How I took on the gene patent industry -- and won | Tania Simoncelli | TEDxAmoskeagMillyard
-
0:05 - 0:08It was an afternoon in the fall of 2005.
-
0:09 - 0:13I was working at the ACLU
as the organization's science advisor. -
0:13 - 0:15I really, really loved my job,
-
0:16 - 0:18but I was having one of those days
-
0:18 - 0:21where I was feeling
just a little bit discouraged. -
0:21 - 0:26So I wandered down the hallway
to my colleague Chris Hansen's office. -
0:27 - 0:30Chris had been at the ACLU
for more than 30 years, -
0:30 - 0:33so he had deep institutional
knowledge and insights. -
0:34 - 0:37I explained to Chris
that I was feeling a little bit stuck. -
0:38 - 0:40I had been investigating
a number of issues -
0:40 - 0:44at the intersection of science
and civil liberties - super interesting, -
0:45 - 0:49but I wanted the ACLU to engage
these issues in a much bigger way, -
0:49 - 0:52in a way that could really
make a difference. -
0:54 - 0:56So Chris cut right
to the chase and he says, -
0:56 - 1:00"Well, of all the issues you've been
looking at, what are the top five?" -
1:00 - 1:02"Well, there's genetic discrimination,
-
1:02 - 1:05and reproductive technologies,
-
1:05 - 1:07and biobanking, and ...
-
1:07 - 1:09Oh! -- there's this really cool issue,
-
1:09 - 1:12functional MRI and using it
for lie detection, and ... -
1:12 - 1:14Oh! and of course, there's gene patents."
-
1:14 - 1:15"Gene patents?"
-
1:16 - 1:18"Yes, you know, patents on human genes."
-
1:18 - 1:20"No!
-
1:20 - 1:22You're telling me that the US government
-
1:22 - 1:26has been issuing patents
on part of the human body? -
1:26 - 1:27That can't be right."
-
1:28 - 1:32I went back to my office
and sent Chris three articles. -
1:32 - 1:35And 20 minutes later,
he came bursting in my office. -
1:36 - 1:39"Oh my god! You're right! Who can we sue?"
-
1:40 - 1:42(Laughter)
-
1:42 - 1:44Now Chris is a really brilliant lawyer,
-
1:44 - 1:47but he knew almost nothing
about patent law, -
1:47 - 1:49and certainly nothing about genetics.
-
1:49 - 1:52I knew something about genetics,
but I wasn't even a lawyer, -
1:52 - 1:54let alone a patent lawyer.
-
1:54 - 1:58So clearly we had a lot to learn
before we could file a lawsuit. -
1:58 - 2:01First, we needed to understand
exactly what was patented -
2:01 - 2:03when someone patented a gene.
-
2:04 - 2:07Gene patents typically contain
dozens of claims, -
2:08 - 2:13but the most controversial of these
are to so-called, "isolated DNA." -
2:13 - 2:17Namely, a piece of DNA
that has been removed from a cell. -
2:18 - 2:20Gene patent proponents say,
-
2:20 - 2:23"See? We didn't patent
the gene in your body, -
2:23 - 2:25we patented an isolated gene."
-
2:26 - 2:27And that's true,
-
2:27 - 2:33but the problem is that any use
of the gene requires that it be isolated. -
2:35 - 2:39And the patents weren't just
to a particular gene that they isolated, -
2:39 - 2:42but on every possible
version of that gene. -
2:43 - 2:44So what does that mean?
-
2:44 - 2:47That means that you can't give
your gene to your doctor -
2:47 - 2:50and ask him or her to look at it,
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2:50 - 2:52say, to see if it has any mutations,
-
2:52 - 2:54without permission of the patent holder.
-
2:55 - 2:59It also means that the patent holder
has the right to stop anyone -
2:59 - 3:02from using that gene
in research or clinical testing. -
3:04 - 3:06Allowing patent holders,
-
3:06 - 3:07often private companies,
-
3:07 - 3:11to lock up stretches of the human genome
was harming patients. -
3:12 - 3:13Consider Abigail,
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3:13 - 3:16a 10-year-old with Long QT Syndrome,
-
3:16 - 3:19a serious heart condition that,
if left untreated, -
3:19 - 3:21can result in sudden death.
