tpjunkie]

Assuming that you're targeting processed mRNA. I feel the same way as you however. I believe that producing cDNA of a naturally occurring protein (whether wild type or novel mutation) is not "creation" per se, so much as translation (well, reverse translation followed by reverse transcription if you want to be anal) of an existing, natural item. Are translations patentable? Perhaps copyright is more appropriate, although the existing copyright laws might actually be worse than patent law.

Re:Be still, my heart!

[afidel]

Perhaps a form of copyright may be more appropriate there than patent.

Oh hell no! Since copyright is DeFacto forever thanks to the MickyMouse Copyright Extension Act it would be MUCH worse if they could be granted a copyright on genes.

Re:Be still, my heart!

[dkleinsc]

Some reasons that you get unanimous SCOTUS decisions:
1. SCOTUS took the case primarily to send a strong message to current and future courts and legislatures and presidents. A lot of those kinds of decisions get handled at the circuit court level, but in future case law it's one thing to cite that the Ninth Circuit said this or the First Circuit said that, and it's another thing entirely to cite a unanimous decision by a fairly divided Supreme Court.
2. It can be a judicial smack-down when a circuit court gets something wildly wrong.
3. It could be that the Chief Justice wants to get everyone to speak with one voice on a particular issue. This usually causes decisions to take a while, as the Chief convinces the 4 holdouts to agree with the majority.

Re:Be still, my heart!

[NatasRevol]

Still didn't stop the three letter agencies from GPS tracking our, and their, phones.

Re:Be still, my heart!

[Hatta]

Identifying particular cDNA that can be used for therapeutic purposes is a whole other thing and requires a lot of research.

Identifying a particular gene or piece of mRNA that can be used for theraputic purposes requires a lot of research too. This has nothing to do with whether that gene, mRNA, or cDNA is a "natural product" or not.

Re:Be still, my heart!

[the eric conspiracy]

> Creating cDNA is not a creative act.

Umm your sentence is self-contradictory.

Re:Be still, my heart!

[OG]

Which is why I said a form of copyright. I don't think this type of innovation falls cleanly under either patent or copyright law, but I think a case can be made for some time-limited protection for the work.

Re:Be still, my heart!

[OG]

If the researchers do isolate a particular strand of cDNA that does not occur in that particular form, by which I mean you're not going to find that piece of cDNA existing as a standalone entity within a cell and that particular sequence as a stand-alone provides functional, therapeutic effects, I think that's a gray area.

Re:Be still, my heart!

[Hatta]

The "particular form" is irrelevant. It's the same sequence whether it's mRNA or cDNA. You might as well allow people to copyright public domain works by doing a ROT13 transformation.

Re:Be still, my heart!

[rahvin112]

The court is not "fairly divided". Something like 80% of their decisions are unanimous. You only hear press about the 5-4 decisions which are an extremely small proportion (about 10%).

Re:Be still, my heart!

[OG]

I don't think it is irrelevant. If someone found a unique splicing from three different areas of a gene, a splicing that is not produced by the body, it's not "natural". The body doesn't produce that particular variant, even though it's composed completely of coding regions from a gene. The researches constructed that sequence from bits of an existing gene. They created that particular sequence. To go to the extreme end, one could say that any sequence is going to be an alternative splicing of individual bases. I think there has to be room for people to create particular molecules that are based on sequences found in nature -- the kicker is that the specific molecule in question isn't found in that organism. Not in that particular form as a single entity.

Re:Be still, my heart!

[thunderclap]

And I believe the Myraid case was 2 and we got 1 to guarantee it doesn't happen again.

Re:Be still, my heart!

[thunderclap]

I would be more worried about the people who built their tech. NSA can't build their own systems. This isn't q here. Reality they are more like Get smart. I would be concerned with Google far more.

Re:Be still, my heart!

[NatasRevol]

Large databases is all the NSA really needs.

Re:Be still, my heart!

[Anonymous Coward]

Only in the same sense that: Creating the 1000th Ford Fusion is not a creative act is self-contradictory. The reason it's actually consistent is that different meanings for create (fabrication vs. production of something original) are being applied.

Re:Be still, my heart!

[elbonia]

The average number of unanimous decisions is nowhere near 80%. "The marquee decisions of the term — on affirmative action, voting rights and same-sex marriage — will almost certainly be closely divided on the core issues. But the overall percentage of unanimous decisions is unlikely to drop to 40 percent, the average rate for full terms in recent years." http://www.nytimes.com/2013/05/28/us/supreme-court-issuing-more-unanimous-rulings.html?_r=0

Re:Be still, my heart!

[AthanasiusKircher]

The court is not "fairly divided". Something like 80% of their decisions are unanimous. You only hear press about the 5-4 decisions which are an extremely small proportion (about 10%).

No, something like 40% of their decisions are unanimous in the Roberts Court (a little higher than normal, but not shockingly so). Another 10% of so tend to be 8-1. So, in roughly half of cases, there is not even the possibility of an ideological division. That's still significantly higher than most people think, but it's not 80%.

Among the 5-4 decisions, roughly 1/3 of them aren't along the supposed ideological lines... the "partisan" 5-4 decisions still happen something like 20% of the time, though.

Re:Be still, my heart!

[AthanasiusKircher]

The unanimous part was the weird bit for me. Partly because they all agreed, and partly because I thought the kind of cases that would have unanimous decisions usually didn't make it to the SCOTUS.

