WEBVTT

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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 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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He 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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00:13:24.968 --> 00:13:26.137
"Nope.

00:13:26.487 --> 00:13:31.108
I want the justices to have
the very same reaction that I had

00:13:31.132 --> 00:13:34.219
when you brought this issue
to me seven years ago."

NOTE Paragraph

00:13:34.896 --> 00:13:37.053
Well, I certainly couldn't
argue with that.

NOTE Paragraph

00:13:37.981 --> 00:13:40.864
The Supreme Court only hears
about one percent

00:13:40.888 --> 00:13:42.554
of the cases that it receives,

00:13:42.578 --> 00:13:44.169
and it agreed to hear ours.

00:13:45.772 --> 00:13:49.899
The day of the oral argument arrives,
and it was really, really exciting --

00:13:49.923 --> 00:13:51.358
long line of people outside,

00:13:51.382 --> 00:13:54.146
people had been standing in line
since 2:30 in the morning

00:13:54.170 --> 00:13:55.904
to try to get into the courthouse.

00:13:55.928 --> 00:13:57.899
Two breast cancer organizations,

00:13:57.923 --> 00:13:59.591
Breast Cancer Action and FORCE,

00:13:59.615 --> 00:14:02.316
had organized a demonstration
on the courthouse steps.

NOTE Paragraph

00:14:03.232 --> 00:14:06.102
Chris and I sat quietly in the hallway,

00:14:06.776 --> 00:14:09.790
moments before he was to walk in and argue

00:14:09.814 --> 00:14:12.130
the most important case of his career.

00:14:12.765 --> 00:14:15.144
I was clearly more nervous than he was.

00:14:16.096 --> 00:14:20.856
But any remaining panic subsided
as I walked into the courtroom

00:14:20.880 --> 00:14:23.693
and looked around
at a sea of friendly faces:

00:14:24.059 --> 00:14:25.824
our individual women clients

00:14:25.848 --> 00:14:28.289
who had shared their
deeply personal stories,

00:14:29.210 --> 00:14:32.836
the geneticists who had taken huge chunks
of time out of their busy careers

00:14:32.860 --> 00:14:34.685
to dedicate themselves to this fight

00:14:35.122 --> 00:14:37.701
and representatives from a diverse array

00:14:37.725 --> 00:14:39.612
of medical, patient advocacy,

00:14:39.636 --> 00:14:41.712
environmental and religious organizations,

00:14:41.736 --> 00:14:45.268
who had submitted friend of the court
briefs in the case.

NOTE Paragraph

00:14:46.609 --> 00:14:49.634
Also in the room were three leaders
of the Human Genome Project,

00:14:49.658 --> 00:14:52.330
including the co-discoverer
of DNA himself,

00:14:52.354 --> 00:14:53.644
James Watson,

00:14:53.668 --> 00:14:55.814
who had submitted a brief to the court,

00:14:55.838 --> 00:14:59.349
where he referred
to gene patenting as "lunacy."

NOTE Paragraph

00:14:59.373 --> 00:15:01.221
(Laughter)

NOTE Paragraph

00:15:01.245 --> 00:15:04.882
The diversity of the communities
represented in this room

00:15:04.906 --> 00:15:08.347
and the contributions each had made
to make this day a reality

00:15:08.371 --> 00:15:10.668
spoke volumes to what was at stake.

NOTE Paragraph

00:15:11.386 --> 00:15:13.599
The argument itself was riveting.

00:15:14.205 --> 00:15:15.868
Chris argued brilliantly.

00:15:15.892 --> 00:15:17.137
But for me,

00:15:17.161 --> 00:15:20.925
the most thrilling aspect was watching
the Supreme Court justices grapple

00:15:20.949 --> 00:15:22.518
with isolated DNA,

00:15:22.542 --> 00:15:25.768
through a series of colorful analogies
and feisty exchanges,

00:15:25.792 --> 00:15:29.132
very much the same way
as our legal team had done

00:15:29.156 --> 00:15:30.846
for the past seven years.