-
3:22 - 3:26The company that obtained a patent on two
genes associated with this condition -
3:26 - 3:28developed a test to diagnose the syndrome.
-
3:28 - 3:31But then they went bankrupt
and they never offered it. -
3:32 - 3:34So another lab tried to offer the test,
-
3:34 - 3:37but the company that held the patents
threatened to sue the lab -
3:37 - 3:38for patent infringement.
-
3:38 - 3:39So as a result,
-
3:39 - 3:42for 2 years, no test was a available.
-
3:43 - 3:44During that time,
-
3:44 - 3:48Abigail died of undiagnosed Long QT.
-
3:49 - 3:52Gene patents clearly were a problem
and were harming patients. -
3:52 - 3:55But was there a way
we could challenge them? -
3:57 - 3:59Turns out that the Supreme Court
-
3:59 - 4:01has made clear
through a long line of cases, -
4:01 - 4:05that certain things
are not patent eligible. -
4:06 - 4:08You can't patent products of nature -
-
4:08 - 4:12the air, the water, minerals,
elements of the periodic table. -
4:13 - 4:16And you can't patent laws of nature -
-
4:16 - 4:19the law of gravity, E = mc2.
-
4:19 - 4:23These things are just too fundamental
and must remain free to all, -
4:24 - 4:26and reserved exclusively to none.
-
4:26 - 4:28It seemed to us that DNA,
-
4:28 - 4:32the most fundamental structure of life,
-
4:32 - 4:34that codes for the production
of all of our proteins, -
4:34 - 4:37is both a product of nature
and a law of nature, -
4:37 - 4:40regardless of whether it's in our bodies
-
4:40 - 4:43or sitting in the bottom of a test tube.
-
4:43 - 4:45As we delved into this issue,
-
4:45 - 4:48we traveled all over the country
to speak with many different experts - -
4:49 - 4:52scientists, medical professionals,
lawyers, patent lawyers. -
4:53 - 4:57Most of them agreed that we were right
as a matter of policy, -
4:57 - 5:00and, at least in theory,
as a matter of law. -
5:01 - 5:02All of them thought
-
5:02 - 5:05our chances of winning
a gene-patent challenge -
5:05 - 5:07were about zero.
-
5:08 - 5:09Why is that?
-
5:10 - 5:13Well, the patent office
had been issuing these patents -
5:13 - 5:15for more than 20 years.
-
5:16 - 5:19There were literally thousands
of patents on human genes. -
5:20 - 5:23The patent bar was deeply
entrenched in the status quo, -
5:24 - 5:27the biotech industry had grown up
around this practice, -
5:27 - 5:31and legislation to ban gene patents
had been introduced -
5:31 - 5:32year after year in Congress,
-
5:32 - 5:34and had gone absolutely nowhere.
-
5:34 - 5:36So the bottom line:
-
5:36 - 5:39courts just weren't going to be willing
to overturn these patents. -
5:40 - 5:44Now, neither Chris nor I were the type
to shy away from a challenge, -
5:44 - 5:48and hearing, "Being right
just isn't enough," -
5:48 - 5:51seemed all the more reason
to take on this fight. -
5:52 - 5:54So we set out to build our case.
-
5:55 - 5:59Now, patent cases tend to be:
Company A sues Company B -
5:59 - 6:02over some really narrow,
obscure technical issue. -
6:03 - 6:05We weren't really interested
in that kind of case, -
6:05 - 6:08and we thought this case
was much bigger than that. -
6:08 - 6:10This was about scientific freedom,
medical progress, -
6:10 - 6:12the rights of patients.
-
6:12 - 6:14So we decided we were going
to develop a case -
6:14 - 6:16that was not like
your typical patent case. -
6:17 - 6:20More like a civil rights case.
