US District Judge Rules Gene Patents Invalid 263
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.'"
Re:Conversely (Score:1, Informative)
Mod parent up.
This is a double edged sword. 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.
Suddenly their competitors are all charging less because they have no costs to recoup, and the companies that are good enough at research to have made the breakthroughs go bankrupt and disappear.
Yeah, I wouldn't exactly call that win/win.
What this DOES do is essentially put all genetics research companies out of business, and leaves it to government organizations and government funded educational institutions to do the research.
Educational institutions, while they have been successful in many areas of research, are diversified in their funding, and can't even begin to touch the levels of specialized funding that the biotech corporations have for doing this kind of research.
Don't forget GMOs (Score:5, Informative)
Gene patents are also big in the agriculture industry [twnside.org.sg]. And they actively sue [iastate.edu] to keep it that way.
Re:Conversely (Score:5, Informative)
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 [ornl.gov]
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,
Henrietta Lacks (Score:2, Informative)
I was dismayed to learn that it would cost millions to test one individual for all known genetic diseases, not because of inherent costs of the technology but because of all the patents and licensing fees. I hope that today's positive ruling cascades in positive ways to other realms of gene patenting and unthrottles scientific progress.
that's not really how the case worked (Score:3, Informative)
It would be one thing if the farmer were complaining he couldn't sell his crop because it was contaminated. Instead he was found to be using the features of the Monsanto crop (Roundup resistance).
If the crop just blew over and he still grew it as normal it'd be one thing, but instead he knew it was genetically modified and he was using that feature of it to make his growing easier.
Re:Conversely (Score:5, Informative)
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 (Score:5, Informative)
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.
Many things that could be said about Celera... (Score:1, Informative)
But remember that the data published by Celera included the Celera generated data (cost about $300e6), but also the public data (cost about $3e9). So, strictly speaking, Celera's data cost more than the public data, because it was a superset.
Don't get me wrong. Celera did a number of great things. The competition made the public project get their act together and come in early and under budget (and is now still going at a much faster clip because of it).
Just remember, like a lot of companies, they stood on the shoulders of giants.
Re:Conversely (Score:2, Informative)
I am not a biochemist so I must ask some questions about your particular example with breast cancer genes. I'm lead to believe that 'discovering a breast cancer gene' is extremely difficult.
It was the first time it was done. Since then, the cost for sequencing an entire human genome has fallen to under $10,000, expected to go down to $1,000 within a year or two. Less comprehensive diagnostics are even cheaper than that - think paternity testing expensive, not "you need your own research institution" expensive.
Doesn't the number of sets of DNA one must collect coupled with the accuracy of those collections coupled with the willingness of the volunteers coupled with the number of potential snippets of DNA that could be the gene coupled with all sorts of other complications and permutations make finding such a gene like finding a needle in a haystack? Doesn't that require vast amounts of resources? And then to do it for all sorts of diseases?
This is the key misconception. Finding disease-linked genes and mutations was extremely difficult in the pre-human genome era. The technology is currently getting cheaper and faster to the same tune as CPU power, it's rather a routine type of exercise now. The problem is that, except for the most trivial of cases, simply isolating and sequencing these genes alone brings us very little insight as to the underlying mechanism of the disease.
The gene probably codes for a protein of unknown function, so you have to isolate it and purify it and figure out what it does. It probably interacts with an unknown number of other proteins, often also of unknown function, so you have to figure all of that too, by knocking the gene out of a rat or mouse. The gene probably gets turned on and off or levels inbetween by other genes, so you have to map out all those interactions too. It probably acts different in diseases tissues vs healthy tissues, so you need to study it in cell culture to figure out the difference. And, of course, if you actually want to bind candidate drugs to it, then you might need to figure out the 3-D structure of the protein so you know the shape and size of any achilles heels it might have. But even after all that, you're still probably screwed because often things works very differently in a test tube than in cell culture than in rats than it does in chimpanzees than it does in actual human patients. But you can't test your hypothesis by mucking with the genes of actual humans, apparently that's unethical :-)
My point is you could spend an entire PhD on every one of these little parts and still not understand how they interact to cause a disease. But you CAN study it - that is the advance that having sequenced the gene allows - before that, we were completely in the dark. But it's a starting address, no more and no less.
it means if anyone uses your genes to develop a cure, you get royalties for that patent term.
Sequencing a gene is cheap, like I said, you seem to assume it's prohibitively expensive. Can one patent raw biological information? If you are Monsanto, then you can patent a GMO that you've added a drought resistance gene into. It's a new creation, and you can describe exactly how you did it and exactly what it does. That requires a level of understanding of a gene that is so detailed that it certainly should be patentable. But I submit to you that noone currently understands what most cancer genes actually DO. Can you patent something if you don't understand how it works? Most of the patents in question barely provide any explanation, if at all, about how a gene actually works. The descriptions read like stuff from high-school biology textbooks. They are really that bad, I kid you not.
I scoff at your claims of gene squatting as you have to say what the gene does and pay the huge patent fees to get the patent (so you can't just patent each gene as the breast cancer ge
Re:Conversely (Score:3, Informative)
But the system isn't set up to honor all firsts. The first person to, say, eat an entire bicycle couldn't get a patent on eating bicycles. Finding things doesn't get you patents. You don't patent a new bug discovered, so why should you be able to patent its genetic code?
They are trying to patent a discovered star and charge all astronomers that look at it. The star was there before them. If they used a new method for discovering it, patent the process or device or whatever. But the actual item that was there before they were born and will be there long after they are dead is not patentable. It wasn't invented, created, or in any way modified by the person filing the patent. They did no work to make it. Patents are for making things, and nothing was made by the person filing, and the thing existed before they filed - it's its own prior art.
Re:Conversely (Score:2, Informative)
Re:They didn't strike down a gene patent (Score:3, Informative)
If you patented a breathalyzer, would you call it a patent on alcohol?
No, but if the patent was written such that any test that detected alcohol would violate the patent, then it would be a patent on alcohol. That's my understanding of Myriad's patent and assertions about it. There is simply no way to create another test for BRCA2-based cancer that does not violate the patent, using any method. That's why the patent is broken and should be thrown out.
FTFA: "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."
That's operationally a patent on the genes, and in your analogy, it would be essentially a patent on alcohol testing of any kind.