With the Roberts Court, roughly 40% of all decisions have tended to be unanimous. Another 10% or so tend to be 8-1, so roughly half of the decisions can't even have the possibility of showing an "ideological" division along the 5/4 supposed conservative/liberal divide.

Even among the 5-4 decisions, about 1/4 to 1/3 of the time, the division isn't along the supposed "factional" division the media always reports on. Those closely divided politicized opinions don't tend to occur more than 20% of the time.

Re:Be still, my heart!

[flarez]

cDNA generally does not concern unique splicings. For the most part creation of cDNA is a blind, undirected (by the researcher) process. Standard cDNA is 100% implied by the mRNA, which the researcher has zero control over.

The market works on expectations

[sjbe]

Oddly, Myriad Genetics stock actually rose on that information.

That's not really surprising. All that means is that the market expected the news to be worse than it actually was. Once the ruling was handed down and the uncertainty removed, the stock rebounds based on the new information. You'll see this all the time where a company has a terrible quarter and their stock price goes up because while it was indeed terrible, it wasn't as terrible as expected.

Re:The market works on expectations

[ColdWetDog]

Ah yes. Thanks. I keep trying to apply rationality to the stock market.

You'd think I would have learned by now.

Re:The market works on expectations

[Sique]

I don't see any sanity in your reasoning. Everyone knew this case was at the SCOTUS, and everyone knew that patenting something that occurs naturally was not what patent law was supposed to do. Thus the stock had been tanking already at the time when the lawsuit became known. Stocks usually move at new information, not at confirmation of old information.

Re:The market works on expectations

[stanlyb]

They asked for $100, they got $50, and they expected to have $1...So, win-win.

Re:The market works on expectations

[the eric conspiracy]

It was actually good news for Myriad, not just non-terrible news. While they did lose some parts of their patent, the core test is still protected.

In addition the way the decision was stated settles the entire field of biotech patents in such a way as to give certainty that there will be lots of opportunity for patentable inventions in the field, AND that R&D activities on isolated human DNA will be able to continue without threat of patent suits.

It isn't just Myriad stock that is up today. The stock market index for the WHOLE BIOTECH INDUSTRY is up substantially.

Re:The market works on expectations

[njnnja]

Stocks usually move at new information, not at confirmation of old information.

Often described as "Buy the rumor, sell the news."

Re:The market works on expectations

[PRMan]

Apply raw animal emotion to the stock market and then do the opposite. That should be the same as "buy low", "sell high".

Wow

[pablo_max]

I am actually surprised by the ruling. I fully expected the courts to say you can patent anything, so long as you are first to file. Glad to hear it nonetheless.

Re:Wow

[fuzzyfuzzyfungus]

I am actually surprised by the ruling. I fully expected the courts to say you can patent anything, so long as you are first to file. Glad to hear it nonetheless.

I'd assume that you can, in fact, apply to patent anything; but one would hope that "Prior art older than human civilization, quite possibly older than humanity, depending on the DNA involved" would cause you problems...

Re:Wow

[rubycodez]

I suspect the mega-corporation with our government in their pockets have already thought this through. They will use big pharmy and gene therapy to get artificial dna sequences into your genome. Then they own your genetic ass anyway.

Laugh now, and just wait about 10 years....

Re:Wow

[riverat1]

Oh, so that's what GMO organisms are for, so big business can own our ass (even more than they already do).

Re:Wow

[slew]

I'd assume that you can, in fact, apply to patent anything;

In the US, alleged "perpetual-motion" machines get a special carveout. Since they want your application fee, accepting your patent application is merely a formality. However, the USPTO specifically requires a working model for machines claiming perpetual motion (and waives this requirement for all other types of patents).

The UK simply does not accept application for patents that claim processes contrary to well-established physical laws and specifically call out a "perpetual-motion" machine as an example of such a patent application that would be rejected.

Entropy infringement?

[Anonymous Coward]

Other bits of manipulated DNA / RNA / protein which take skill and time to create are potentially patentable."

I won't claim to understand enough genetics to make an assessment which is why I'm posing the question instead: Can these 'other bits' of manipulation occur naturally, over time, due to natural mutations and evolution?

Re:Entropy infringement?

[berashith]

possibly, but the next big question after that is ... can Monsanto sue nature?

Re:Entropy infringement?

[ebno-10db]

Of course - Monsanto has more money than nature.

THIS MADE MY DAY!!

[LF11]

This is definitely call-everybody-I-know newsworthy! Holy cow! Gonna mark this day and celebrate it next year! I can't believe this is happening!

Re:THIS MADE MY DAY!!

[Richy_T]

Do you find you often get peoples' voicemail?

Re:THIS MADE MY DAY!!

[LF11]

Yes, but they call me back. :) I don't call people unless it's important. :)

Re:The bigger news here...

[fuzzyfuzzyfungus]

is that Clarence Thomas said something (even writing an opinion). He's only been on the court, what, 10+ years or something?

Antonin Scalia's mind-meld field is vulnerable to disruption by sunspots, geomagnetic anomalies, and nearby homosexuals. Some mistakes are inevitable from time to time...

Re:The bigger news here...

[Wyatt Earp]

22 years come this fall.

Re:Problems with this ruling

[Anonymous Coward]

2 questions.

What drug, and where can I get some?

Re:The bigger news here...

[clarkkent09]

Contrary to the uninformed popular opinion, Clarence Thomas has been very active during his time on the court. He just mostly leaves questions in oral arguments to other judges, which is only a small part of what judges do. It used to be common for Justices to take that approach, but recently it stands out since the others have started to enjoy the sound of their own cleverness much more, whether it contributes to the resolution of a case or not.

