ABOUT THE SPEAKER
Tania Simoncelli - Policy expert
Tania Simoncelli advises the White House on science and technology policy.

Why you should listen

Tania Simoncelli is Assistant Director for Forensic Science in the White House Office of Science and Technology Policy (OSTP). She came to OSTP from the U.S. Food and Drug Administration (FDA), where she served as Senior Advisor in the Office of Medical Products and Tobacco, providing guidance and leadership on complex initiatives that required coordination across the centers for drugs, biologics, medical devices and tobacco products. Prior to this role, she served for two years as Special Assistant to FDA Commissioner Margaret Hamburg, where she advised the Commissioner and her staff on a wide range of issues, including nutrition labeling, food safety, genetically modified foods, scientific integrity, drug safety communication, direct-to-consumer genetic testing and personalized medicine.

From 2003-2010, Simoncelli worked as the Science Advisor to the American Civil Liberties Union, where she guided the organization’s responses to cutting-edge developments in science and technology that pose challenges for civil liberties. In this capacity, she spearheaded the development of ACLU’s successful Supreme Court challenge to the patenting of human genes and advised ACLU leadership and staff on a number of other science policy issues. 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.

Simoncelli is co-author with Sheldon Krimsky of Genetic Justice: DNA Data Banks, Criminal Investigations, and Civil Liberties (Columbia University Press: 2010). She has published articles in a range of scientific, legal and policy journals, including the Journal of the American Medical Association (JAMA), The Journal of Law, Medicine & Ethics (JLME) and Genewatch Magazine.

Simoncelli holds a BA in Biology & Society from Cornell University and an MS in Energy and Resources from the University of California, Berkeley. She has worked as a researcher, analyst, and consultant for a range of nonprofit environmental and social justice organizations, including the Environmental Defense Fund and the Center for Genetics and Society, and served for five years as a board member of the Council for Responsible Genetics.

More profile about the speaker
Tania Simoncelli | Speaker | TED.com
TEDxAmoskeagMillyard

Tania Simoncelli: Should you be able to patent a human gene?

Tania Simoncelli: Como desafiamos á industria das patentes xenéticas... e gañamos

Filmed:
1,131,297 views

Son patentábeis os xenes humanos? No 2005, cando Tania Simoncelli pensou por primeira vez nesta revirada cuestión, a lei de patentes estadounidense contestoulle afirmativamente, o que significaba que os titulares das patentes tiñan o dereito de impedir que alguén determinase a secuencia, probase ou mesmo ollase xenes patentados. Molesta por como esta lei prexudicaba ós pacientes e lle puña trabas á innovación biomédica, Simoncelli e os seus compañeiros do ACLU enfrontáronse a iso. Esta fascinante conferencia fala de como arrostraron un caso que todo o mundo daba por perdido e que chegou ata a Corte Suprema dos Estados Unidos.
- Policy expert
Tania Simoncelli advises the White House on science and technology policy. Full bio

Double-click the English transcript below to play the video.

