I didn’t know that a company could patent two of the genes that cause breast and ovarian cancer:
The patents granted to Myriad give the company the exclusive right to perform diagnostic tests on the BRCA1 and BRCA2 genes and to prevent any researcher from even looking at the genes without first getting permission from Myriad. Myriad’s monopoly on the BRCA genes makes it impossible for women to access alternate tests or get a comprehensive second opinion about their results and allows Myriad to charge a high rate for their tests.
That was how it worked until yesterday, when the ACLU and allied groups won a suit in federal court, which ruled those patents invalid. The ACLU claims that this will affect patents on 2,000 human genes.
Of course, this will remove the incentives for innovation and all drug companies will immediately close down. The only explanation for my satisfaction that Pfizer can’t patent my DNA must be an ignorance of the free market.
The Grand Panjandrum
As long as fat old white guys have access to those little blue pills everything is still peachy king in pharma world.
Hmmm, if they could patent the genes, could they not also have sued women for being in possession of material that belonged to them (a la Monsanto suing people for having in their possession, patent seeds)?
Could breast cancer patients have sued Myriad because their genes were trespassing in their tatas?
Put on your mocking hat because a long McArdle post is on its way.
Calvin Jones and the 13th Apostle
Expect to be attacked by McMegan in …. 3, … 2, .. 1.
This was in district court. Unless one of it’s right wingers drops dead and is replaced by an Obama appointee, the USSC will overrule this decision.
Calvin Jones and the 13th Apostle
@Morbo: Damn it!! You beat me to it!!
More likely that Myriad could sue breast cancer patients for possessing genes that belong to Myriad. That’s how it works in Canada, anyway.
i don’t see what the problem is, i’m sure phizer, merck, whomever, would be more than happy to license you as a user of your dna, now if you want to transfer that license, or even engage in activities that might result in a partial transfer of said license, well you have to call them and negotiate….
That’s exactly what worries me. With luck they’ll have realized that Citizens United was a bit too obvious to escape the national consciousness.
Besides, even Citizens United dealt with elections and campaign financing – you know, stuff you and I aren’t supposed to care about and leave to the big dogs and fat cats. Maybe the messaging on this one will be different given that a decision for Myriad here could be portrayed as a “win for cancer” or something.
The Moar You Know
@mai naem: You’re unfortunately right. The Supremes gave the green light to genetic patenting back in the late 1980s.
That patenting a gene, or an entire living thing, is ridiculous is obvious on its face. Didn’t stop them. That this would have incredibly horrific effects on the practice of medicine and medical research was also transparently obvious to them, and again, it did not stop them.
My bet: 6-3 decision to overturn the lower court ruling. If there is one thing that this court is solidly on the side of, it is that corporate rights take precedence over the rights of people.
What a legacy. People 200 years from now will think we were out of our minds.
Pigs & Spiders
Aaaaand we’re back to the origins of the word fuck.
Consent of the
All things are cyclical baby!
Soylent Green is
Brick Oven Bill
So why is the ACLU involved in medical research?
The answer is that it is the ACLU, to a far greater degree than the Christians, who fear the study of the theory of evolution.
It would be fun to presently spin up SGEW, but, alas, I have to go to work.
You all have a nice day.
Pigs & Spiders
Your optimism for our species knows no bounds.
Patents are just a scam to help the rich get richer. They aren’t a lot different than copyright in music. So in this case, Phizer = Metallica except without the socially redeeming value of having once been sorta good.
This another good example of why you should donate to the ACLU.
It is one of the precious few institutions remaining between the individual and complete corporate rule.
It is, unfortunately, difficult to disagree with mai naem (#5, above).
But it will take money for the ACLU to defend the lower court decision at the SCOTUS and, at least, continue to expose the pernicious abuses “the market” is heaping on us.
@Brick Oven Bill: You mean people on Social Security Disability have to go to work? I thought the constitution prohibited that.
Or should I look “work” up in the Urban Dictionary? Is it kind of like “felching” or “rusty trombone”?
I’m glad of this decision. I doubt seriously it will be struck down by the Supreme Court, but that court is unpredictably political. With any luck it won’t get there.