Michael Crichton would be proud

[SpaceManFlip]

Reading the book "Next" by Michael Crichton awhile back alerted me to the nonsense going on with gene patents. There's even a scene in the book where a guy with a rare genetic mutation is chased by the equivalent of bail bondsmen for a company holding a patent on his genes. They want to capture him and bring him in for running around with "their" genes in his body or something like that.

Good job, SCOTUS

Re:If you go to hospital

[ColdWetDog]

but it is well known fact that everything changes your DNA, even the food that you eat, could cause a change..

Put the comic books down.

Re:The bigger news here...

[Antipater]

Thomas writes opinions as often as any other justice. His famed silence only applies during oral arguments. And he's hardly the first "silent" justice - it's simply made more prominent by how verbose his colleagues are.

Re:The bigger news here...

[sed quid in infernos]

Justice Thomas has been on the court for more than 20 years (which, yes, is technically 10+, but still). During that time, he has authored more than 600 opinions.

A thought experiment

[wbr1]

What if a company makes and patents a cDNA that is later found to also exist naturally?

Have we sequenced every variant of every species?

Case in point, Monsato make GM crops that resist herbicides. What if the parts they are patenting, have analouges in some other plant in the wild?

Re:A thought experiment

[Nutria]

Then presumably they'd be overturned by prior art.

Re:A thought experiment

[stanlyb]

They will sue the "Nature", and rape her...

Re:A thought experiment

[SecurityGuy]

Realistically, it goes back to court.

Re:A thought experiment

[ankhank]

! yep

We already know that's the case for antibiotics. And we know plants compete with one another by suppressing competitors' growth.

Seems to me Thomas's comment is intended to add a loophole -- "we created this cDNA and patented it, so we have the patent, so if you claim you found the exact same thing out there in nature somewhere, it must be you stole it from us." Betcha.

http://www.nejm.org/doi/full/10.1056/NEJMp1215093
The Future of Antibiotics and Resistance
Brad Spellberg, M.D., John G. Bartlett, M.D., and David N. Gilbert, M.D.
N Engl J Med 2013; 368:299-302January 24, 2013DOI: 10.1056/NEJMp1215093
----------------
"... after billions of years of evolution, microbes have most likely invented antibiotics against every biochemical target that can be attacked — and, of necessity, developed resistance mechanisms to protect all those biochemical targets. Indeed, widespread antibiotic resistance was recently discovered among bacteria found in underground caves that had been geologically isolated from the surface of the planet for 4 million years.2 Remarkably, resistance was found even to synthetic antibiotics that did not exist on earth until the 20th century. These results underscore a critical reality: antibiotic resistance already exists, widely disseminated in nature, to drugs we have not yet invented.

"Thus, from the microbial perspective, all antibiotic targets are “old” targets...."
-----------------

Re:A thought experiment

[the eric conspiracy]

If you find it you can use the natural form.

Re:A thought experiment

[kwyjibo87]

What if a company makes and patents a cDNA that is later found to also exist naturally?

Have we sequenced every variant of every species?

Case in point, Monsato make GM crops that resist herbicides. What if the parts they are patenting, have analouges in some other plant in the wild?

Monsanto is, in part, doing exactly what you suggested. The genetic element that grants their crops resistance to glyphosate (Round-Up) was discovered in microbes growing in waste runoff containing glyphosate. The patent is on the plants that have been transformed / engineered to contain this naturally occurring resistance gene in their genome and express it to garner resistance to the herbicide.

The cDNA argument is much worse to ludicrous. The only thing one could imagine is patentable surrounding the issue of cDNA is the technique involved in its generation, but that ship has sailed long ago. The entire process of generating cDNA is by using materials all found in nature. The RNA template that is used to generate cDNA in these cases of naturally occurring genes is obviously naturally occurring* and the technology to even create cDNA in the first place is using a naturally occurring enzyme, reverse transcriptase (found in retroviruses like HIV to catalyze the conversion of their genomic RNA to DNA). Because all these elements exist in the natural world, it is certainly possible in say HIV infected humans that random gene mRNA molecules have been converted to cDNA, thus negating the argument of generating something that does not exist in the natural world. More importantly, the only facet of this whole process of generating cDNA that is artificial is placing the materials in a tube together, NOT inventing any novel chemicals or enzymes to catalyze the process!

* In cells, mRNA molecules are heavily modified, sections spliced out, nucleotides edited, the 5' end capped, the 3' end poly-adenylated, so with the arguments placed forth concerning cDNA, one can imagine in vitro transcription of a gene creates an RNA molecule that doesn't exist in nature and can therefore be patented. Ridiculous, right?

Re:A thought experiment

[gringer]

Oh well, they can canola Nature then.

Re: A thought experiment

[HydroPhonic]

If they didn't have analogs in nature before, they certainly do now!

WTF does 'natural' mean?

[Anonymous Coward]

Sounds like a very vague ruling. Any sequence is possible in nature and thus natural so no DNA may be patented!

Re:WTF does 'natural' mean?

[Sarten-X]

Thanks to quantum mechanics, it's also fully possible for my entire body to randomly disintegrate over here, and reintegrate perfectly intact in your closet. That does not mean that someone who produces a machine for that should be denied patent protection... Unless, of course, the invention consists of a box holding a leprechaun, who have had the natural ability to teleport for thousands of years.