00:13
It was an afternoon in the fall of 2005.
0
1424
3158
Era unha tarde de outono de 2005.
00:17
I was working at the ACLU
as the organization's science advisor.
1
5325
3599
Traballaba de asesora científica na ACLU,
a Unión polas Liberdades Civís.
00:21
I really, really loved my job,
2
9388
2607
Encantábame o meu traballo,
00:24
but I was having one of those days
3
12019
1636
pero precisamente ese día
00:25
where I was feeling
just a little bit discouraged.
4
13679
2569
sentíame un chisco desanimada.
00:29
So I wandered down the hallway
to my colleague Chris Hansen's office.
5
17265
4104
Así que me acheguei ata o despacho
do meu compañeiro Chris Hansen.
00:34
Chris had been at the ACLU
for more than 30 years,
6
22367
3654
Chris levaba máis de 30 anos
traballando na ACLU,
00:38
so he had deep institutional
knowledge and insights.
7
26045
3075
polo que coñecía ben
o funcionamento das institucións.
00:41
I explained to Chris
that I was feeling a little bit stuck.
8
29640
2973
Díxenlle a Chris
que me sentía un chisco trabada.
00:45
I had been investigating
a number of issues
9
33512
2182
Eu estaba investigando
unha serie de cuestións
00:47
at the intersection of science
and civil liberties -- super interesting.
10
35718
5301
sobre o cruzamento de ciencia
e liberdades civís: moi interesante.
00:53
But I wanted the ACLU to engage
these issues in a much bigger way,
11
41043
3910
Pero quería que a ACLU abordase
estes problemas máis de cara,
00:56
in a way that could really
make a difference.
12
44977
2245
dun xeito que puidese
supor unha diferenza.
01:01
So Chris cut right
to the chase, and he says,
13
49603
2100
Chris foi directo ó gran e preguntoume:
01:03
"Well, of all the issues you've been
looking at, what are the top five?"
14
51727
3460
"De todas esas cuestións,
cales son as cinco que máis te inquietan?"
01:07
"Well, there's genetic discrimination,
15
55524
2656
"Pois está a da discriminación xenética,
01:10
and reproductive technologies,
16
58204
2425
as tecnoloxías reprodutivas,
01:12
and biobanking, and ...
17
60653
2141
os biobancos e...
01:14
oh, there's this really cool issue,
18
62818
1842
vaites, tamén hai unha xenial,
01:16
functional MRI and using it
for lie detection, and ...
19
64684
2649
o emprego das IMRf
como detector de mentiras e...
01:19
oh, and of course, there's gene patents."
20
67357
2121
claro, o tema das patentes xenéticas".
01:21
"Gene patents?"
21
69502
1629
"Patentes xenéticas?"
01:23
"Yes, you know, patents on human genes."
22
71967
2082
"Si, iso é, patentes de xenes humanos".
01:26
"No!
23
74073
1506
"Non!"
01:27
You're telling me that the US government
24
75603
2461
"Estasme dicindo que
o goberno estadounidense
01:30
has been issuing patents
on part of the human body?
25
78088
2924
expide patentes de partes do corpo humano?
01:33
That can't be right."
26
81543
1683
Non pode ser".
01:35
I went back to my office
and sent Chris three articles.
27
83861
3459
Volvín para o meu despacho
e envieille a Chris tres artigos.
01:39
And 20 minutes later,
he came bursting in my office.
28
87954
3327
E 20 minutos despois,
chegou el botando centellas.
01:43
"Oh my god! You're right! Who can we sue?"
29
91305
3616
"Raios! Tiñas razón!
A quen hai que demandar?"
01:47
(Laughter)
30
95330
1509
(Risos)
01:49
Now Chris is a really brilliant lawyer,
31
97713
2374
E é que Chris é un grande avogado,
01:52
but he knew almost nothing
about patent law
32
100111
2909
pero non sabía case nada
sobre lexislación de patentes
01:55
and certainly nothing about genetics.
33
103044
2436
e absolutamente nada sobre xenética.
01:57
I knew something about genetics,
but I wasn't even a lawyer,
34
105504
2878
Eu sabia algo sobre xenética,
pero non era avogada,
02:00
let alone a patent lawyer.
35
108406
1661
moito menos avogada de patentes.
02:02
So clearly we had a lot to learn
before we could file a lawsuit.
36
110091
3466
Quedaba claro que había moito que aprender
antes de demandar a ninguén.
02:06
First, we needed to understand
exactly what was patented
37
114036
2858
Primeiro, tiñamos que saber
exactamente qué se patentaba
02:08
when someone patented a gene.
38
116918
1681
cando alguén patentaba un xene.
02:11
Gene patents typically contain
dozens of claims,
39
119679
3822
As patentes xenéticas adoitan
incluír ducias de reivindicacións,
02:15
but the most controversial of these
are to so-called "isolated DNA" --
40
123525
4777
pero as máis discutidas de todas
son as chamadas "ADN illado"
02:20
namely, a piece of DNA
that has been removed from a cell.
41
128699
4441
ou sexa, un anaco de ADN
que se extraeu dunha célula.
02:26
Gene patent proponents say,
42
134073
1299
Os defensores disto din:
02:27
"See? We didn't patent
the gene in your body,
43
135396
3174
"Non patentamos os xenes do voso corpo,
02:30
we patented an isolated gene."
44
138594
1935
patentamos os xenes illados".
02:33
And that's true,
45
141148
1201
E é verdade,
02:34
but the problem is that any use
of the gene requires that it be isolated.
46
142373
6733
mais o problema radica en que
é preciso illar os xenes para utilizalos.
02:42
And the patents weren't just
to a particular gene that they isolated,
47
150510
4405
E as patentes non cobren
un xene illado en particular,
02:46
but on every possible
version of that gene.
48
154939
2887
senón todas as posibles
versións dese xene.
02:50
So what does that mean?
49
158183
1337
E que significa isto?
02:51
That means that you can't give
your gene to your doctor
50
159981
3062
Pois que non lle podes pasar
os teus xenes a un médico
02:55
and ask him or her to look at it,
51
163067
2296
e pedirlle que os examine,
02:57
say, to see if it has any mutations,
52
165387
2100
para ver se conteñen mutacións,
02:59
without permission of the patent holder.
53
167511
2076
