How I took on the gene patent industry -- and won | Tania Simoncelli | TEDxAmoskeagMillyard
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0:01 - 0:05It was an afternoon in the fall of 2005.
-
0:05 - 0:09I was working at the ACLU
as the organization's science advisor. -
0:09 - 0:12I really, really loved my job,
-
0:12 - 0:14but I was having one of those days
-
0:14 - 0:16where I was feeling
just a little bit discouraged. -
0:17 - 0:21So I wandered down the hallway
to my colleague Chris Hansen's office. -
0:22 - 0:26Chris had been at the ACLU
for more than 30 years, -
0:26 - 0:29so he had deep institutional
knowledge and insights. -
0:30 - 0:33I explained to Chris
that I was feeling a little bit stuck. -
0:34 - 0:36I had been investigating
a number of issues -
0:36 - 0:41at the intersection of science
and civil liberties -- super interesting, -
0:41 - 0:45but I wanted the ACLU to engage
these issues in a much bigger way, -
0:45 - 0:47in a way that could really
make a difference. -
0:50 - 0:52So Chris cut right
to the chase and he says, -
0:52 - 0:55"Well, of all the issues you've been
looking at, what are the top five?" -
0:56 - 0:58"Well, there's genetic discrimination,
-
0:58 - 1:01and reproductive technologies,
-
1:01 - 1:03and biobanking, and ...
-
1:03 - 1:05Oh! -- there's this really cool issue,
-
1:05 - 1:07functional MRI and using it
for lie detection, and ... -
1:07 - 1:09Oh! and of course, there's gene patents."
-
1:10 - 1:11"Gene patents?"
-
1:12 - 1:14"Yes, you know, patents on human genes."
-
1:14 - 1:16"No!
-
1:16 - 1:18You're telling me that the US government
-
1:18 - 1:21has been issuing patents
on part of the human body? -
1:22 - 1:23That can't be right."
-
1:24 - 1:27I went back to my office
and sent Chris three articles. -
1:28 - 1:31And 20 minutes later,
he came bursting in my office. -
1:31 - 1:35"Oh my god! You're right! Who can we sue?"
-
1:35 - 1:37(Laughter)
-
1:38 - 1:40Now Chris is a really brilliant lawyer,
-
1:40 - 1:43but he knew almost nothing
about patent law, -
1:43 - 1:45and certainly nothing about genetics.
-
1:46 - 1:48I knew something about genetics,
but I wasn't even a lawyer, -
1:48 - 1:50let alone a patent lawyer.
-
1:50 - 1:54So clearly we had a lot to learn
before we could file a lawsuit. -
1:54 - 1:57First, we needed to understand
exactly what was patented -
1:57 - 1:59when someone patented a gene.
-
2:00 - 2:04Gene patents typically contain
dozens of claims, -
2:04 - 2:08but the most controversial of these
are to so-called, "isolated DNA." -
2:09 - 2:13Namely, a piece of DNA
that has been removed from a cell. -
2:14 - 2:15Gene patent proponents say,
-
2:15 - 2:19"See? We didn't patent
the gene in your body, -
2:19 - 2:21we patented an isolated gene."
-
2:21 - 2:22And that's true,
-
2:22 - 2:29but the problem is that any use
of the gene requires that it be isolated. -
2:31 - 2:35And the patents weren't just
to a particular gene that they isolated, -
2:35 - 2:38but on every possible
version of that gene. -
2:38 - 2:40So what does that mean?
-
2:40 - 2:43That means that you can't give
your gene to your doctor -
2:43 - 2:45and ask him or her to look at it,
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2:45 - 2:47say, to see if it has any mutations,
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2:48 - 2:50without permission of the patent holder.
-
2:50 - 2:55It also means that the patent holder
has the right to stop anyone -
2:55 - 2:58from using that gene
in research or clinical testing. -
2:59 - 3:01Allowing patent holders,
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3:01 - 3:02often private companies,
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3:02 - 3:06to lock up stretches of the human genome
was harming patients. -
3:07 - 3:08Consider Abigail,
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3:08 - 3:11a 10-year-old with Long QT Syndrome,
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3:11 - 3:14a serious heart condition that,
if left untreated, -
3:14 - 3:16can result in sudden death.
-
3:17 - 3:21The company that obtained a patent on two
genes associated with this condition -
3:21 - 3:23developed a test to diagnose the syndrome.
-
3:23 - 3:26But then they went bankrupt
and they never offered it. -
3:27 - 3:29So another lab tried to offer the test,
-
3:29 - 3:32but the company that held the patents
threatened to sue the lab -
3:32 - 3:33for patent infringement.
