 Okay, so does everyone actually know what the decision was? I know it's been sprinkling around, so Meriad had taken their case to patent of human genes to the Supreme Court, and the Supreme Court hours ago, maybe even minutes ago, returned the decision that the patents that covered the genomic DNA, that the genes themselves were not patentable, but the patents covering cDNA, and I'll explain for those of you that don't follow this, what that means in a second, were eligible. So the core of the diagnostics that are used to figure out whether someone carries a BRCA 1 or 2 breast cancer susceptibility required the patent on the genomic DNA, which is now invalid. And I said I could tell you about what it means. We just actually read the decision 30 seconds ago. On that reading, it seems to me that the field of diagnostics, specifically for breast cancer, would be much more wide open and much more competitive. Probably more important, because the BRCA 1 and 2 patents were set to expire relatively soon anyway, are the 5 to 7,000, depending upon who's doing the estimate, genes of the 22,000 human genes, a good number of them have patents that have been taken out on them. And most of those are on the genomic DNA, and again I'll mention what that is in a second. Those my reading of this, and we're trying to get some confirmation, those would also be invalidated. And this is critically important if you're going to look at the genome as a whole. You could imagine that in our labs we could sequence the entire human genome, but we'd have to figure out who owns the 7,000 different bits if we wanted to actually use that. And that shouldn't be an issue based on this patent. By way of background, as Ari said, we've been working with the Solicitor General's Office on the technical sides of their brief, do this because I used to work on the BRCA 1 gene in my lab, and I continue to work on the BRCA 1 and 2 gene from the point of view of bioinformatics and databases, and we at NIH have a database that collects all of the world's mutations in these genes that we then redistribute to all the researchers in the world on a free basis from a website that we run. There'll be a lot of buzzing about the patent, and I'm sitting with our consultant, the former dean or current dean of the University of Maryland School of Law, and we're still trying to digest exactly what the decision said, but at least by first blush it invalidates the core of the patents for using the human genomic sequence to do diagnostics or to do any kind of inventions. For those of you that don't know the molecular biology, a CDNA is a process where you take the product of a gene and you do some laboratory tricks to have a new molecule that you can then manipulate in the laboratory. Those molecules are critically important to probably 80 or 90 percent of the biotech industry, which makes new molecules. The Supreme Court upon our reading of it would say that those molecules are still valid, so many of the recombinant drugs and the antibody-based drugs that you hear about, some of which are featured in the exhibit today, are based on recombinant DNA molecules, CDNA molecules, as well as when you take two molecules and you stitch them together from different organisms under the reading of that, those are still patent eligible. But what not, what the Supreme Court ruled is that your genome and the information in your genome exist in nature and is not patent eligible under the statutes that patents are laid out. I know that was kind of very somewhat unstructured response, but I think we have time for questions. Yes. Do I have questions from the audience? Since we are webcasting, I will bring you a microphone, so your question is on Mike. Questions? Yes. Tell us who you are and ask your question. Hi. Donna Young from Scrip News. My question is for the biotech industry then that this ruling was actually then okay for them because it's the recombinant DNA or how would it negatively affect them? So it was actually discussed during oral arguments as well. We think, and I'm not an expert in the biotech field, but just at first blushed through all of the things that we think of as biotech advances, most of those do not use native genomic DNA. They use recombinant molecules in some sort or engineered molecules that add additional information that wasn't there in nature. And from the reading of this ruling, those are patent eligible. The patents will still stand and will still be issued. In fact, at the very end, the very last paragraph in the ruling even says there can be new patents about the BRCA1 and 2 gene that involve it. So if I want to make a new form of the BRCA gene and do something with it in the lab that makes it useful, that would also be patent eligible. So I think the bulk of the dollars that are invested and spent in the biotech industry, most of them are focused on recombinant molecules and new products of nature. Other questions? Please tell us who you are. Yeah, Jason Kebler with the U.S. News & World Report. Is there anything in the decision that suggests you can't patent, you know, crop DNA or other living things or does this only apply to humans? No. In fact, there's precedent and they cite in the decision several other cases where naturally occurring things are very difficult to patent or not patent eligible. In fact, one of the precedent cases is the case of the funk brothers who developed a microbial mix that they used to apply to crops. It was beneficial to crops and I believe if I'm reading correctly that that patent was disallowed because those microbes exist in nature, all the funk brothers did was come up with a cocktail of them. And so I don't see that it lets you patent naturally occurring organisms, naturally occurring