I’m fairly sure this patent gets struck down under whatever clause says you can’t patent the sun. This is a preexisting natural phenomenon, not one that the company invented. The difficulty is explaining the difference to a non-scientist.
Patents are very important, but there’s always going to be some asshole who finds a way to game the system no matter how good your laws are. With genetic technology taking off, we’re going to be awhile refining our laws to cover for concepts the original writers of patent law couldn’t imagine.
Free Market Baby! American Dream! It’s not the death panels they objected to, it’s that the government ones weren’t making anyone a profit. And this bit of owning your genes? Brilliant! They could market it as Green! They’re reducing the environmental footprint of actually producing all that shit and transporting all that shit and putting it in places so that you can choose between all that shit. Now? Just pay ’em money for simply existing. Eliminate the middle man. Free Market Wonderland.
How about we just chop off the heads of the board members and mount them on pikes in front of the Supreme Court? You know, deterrence.
In 1998, researchers tried to patent genes from samples they took from Panama’s Guaymi Indians. They probably would’ve gotten away with it if it weren’t for those
meddlin’ kidsinternational outcries.
Saw this page last night about the origins of that whole corporate person thing.
Santa Clara County v. Southern Pacific Railroad http://en.wikipedia.org/wiki/Santa_Clara_County_v._Southern_Pacific_Railroad
@The Moar You Know:
Wow, I hadn’t heard about that. What decision allowed genetic patenting?
On your bet, who do you think are the six and the three? Roberts, Alito, Thomas, Scalia and Kennedy are probable locks for the corporate side. That leaves Bader Ginsburg, Breyer, Stevens, Sotomayor; who’s likely to go over on this one?
I can understand patenting a genetic sequence that *you*, yourself, created. Like the one for glow-in-the-dark bunnies or whatever. But something that Mother Nature created? No fucking way. Those belong to everyone.
If they own a patent on a gene, could they not be held liable for damage caused by their product?
There is one problem with ACLU support. I dropped my membership when I found out they filed an Amicus brief on Citizens United.
I am not a lawyer, so if I am wrong I’m sure I’ll be told, but this really pissed me off. I think SCOTUS will overturn this BRCA ruling, but the Patent Office is out of control and overwhelmed. According to IEEE Spectrum a young boy got a patent on the packaging of a fake carrot, 2 fake lumps of coal and a few buttons to decorate a snowman. Patents are supposed to be for innovations and be “non-obvious”. I’m sure no one here has heard of a snowman being decorated…
This. Intellectual property laws have become massively distorted from what they were supposed to do. The patent system and copyrighting are now just more territory to seek rent on. The patent system is massively broken, and Disney (and the Scientologists) want to extend copyright into perpetuity. I think we might have to start ignoring them.
@Brick Oven Bill:
So why is the Supreme Court involved in medical research?
well, it wouldn’t be an issue of suing someone for having the gene. that would obviously get laughed out of court. the patents are for the genes outside the human body, that is after a manmade (and complicated) process that allowed their extraction. in other words, the gene may be natural, but it aint when it’s been pulled out and being manipulated in a dish.
that being said, what body parts, exactly, are patentable in this manner? if i come up with a rad way to remove a kidney and keep it in a machine for 2 months, does that mean i get to patent a kidney as long as it’s out of a donor body?
i’ve never gotten used to patented life.
This is not only a natural phenomena, ie cannot be patented, but if this company patents one gene, it would make sense that they could only patent one exact version of that gene. If that gene is at least 1000 base pairs in length there is a 50% chance that there will be between 5 and 10 silent mutations in that 1000 bp length. To me that means that the patent is meaningless as one could argue that they did not patent your gene, just one random and meaningless gene. The crafty cumguzzlers might have figured a way around this already though. Also I think this is good news for John McCain
The Moar You Know
@Menzies: Diamond v. Chakrabarty, 447 U.S. 303 – 1980.
As to the bet: for reversal –
Possibly Breyer as well.
For sustaining the verdict:
You cannot patent the gene itself, what you patent is the isolated gene, i.e. an article of manufacture that has the gene doing something useful.
Usefulness (“utility”) is one of the keystones of patentability.