A "natural" gene would have been found in nature and isolated. The researchers don't really need to know how or why the gene does what it does - they just put it in a box. On the other hand, they can take a look at the gene, figure out what makes it work, and synthesize a cDNA sequence that does the job effectively - Building a leprechaun-like machine.

Splitting the baby

[the eric conspiracy]

This is really a great decision that benefits everyone, in the following ways.

1. Isolated DNA is not patentable. This allows R&D on DNA to proceed unencumbered.

2. Commercial development of technologies using synthetic DNA derivatives for useful products is encouraged by allowing patent coverage.

Re:Splitting the baby

[glwtta]

Unfortunately, that's not what the decision means: cDNA isn't "synthetic DNA", it's derived from mRNA and is a widely used tool in genetic research.

Most "commercially useful products" actually involve RNA, not DNA.

Re:Splitting the baby

[the eric conspiracy]

This decision puts up a big neon sign "you can use BRCA if you come up with a different form."

Before you were stuck because there is no getting around the patent on the isolated human gene.

Some have called it the narrowest scope for patenting of genetic material in the world.

Who knew...

[firesyde424]

SCOTUS agrees unanimously on something? *Looks at the calendar* It's not April 1st... Am I being punked??

Re:Who knew...

[AthanasiusKircher]

The Roberts Court actually puts out unanimous decisions roughly 40% of the time.

Re:If you go to hospital

[jbeaupre]

And give you a cure, that "modifies" your DNA, then do they own you???

No. No more than the hundreds of patented products you have bought are owned by the patent holder. By providing you the cure, a hospital would be granting you a license to the end result. You own the result. But you might still face restrictions from providing the cure to others such as your descendents.

Good, because otherwise....

[tekrat]

I was planning to patent Sunshine.

Re:If you go to hospital

[stanlyb]

You mean, i cannot give my blood for free? or my lilver? or my kidney? or my heart? or my brain? And after a very long thinking process (2seconds), even the thinking process is owned by the patent holder???

Re:If you go to hospital

[medv4380]

You're clearly mixed up some of the latest information on epigenetics with genetics. So how about you go back to your half read science articles, and finish them.

Unanimous defeat of common sense

[mar.kolya]

Isn't cDNA just same DNA but written a bit differently? That is, it contains same information. And it looks like this ruling allows one to patent that information! The very same information that is used to produce proteins in YOUR body. This ruling sounds like - we cannot allow you to patent your record in MP3 format, but if you transcode it to FLAC - go ahead and patent it. Doesn't make any sense.

Re:Problems with this ruling

[xevioso]

This is entirely a reasonable opinion. Most jeans don't fit the average whale, and whales have no legs, so any jeans being worn by a whale would be more akin to a locust playing a fiddle on a 10-ft tall aquarium light bulb. Seriously, since a glittering gem is nothing at all, a absquatulatory prodigous profile would wake the prime minister.

Markets are chaotic and (usually) rational

[sjbe]

Ah yes. Thanks. I keep trying to apply rationality to the stock market.

It is extremely rational behavior. Think of it like playing a poker hand. You have imperfect information so you make your bets based on the likelihoods of various results. Some results are more likely that others and you play accordingly. As more information becomes available your betting strategy may change. That is exactly what is happening here.

One has to understand what is driving prices for the stock market to make any sense. Information about company performance is at the core but it is NOT what drives prices. There is no direct link between a company's financial performance and their stock price. What drives prices is peoples expectations and in some cases people's expectations about other people's expectations. (and even expectations about expectations about expectations... you can keep going) If you invest in the stock market you are placing a bet not so much on what a company will do but on what other people will think about the company. When you buy IBM stock you are saying in essence "I expect more people to find this valuable in the future". Any secondary market (stocks, baseball cards, tulips, real estate, etc) works this way. It's shockingly rational (with some exceptions) but highly chaotic and thus hard to predict.

Re:Markets are chaotic and (usually) rational

[rahvin112]

Absent a large shareholder making a major move in position you can't know what is driving the market on any day. It's an irrational and unpredictable well of emotion. Anyone that tells you differently is an idiot or trying to sell you something. The market and what drives it is a black box of emotion, those news stories that claim that X event is driving Y change are complete speculation.

Absent direct polling of all players in the market no one has any idea what is driving the market. That isn't to say you can't identify some things affecting prices but you can never know them all nor their percentage of effect. The only major events I've ever seen where you can broadly claim X caused pricing to change Y is major political events like presidential elections, war, terrorist attacks, etc and these are generally limited to broad market changes not specific stocks. Everything else varies from educated speculation to "pull out of your ass" causation.

Re:Problems with this ruling

[xevioso]

An old apple is omni-present, much like candy.

Re:The bigger news here...

[jellie]

Judges also ask questions during oral arguments specifically to direct the subject or issues in a certain direction. For example, during the debate over Obama's health plan (PPACA), Scalia asked questions about the government forcing people to eat broccoli, while other justices asked questions about requiring car insurance payments.

Thomas is unusual because he almost never speaks, yet he clearly has a political bias. Back in January, he finally asked a question (or made a comment, no one is quite sure) for the first time in seven years. It was surprising enough that it was noteworthy.

Re:The bigger news here...

[jellie]

Oops, here's the link.

Can we take this further, please?

[FuzzNugget]

Could we please use this same logic to say that the human desire to openly and freely share thoughts and ideas is natural and therefore ineligible for legal protection? Thanks.