molecules. It does not preclude patenting recombinant corn, recombinant soybeans. All of those things are not products of nature. They require the intervention of people to create a new organism. And this is consistent with the original ruling on one of the microbes that was genetically engineered was given a patent. Well, I think the first patent that was issued, the Chakavarti decision. Thank you for waiting for the mic. Hi, can you, oh, Meredith Wadman with nature, can you just review or remind us what exactly myriad did to get from genome to product? Just in the context you've been talking. Okay, so and this goes back more than 15 years. What, this is before there was a genome sequenced. In order to find a disease gene, you had to essentially build an entire map of the genomic region you're interested in and then identify all the genes in the region and then figure out which gene might be involved in your particular disease. And there was an international race to do this 15, 16 years ago and Meredith built the map first and found which of the genes at the point, the official public information was it was somewhere in this few million bases of DNA. They pinpointed which 100,000 bases the gene was located in and got the sequence of the gene first and then applied for patents on the sequence of the gene in the genome. Any other questions? Hang on. I will get my exercise this way. And just as a follow-up in the decision, they highlight the fact that you can be incredibly inventive, incredibly smart and get the Nobel Prize, but it doesn't mean what you find is patent eligible. Einstein did not get a patent on the laws of nature. This is Dan Bergano from USA Today. I was wondering if actually if you can expand on that a little bit. My understanding is that they're saying that gene sequences are products of nature whereas Meredith's argument had been somewhere along the lines of isolating these genes is not a natural thing and so they were entitled to patent protections and so the decision is very much hanging on this patent requirement about products of nature. It wasn't the things, the other patent requirements of being non-obvious and so forth that we're keeping. Correct, correct, and Meredith actually, for those of you that don't study patent law like me, there are several different flavors of patents. There can be composition of matter patents. So if you make a new alloy of something that you had to do chemically, you can get a composition of matter, some carbon fiber new thing. And then there are process patents. Meredith was issued composition of matter patents for the human genome sequence covering these genes. And the court has ruled that the human genome is naturally occurring. And the fact that Meredith was able to pluck it out of the human genome and analyze it doesn't mean that they created something new, a new composition of matter. Greg Lucir, Life Technologies. Just if you could share with us your opinion then of what the ruling means in terms of mutation analysis when you're doing sequencing on a human genome. Mutations then are free and clear in terms of being able to read across? So there are different ways to do mutation analysis on a given gene. So what the test that has been offered up until now, because it took advantage of the technology that was the one we knew the best, required knowing a little bit about the sequence of the gene you wanted to sequence. And that was protected under the Meredith patents. It no longer would be. Coincident with this ruling is the fact that as you saw in the exhibit, the technology is changing tremendously. And so now if I want to sequence your genome, I don't need to know anything about your genome. I can use these machines and the knowledge of the publicly available reference genome to assemble your genome. There's an in-between step that we're doing now where we just go in using these next generation technologies and just pull out the parts of the genome we wanted to learn about. And that may be something we were doing for a while. That does require knowing the naturally occurring sequence in order to pull the parts out to then put them on the next generation machine. In the interpretation of the patent as it stood, that would be not something you could do without infringing upon the patent. I can tell you in the briefs that Miri had issued, the next generation whole genome sequencing that we're talking about where you don't need to know anything ahead of time. You just take some of your DNA and I sequence your entire genome. In one of their briefs they very specifically said they did not think that that would infringe upon their patents. So going forward, I mean they were looking forward to the time when they wouldn't have the patents anyway because they would expire probably. But going forward we won't need that if we can sequence whole genomes very, very cheaply. But it is interim period when you want to have a test where I'm going to use next generation sequencing to sequence the 30 most important breast cancer genes. And just them, that would require knowledge and use of the intact genomic DNA which the Supreme Court has now said is in the public domain, so to speak. So one last question perhaps or we'll let Dr. Brody go eat lunch. Anyone else have a burning issue, burning question? Dr. Brody, thank you very much for being, for doing this in such an impromptu way. Well done, sir. I would next like to introduce Dr. Eric Green, who's the director of the National Human Genome Research Institute. I would like to ask him to come up here and give us sort of the state of the art of the field and give us a taste of what's coming because there's a huge amount of things going on across the field. And he knows it better than anybody, Dr. Green.