-
6:20 - 6:23We set out to identify
a gene-patent holder -
6:23 - 6:26that was vigorously enforcing its patents,
-
6:26 - 6:30and then to organize a broad coalition
of plaintiffs and experts -
6:30 - 6:31that could tell the court
-
6:31 - 6:35about all the ways that these patents
were harming patients and innovation. -
6:37 - 6:40We found the prime candidate
to sue in Myriad Genetics, -
6:40 - 6:43a company that's based
in Salt Lake City, Utah. -
6:45 - 6:47Myriad held patents on two genes,
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6:47 - 6:50the BRCA1 and the BRCA2 genes.
-
6:51 - 6:54Women with certain mutations
along these genes -
6:54 - 6:56are considered to be
at a significantly increased risk -
6:56 - 6:58of developing breast and ovarian cancer.
-
7:00 - 7:02Myriad had used its patents to maintain
-
7:02 - 7:06a complete monopoly on BRCA testing
in the United States. -
7:07 - 7:11It had forced multiple labs
that were offering BRCA testing, to stop. -
7:11 - 7:14It charged a lot of money for its test -
-
7:14 - 7:15over 3,000 dollars.
-
7:16 - 7:18It had stopped sharing its clinical data
-
7:18 - 7:21with the international
scientific community. -
7:21 - 7:23And perhaps worst of all,
-
7:23 - 7:25for a period of several years,
-
7:26 - 7:29Myriad refused to update its test
to include additional mutations -
7:29 - 7:33that had been identified
by a team of researchers in France. -
7:34 - 7:36It has been estimated
that during that period, -
7:36 - 7:38for several years,
-
7:38 - 7:42as many as 12 percent of women
undergoing testing -
7:42 - 7:45received the wrong answer -
-
7:45 - 7:49a negative test result
that should have been positive. -
7:50 - 7:52This is Kathleen Maxian.
-
7:53 - 7:57Kathleen's sister Eileen
developed breast cancer at age 40 -
7:57 - 7:58and she was tested by Myriad.
-
7:59 - 8:01The test was negative.
-
8:01 - 8:03The family was relieved.
-
8:03 - 8:06That meant that Eileen's cancer
most likely didn't run in the family, -
8:06 - 8:09and that other members of her family
didn't need to be tested. -
8:10 - 8:11But two years later,
-
8:11 - 8:15Kathleen was diagnosed
with advanced-stage ovarian cancer. -
8:16 - 8:20It turned out that Kathleen's sister
was among the 12 percent -
8:20 - 8:23who received a false-negative test result.
-
8:23 - 8:27Had Eileen received the proper result,
-
8:27 - 8:29Kathleen would have then been tested,
-
8:29 - 8:31and her ovarian cancer
could have been prevented. -
8:34 - 8:35Once we settled on Myriad,
-
8:35 - 8:39we then had to form a coalition
of plaintiffs and experts -
8:39 - 8:41that could illuminate these problems.
-
8:42 - 8:44We ended up with 20
highly committed plaintiffs, -
8:45 - 8:47genetic counselors,
-
8:47 - 8:50geneticists who had received
cease and desist letters, -
8:50 - 8:52advocacy organizations,
-
8:53 - 8:56four major scientific organizations
that collectively represented -
8:56 - 9:00more than 150,000 scientists
and medical professionals -
9:00 - 9:04and individual women who either
couldn't afford Myriad's test, -
9:04 - 9:07or who wanted to obtain
a second opinion but could not, -
9:07 - 9:09as a result of the patents.
-
9:10 - 9:13One of the major challenges
we had in preparing the case -
9:13 - 9:16was figuring out how best
to communicate the science. -
9:16 - 9:21So in order to argue that what Myriad did
was not an invention, -
9:21 - 9:24and that isolated BRCA genes
were products of nature, -
9:25 - 9:28we had to explain a couple
of basic concepts, like: -
9:28 - 9:30What's a gene? What's DNA?
-
9:30 - 9:35How is DNA isolated,
and why isn't that an invention? -
9:35 - 9:39We spent hours and hours
with our plaintiffs and experts, -
9:39 - 9:42trying to come up with ways
of explaining these concepts -
9:42 - 9:44simply yet accurately.
-
9:44 - 9:47And we ended up relying heavily
on the use of metaphors, -
9:48 - 9:49like gold.
-
9:50 - 9:52So isolating DNA -
-
9:52 - 9:55it's like extracting gold from a mountain,
-
9:55 - 9:57or taking it out of a stream bed.