A good start

[GameboyRMH]

Naturally-occurring human genes is a narrowly defined set that isn't patentable, but still this will save many lives by allowing cheap genetic testing for things such as breast cancer susceptibility.

New information vs expectations

[sjbe]

Everyone knew this case was at the SCOTUS, and everyone knew that patenting something that occurs naturally was not what patent law was supposed to do.

There is NEVER certainty regarding a SCOTUS ruling. Expectations cover a spectrum and not everyone makes the same bet. SCOTUS could have ruled in such a way that this company lost their patent protection altogether which appears to not have happened. Just because what you outlined is the most likely outcome does not mean it is the only possible outcome. Some people were clearly betting on other, more pessimistic, outcomes than the one that actually occurred. It's pretty much the same thing as betting on the long shot in a horse race instead of betting on the favorite. The odds are against you but if you are right the profit is much higher.

Stocks usually move at new information, not at confirmation of old information.

The SCOTUS ruling IS new information. Prior to the decision there were expectations regarding the ruling but it could not be treated as a certainty.

Re:The bigger news here...

[jfengel]

Perhaps you can explain this to me... what is the value of oral arguments at all?

The justices get vast piles of paper documents, extensive briefs, case histories, etc etc etc. The oral arguments are generally given only a single hour; if I remember correctly the PPACA was given a whopping afternoon. These are complex issues; a case doesn't reach the Supreme Court unless there is genuine disagreement among very high level legal minds. They will proceed to hash it out among themselves and with their clerks, for many hours.

Is anything actually achieved by oral arguments? It seems mainly an opportunity for lawyers to get flustered, choose the wrong tack while thinking on their feet, be manipulated by the justices, and oversimplify.

Is Thomas' silence really a comment on the fact that this is a waste of his, and everybody else's, time?

I'm asking this in all seriousness. I'm not a lawyer and I wouldn't presume to tell them how to do their business. But as an outsider, I find this perplexing.

Re:The bigger news here...

[dkleinsc]

The reason the other justices ask a lot of questions is not because they want to hear themselves talk. They walk in there having already read the gist of what each lawyer is arguing in the briefs that were filed a long time ago. What they're usually after in oral argument is counsel's response to any issues the justices may have thought of that counsel did not, and those are the questions they typically pepper counsel with.

I assume Myriad didn't invent cDNA...

[Rob Y.]

Right. The process for making a cDNA copy of a particular sequence is probably patentable. But I'm betting Myriad didn't invent that process. Whoever did should be able to patent it, and Myriad should have to pay them royalties for applying the process to the BRCA gene. And maybe something as general as cDNA construction should be a FRAND-type patent, so that it's owner can't 'own' all DNA by owning the standard testing methodology. Just like Motorola isn't allowed to own the cellphone industry by virtue of having come up with the standard communications protocol used by cellphones.

Re:I assume Myriad didn't invent cDNA...

[Samantha Wright]

The core enzyme in question, reverse transcriptase, occurs naturally in humans, and was first isolated in 1970 by two independent teams. The process is something like "put it in hot water with raw materials, your template sequence, and some salt." Even if a patent were awarded for it, it would have expired in the late nineties.

Re:I assume Myriad didn't invent cDNA...

[Samantha Wright]

The method can be described as "put the enzyme in conditions where it can operate naturally." The conditions are defined by the enzyme (i.e. nature), and for most enzymes there's no cleverness required to figure them out; just a bit of trial and error to determine what components of the original environment are important, so even if the natural defence is ignored, the method for getting reverse transcriptase to work would be unpatentable because it's obvious. Patents involving enzymes usually include either (a) a really heinously tricky replacement for natural conditions, such as developing a new molecule or mechanism to emulate an environment that's hard to recreate on a bench, or (b) an engineered enzyme. There are actually engineered reverse transcriptases which are patent-protected, but Myriad isn't an enzyme company; they just do testing. Their entire business model is dependent on exclusive control of information.

Also, even more obnoxiously, even if cDNA didn't exist naturally, you can produce an identical piece of DNA—atom for atom—using a copying and splicing technique known as PCR. It's slightly more inconvenient to do this, but people will do it anyway, and Myriad's shareholders seem to think they can sue them too.

Next step

[Anonymous Coward]

The next step is to specify that cDNA looses its patent when acts of nature cause it to cross-pollinate/hybridize with natural genes. The patent remains with the original product (seed)

what if it's the only way to read it?

[gl4ss]

what if it's the only way to read it? doesn't this refer that the middle product in the test is patented?

wouldn't it be more apt that the methods - machinery etc and how they're used - involved in the test was under patent and not some molecyles.

Not Exactly Unanimous

[Etherwalk]

Mostly Unanimous. Justice Scalia wrote a brief concurrence that, depending on how it read, suggests he doesn't believe in molecular biology. I am giving him the benefit of the doubt and assuming he is just trying to say that SCOTUS should avoid pronouncing scientific facts in binding legal opinions.

JUSTICE SCALIA, concurring in part and concurring in the judgment. 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.

Re:Not Exactly Unanimous

[bws111]

That statement in no way 'suggests' that he doesn't beleive in molecular biology. That statement simply means that he is a) not an expert on molecular biology (the 'knowledge' part), and b) does not know enough about the subject to even know if he should believe the information he has been told.

This sort of phrase appears often in legal documents. If you see a phrase like 'on information and belief' it means 'I was given this information, and based on what I know I believe it to be true. It has absolutely NOTHING to do with the persons 'beliefs'.

