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It was an afternoon in the fall of 2005.
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I was working at the ACLU
as the organization's science advisor.
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I really, really loved my job,
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but I was having one of those days
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where I was feeling
just a little bit discouraged.
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So I wandered down the hallway
to my colleague Chris Hansen's office.
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Chris had been at the ACLU
for more than 30 years,
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so he had deep institutional
knowledge and insights.
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I explained to Chris
that I was feeling a little bit stuck.
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I had been investigating
a number of issues
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at the intersection of science
and civil liberties -- super interesting,
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but I wanted the ACLU to engage
these issues in a much bigger way,
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in a way that could really
make a difference.
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So Chris cut right
to the chase and he says,
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"Well, of all the issues you've been
looking at, what are the top five?"
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"Well, there's genetic discrimination,
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and reproductive technologies,
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and biobanking, and ...
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Oh! -- there's this really cool issue,
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functional MRI and using it
for lie detection, and ...
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Oh! and of course, there's gene patents."
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"Gene patents?"
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"Yes, you know, patents on human genes."
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"No!
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You're telling me that the US government
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has been issuing patents
on part of the human body?
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That can't be right."
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I went back to my office
and sent Chris three articles.
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And 20 minutes later,
he came bursting in my office.
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"Oh my god! You're right! Who can we sue?"
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(Laughter)
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Now Chris is a really brilliant lawyer,
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but he knew almost nothing
about patent law,
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and certainly nothing about genetics.
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I knew something about genetics,
but I wasn't even a lawyer,
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let alone a patent lawyer.
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So clearly we had a lot to learn
before we could file a lawsuit.
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First, we needed to understand
exactly what was patented
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when someone patented a gene.
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Gene patents typically contain
dozens of claims,
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but the most controversial of these
are to so-called, "isolated DNA."
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Namely, a piece of DNA
that has been removed from a cell.
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Gene patent proponents say,
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"See? We didn't patent
the gene in your body,
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we patented an isolated gene."
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And that's true,
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but the problem is that any use
of the gene requires that it be isolated.
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And the patents weren't just
to a particular gene that they isolated,
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but on every possible
version of that gene.
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So what does that mean?
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That means that you can't give
your gene to your doctor
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and ask him or her to look at it,
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say, to see if it has any mutations,
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without permission of the patent holder.
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It also means that the patent holder
has the right to stop anyone
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from using that gene
in research or clinical testing.
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Allowing patent holders,
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often private companies,
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to lock up stretches of the human genome
was harming patients.
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Consider Abigail,
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a 10-year-old with Long QT Syndrome,
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a serious heart condition that,
if left untreated,
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can result in sudden death.
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The company that obtained a patent on two
genes associated with this condition
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developed a test to diagnose the syndrome.
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But then they went bankrupt
and they never offered it.
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So another lab tried to offer the test,
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but the company that held the patents
threatened to sue the lab
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for patent infringement.
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So as a result,
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for 2 years, no test was a available.
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During that time,
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Abigail died of undiagnosed Long QT.
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Gene patents clearly were a problem
and were harming patients.
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But was there a way
we could challenge them?
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Turns out that the Supreme Court
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has made clear
through a long line of cases,
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that certain things
are not patent eligible.
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You can't patent products of nature --
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the air, the water, minerals,
elements of the periodic table.
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And you can't patent laws of nature --
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the law of gravity, E = mc2.
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These things are just too fundamental
and must remain free to all,
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and reserved exclusively to none.
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It seemed to us that DNA,
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the most fundamental structure of life,
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that codes for the production
of all of our proteins,
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is both a product of nature
and a law of nature,
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regardless of whether it's in our bodies
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or sitting in the bottom of a test tube.
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As we delved into this issue,
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we traveled all over the country
to speak with many different experts --
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scientists, medical professionals,
lawyers, patent lawyers.
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Most of them agreed that we were right
as a matter of policy,
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and, at least in theory,
as a matter of law.
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All of them thought
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our chances of winning
a gene-patent challenge
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were about zero.
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Why is that?
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Well, the patent office
had been issuing these patents
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for more than 20 years.
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There were literally thousands
of patents on human genes.
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The patent bar was deeply
entrenched in the status quo,
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the biotech industry had grown up
around this practice,
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and legislation to ban gene patents
had been introduced
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year after year in Congress,
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and had gone absolutely nowhere.
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So the bottom line:
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courts just weren't going to be willing
to overturn these patents.
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Now, neither Chris nor I were the type
to shy away from a challenge,
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and hearing, "Being right
just isn't enough,"
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seemed all the more reason
to take on this fight.
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So we set out to build our case.
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Now, patent cases tend to be:
Company A sues Company B
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over some really narrow,
obscure technical issue.
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We weren't really interested
in that kind of case,
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and we thought this case
was much bigger than that.