-
10:00 - 10:03You might be able to patent
the process for mining the gold, -
10:03 - 10:05but you can't patent the gold itself.
-
10:06 - 10:09It might've taken a lot
of hard work and effort -
10:09 - 10:11to dig the gold out of the mountain;
-
10:11 - 10:13you still can't patent it,
it's still gold. -
10:14 - 10:16And the gold, once it's extracted,
-
10:16 - 10:18can clearly be used
for all sorts of things -
10:18 - 10:20that it couldn't be used
for when it was in the mountain; -
10:20 - 10:23you can make jewelry
out of it for example - -
10:23 - 10:25still can't patent the gold,
it's still gold. -
10:27 - 10:31So now it's 2009,
and we're ready to file our case. -
10:32 - 10:35We filed in federal court
in the southern district of New York, -
10:36 - 10:40and the case was randomly assigned
to Judge Robert Sweet. -
10:40 - 10:43In March 2010, Judge Sweet
issued his opinion - -
10:44 - 10:46152 pages -
-
10:46 - 10:49and a complete victory for our side.
-
10:50 - 10:51In reading the opinion,
-
10:51 - 10:57we could not get over how eloquently
he described the science in the case. -
10:58 - 11:00I mean, our brief -
it was pretty good, -
11:00 - 11:02but not this good.
-
11:03 - 11:07How did he develop such a deep
understanding of this issue -
11:07 - 11:08in such a short time?
-
11:08 - 11:11We just could not comprehend
how this had happened. -
11:12 - 11:13So it turned out,
-
11:13 - 11:16Judge Sweet's clerk
working for him at the time, -
11:16 - 11:18was not just a lawyer -
-
11:18 - 11:20he was a scientist.
-
11:20 - 11:21He was not just a scientist -
-
11:21 - 11:24he had a PhD in molecular biology.
-
11:25 - 11:26(Laughter)
-
11:26 - 11:29What an incredible stroke of luck!
-
11:30 - 11:31Myriad then appealed
-
11:31 - 11:34to the US Court of Appeals
for the Federal Circuit. -
11:34 - 11:37And here things got really interesting.
-
11:37 - 11:40First, in a pivotal moment of this case,
-
11:41 - 11:44the US government switched sides.
-
11:45 - 11:48So in the district court the government
submitted a brief on Myriad's side. -
11:48 - 11:53But now in direct opposition
to its own patent office, -
11:53 - 11:56the US government files a brief
that states that is has -
11:56 - 12:00"reconsidered this issue
in light of the district court's opinion, -
12:00 - 12:03and has concluded that isolated DNA
is not patent eligible." -
12:04 - 12:06This was a really big deal,
-
12:06 - 12:07totally unexpected.
-
12:08 - 12:11The Court of Appeals
for the Federal Circuit -
12:11 - 12:12hears all patent cases,
-
12:12 - 12:16and it has a reputation for being
very, very pro-patent. -
12:16 - 12:19So even with this remarkable development,
-
12:19 - 12:20we expected to lose.
-
12:20 - 12:22And we did.
-
12:22 - 12:24Sort of.
-
12:25 - 12:27Ends up split decision, 2 to 1.
-
12:28 - 12:31But the two judges who ruled against us,
-
12:31 - 12:33did so for completely different reasons.
-
12:34 - 12:35The first one, Judge Lourie,
-
12:35 - 12:38made up his own novel,
biological theory - -
12:38 - 12:40totally wrong.
-
12:40 - 12:41(Laughter)
-
12:41 - 12:43Decided Myriad had created
a new chemical - -
12:43 - 12:45made absolutely no sense.
-
12:45 - 12:49Myriad didn't even argue this,
so it came out of the blue. -
12:50 - 12:51The other, Judge Moore,
-
12:51 - 12:56said she basically agreed with us
that isolated DNA is a product of nature. -
12:57 - 13:00But she's like, "I don't want
to shake up the biotech industry." -
13:02 - 13:04I can think of a lot of things
-
13:04 - 13:08that if judges had said that, we'd be
in a very different society right now. -
13:09 - 13:11The third, Judge Bryson,
-
13:11 - 13:13agreed with us.
