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,
-
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,
-
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,
-
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:
-
In 2005, Tania Simoncelli, then the Science Advisor for the American Civil Liberties Union, contemplated a question at once simple and complex: Are human genes patentable? At the time, U.S. patent law said they were -- which meant patent holders had the right to stop anyone from sequencing, testing, or even looking at a gene they had patented. Troubled by the way this law both harmed patients and created a barrier to biomedical discovery and innovation, Simoncelli partnered with ACLU attorney Chris Hansen to challenge it. In this riveting talk, she tells the story of how they took a case everybody told them they would lose all the way to the Supreme Court -- and won.
Learn more about #TEDxAM14at http://bit.ly/1DZMWzo.
Tania Simoncelli is Assistant Director for Forensic Science and Biomedical Information in the White House Office of Science and Technology Policy. She previously worked for the U.S. Food and Drug Administration, where she served as Senior Advisor in the Office of Medical Products and Tobacco. From 2003-2010, Simoncelli worked as the Science Advisor to the ACLU, where she guided the organization’s responses to cutting-edge developments in science and technology that pose challenges for civil liberties. In 2013, Simoncelli was named by the journal Nature as one of “ten people who mattered this year” for her work with the ACLU in overturning gene patents.
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 |