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This was about scientific freedom,
medical progress,
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the rights of patients.
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So we decided we were going
to develop a case
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that was not like
your typical patent case.
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More like a civil rights case.
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We set out to identify
a gene-patent holder
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that was vigorously enforcing its patents,
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and then to organize a broad coalition
of plaintiffs and experts
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that could tell the court
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about all the ways that these patents
were harming patients and innovation.
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We found the prime candidate
to sue in Myriad Genetics,
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a company that's based
in Salt Lake City, Utah.
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Myriad held patents on two genes,
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the BRCA1 and the BRCA2 genes.
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Women with certain mutations
along these genes
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are considered to be
at a significantly increased risk
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of developing breast and ovarian cancer.
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Myriad had used its patents to maintain
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a complete monopoly on BRCA testing
in the United States.
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It had forced multiple labs
that were offering BRCA testing, to stop.
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It charged a lot of money for its test --
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over 3,000 dollars.
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It had stopped sharing its clinical data
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with the international
scientific community.
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And perhaps worst of all,
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for a period of several years,
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Myriad refused to update its test
to include additional mutations
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that had been identified
by a team of researchers in France.
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It has been estimated
that during that period,
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for several years,
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as many as 12 percent of women
undergoing testing
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received the wrong answer --
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a negative test result
that should have been positive.
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This is Kathleen Maxian.
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Kathleen's sister Eileen
developed breast cancer at age 40
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and she was tested by Myriad.
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The test was negative.
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The family was relieved.
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That meant that Eileen's cancer
most likely didn't run in the family,
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and that other members of her family
didn't need to be tested.
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But two years later,
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Kathleen was diagnosed
with advanced-stage ovarian cancer.
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It turned out that Kathleen's sister
was among the 12 percent
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who received a false-negative test result.
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Had Eileen received the proper result,
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Kathleen would have then been tested,
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and her ovarian cancer
could have been prevented.
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Once we settled on Myriad,
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we then had to form a coalition
of plaintiffs and experts
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that could illuminate these problems.
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We ended up with 20
highly committed plaintiffs,
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genetic counselors,
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geneticists who had received
cease and desist letters,
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advocacy organizations,
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four major scientific organizations
that collectively represented
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more than 150,000 scientists
and medical professionals
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and individual women who either
couldn't afford Myriad's test,
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or who wanted to obtain
a second opinion but could not,
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as a result of the patents.
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One of the major challenges
we had in preparing the case
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was figuring out how best
to communicate the science.
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So in order to argue that what Myriad did
was not an invention,
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and that isolated BRCA genes
were products of nature,
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we had to explain a couple
of basic concepts, like:
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What's a gene? What's DNA?
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How is DNA isolated,
and why isn't that an invention?
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We spent hours and hours
with our plaintiffs and experts,
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trying to come up with ways
of explaining these concepts
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simply yet accurately.
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And we ended up relying heavily
on the use of metaphors,
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like gold.
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So isolating DNA --
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it's like extracting gold from a mountain,
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or taking it out of a stream bed.
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You might be able to patent
the process for mining the gold,
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but you can't patent the gold itself.
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It might've taken a lot
of hard work and effort
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to dig the gold out of the mountain;
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you still can't patent it,
it's still gold.
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And the gold, once it's extracted,
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can clearly be used
for all sorts of things
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that it couldn't be used
for when it was in the mountain;
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you can make jewelry
out of it for example --
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still can't patent the gold,
it's still gold.
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So now it's 2009,
and we're ready to file our case.
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We filed in federal court
in the southern district of New York,
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and the case was randomly assigned
to Judge Robert Sweet.
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In March 2010, Judge Sweet
issued his opinion --
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152 pages --
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and a complete victory for our side.
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In reading the opinion,
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we could not get over how eloquently
he described the science in the case.
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I mean, our brief --
it was pretty good,
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but not this good.
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How did he develop such a deep
understanding of this issue
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in such a short time?
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We just could not comprehend
how this had happened.
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So it turned out,
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Judge Sweet's clerk
working for him at the time,
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was not just a lawyer --
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he was a scientist.
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He was not just a scientist --
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he had a PhD in molecular biology.
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(Laughter)
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What an incredible stroke of luck!
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Myriad then appealed
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to the US Court of Appeals
for the Federal Circuit.
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And here things got really interesting.
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First, in a pivotal moment of this case,
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the US government switched sides.
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So in the district court the government
submitted a brief on Myriad's side.
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But now in direct opposition
to its own patent office,
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the US government files a brief
that states that is has
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"reconsidered this issue
in light of the district court's opinion,
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and has concluded that isolated DNA
is not patent eligible."
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This was a really big deal,
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totally unexpected.
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The Court of Appeals
for the Federal Circuit
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hears all patent cases,
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and it has a reputation for being
very, very pro-patent.
