Lawrence Brody: Okay, so, does everyone actually know what
the decision was?
I know it's been sprinkling around, so Myriad 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, 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 BRCA1
or 2 breast cancer susceptibility required the patent on the genomic DNA, which is now
invalid.
All right, so I can tell you about what it means.
We just actually read the decision 30 seconds ago.
And upon 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 or 2 patents were set to expire relatively
soon anyway, are the 5,000 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 can imagine that in our labs, we could sequence the entire human genome, but we 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.
But, by way of background, as I 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 BRCA1
gene in my lab, and I continue to work on the BRCA1 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 will be a lot of buzzing about the patent, and I'm sitting with our consultant, the former
dean, or the current dean of the University of Maryland School of Law, and we're trying
to digest exactly what that 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 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 a 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 were 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, exists 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,
and --
Larry Thompson: Yes, so, do I have questions from the audience?
Since we are webcasting, I will bring you a microphone so your question is on mic.
Questions?
Yes.
Tell us who you are, and ask your question.
Donna Young: 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?
Lawrence Brody: 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 blush, through all
of the things 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 had 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 a 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.
Larry Thompson: Other questions?
Please tell us who you are.
Jason Koebler: Jason Koebler, with the US 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?
Lawrence Brody: 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, and 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 those things are not products of nature; they require the intervention of people to
create a new organism.
And this is consistent with the regional ruling on one of the microbes that was genetically
engineered was given a patent.
Well, I think the first patent, it was issued, the Chakravarti decision.
Larry Thompson: Are you waiting for the mic?
Meredith Wadman: 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 with us.
Lawrence Brody: 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 were 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 Myriad wrote 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.
Larry Thompson: Any other questions?
Hang on.
I will get my exercise this way.
Lawrence Brody: 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 that what you find isn't patent-eligible.
So Einstein did not get a patent on the laws of nature.
Dan Vergano: This is Dan Vergano from USA Today.
I was wondering, if, actually, if you could expand on that a little bit.
My understanding is that they're saying that gene sequences are products of nature, whereas
Myriad'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.
Lawrence Brody: Correct, that's correct.
And Myriad, 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, you know, carbon, some carbon fiber new thing.
And then there are processed patents.
Myriad 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 Myriad 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.
Larry Thompson: Who are you, sir?
Greg Lucier: I'm Greg Lucier, 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?
Lawrence Brody: 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 that you wanted -- of the gene you wanted to sequence, and
that was protected under the Myriad 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 wanted 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 want to learn about, and
that may be something we are 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 Myriad 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 -- no, they were -- 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 genes -- whole genomes very, very cheaply.
But in this 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.
Larry Thompson: 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.
[applause]
I would next like to introduce Dr. Eric Green, who is the director of the National Human
Genome Research Institute.
I would like to ask him to come up here and give us sort of a 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.