For example, most of you have perfectly functional insulin genes, and your pancreas does an adequate job of generating the proper amount of insulin for your personal use. However, your genes and your pancreas aren’t useful to someone with diabetes. In order for your gene to be useful for treating diabetes, it has to be identified and isolated, then through costly trial and error an expression system has to be developed to express insulin at a high enough level to be commercially viable.
In this case, the utility of the breast cancer gene was diagnosis. It is assumed that a plethora of other diagnostic markers exist for the whole spectrum of genetic diseases, and a great deal of money and effort is chasing them down. Once you’ve spent the resources identifying such a marker, it is trivial for someone else to copy it. This is why the exclusivity for a limited time provided by a patent is needed to maintain the incentive to identify and isolate these markers.
For what it’s worth, this decision goes against a boatload of precedent, and I would be surprised if it doesn’t get overturned.
This is something I’ve been thinking about for a while, because a good friend of mine happens to be very conservative and a patent lawyer. The entirety of the patent system is inherently anti-free market. It’s a government-mandated system of red-tape that involves using the state-funded legal system to register ideas whose fates are ultimately decided upon some soulless bureaucrat sitting in a dank, govt office in DC. Why does the govt have to meddle in the free-market like this? Wouldn’t it be better to just let the invisible hand decide who is best able to produce, distribute, and sell new goods?
Of course, as a liberal, I think differently, because there should be (limited) protections for individuals that come up with novel ideas, because the reality is that corporations would simply devour any new ideas invented by small businesses and entrepreneurs. But I don’t get how free-market conservatives can defend the patent system. Though, I suppose no one has ever accused that side of the aisle of intellectual consistency.
actually, our offices are quite well-lit, and in alexandria.
@Pigs & Spiders:
Sorry, but No.
What a disappointing story. I vote that the farmer inform Monsanto of the contamination, and the sue Monsanto for trespassing, destruction of property and loss of livelihood when they come in to destroy the GM wheat. Lets face it, can Monsanto PROVE that they ONLY removed the GM wheat, and didn’t also destroy any of the non-hybrid kind that belongs to the farmer?
It’s like the old Loki thing: “You can chop my head off, so long as you don’t get any of my neck.”
As a patent lawyer, I can’t help but respond.
First, I think the court’s reasoning was wrong. Isolated DNA strands are not “naturally occuring” phenomena. Just like it was inventive to isolate adrenaline from oxen for medical use, it was also inventive to isolate DNA. Being the first to recognize that something can be isolated in a useful manner is a pretty big friggin’ deal, and furthers technology.
Second, I think that the court’s ultimate conclusion was correct. Isolated DNA strands shouldn’t be patentable. Not b/c it’s non-patentable subject matter, but b/c it’s obvious. The first person to develop the technology to isolate DNA should have obtained a patent and been rewarded for his inventive efforts. That was pretty inventive and creative. The big pharmaceutical giants who then did the gruntwork of applying the exact same technique to other parts of DNA strands should not be rewarded. I hope that the upper courts rule that way.
Third, I think that patent monopolies on medical devices are morally wrong period, but that is something that courts can’t, and shouldn’t, control. That’s the job of legislature. Personally, I think patent owners of medical devices should be forced to license their patents at reasonable rates (i.e. 25-50 cents per test or something). This rewards them for their efforts, but doesn’t prevent people from receiving medical care.
True story: Back in Charles Dickens day there was no such thing as copyright, at least in America, and so he was endlessly frustrated that as soon as he wrote a book everyone else immediately copied and started selling it themselves without giving him a dime.
It’s stories like this that underline the original need for some amount of copyright/ patent in order to make the market viable… but a reasonable balance is obviously required to stop the process going crazy.
So my brother-in-law, a former bio-tech engineer turned patent law student, is staying with us for Passover this weekend, and it turns out he’s connected to this case (we’ll leave out how for his sake). First off, the ruling was made by a 93 year old judge who has never looked at a patent case before, and who basically overturned years of case law. Interesting side-effect of this ruling is that it invalidates all those other patents, and does make it useless to patent the methods of developing these particular genes. Not exactly a win-win for society either way.
My hope is that a legislative fix can be made that splits the difference between giving biotech companies ownership over their methods (and therefore a reason to continue doing life-saving research), and making research that has a high level of public interest available to those who need it.