-
13:14 - 13:17So now we sought review
by the Supreme Court. -
13:17 - 13:19And when you petition the Supreme Court,
-
13:19 - 13:23you have to present a question
that you want the court to answer. -
13:23 - 13:27Usually these questions take the form
of a super-long paragraph, -
13:27 - 13:30like a whole page long
with lots and lots of clauses, -
13:30 - 13:32"wherein this" and "therefore that."
-
13:32 - 13:36We submitted perhaps
the shortest question presented ever. -
13:38 - 13:39Four words:
-
13:41 - 13:43Are human genes patentable?
-
13:43 - 13:46Now when Chris first asked me
what I thought of these words, -
13:46 - 13:48I said, "Well, I don't know.
-
13:48 - 13:51I think you have to say,
'Is isolated DNA patentable?'" -
13:51 - 13:52"Nope.
-
13:52 - 13:57I want the justices to have
the very same reaction that I had -
13:57 - 14:01when you brought this issue
to me seven years ago." -
14:01 - 14:03Well, I certainly couldn't
argue with that. -
14:04 - 14:08The Supreme Court only hears
about one percent -
14:08 - 14:09of the cases that it receives,
-
14:09 - 14:11and it agreed to hear ours.
-
14:12 - 14:16The day of the oral argument arrives
and it was really, really exciting - -
14:16 - 14:18long line of people outside,
-
14:18 - 14:21people had been standing in line
since 2:30 in the morning -
14:21 - 14:23to try to get into the courthouse.
-
14:23 - 14:25Two breast cancer organizations,
-
14:25 - 14:27Breast Cancer Action and FORCE,
-
14:27 - 14:30had organized a demonstration
on the courthouse steps. -
14:30 - 14:32Chris and I sat quietly in the hallway,
-
14:34 - 14:37moments before he was to walk in and argue
-
14:37 - 14:39the most important case of his career.
-
14:39 - 14:42I was clearly more nervous than he was.
-
14:42 - 14:45It's a good thing he was arguing,
and not me. -
14:45 - 14:49And I sat there, sort of thinking,
"Oh, God, is he ready? -
14:50 - 14:53Did I do everything I could have done
to help prepare him for this day?" -
14:53 - 14:59But any remaining panic subsided
as I walked into the courtroom -
14:59 - 15:01and looked around
at a sea of friendly faces: -
15:01 - 15:03our individual women clients,
-
15:03 - 15:06who had shared their
deeply personal stories; -
15:06 - 15:11the geneticists who had taken huge chunks
of time out of their busy careers -
15:11 - 15:13to dedicate themselves to this fight;
-
15:13 - 15:15and representatives from a diverse array
-
15:15 - 15:17of medical, patient advocacy,
-
15:17 - 15:20environmental and religious organizations,
-
15:20 - 15:23who had submitted friend of the court
briefs in the case. -
15:24 - 15:27Also in the room were three leaders
of the Human Genome Project, -
15:27 - 15:30including the co-discoverer
of DNA himself, -
15:30 - 15:31James Watson,
-
15:31 - 15:33who had submitted a brief to the court,
-
15:33 - 15:37where he referred
to gene patenting as "lunacy." -
15:38 - 15:39(Laughter)
-
15:39 - 15:42The diversity of the communities
represented in this room -
15:42 - 15:46and the contributions each had made
to make this day a reality -
15:46 - 15:48spoke volumes to what was at stake.
-
15:49 - 15:51The argument itself was riveting.
-
15:52 - 15:53Chris argued brilliantly.
-
15:53 - 15:55But for me,
-
15:55 - 15:59the most thrilling aspect was watching
the Supreme Court Justices grapple -
15:59 - 16:01with isolated DNA,
-
16:01 - 16:05through a series of colorful analogies
and feisty exchanges, -
16:05 - 16:09very much the same way
as our legal team had done -
16:09 - 16:11for the past seven years.