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So even with this remarkable development,
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we expected to lose.
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And we did.
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Sort of.
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Ends up split decision, 2 to 1.
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But the two judges who ruled against us,
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did so for completely different reasons.
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The first one, Judge Lourie,
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made up his own novel,
biological theory --
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totally wrong.
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(Laughter)
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Decided Myriad had created
a new chemical --
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made absolutely no sense.
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Myriad didn't even argue this,
so it came out of the blue.
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The other, Judge Moore,
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said she basically agreed with us
that isolated DNA is a product of nature.
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But she's like, "I don't want
to shake up the biotech industry."
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The third, Judge Bryson,
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agreed with us.
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So now we sought review
by the Supreme Court.
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And when you petition the Supreme Court,
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you have to present a question
that you want the court to answer.
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Usually these questions take the form
of a super-long paragraph,
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like a whole page long
with lots and lots of clauses,
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"wherein this" and "therefore that."
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We submitted perhaps
the shortest question presented ever.
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Four words:
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Are human genes patentable?
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Now when Chris first asked me
what I thought of these words,
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I said, "Well, I don't know.
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I think you have to say,
'Is isolated DNA patentable?'"
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"Nope.
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I want the justices to have
the very same reaction that I had
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when you brought this issue
to me seven years ago."
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Well, I certainly couldn't
argue with that.
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The Supreme Court only hears
about one percent
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of the cases that it receives,
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and it agreed to hear ours.
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The day of the oral argument arrives
and it was really, really exciting --
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long line of people outside,
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people had been standing in line
since 2:30 in the morning
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to try to get into the courthouse.
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Two breast cancer organizations,
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Breast Cancer Action and FORCE,
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had organized a demonstration
on the courthouse steps.
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Chris and I sat quietly in the hallway,
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moments before he was to walk in and argue
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the most important case of his career.
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I was clearly more nervous than he was.
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But any remaining panic subsided
as I walked into the courtroom
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and looked around
at a sea of friendly faces:
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our individual women clients,
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who had shared their
deeply personal stories;
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the geneticists who had taken huge chunks
of time out of their busy careers
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to dedicate themselves to this fight;
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and representatives from a diverse array
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of medical, patient advocacy,
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environmental and religious organizations,
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who had submitted friend of the court
briefs in the case.
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Also in the room were three leaders
of the Human Genome Project,
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including the co-discoverer
of DNA himself,
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James Watson,
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who had submitted a brief to the court,
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where he referred
to gene patenting as "lunacy."
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(Laughter)
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The diversity of the communities
represented in this room
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and the contributions each had made
to make this day a reality
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spoke volumes to what was at stake.
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The argument itself was riveting.
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Chris argued brilliantly.
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But for me,
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the most thrilling aspect was watching
the Supreme Court Justices grapple
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with isolated DNA,
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through a series of colorful analogies
and feisty exchanges,
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very much the same way
as our legal team had done
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for the past seven years.
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Justice Kagan likened isolating DNA
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to extracting a medicinal plant
from the Amazon.
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Justice Roberts distinguished it
from carving a baseball bat from a tree.
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And in one of my absolutely
favorite moments,
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Justice Sotomayor proclaimed isolated DNA
to be "just nature sitting there."
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(Laughter)
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We felt pretty confident
leaving the courtroom that day,
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but I could never have
anticipated the outcome:
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Nine to zero.
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"A naturally occurring DNA segment
is a product of nature,
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and not patent-eligible merely because
it has been isolated.
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And furthermore,
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Myriad did not create anything."
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Within 24 hours of the decision,
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five labs had announced
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that they would begin to offer testing
for the BRCA genes.
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Some of them promised to offer the tests
at a lower price than Myriad's.
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Some promised to provide
a more comprehensive test
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than the one Myriad was offering.
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But of course the decision
goes far beyond Myriad.
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It ends a 25-year practice
of allowing patents on human genes
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in the United States.
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It clears a significant barrier
to biomedical discovery and innovation.
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And it helps to ensure that patients
like Abigail, Kathleen and Eileen
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have access to the tests that they need.
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A few weeks after the court
issued its decision,
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I received a small package in the mail.
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It was from Bob Cook-Deegan,
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a professor at Duke University,
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and one the very first people
Chris and I went to visit
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when we started to consider
whether to bring this case.
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I opened it up to find
a small stuffed animal.
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(Laughter)
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We took a big risk in taking this case.
-
Part of what gave us the courage
to take that risk
-
was knowing that we were doing
the right thing.
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The process took nearly eight years
from the start to finish,
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with many twists and turns along the way.
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A little luck certainly helped,
-
but it was the communities
that we bridged,
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the alliances that we created,
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that made pigs fly.
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Thank you.
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(Applause)
Brian Greene
The headline for this talk has been changed.
The new headline is:
Should you be able to patent a human gene?