US District Judge Rules Gene Patents Invalid

shriphani writes "A US judge has ruled that Myriad Genetics' breast cancer gene patent is invalid. Hopefully this will go a long way in ensuring that patents on genes do not stand in the way of research. From the article: 'Patents on genes associated with hereditary breast and ovarian cancer are invalid, ruled a New York federal court today. The precedent-setting ruling marks the first time a court has found patents on genes unlawful and calls into question the validity of patents now held on approximately 2,000 human genes.'"

Comments

Conversely

[eldavojohn]

Hopefully this will go a long way in ensuring that patents on genes do not stand in the way of research.

And let us also hope that financial backers and investors don't pass on the idea of investing in said research without the potential payout of a full term patent.

As unpopular as the above statement is on Slashdot and as flawed as the patent system is, it still fulfills purposes making this at least a two sided issue. Ignoring either side is nothing but folly.

You can revise your statement to read: Hopefully it's a net positive for gene research.

Re:Conversely

[alex_guy_CA]

However, most research and medical breakthroughs come from publicly funded money, research, and institutions. They only find their way into the corporate portfolio latter.

Re:Conversely

[Anonymous Coward]

There is absolutely no way we can grant monopolies on certain aspects of life, to anyone. Whether it is a good business proposal to found science or not, it is not correct at all.

Patents like this come with the power to hold people ransom on existential needs. That cannot, ever, be right.

Another reason, Gene's are nature's "programming language". Once you can read some of it, reasonable efforts will help you to understand more of it.
 
  But, there is no point or fairness in granting anyone who finds out "something" first the right to, for many years, control its use. Things will be found out because people NEED to figure them out, even without prospect to get money from patents. This is also why you don't need to patent software - just because someone needed a selectable button and did it first, that does not mean they should be able to patent it and henceforth control all selectable buttons - someone will absolutely, positively need the exact same thing and would have figured it out themselves anyways, with a reasonable degree of certainty.

Re:Conversely

[Bigjeff5]

The genes can't be patented, because they were discovered, not created, and not discovered in the "OMG I just discovered how to make rubber!" kind of way. They were discovered in the "I just patented New England" kind of way.

Now, the tools and methods of discovery, those certainly should be patentable. The genes were always there, however, and we knew they were there somewhere, and the patent does not allow you to do anything with them, it just tells you where they are.

That is why it was struck down, and that is why this won't have any serious effect on medical research. The stuff that should be patentable is patentable, the stuff that should not be patentable is no longer patentable.

Re:Conversely

[Anonymous Coward]

No it doesn't. They can actually make proper inventions. They can invent treatments that target the gene, detection methods to find the gene, methods to remove it, alter it, whatever.

Just because they found it doesn't mean it's patentable. It's naturally occurring, and they had nothing to do with creating it.

Imagine if the guys at the LHC discovered another fundamental force. Should they be able to patent it and claim royalties on everyone who "takes advantage" of their discovery of "new gravity"?

They discovered a gene. They shouldn't have patented it in the first place, they should have invested a tiny bit more to patent a efficient detection method, and still made shitloads of money.

Re:Conversely

[Burdell]

Do you think that an astronomer should be able to patent a planet because they saw it first? How about the particle physicists working on the LHC patenting the Higgs bosun if they find it (sorry, no gravity without a license!)? Why should someone be able to patent a naturally occurring gene, just because they found it first? If they find something original, such as an easy way to detect the presence or absence of a gene that can lead to illness, or a way to use that knowledge to treat the condition caused by the gene, patent away, but nobody should be able to patent something that has existed in thousands or millions of people for decades or centuries just because they were the first to track it down. They didn't invent or create anything.

Re:Conversely

[martin-boundary]

Yeah, I wouldn't exactly call that win/win.

Then you need to learn some math. Lower drug prices is a WIN for customers. No patents to prevent public research breakthroughs is a WIN for science. That's two WINs, count'em.