Re:Not Exactly Unanimous

[Etherwalk]

"On information and belief" means something entirely different, and is mostly used when filing an affidavit or complaint and there is some fact of which one is reasonably sure but lacks direct knowledge.

You are interpreting his statement to have one meaning, but he was not clear enough to be certain that it is the correct one. "I am unable to affirm those details [of molecular biology] on my own knowledge or even my belief" can be read as implying that he does not believe them, as it is very unusual for an opinion to say something like that about a statement of facts, even in a technical area. In any event, that is how many people are considering it, and I have heard a number of people suggest that it is one of the "stupidest" concurrences they have ever read. As I said, I think these people are being anti-Scalia as opposed to really critiquing the opinion, but without more exposition it can definitely be read as anti-science, since it is saying "I'm not sure about all these decades of established science."

Supreme Court contradicts itself

[Anonymous Coward]

This ruling used sound reasoning with regard to DNA (imo), but, following the Court's own logic, patents on cDNA should be disallowed as well.

When saying DNA is not patentable, Thomas writes, "[Myriad's] claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule."

BUT THEN, he goes on to talk about how cDNA is made trivially in the lab by matching DNA nucleotides to the naturally occuring mRNA sequence.

The difference between mRNA and cDNA is splitting hairs. We are talking about the chemical composition, pretty much. cDNA bases have an -OH group in one spot instead of a hydrogen. The cDNA version of the "alphabet" (thymine - T) has a methyl group where the mRNA equivalent (uracil - U) has a hydrogen instead.

These are tiny chemical differences. What matters is the sequence of mRNA/cDNA, which occurs naturally. It most definitely is a "product of nature," and based on this opinion, should not be patentable.

Re:Supreme Court contradicts itself

[sanchom]

The court on the one hand looked to the "information" contained in the isolated DNA sequence to say that it was a product of nature, and ignored the molecular changes due to cleaving the sequence from the chromosome.

On the other hand, with respect to cDNA, the court ignored the information similarity between mRNA and cDNA and instead looked at the molecular differences.

These two situations are distinguishable. The court said that Myriad does not "rely in any way on the chemical changes that result from the isolation of a particular section of DNA". (p 14) However, Myriad does rely on the chemical changes that distinguish cDNA from mRNA.

Thomas did not call the construction of cDNA "trivial".

Nowhere in nature do you find genes encoded in GATC sequences on a dioxyribose backbone with their introns removed.

Re:Supreme Court contradicts itself

[slew]

The difference between mRNA and cDNA is splitting hairs.

I don't buy that arguement. Let's say you have a phonograph (vinyl record), with a song. You could patent a phonograph player with a diamond stylus that transcribed that phonograph back to an audible sound, because that isn't only way to do it, you could also have a different instrument (say a laser-pickup), that transcribed that phonograph back to an audible sound and that would be a different invention.

However, in this case they are trying to patent using a phonograph to see if there is a specific chord on that record. Just because, everyone uses a diamond stylus to transcribe the record today, doesn't mean that that process to identify a specific chord on a record using a diamond stylus is or isn't patentable. You need to look more at the details. It may be that it doesn't pass the "obvious to someone skilled in the arts" test, but it isn't just on the face of it unpatenable or a product of nature.

Re:Supreme Court contradicts itself

[ebno-10db]

dioxyribose backbone with their introns removed

I think that's today's special at the Cheesecake Factory.

Re:Supreme Court contradicts itself

[flarez]

The Court correctly identified that Myriad is not patenting a specific molecule--but rather the information contained within. It is not even a specific nucleotide sequence that is at stake--codon degeneracy and of course medically significant mutations within the BRCA gene necessitate some ambiguity in the specific of DNA sequence for the patent.

The Myriad claim has nothing to do with the creation of BRCA cDNA. They were not the first to perform reverse transcription (and as Thomas notes, Myriad makes no method claims). Nor were they the first to synthesize the cDNA. Anybody who has ever created a cDNA library (thousands of people, both before and after Myriad) have done so. What their patent concerns is the sequence, i.e., the information contained within the cDNA--which is 100% determined by nature.

Nowhere in nature do you find genes encoded in GATC sequences on a dioxyribose backbone with their introns removed.

The latter part of your statement belies the inherent awkwardness of the "chemical not found in nature" argument. When a researcher makes cDNA from mRNA, is the result only "not found in nature" if the original genomic DNA had introns.

So as a result should all prokaryote-derived cDNA be unpatentable? Perhaps only certain cDNA from humans are patentable (from genes with introns)?

Re:Supreme Court contradicts itself

[flarez]

I'm going to assume phonograph=genome, song=BRCA gene, chord=mutation. What is the diamond stylus and laser pickup? Are these techniques for conversion of the song/gene into a scientifically useful format?

If so, it sounds to me like you misunderstand this case. It doesn't pertain to the methods with which one would analyze BRCA scientifically--these have been around for decades and as far as I know have not been patented. It's a question of whether a) the "song" itself is patentable (SCOTUS says no), and whether a derived substance based on this song is patentable (SCOTUS says yes, since nature didn't make it.)

Re:Supreme Court contradicts itself

[sanchom]

When a researcher makes cDNA from mRNA, is the result only "not found in nature" if the original genomic DNA had introns.

So as a result should all prokaryote-derived cDNA be unpatentable? Perhaps only certain cDNA from humans are patentable (from genes with introns)?