-
3:33 - 3:34So as a result,
-
3:34 - 3:37for 2 years, no test was a available.
-
3:38 - 3:39During that time,
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3:39 - 3:43Abigail died of undiagnosed Long QT.
-
3:44 - 3:47Gene patents clearly were a problem
and were harming patients. -
3:47 - 3:50But was there a way
we could challenge them? -
3:50 - 3:52Turns out that the Supreme Court
-
3:52 - 3:55has made clear
through a long line of cases, -
3:55 - 3:58that certain things
are not patent eligible. -
3:59 - 4:01You can't patent products of nature --
-
4:02 - 4:06the air, the water, minerals,
elements of the periodic table. -
4:07 - 4:09And you can't patent laws of nature --
-
4:10 - 4:12the law of gravity, E = mc2.
-
4:13 - 4:18These things are just too fundamental
and must remain free to all, -
4:18 - 4:20and reserved exclusively to none.
-
4:20 - 4:22It seemed to us that DNA,
-
4:23 - 4:25the most fundamental structure of life,
-
4:25 - 4:28that codes for the production
of all of our proteins, -
4:28 - 4:31is both a product of nature
and a law of nature, -
4:31 - 4:34regardless of whether it's in our bodies
-
4:34 - 4:36or sitting in the bottom of a test tube.
-
4:37 - 4:38As we delved into this issue,
-
4:38 - 4:42we traveled all over the country
to speak with many different experts -- -
4:43 - 4:46scientists, medical professionals,
lawyers, patent lawyers. -
4:47 - 4:51Most of them agreed that we were right
as a matter of policy, -
4:51 - 4:53and, at least in theory,
as a matter of law. -
4:54 - 4:55All of them thought
-
4:55 - 4:58our chances of winning
a gene-patent challenge -
4:58 - 5:00were about zero.
-
5:02 - 5:03Why is that?
-
5:03 - 5:06Well, the patent office
had been issuing these patents -
5:06 - 5:08for more than 20 years.
-
5:09 - 5:12There were literally thousands
of patents on human genes. -
5:13 - 5:16The patent bar was deeply
entrenched in the status quo, -
5:17 - 5:20the biotech industry had grown up
around this practice, -
5:20 - 5:23and legislation to ban gene patents
had been introduced -
5:23 - 5:25year after year in Congress,
-
5:25 - 5:27and had gone absolutely nowhere.
-
5:27 - 5:29So the bottom line:
-
5:29 - 5:32courts just weren't going to be willing
to overturn these patents. -
5:33 - 5:38Now, neither Chris nor I were the type
to shy away from a challenge, -
5:38 - 5:41and hearing, "Being right
just isn't enough," -
5:41 - 5:43seemed all the more reason
to take on this fight. -
5:44 - 5:46So we set out to build our case.
-
5:47 - 5:51Now, patent cases tend to be:
Company A sues Company B -
5:51 - 5:54over some really narrow,
obscure technical issue. -
5:55 - 5:57We weren't really interested
in that kind of case, -
5:57 - 6:00and we thought this case
was much bigger than that. -
6:00 - 6:02This was about scientific freedom,
medical progress, -
6:02 - 6:04the rights of patients.
-
6:04 - 6:07So we decided we were going
to develop a case -
6:07 - 6:09that was not like
your typical patent case. -
6:10 - 6:12More like a civil rights case.
-
6:13 - 6:16We set out to identify
a gene-patent holder -
6:16 - 6:18that was vigorously enforcing its patents,
-
6:18 - 6:22and then to organize a broad coalition
of plaintiffs and experts -
6:22 - 6:24that could tell the court
-
6:24 - 6:28about all the ways that these patents
were harming patients and innovation. -
6:29 - 6:33We found the prime candidate
to sue in Myriad Genetics, -
6:33 - 6:35a company that's based
in Salt Lake City, Utah. -
6:37 - 6:39Myriad held patents on two genes,
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6:39 - 6:42the BRCA1 and the BRCA2 genes.
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6:43 - 6:46Women with certain mutations
along these genes -
6:46 - 6:49are considered to be
at a significantly increased risk -
6:49 - 6:51of developing breast and ovarian cancer.
-
6:52 - 6:54Myriad had used its patents to maintain
-
6:54 - 6:58a complete monopoly on BRCA testing
in the United States. -
6:59 - 7:03It had forced multiple labs
that were offering BRCA testing, to stop. -
7:03 - 7:05It charged a lot of money for its test --
-
7:05 - 7:07over 3,000 dollars.