If companies can't get a patent, why would they invest millions, even billions, into the research, if the moment they make a discovery, the company next door gets to profit from their research for free with ZERO seed investment.

For the same reason companies today invest millions, even billions into contributing to open source, like the Linux kernel, even though their competitors get to profit from those contributions for free with ZERO seed investment.

What this DOES do is essentially put all genetics research companies out of business,

Good riddance to bad rubbish. If the only way they can contribute research is by blocking others with patents, then we don't need their "research".

and leaves it to government organizations and government funded educational institutions to do the research.

That's a good idea. Medical breakthroughs should be available to all citizens unencumbered by patents, and at affordable prices, and that's the best way to ensure this in the long term. Some industries, like health care, are strategically important. Moreover, with fewer private companies to drain the smart people from universities, the next generation of students would have a higher quality education. Yet another WIN.

Re:Conversely

[robotkid]

As unpopular as the above statement is on Slashdot and as flawed as the patent system is, it still fulfills purposes making this at least a two sided issue. Ignoring either side is nothing but folly. You can revise your statement to read: Hopefully it's a net positive for gene research.

Good thought, especially for more tricky examples like patient-derived cell lines or naturally occurring therapeutic molecules, but in this case such worry is not warranted. Treatments, cures, diagnostics, etc are all still patentable, and they are what the investors were looking to make their money from in the first place.

The central issue at stake was whether the discovery of a gene in and of itself, which is just a snipped of biological information, was patentable, and all the resulting technology that utilized that information would be rendered derivative works. Think about that for a moment, if someone went out and discovered a new type of fish, maybe they'd get to name it but they certainly can't claim to own all future profits made by anyone else catching and selling that fish. More to the point, if someone then discovered that the fish produced a chemical that cured some disease, they original discoverer of the fish would not have the ability to sue and say that was reverse engineering of his patented intellectual property. Discovering a gene is not terribly different - it already existed all over the world long before we had to tools to identify and study it. Discovering is different than inventing, and in the case of genes discovery by itself is a far cry from understanding how it works, much less how to manipulate it to fix a disease.

Also, for context, the only real reason one would want to patent a gene is some sort of exclusivity clause (i.e. I discovered this breast cancer gene so now only I can work on a cure for it) or for patent trolling (now lets sue all the other folks working on breast cancer cures). Both scenarios would effectively destroy the ability for competing companies to work on the same disease, and lead to a massive gene-squatting free for all. IAAB (I am a biochemist), and I honestly can't think of any scenarios where being able to patent a naturally occurring gene would be good for either society as a whole or even just letting the market do what it does best.

Re:Conversely

[NFN_NLN]

However, most research and medical breakthroughs come from publicly funded money, research, and institutions. They only find their way into the corporate portfolio latter.

[citation needed]

http://www.ornl.gov/sci/techresources/Human_Genome/home.shtml

Completed in 2003, the Human Genome Project (HGP) was a 13-year project coordinated by the U.S. Department of Energy and the National Institutes of Health.

  Project goals were to

        * identify all the approximately 20,000-25,000 genes in human DNA,
        * determine the sequences of the 3 billion chemical base pairs that make up human DNA,
        * store this information in databases, ...

Re:Conversely

[PitaBred]

The device or a novel process? Yes. But you should not be able to patent the gene which effectively makes your device the only way to detect the disease. That is not what the patent system is for. It is for protecting novel inventions, not for locking up essential, basic knowledge with a toll booth.

Re:Conversely

[sweatyboatman]

I'm sorry, this is a very poor argument.

without patents there is no monetary incentive for identifying the function of a gene

If you figure out the function of a gene you can then make a drug to suppress or improve the function of the gene. Or whatever else. And that drug will be, wait for it, patentable! And when that patent comes out and the FDA approves the drug, it's gonna be kinda obvious to people who should know what the drug you're patenting does to what genes and why.

