First, and unrelated to this post, I wanted to say that like everyone here in Boston (and it seems throughout the U.S.) my heart goes out to the folks injured by Monday’s blast and their friends and family.
Now on to the substance. I have participated in a number of Supreme Court amicus briefs both in my life as a litigator and as an academic. In big name cases the Court is often inundated with them, and one can only hope that the brief is read, let alone put to good use. This is why I was incredibly happy and honored that the Supreme Court devoted a significant chunk of its oral argument time on Monday in the Association for Molecular Pathology v. Myriad Genetics, No. 12-398, the gene patent case, to discussing the brief I authored with Gideon Schor and Vern Noviel on behalf of Dr. Eric S. Lander. As Nature reported on the argument:
“The justices seemed to have been heavily influenced by a friend-of-the-court brief filed by Eric Lander, genomics whiz and founding director of the Broad Institute in Cambridge, Massachusetts. The brief argued against a lower court’s ruling that a snippet of DNA isolated from its chromosome does not occur in nature and is therefore patentable. To the contrary, wrote Lander, isolated DNA fragments do exist and are found circulating free in the blood. Indeed, a search of two public databases of DNA sequence data obtained from fetal DNA circulating in maternal blood revealed fragments that contained the BRCA1 and BRCA2 genes. “I think that raised a whole new ‘oops’,” said Robert Cook-Deegan, a policy researcher who has studied the case at Duke University in Durham, North Carolina. The justices never heard a proper response to Lander’s argument from Myriad’s attorney, who seemed to have either misunderstood the Lander brief or confused it with another when questioned.”
I reproduce some snippets from the actual transcript below the fold discussing our brief and its significance for how the Court rules.
JUSTICE BREYER: Well, that’s true, but then
you were saying something that I just didn’t understand,
because I thought the — the scientists who had filed
briefs here, as I read it, said it’s quite true that the
chromosome has the BRCA gene in the middle of it and
it’s attached to two ends.
But also in the body, perhaps because cells
die, there is isolated DNA. And that means that the DNA
strand, the chromosome strand is cut when a cell dies,
and then isolated bits get around, and there may be very
few of them in the world, but there are some, by the
laws of probability, that will in fact match precisely
the BRCA1 gene.
Now, have I misread what the scientists told
us, or are you saying that the scientists are wrong?
MR. CASTANIAS: Well, I will tell you
that —
JUSTICE BREYER: I probably misread it.
There’s a better chance that I’ve misread it.
(Laughter.)
MR. CASTANIAS: Well, no, I think — I think
you may have read some of the submissions correctly,
Justice Breyer. I think that’s a question —
JUSTICE BREYER: Well, which one have I not
read —
MR. CASTANIAS: I think that’s a question of
some dispute in this record.
JUSTICE BREYER: So, in other words, you’re
saying that the Lander brief is wrong.
MR. CASTANIAS: Well, what I will tell
you —
JUSTICE BREYER: I want to know, because I
have to admit that I read it and I did assume that as a
matter of science it was correct. So I would like to
know whether you agree, as a matter of science, that it
is correct, not of law, but of science, or if you are
disagreeing with it, as a matter of science.
MR. CASTANIAS: What I will tell you is that
what are called pseudogenes —
JUSTICE BREYER: I’d like a yes or no
answer.
MR. CASTANIAS: Yes. So the answer — I
would say the answer is no, because there is no
evidence —
JUSTICE BREYER: Was the answer no, you do
not disagree with it? I wonder, I disagree or I do
disagree?
MR. CASTANIAS: I do disagree with it with
the following —
JUSTICE BREYER: As a matter of science.
MR. CASTANIAS: As a matter of science with
the following — okay.
JUSTICE BREYER: Okay. Very well. If you
are saying it is wrong, as a matter of science, since
neither of us are scientists, I would like you to tell
me what I should read that will, from a scientist, tell
me that it’s wrong.
MR. CASTANIAS: You want me to tell you
something from a scientist that you should read that
tells you that it is wrong?
JUSTICE BREYER: No, I need to know —
MR. CASTANIAS: I think you could look at
the declaration in the — the Joint Appendix for
Dr. Kay, for example. Dr. Kay’s declaration appears
at — starting at page 370. You’ll find an extensive
discussion in there of the technology here and — and of
the genetics.
But, Justice Breyer, just to explain the
finishing thought, what — what Dr. Lander says in his
brief is that these pseudogenes, which are un —
undifferentiated fragments, exist in the body. What
hasn’t been brought to the — to the forefront is
something that is new and useful and available to the
public for — for allowing women to determine whether
they have breast or ovarian —
* * *
JUSTICE GINSBURG: Do you concede at least
that the decision in the Federal Circuit, that Judge
Lourie did make an incorrect assumption, or is the
Lander brief inaccurate with respect to that, too? That
is, Judge Lourie thought that isolated DNA fragments did
not exist in the human body and Dr. Lander says that —
MR. CASTANIAS: No, what — I think
Justice — Judge Lourie was exactly correct to say that
there is nothing in this record that says that isolated
DNA fragments of BRCA1 exist in the body. Neither does
Dr. Lander’s brief, for that matter. And for that
matter, those isolated fragments that are discussed in
Dr. Lander’s brief again are — are what are known
not — not in any way as isolated DNA, but as
pseudogenes. They’re typically things that have been
killed off or mutated by a virus, but they do not —
JUSTICE ALITO: But isn’t this just a
question of probability? To get back to your baseball
bat example, which at least I — I can understand better
than perhaps some of this biochemistry, I suppose that
in, you know, I don’t know how many millions of years
trees have been around, but in all of that time possibly
someplace a branch has fallen off a tree and it’s fallen
into the ocean and it’s been manipulated by the waves,
and then something’s been washed up on the shore, and
what do you know, it’s a baseball bat.
Is that —
(Laughter.)
JUSTICE ALITO: — is that what Dr. Lander
is talking about?
MR. CASTANIAS: That’s pretty much the same
as what he’s talking about, is that there might be
something that was out there somewhere. But — but
that’s really — the search for this sort of thing that
might be very similar to the thing but never was known
before. The patent law has taught — the patent law is
all about pushing the frontiers.
* * *
MR. HANSEN: Right, right. Now I don’t
think cDNA is recombinant DNA, that’s what we’ve argued,
but that’s — that’s at least one plausible way of
looking at it.
The genes in this case, the patents on the
genes in this case cover the genes of every man, woman,
and child in the United States. And as I just said, it
gives the — the government has given Myriad the
authority to stop research on every one of our genes.
That simply can’t be right.
And I would like to make one other point
with respect to Dr. Lander’s brief. On page 16 of Dr.
Lander’s brief he discusses specifically that the BRCA
genes appear in the body with covalent bonds in
fragments. There isn’t any real — there isn’t any
scientific dispute about that fact.
The full brief can be downloaded here https://www.americanbar.org/content/dam/aba/publications/supreme_court_preview/briefs-v2/12-398_neither_amcu_lander.pdf.