-
7:07 - 7:09It had stopped sharing its clinical data
-
7:09 - 7:12with the international
scientific community. -
7:13 - 7:14And perhaps worst of all,
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7:14 - 7:17for a period of several years,
-
7:17 - 7:21Myriad refused to update its test
to include additional mutations -
7:21 - 7:24that had been identified
by a team of researchers in France. -
7:25 - 7:27It has been estimated
that during that period, -
7:28 - 7:29for several years,
-
7:29 - 7:33as many as 12 percent of women
undergoing testing -
7:33 - 7:35received the wrong answer --
-
7:36 - 7:40a negative test result
that should have been positive. -
7:41 - 7:43This is Kathleen Maxian.
-
7:44 - 7:47Kathleen's sister Eileen
developed breast cancer at age 40 -
7:47 - 7:49and she was tested by Myriad.
-
7:50 - 7:52The test was negative.
-
7:52 - 7:53The family was relieved.
-
7:53 - 7:57That meant that Eileen's cancer
most likely didn't run in the family, -
7:57 - 8:00and that other members of her family
didn't need to be tested. -
8:01 - 8:02But two years later,
-
8:02 - 8:06Kathleen was diagnosed
with advanced-stage ovarian cancer. -
8:07 - 8:11It turned out that Kathleen's sister
was among the 12 percent -
8:11 - 8:14who received a false-negative test result.
-
8:14 - 8:17Had Eileen received the proper result,
-
8:17 - 8:20Kathleen would have then been tested,
-
8:20 - 8:23and her ovarian cancer
could have been prevented. -
8:25 - 8:26Once we settled on Myriad,
-
8:26 - 8:30we then had to form a coalition
of plaintiffs and experts -
8:30 - 8:32that could illuminate these problems.
-
8:32 - 8:35We ended up with 20
highly committed plaintiffs, -
8:35 - 8:37genetic counselors,
-
8:37 - 8:40geneticists who had received
cease and desist letters, -
8:41 - 8:43advocacy organizations,
-
8:44 - 8:47four major scientific organizations
that collectively represented -
8:47 - 8:50more than 150,000 scientists
and medical professionals -
8:51 - 8:54and individual women who either
couldn't afford Myriad's test, -
8:54 - 8:57or who wanted to obtain
a second opinion but could not, -
8:57 - 8:59as a result of the patents.
-
9:00 - 9:04One of the major challenges
we had in preparing the case -
9:04 - 9:07was figuring out how best
to communicate the science. -
9:07 - 9:11So in order to argue that what Myriad did
was not an invention, -
9:11 - 9:14and that isolated BRCA genes
were products of nature, -
9:15 - 9:18we had to explain a couple
of basic concepts, like: -
9:18 - 9:20What's a gene? What's DNA?
-
9:20 - 9:24How is DNA isolated,
and why isn't that an invention? -
9:25 - 9:29We spent hours and hours
with our plaintiffs and experts, -
9:29 - 9:32trying to come up with ways
of explaining these concepts -
9:32 - 9:34simply yet accurately.
-
9:34 - 9:38And we ended up relying heavily
on the use of metaphors, -
9:38 - 9:39like gold.
-
9:40 - 9:42So isolating DNA --
-
9:42 - 9:45it's like extracting gold from a mountain,
-
9:45 - 9:47or taking it out of a stream bed.
-
9:47 - 9:51You might be able to patent
the process for mining the gold, -
9:51 - 9:53but you can't patent the gold itself.
-
9:54 - 9:57It might've taken a lot
of hard work and effort -
9:57 - 9:59to dig the gold out of the mountain;
-
9:59 - 10:01you still can't patent it,
it's still gold. -
10:01 - 10:03And the gold, once it's extracted,
-
10:03 - 10:05can clearly be used
for all sorts of things -
10:05 - 10:08that it couldn't be used
for when it was in the mountain; -
10:08 - 10:10you can make jewelry
out of it for example -- -
10:10 - 10:12still can't patent the gold,
it's still gold. -
10:13 - 10:17So now it's 2009,
and we're ready to file our case. -
10:18 - 10:22We filed in federal court
in the southern district of New York, -
10:22 - 10:26and the case was randomly assigned
to Judge Robert Sweet. -
10:27 - 10:30In March 2010, Judge Sweet
issued his opinion -- -
10:31 - 10:32152 pages --
-
10:33 - 10:35and a complete victory for our side.
-
10:36 - 10:37In reading the opinion,
-
10:37 - 10:42we could not get over how eloquently
he described the science in the case. -
10:43 - 10:45I mean, our brief --
it was pretty good, -
10:45 - 10:47but not this good.