Yes, this is correct. Justice Thomas writes (at page 17 of the slip opinion): "As a result, cDNA is not a “product of nature” and is patent eligible under 101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA."

Re:Supreme Court contradicts itself

[slew]

record=chromosome
song=the DNA in some specific person's chromosome
chord=mutated BRCA gene
diamond stylus=the cDNA technique to read DNA
laser pickup=some new way to read DNA

AFAIK the decision was that the "chord" is not patentable, because it's part of the naturally occurring "song".
However, since the current method to find if the "chord" is present in the "song" uses a "diamond stylus" pickup to read the "record" and is described in a patent, it might be patentable (they didn't address this in the ruling the issue of obviousness) since it uses a method to read the "song" which isn't a natural process. SCOTUS simply upheld the patent (it still can be re-examined).

The inference I made is that if someone else comes up with another way to detect the "chord" in the "song" that doesn't use a "diamond stylus" (say a "laser pickup" mechanism, or taking a picture of the groves on the record and having a computer recreate the audio), then the current patent is totally circumvented because SCOTUS says that it is not possible to patent nearly all possible uses of the "chord" (which is apparently what the patent tried to do). Unfortunately, everyone currently commonly plays "records" using a "diamond stylus" because that's the easy way to do it, so it apparently reads on their patent. However, that in itself might just make it obvious enough to invalidate their patent too, but easy and common does not necessarily make it "obvious" from a patent protection point of view (in fact some of the most valuable patents often illustrate how easy it is to do something new with an existing technique).

Also this inference I made doesn't address the issue of patentability of any specific methods to identify the "chord" in the "song" after you have read the "record" (which apparently is done with yet another common method and process which forms part of the diagnostics test that they tried to claim patent for). Maybe that part is "obvious" (in the patent sense) or easy to circumvent, but maybe not.

Re:The bigger news here...

[will_die]

It is not that he leaves others to do the questioning it is that he believes, and has written on this, that the Supreme Court should not be asking questions. According to him, and others, the oral agreements are a side show and that decisions should be based on "written briefs and the lower-court opinions in making their decisions"

Re:Problems with this ruling

[Anonymous Coward]

Most jeans don't fit the average whale, and whales have no legs, so any jeans being worn by a whale would be more akin to a locust playing a fiddle on a 10-ft tall aquarium light bulb. Seriously, since a glittering gem is nothing at all, a absquatulatory prodigous profile would wake the prime minister.

Thank you, President Obama, but would you please stick to reading what's on the teleprompter?

Re:Problems with this ruling

[RenderSeven]

what we need is more MEXICO and less COMPUTERS.

What we REALLY need is more cowbell!

Re:What about other genes?

[sanchom]

"the US Supreme Court has decided that human genes cannot be patented."

Does it means animals and plants DNA can be patented?

"Human genes cannot be patented" is an overly broad interpretation of the ruling.

To say that these "isolated segments of naturally occurring human genes cannot be patented" would be more correct.

In the case where an inventor creates nonnaturally occurring gene sequence with markedly different characteristics from anything occurring in nature, it is left open whether or not those are patentable.

Plant genes meeting these criteria have been held to be patentable. See Monsanto, for example. It is possible that animal genes, or even human genes that meet this criteria would be patentable.

Re:The bigger news here...

[slew]

FWIW, Clarence Thomas has written nearly 500 Supreme Court opinions during his tenure.
A quick glance at a few years' statistics shows that he's often in the middle of the pack when it comes to writing opinions (both majority and dissenting)...

http://en.wikipedia.org/wiki/2012_term_opinions_of_the_Supreme_Court_of_the_United_States

Re:The bigger news here...

[clarkkent09]

I wouldn't say there is no value as Justices may need to have a chance to clarify something etc. It is vastly overrated though and it is one of the reasons most Justices do not want cameras in court during oral arguments. As Scalia said, if the media is willing to follow all the relevant details of a case from beginning to end and devote a large amount of time to it (such as on CSPAN for example) then cameras would be fine, but just focusing all the attention on few soundbites and back and forth between judges and lawyers during oral arguments would be entirely unrepresentative of what the court actually does.

Re:The bigger news here...

[AthanasiusKircher]

Is anything actually achieved by oral arguments? It seems mainly an opportunity for lawyers to get flustered, choose the wrong tack while thinking on their feet, be manipulated by the justices, and oversimplify.

These days, oral arguments tend to be a place for the justices to prod attorneys with particular questions. Often, it seems they do this with the intention of bringing up a point that might influence or accentuate an idea that could sway one of the other justices, rather than necessarily to clarify a question for themselves -- though, if they are really curious about a particular issue themselves, you can tell. They will keep cutting through the BS spouted by the attorney and hammer the same question until they get an answer. Maybe this is to prove a point to the other justices, but it can also be to assure themselves that they've gotten all possible perspectives on the question. Another common tactic in oral arguments is for the justices to pose interesting hypotheticals that they think may clarify the case, but which may not have been adequately addressed in briefs.

Is Thomas' silence really a comment on the fact that this is a waste of his, and everybody else's, time?

Actually, he's explicitly said why he doesn't talk. Oral arguments tend to be a lot of banter among the justices these days, but they used to let lawyers at least speak a little more. Thomas has said that he thinks his colleagues should give a little more room for attorneys to try to make points and bring up what they think is important.

I think he'd like to hear a little more and perhaps then ask questions relevant to the lawyers' points. But in the current court, we rarely ever get to hear a lawyer talk for more than 30 seconds on his/her own material before being interrupted. Thomas thinks this makes oral arguments more about the justices' preoccupations rather than what the lawyers think is important.