-
16:12 - 16:14Justice Kagan likened isolating DNA
-
16:14 - 16:18to extracting a medicinal plant
from the Amazon. -
16:19 - 16:23Justice Roberts distinguished it
from carving a baseball bat from a tree. -
16:25 - 16:27And in one of my absolutely
favorite moments, -
16:27 - 16:32Justice Sotomayor proclaimed isolated DNA
to be "just nature sitting there." -
16:33 - 16:34(Laughter)
-
16:34 - 16:37We felt pretty confident
leaving the courtroom that day, -
16:37 - 16:40but I could never have
anticipated the outcome: -
16:41 - 16:43Nine to zero.
-
16:45 - 16:49"A naturally occurring DNA segment
is a product of nature, -
16:49 - 16:51and not patent-eligible merely because
it has been isolated. -
16:52 - 16:53And furthermore,
-
16:53 - 16:56Myriad did not create anything."
-
16:58 - 17:00Within 24 hours of the decision,
-
17:00 - 17:01five labs had announced
-
17:01 - 17:04that they would begin to offer testing
for the BRCA genes. -
17:05 - 17:09Some of them promised to offer the tests
at a lower price than Myriad's. -
17:09 - 17:12Some promised to provide
a more comprehensive test -
17:12 - 17:14than the one Myriad was offering.
-
17:14 - 17:17But of course the decision
goes far beyond Myriad. -
17:17 - 17:21It ends a 25-year practice
of allowing patents on human genes -
17:21 - 17:23in the United States.
-
17:23 - 17:27It clears a significant barrier
to biomedical discovery and innovation. -
17:28 - 17:33And it helps to ensure that patients
like Abigail, Kathleen and Eileen -
17:33 - 17:35have access to the tests that they need.
-
17:37 - 17:40A few weeks after the court
issued its decision, -
17:40 - 17:42I received a small package in the mail.
-
17:43 - 17:45It was from Bob Cook-Deegan,
-
17:45 - 17:47a professor at Duke University,
-
17:47 - 17:50and one the very first people
Chris and I went to visit -
17:50 - 17:55when we started to consider
whether to bring this case. -
17:56 - 17:59I opened it up to find
a small stuffed animal. -
17:59 - 18:03(Laughter)
-
18:05 - 18:08We took a big risk in taking this case.
-
18:08 - 18:11Part of what gave us the courage
to take that risk -
18:11 - 18:14was knowing that we were doing
the right thing. -
18:14 - 18:17The process took nearly eight years
from the start to finish, -
18:17 - 18:19with many twists and turns along the way.
-
18:20 - 18:22A little luck certainly helped,
-
18:22 - 18:25but it was the communities
that we bridged, -
18:25 - 18:27the alliances that we created,
-
18:27 - 18:29that made pigs fly.
-
18:29 - 18:31Thank you.
-
18:31 - 18:33(Applause)
- Title:
- How I took on the gene patent industry -- and won | Tania Simoncelli | TEDxAmoskeagMillyard
- Description:
-
Are human genes patentable? Back in 2005, when Tania Simoncelli first contemplated this complex question, US patent law said they were -- which meant patent holders had the right to stop anyone from sequencing, testing or even looking at a patented gene. Troubled by the way this law both harmed patients and created a barrier to biomedical innovation, Simoncelli and her colleagues at the ACLU challenged it. In this riveting talk, hear the story of how they took a case everybody told them they would lose all the way to the Supreme Court.
This talk was given at a TEDx event using the TED conference format but independently organized by a local community. Learn more at http://ted.com/tedx
- Video Language:
- English
- Team:
- closed TED
- Project:
- TEDxTalks
- Duration:
- 18:43
TED Translators admin edited English subtitles for Are human genes patentable? | Tania Simoncelli | TEDxAmoskeagMillyard | ||
TED Translators admin edited English subtitles for Are human genes patentable? | Tania Simoncelli | TEDxAmoskeagMillyard | ||
TED Translators admin edited English subtitles for Are human genes patentable? | Tania Simoncelli | TEDxAmoskeagMillyard | ||
TED Translators admin edited English subtitles for Are human genes patentable? | Tania Simoncelli | TEDxAmoskeagMillyard | ||
TED Translators admin edited English subtitles for Are human genes patentable? | Tania Simoncelli | TEDxAmoskeagMillyard |