-
10:48 - 10:51How did he develop such a deep
understanding of this issue -
10:51 - 10:52in such a short time?
-
10:52 - 10:56We just could not comprehend
how this had happened. -
10:56 - 10:57So it turned out,
-
10:57 - 11:01Judge Sweet's clerk
working for him at the time, -
11:01 - 11:02was not just a lawyer --
-
11:02 - 11:04he was a scientist.
-
11:04 - 11:05He was not just a scientist --
-
11:05 - 11:09he had a PhD in molecular biology.
-
11:09 - 11:10(Laughter)
-
11:10 - 11:13What an incredible stroke of luck!
-
11:14 - 11:15Myriad then appealed
-
11:15 - 11:18to the US Court of Appeals
for the Federal Circuit. -
11:18 - 11:21And here things got really interesting.
-
11:21 - 11:25First, in a pivotal moment of this case,
-
11:25 - 11:28the US government switched sides.
-
11:29 - 11:32So in the district court the government
submitted a brief on Myriad's side. -
11:33 - 11:38But now in direct opposition
to its own patent office, -
11:38 - 11:40the US government files a brief
that states that is has -
11:40 - 11:44"reconsidered this issue
in light of the district court's opinion, -
11:44 - 11:47and has concluded that isolated DNA
is not patent eligible." -
11:48 - 11:50This was a really big deal,
-
11:50 - 11:51totally unexpected.
-
11:53 - 11:55The Court of Appeals
for the Federal Circuit -
11:55 - 11:57hears all patent cases,
-
11:57 - 12:00and it has a reputation for being
very, very pro-patent. -
12:00 - 12:03So even with this remarkable development,
-
12:03 - 12:04we expected to lose.
-
12:04 - 12:06And we did.
-
12:06 - 12:08Sort of.
-
12:08 - 12:11Ends up split decision, 2 to 1.
-
12:12 - 12:14But the two judges who ruled against us,
-
12:14 - 12:17did so for completely different reasons.
-
12:17 - 12:19The first one, Judge Lourie,
-
12:19 - 12:22made up his own novel,
biological theory -- -
12:22 - 12:23totally wrong.
-
12:23 - 12:24(Laughter)
-
12:24 - 12:27Decided Myriad had created
a new chemical -- -
12:27 - 12:28made absolutely no sense.
-
12:29 - 12:31Myriad didn't even argue this,
so it came out of the blue. -
12:32 - 12:34The other, Judge Moore,
-
12:34 - 12:38said she basically agreed with us
that isolated DNA is a product of nature. -
12:38 - 12:41But she's like, "I don't want
to shake up the biotech industry." -
12:42 - 12:45The third, Judge Bryson,
-
12:45 - 12:46agreed with us.
-
12:48 - 12:50So now we sought review
by the Supreme Court. -
12:50 - 12:53And when you petition the Supreme Court,
-
12:53 - 12:56you have to present a question
that you want the court to answer. -
12:57 - 13:00Usually these questions take the form
of a super-long paragraph, -
13:00 - 13:03like a whole page long
with lots and lots of clauses, -
13:03 - 13:06"wherein this" and "therefore that."
-
13:06 - 13:10We submitted perhaps
the shortest question presented ever. -
13:11 - 13:13Four words:
-
13:14 - 13:16Are human genes patentable?
-
13:17 - 13:20Now when Chris first asked me
what I thought of these words, -
13:20 - 13:21I said, "Well, I don't know.
-
13:21 - 13:24I think you have to say,
'Is isolated DNA patentable?'" -
13:25 - 13:26"Nope.
-
13:26 - 13:31I want the justices to have
the very same reaction that I had -
13:31 - 13:34when you brought this issue
to me seven years ago." -
13:35 - 13:37Well, I certainly couldn't
argue with that. -
13:38 - 13:41The Supreme Court only hears
about one percent -
13:41 - 13:43of the cases that it receives,
-
13:43 - 13:44and it agreed to hear ours.
-
13:46 - 13:50The day of the oral argument arrives
and it was really, really exciting -- -
13:50 - 13:51long line of people outside,
-
13:51 - 13:54people had been standing in line
since 2:30 in the morning -
13:54 - 13:56to try to get into the courthouse.
-
13:56 - 13:58Two breast cancer organizations,
-
13:58 - 14:00Breast Cancer Action and FORCE,
-
14:00 - 14:02had organized a demonstration
on the courthouse steps. -
14:03 - 14:06Chris and I sat quietly in the hallway,
-
14:07 - 14:10moments before he was to walk in and argue
-
14:10 - 14:12the most important case of his career.