Perhaps what you mean to say is that without patents, when private industry figures out the function of a gene they will keep it to themselves. But that still doesn't make much sense. Unless you're going to take that information and make a treatment out of it, you're not going to be able to monetize it. (And as soon as you make a treatment, you're going to have to explain to the FDA how that treatment works.)

You could, I suppose, make a treatment and not patent it (like a trade secret). But then you're running the extreme risk of having someone else steal/recreate your discovery and patent your medicine out from under you.

Regardless, the motive to research the function of genes is that if you can figure out what a gene does (and it does something useful), you can develop patentable treatments that manipulate that gene. Patenting the gene is just the icing on the cake.

Re:Conversely

[laughingcoyote]

But the fact still remains, any treatment, drug, etc., based upon the gene's discovery, is as patentable as it ever was. The only thing you can't patent is the gene itself, and that's quite correct. If you discover a certain isotope, and find a way to make workable fusion energy from it, you can patent your reactor, but not the isotope itself. That's exactly how the patent system is meant to work-you can patent things you invent, but not things you just find.

That being said, it always saddens me to see "capitalism" thrown around like it's some unimpeachable, unquestionable good force. I wish people would question it, as it's sure got an awful lot of negatives. At some point, I sure hope we can find a better system.

Re:Conversely

[besalope]

The drug formulas can still patented.

The judge just invalidated corporate patents that restricted others from working on trying to cure problems from "patented" genes without paying royalties.

Re:Conversely

[reverseengineer]

The real issue, in my opinion, with these patents is that Myriad tries to make the information of the gene sequence essential to any detection method for that gene. Take a look at Myriad's patent for the breast cancer-related gene BRCA2. Right at the beginning, "Specifically, the present invention relates to methods and materials used to isolate and detect a human breast cancer predisposing gene (BRCA2), some mutant alleles of which cause susceptibility to cancer, in particular breast cancer. More specifically, the invention relates to germline mutations in the BRCA2 gene and their use in the diagnosis of predisposition to breast cancer." So at first glance, you might think that this patent refers to a diagnostic test for BRCA2, which seems to be an acceptable place for a patent for many people. After all, DNA sequences are just molecules, and there are any number of non-contentious patented tests for biological molecules already- think of glucose test strips, for instance. Manufacturers have found ways to patent various advances in testing for blood glucose without actually asserting a patent on glucose itself.

However, when you test for something like glucose, the test result is going to be a concentration. When you talk about performing a test for BRCA2-based cancer susceptibility, you don't just need to "detect" BRCA2, but be able to isolate it and determine whether it differs from the wild-type BRCA2. So Myriad had the idea that in their patent claims they could define their "methods and materials" to be both the likely molecular bio technique intermediates, and also the molecules that are the theoretical outcomes of any BRCA2 test.

Paraphrasing some of their claims: -We claim the isolated normal BRCA2 sequence, and any isolated subset of that sequence comprised of at least 15 contiguous nucleotides.
-We claim the isolated major mutant sequence of BRCA2 known to be involved in susceptibility to cancer, and any isolated subset of that sequence comprised of at least 15 contiguous nucleotides.
-We claim nearly 40 different variants of the major mutant sequence.
-We claim any sort of cloning vector, expression vector, recombinant cell line, or PCR primer involving an at least 15 contiguous nucleotide stretch of any of the above sequences.

So Myriad was trying to claim that the invention was a diagnostic method, just that any molecule corresponding to the nucleotide sequences they claimed were an intrinsic part of the "method." What's interesting about the "15 contiguous nucleotides" mention that keeps cropping up is that BRCA2 is over 11000 nucleotides long, producing a protein 3400 amino acids long, such that Myriad laid claim to tiny fragments of the gene which would have had no BRCA2 function on their own.

Re:Conversely

[oiron]

And if someone, purely out of random mutation naturally develops that sequence? Sue them for infringement?