BTW, sorry if I buried my lead there: it’s not the gene patent’s invalidation that is the problem, it’s the patent on the *method* of finding and synthesizing it. The judge didn’t understand the law he was dealing with, and this will prolly be overturned.
See, you make a good point, and while I didn’t know they specifically meant the isolated strand, this is why I think it would be complicated and hard to explain in court.
The process of extraction you’re using is the patent. Maybe even the DNA itself if it’s extracted using exactly your technique – it is, after all, a product created using your patent. But if no one can research this gene or produce other medicines for it without the approval of the company, it is the *gene* being treated as patented. That gene is a naturally preexisting phenomenon.
Unless the article itself is wildly misrepresenting the situation, which is also possible. These issues are even harder for newspapers than judges.
@SGEW: Man, I’m a schmuck for doing this, but
As to patent law, I say Hack the Planet!
But did the company actually spend the money to chase the gene down, or did we the taxpayers? Remember, the Human Genome Project is a government-funded affair, as is most basic R&D performed by universities and then
stolenexploited by pharmaceutical companies. If we’re footing the bill, they shouldn’t have any right to turn around and patent the result.
Even if they *did* do all the work themselves, there is still no reason they should be able to patent the gene. It would be like a company trying to patent the seretonin re-uptake process. It’s something that naturally occurs in the body and can’t be controlled by a patent. On the other hand, a drug that changes that process (or a test that detects a faulty gene) is unique and therefore can be patented. Which is why there are multiple SSRIs on the market today. If the seretonin re-uptake process *had* been patented, Prozac would be the only (and expensive) choice.
The breast cancer gene by itself lacks usuability. It merely exists. The test, on the other hand, has usuability. It *does* something. So Myriad can patent the test, but not the gene.
it also depends on the use of the item. obviously, extracting a chemical from tree bark does not make the chemical patentable per se. it would be, if it was used in a novel manner (say, as an analgesic).
but if the use of the chemical is type of use that is considered not patentable under 101, i wouldn’t see that the overall chemical could be considered patentable.
The court invalidated both the claims on the gene itself, and on the method of detecting that gene. Although, the only “novel” aspect of the method claim is that it’s a method of detecting the BRCA1 gene specifically.
Yeah, I’d agree with that analysis. If the use of a chemical would not be patentable, then the overall chemical itself wouldn’t be “useful” at all. And we’re only allowed to patent “useful” compositions.
so the question is, how is the segment of DNA used? if it’s actively used (for example, some form of gene therapy), then i could see it passing 101 muster. if it’s merely used as a correlative marker i.e. ‘hey, you have this gene so you’re likely to get cancer’ i don’t see it passing the machine-or-transformation test.
in which case it’s really just a general business method-type issue a la bilski with a bunch of fluff on top – the life/natural material angle is just a sidebar.
IANAL, but can I now sue them if my wife or daughter gets breast cancer? It’s their patented gene…
It doesn’t have to pass the machine-or-transformation test. That test is only applicable to processes, not to chemical compositions.
You can see how the gene is used by Myriad, you don’t need to read the patent. If the gene wasn’t useful, we wouldn’t have this lawsuit, b/c nobody would want to use it. The very existence of this lawsuit attests to the usefulness of isolating the gene.
First, I think the court’s reasoning was wrong. Isolated DNA strands are not “naturally occuring” phenomena.
From the court document linked on the ACLU site, it seems that the argument was that the isolated DNA strand is not “markedly different” from its naturally occurring counterpart.
The first person to develop the technology to isolate DNA should have obtained a patent and been rewarded for his inventive efforts.
Right, and many of the techniques have been patented- most importantly, polymerase chain reaction (PCR), but that patent has recently expired. With PCR you can amplify almost any stretch of DNA using completely standard methods, the only “novel” thing you might need are the specific primers (short oligonucleotides) that bind to the desired DNA. Since the patent apparently tried to cover all possible ways of detecting this particular gene or parts of it, it ends up being rather overbroad given current knowledge about the genome.
The very existence of this lawsuit attests to the usefulness of isolating the gene.
But in this case, isolating the gene is useful only in that it reveals what genetic sequence the patient has- the product is not “useful” for anything except determining what biological information it carries.