I can see his point. The justices get to debate each other and their clerks for hours on end about their preoccupations. Oral argument could be a place to get a few insights into the major concerns of the litigants, if we could ever hear them talk.

On the other hand, the justices will be the ones who ultimately decide things, so maybe it's best if they stick to the stuff that actually concerns them. It's just unfortunate when they start using lawyers as legal "punching bags," clearly only to drive home a point to one of the other justices.

Re:cDNA

[ebno-10db]

For those of you who don't know:

Complementary DNA (http://en.wikipedia.org/wiki/Complementary_DNA) is basically a copy of the information from a gene.

Cells make RNA using the information from DNA and then the information is used to make a protein (which does the "real work"). cDNA is generally made by isolating the RNA from a cell and adding a protein called Reverse Transcriptase (from retroviruses) that converts the information of the RNA into DNA (mainly because DNA is easier to sequence and use).

The information from cDNA is identical to parts of the original DNA sequence, except it will sometimes have naturally occurring "edits". Other differences can be the result of "errors" produced by reverse transcriptase (usually contributes to the mutation rate of the virus).

Short version: cDNA is a copy of information encoded in the genome.

Would it be correct to say that using cDNA is a way to get rid of a lot of the cruft (inactive or unnecessary parts) of the original DNA sequence?

23&Me tests are $99 vs. Myriad's $3000

[billstewart]

23andme.com's genetic test does have a "not for diagnostic use" disclaimer, but their standard test looks at three of the BRCA genes and five other breast-cancer genes, as well as a lot of other gene snips for medical and ancestry factors. (And hey, Myriad's not going to tell you what percentage Neanderthal you are :-) For some traits, there's one well-understood gene, so they can tell you if you've got it or not; for many others, there are a bunch of genes that affect it, so they may tell you that you've got a lower risk of diabetes or a higher risk of Parkinson's or whatever. And for a couple of the more scary genetic traits, they ask you if you really want to know the results before showing you (I forget which ones, but I think that included BRCA and Huntington's chorea.)

But what is natural?

[BlueCoder]

I can easily see that question coming up next to bring back this case.

First you can have someone do an exhaustive search to prove that a sequence has occurred naturally through random chance. And just because it occurs does not mean it will catch and become significantly dominant. I can predict right now that every possible sequence has probably occurred many times on this planet.

Second one can create the environment for the sequence to naturally evolve. And even if you did define something like this as unnatural you can't so easily prove such an example if released in the wild didn't evolve naturally.

It also doesn't address the issue of artificial human DNA. Can a corporation sue for infringement if a modified human has a child?

It isn't just a random mess of emotion

[sjbe]

Absent a large shareholder making a major move in position you can't know what is driving the market on any day.

You cannot (usually) know with absolute certainty but it is demonstrably incorrect to say a large shareholder move is the only thing that can be shown to drive stock price on a given day. Take earnings releases. There will (usually) be a consensus estimate of what earnings will be. If the company exceeds earnings expectations the stock price will reliably (though not always) go up. If it is lower than expectations the stock price will reliably (though not always) go down. This has been demonstrated time and again to happen and it makes sense because stock prices are fundamentally based on expectations. While the evidence is more of a strong correlation than certain causation, the evidence is strong enough and consistent enough to have confidence regarding what is influencing the market. If the earnings news had no effect we would see no correlation between the two but that is not what the evidence shows. Sometimes it is plainly obvious what is moving a given stock on a given day. Not always but often. Correlations with news are easier to demonstrate for big news or issues like earnings releases but they can be teased out for lesser events as well.

Now there is a LOT of what amounts to brownian motion in stock prices too. Not everything is predictable because there are so many moving parts and unknown motivations. Even people behaving perfectly rationally can seem like just random motion because we have incomplete information. Sometimes it is just Joe Random needing to sell some stock to make a car payment which will never become public information.

The market and what drives it is a black box of emotion, those news stories that claim that X event is driving Y change are complete speculation.

Given that a huge amount of trading volume is done by computer algorithms the facts don't really back you up on this unless you can explain to me how a computer algorithm has emotion. Furthermore there is a HUGE amount of academic research on the topic of what caused markets and stocks to move and it demonstrably is not all random emotion. I'm not saying that emotion isn't a part of the equation (remember we're trading on expectations, not cold hard facts). There have been Nobel prizes given for work related to human psychology in economics. But it is easy to demonstrate that it isn't just a random mess of emotional decisions either.

That said, you are correct when you say that the news stories about what drove a stock on a certain day are generally speculation. The vast majority of the time they are just pundits looking for a sound bite and not basing what they are saying on data that they have analyzed with any academic rigor. It's well known how to check if there is a correlation between a bit of news and a stock movement but we both know that the talking heads on the news never bother to actually check. Sometimes they are right but it isn't because the did the detailed research.

The world turely is coming to an end...

[DiEx-15]

...when a unanimous vote comes out of the SCOTUS nowadays.

Seriously. I wouldn't have dreamed they would unanimously agree. Maybe they are coming down with a terminal case of common sense?

Re:If you go to hospital

[jbeaupre]

No, none of your examples apply. You can still give parts of yourself (assuming those aren't the cure). Same as you can sell or give away your car, which is covered by hundreds, possibly thousands, of patents.

The thought process is not owned by a patent holder (mental feats are barred from patent protection).

Please learn what a patent is and isn't.