-
14:13 - 14:15I was clearly more nervous than he was.
-
14:16 - 14:21But any remaining panic subsided
as I walked into the courtroom -
14:21 - 14:24and looked around
at a sea of friendly faces: -
14:24 - 14:26our individual women clients,
-
14:26 - 14:28who had shared their
deeply personal stories; -
14:29 - 14:33the geneticists who had taken huge chunks
of time out of their busy careers -
14:33 - 14:35to dedicate themselves to this fight;
-
14:35 - 14:38and representatives from a diverse array
-
14:38 - 14:40of medical, patient advocacy,
-
14:40 - 14:42environmental and religious organizations,
-
14:42 - 14:45who had submitted friend of the court
briefs in the case. -
14:47 - 14:50Also in the room were three leaders
of the Human Genome Project, -
14:50 - 14:52including the co-discoverer
of DNA himself, -
14:52 - 14:54James Watson,
-
14:54 - 14:56who had submitted a brief to the court,
-
14:56 - 14:59where he referred
to gene patenting as "lunacy." -
14:59 - 15:01(Laughter)
-
15:01 - 15:05The diversity of the communities
represented in this room -
15:05 - 15:08and the contributions each had made
to make this day a reality -
15:08 - 15:11spoke volumes to what was at stake.
-
15:11 - 15:14The argument itself was riveting.
-
15:14 - 15:16Chris argued brilliantly.
-
15:16 - 15:17But for me,
-
15:17 - 15:21the most thrilling aspect was watching
the Supreme Court Justices grapple -
15:21 - 15:23with isolated DNA,
-
15:23 - 15:26through a series of colorful analogies
and feisty exchanges, -
15:26 - 15:29very much the same way
as our legal team had done -
15:29 - 15:31for the past seven years.
-
15:32 - 15:34Justice Kagan likened isolating DNA
-
15:34 - 15:37to extracting a medicinal plant
from the Amazon. -
15:39 - 15:43Justice Roberts distinguished it
from carving a baseball bat from a tree. -
15:44 - 15:46And in one of my absolutely
favorite moments, -
15:47 - 15:52Justice Sotomayor proclaimed isolated DNA
to be "just nature sitting there." -
15:52 - 15:53(Laughter)
-
15:53 - 15:56We felt pretty confident
leaving the courtroom that day, -
15:56 - 15:59but I could never have
anticipated the outcome: -
16:01 - 16:02Nine to zero.
-
16:03 - 16:07"A naturally occurring DNA segment
is a product of nature, -
16:07 - 16:10and not patent-eligible merely because
it has been isolated. -
16:10 - 16:12And furthermore,
-
16:12 - 16:14Myriad did not create anything."
-
16:16 - 16:18Within 24 hours of the decision,
-
16:18 - 16:20five labs had announced
-
16:20 - 16:23that they would begin to offer testing
for the BRCA genes. -
16:23 - 16:27Some of them promised to offer the tests
at a lower price than Myriad's. -
16:27 - 16:30Some promised to provide
a more comprehensive test -
16:30 - 16:32than the one Myriad was offering.
-
16:32 - 16:35But of course the decision
goes far beyond Myriad. -
16:35 - 16:40It ends a 25-year practice
of allowing patents on human genes -
16:40 - 16:41in the United States.
-
16:41 - 16:46It clears a significant barrier
to biomedical discovery and innovation. -
16:46 - 16:51And it helps to ensure that patients
like Abigail, Kathleen and Eileen -
16:51 - 16:54have access to the tests that they need.
-
16:55 - 16:58A few weeks after the court
issued its decision, -
16:58 - 17:00I received a small package in the mail.
-
17:01 - 17:03It was from Bob Cook-Deegan,
-
17:03 - 17:05a professor at Duke University,
-
17:05 - 17:08and one the very first people
Chris and I went to visit -
17:08 - 17:11when we started to consider
whether to bring this case. -
17:12 - 17:15I opened it up to find
a small stuffed animal. -
17:16 - 17:19(Laughter)
-
17:22 - 17:24We took a big risk in taking this case.
-
17:25 - 17:27Part of what gave us the courage
to take that risk -
17:27 - 17:30was knowing that we were doing
the right thing. -
17:30 - 17:34The process took nearly eight years
from the start to finish, -
17:34 - 17:36with many twists and turns along the way.
-
17:37 - 17:38A little luck certainly helped,
-
17:39 - 17:42but it was the communities
that we bridged, -
17:42 - 17:44the alliances that we created,
-
17:44 - 17:45that made pigs fly.
-
17:46 - 17:47Thank you.
-
17:47 - 17:52(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 |