Re:Conversely

[AK Marc]

You can still patent the vaccine for polio (which the inventor could have patented and declined to because he thought it should be free), but you can't patent the genetic sequence of it. You can patent any treatment for breast cancer you want. However, patenting a discovery about a gene linked to breast cancer can't be done. There's nothing at all in this ruling that would jeopardize any actual or potential treatment or cure. The patent was to block research so no one could treat the "disease" as if someone patented polio was was suing anyone else working on a cure for polio.

Re:Conversely

[AK Marc]

You're not really this ignorant are you?

Yes, I am. I understand that the patent system only patents creations and not discoveries. That makes me ignorant.

Ok, I'm a researcher, I want to find out the genetic cause of some untreatable disease.. because I want the disease to be treated. Who's going to pay for my lab time?

You either look out there for those who have posted requests for researchers and do what they ask, or you write proposals. Duh, now who's ignorant?

Previously, I could go to industry and say "ok, here's my credentials, you get the patents, deal?" and that's where the funding could come from.

Ah, so you are a whore who sells his soul for profit. And you blame people like me for getting in the way of you selling yourself for profit. You do all the work, they get all the rewards, and the two of you lock out everyone else. And, once the patent on the discovery is obtained, they use it to *prevent* a cure for profit for themselves at the cost of lives. And you like that system because it's easier for you to make money in that system.

No drug companies target the genes I discovered for treatments. After all, that'd start a race and no drug company can afford to get into a race.

So, making the first drug and patenting it to block others would make them billions, but they won't try because they would spend money and someone else might come up with something first? So, 400 years later, when the gene is known for hundreds of years and no one has started making a drug to fight it, do you think that one of them might try? No, they'll still be paralyzed because they think someone else might do it at the same time? Yup, that's consistent with your logic so far. After all, since the swine flu was well known, no one tried to make a vaccine for it. Or polio. Or HPV. Nope, those are well known viruses, so no one would ever waste money trying to cure those because someone else might also come up with a cure.

Well of course its invalid...

[paper tape]

Well of course its invalid...

God could claim Prior Art.

;)

Re:Well of course its invalid...

[Cryacin]

Come on, if God was such a freaking fantastic engineer, why the hell did he put a sewage outlet right in the middle of a recreational zone?

Monsanto

[Anarki2004]

I would like to see something similar happen to Monsanto's patents.

Re:Monsanto

[Bruha]

I think it should be illegal though. If you have a farm next door to a patented crop, bees cross polinate, and then monsanto is knocking on your door.

In essence their patent is viral in nature.

I'm glad and all...

[JorDan Clock]

But I'm kind of upset that we live in a society that we have to tell someone "No, you cannot have exclusive rights to a natural occurrence." Worse yet, this "patent" prevented anyone from even looking at the gene, whether it was for diagnostic or research purposes.

Natural Resource

[LightPhoenix7]

You can't patent coal, or wood, so why should you be able to patent a natural resource like DNA? If they create something new from it, like a new allele or treatment, I'd say that's fair game. In the end, this is an extremely important ruling, but unfortunately it's probably not the end. It will probably require the Supreme Court to make a ruling. I don't see anyone involved giving up that easily.

Discovery, not Invention

[BlueBoxSW.com]

See the difference?

Don't forget GMOs

[JumboMessiah]

Gene patents are also big in the agriculture industry. And they actively sue to keep it that way.

The US Supreme Court ruling

[pearl298]

The US Supreme Court ruling used the term "anything under the sun that is made by man".

The essence of this lawsuit is that the natural genes were "discovered" not "made by man".

In other words these patents were invalid under existing law. Nothing new here, bad patents have been around since King James (the gay King of England and Scotland).

Re:I don't get it !

[Jurily]

Prior art.

Re:I don't get it !

[Shikaku]

Yep. There was a lot of prior art in your mother before you were born I bet too.