00:15:31.666 --> 00:15:34.322
Justice Kagan likened isolating DNA

00:15:34.346 --> 00:15:37.122
to extracting a medicinal plant
from the Amazon.

00:15:38.516 --> 00:15:42.526
Justice Roberts distinguished it
from carving a baseball bat from a tree.

00:15:43.995 --> 00:15:46.477
And in one of my absolutely
favorite moments,

00:15:46.501 --> 00:15:51.770
Justice Sotomayor proclaimed isolated DNA
to be "just nature sitting there."

NOTE Paragraph

00:15:51.794 --> 00:15:52.894
(Laughter)

NOTE Paragraph

00:15:53.318 --> 00:15:56.193
We felt pretty confident
leaving the courtroom that day,

00:15:56.217 --> 00:15:59.223
but I could never have
anticipated the outcome:

00:16:00.574 --> 00:16:02.081
nine to zero.

NOTE Paragraph

00:16:03.025 --> 00:16:06.747
"A naturally occurring DNA segment
is a product of nature,

00:16:06.771 --> 00:16:09.818
and not patent-eligible merely because
it has been isolated.

00:16:10.394 --> 00:16:11.741
And furthermore,

00:16:11.765 --> 00:16:14.310
Myriad did not create anything."

NOTE Paragraph

00:16:16.160 --> 00:16:18.156
Within 24 hours of the decision,

00:16:18.180 --> 00:16:19.572
five labs had announced

00:16:19.596 --> 00:16:22.610
that they would begin to offer testing
for the BRCA genes.

00:16:23.149 --> 00:16:26.632
Some of them promised to offer the tests
at a lower price than Myriad's.

00:16:27.142 --> 00:16:30.062
Some promised to provide
a more comprehensive test

00:16:30.086 --> 00:16:31.769
than the one Myriad was offering.

NOTE Paragraph

00:16:32.490 --> 00:16:35.328
But of course the decision
goes far beyond Myriad.

00:16:35.352 --> 00:16:39.748
It ends a 25-year practice
of allowing patents on human genes

00:16:39.772 --> 00:16:40.979
in the United States.

00:16:41.383 --> 00:16:46.076
It clears a significant barrier
to biomedical discovery and innovation.

00:16:46.484 --> 00:16:51.385
And it helps to ensure that patients
like Abigail, Kathleen and Eileen

00:16:51.409 --> 00:16:53.565
have access to the tests that they need.

NOTE Paragraph

00:16:54.991 --> 00:16:58.206
A few weeks after the court
issued its decision,

00:16:58.230 --> 00:17:00.490
I received a small package in the mail.

00:17:01.246 --> 00:17:02.853
It was from Bob Cook-Deegan,

00:17:02.877 --> 00:17:05.146
a professor at Duke University

00:17:05.170 --> 00:17:08.394
and one the very first people
Chris and I went to visit

00:17:08.418 --> 00:17:11.117
when we started to consider
whether to bring this case.

00:17:12.033 --> 00:17:14.842
I opened it up to find
a small stuffed animal.

NOTE Paragraph

00:17:16.344 --> 00:17:19.303
(Laughter)

NOTE Paragraph

00:17:21.568 --> 00:17:23.896
We took a big risk in taking this case.

00:17:24.722 --> 00:17:27.232
Part of what gave us the courage
to take that risk

00:17:27.256 --> 00:17:29.694
was knowing that we were doing
the right thing.

00:17:30.079 --> 00:17:33.809
The process took nearly eight years
from the start to finish,

00:17:33.833 --> 00:17:36.054
with many twists and turns along the way.

00:17:36.578 --> 00:17:38.269
A little luck certainly helped,

00:17:38.888 --> 00:17:41.700
but it was the communities
that we bridged,

00:17:41.724 --> 00:17:43.815
the alliances that we created,

00:17:43.839 --> 00:17:45.259
that made pigs fly.

NOTE Paragraph

00:17:45.802 --> 00:17:46.958
Thank you.

NOTE Paragraph

00:17:46.982 --> 00:17:52.496
(Applause)