sen o permiso do titular da patente.
03:02
It also means that the patent holder
has the right to stop anyone
54
170363
4193
Tamén implica que o titular da patente
ten o dereito de impedir
03:06
from using that gene
in research or clinical testing.
55
174580
3482
que ese xene se empregue
en investigacións ou ensaios clínicos.
03:10
Allowing patent holders,
56
178871
1698
Permitir que estes titulares,
03:12
often private companies,
57
180593
1284
a miúdo empresas privadas,
03:13
to lock up stretches of the human genome
was harming patients.
58
181901
4486
fechen partes do xenoma humano
estaba a prexudicar ós pacientes.
03:18
Consider Abigail,
59
186958
1152
Temos o caso de Abigail,
03:20
a 10-year-old with long QT syndrome,
60
188134
2393
una pequena de 10 anos
con síndrome do QT longo,
03:22
a serious heart condition that,
if left untreated,
61
190551
3424
unha doenza cardíaca que, se non se trata,
03:25
can result in sudden death.
62
193999
1778
pode provocar a morte súbita.
03:28
The company that obtained a patent on two
genes associated with this condition
63
196911
3922
A empresa que patentou
os dous xenes asociados a esta doenza
03:32
developed a test to diagnose the syndrome.
64
200857
2482
creara unha proba
para diagnosticar a síndrome.
03:35
But then they went bankrupt
and they never offered it.
65
203363
2824
Pero entón entrou en bancarrota
e nunca chegaron a ofrecela.
Outro laboratorio tentou ofrecer a proba,
03:39
So another lab tried to offer the test,
66
207060
1928
03:41
but the company that held the patents
threatened to sue the lab
67
209012
2988
pero a empresa que posuía as patentes
ameazou con demandalos
03:44
for patent infringement.
68
212024
1182
por infrinxir a patente.
03:45
So as a result,
69
213230
1159
O resultado:
03:46
for 2 years, no test was available.
70
214413
2862
dous anos sen poder facer a proba.
03:50
During that time,
71
218291
1150
Durante ese tempo,
03:51
Abigail died of undiagnosed long QT.
72
219465
3250
Abigail morreu de QT longo
sen diagnosticar.
03:55
Gene patents clearly were a problem
and were harming patients.
73
223776
3237
As patentes xenéticas eran un problema
que prexudicaba ós pacientes.
03:59
But was there a way
we could challenge them?
74
227467
2406
Habería algunha forma de facerlles fronte?
04:02
Turns out that the Supreme Court
75
230266
1732
Pois resulta que o Tribunal Supremo
04:04
has made clear
through a long line of cases,
76
232022
3114
deixou claro nunha longa lista
de casos anteriores,
04:07
that certain things
are not patent eligible.
77
235160
2786
que existen unha serie de cousas
que non son patentábeis.
04:10
You can't patent products of nature --
78
238925
2374
Non se poden patentar
produtos da natureza:
04:14
the air, the water, minerals,
elements of the periodic table.
79
242148
4209
o aire, a auga, os minerais,
os elementos da táboa periódica.
04:19
And you can't patent laws of nature --
80
247170
2112
Nin tampouco as leis da natureza:
04:22
the law of gravity, E = mc2.
81
250193
2279
a lei da gravidade, E = mc2.
04:24
These things are just too fundamental
and must remain free to all
82
252909
4806
Son cousas moi fundamentais
e deben de estar ó alcance de todos,
ninguén pode posuílas en exclusividade.
04:29
and reserved exclusively to none.
83
257739
1823
04:32
It seemed to us that DNA,
84
260348
2147
Na nosa opinión o ADN,
04:34
the most fundamental structure of life,
85
262519
2516
a estrutura da vida máis fundamental,
04:37
that codes for the production
of all of our proteins,
86
265059
2656
que codifica a produción
de todas as nosas proteínas,
04:39
is both a product of nature
and a law of nature,
87
267739
3226
é tanto un produto da natureza
coma unha lei da natureza,
04:42
regardless of whether it's in our bodies
88
270989
2702
independentemente
de que se atope nos nosos corpos
04:45
or sitting in the bottom of a test tube.
89
273715
2038
ou no fondo dunha probeta.
04:48
As we delved into this issue,
90
276523
1455
Para informarnos mellor,
04:50
we traveled all over the country
to speak with many different experts --
91
278002
3908
viaxamos por todo o país
para falar con distintos expertos:
04:54
scientists, medical professionals,
lawyers, patent lawyers.
92
282588
3713
científicos, profesionais médicos,
avogados, avogados de patentes.
04:58
Most of them agreed that we were right
as a matter of policy,
93
286753
3910
A maioría dixéronnos que tiñamos razón
desde un punto de vista político,
05:02
and, at least in theory,
as a matter of law.
94
290687
2785
e, cando menos en teoría,
desde un punto de vista legal.
05:06
All of them thought
95
294313
1155
Todos eles pensaban
05:07
our chances of winning
a gene-patent challenge
96
295492
2570
que as posibilidades
de saír coa nosa neste tema
05:10
were about zero.
97
298086
1867
eran tantas coma cero.
05:13
Why is that?
98
301628
1363
Pero por que?
05:15
Well, the patent office
had been issuing these patents
99
303015
3087
Resulta que a oficina de patentes
leva emitindo estas patentes
05:18
for more than 20 years.
100
306126
1701
máis de 20 anos.
05:20
There were literally thousands
of patents on human genes.
101
308686
2880
Literalmente, había milleiros
de patentes de xenes humanos.
05:24
The patent bar was deeply
entrenched in the status quo,
102
312843
2941
O tribunal de patentes estaba
moi atrincheirado no statu quo,
05:28
the biotech industry had grown up
around this practice,
103
316581
3623
a industria da biotecnoloxía medrara
arredor desta práctica,
05:32
and legislation to ban gene patents
had been introduced
104
320228
3119
e a lexislación para prohibir
as patentes xenéticas presentárase
05:35
year after year in Congress,
105
323371
1398
ano tras ano ó Congreso,
05:36
and had gone absolutely nowhere.
106
324793
1791
sen saír xamais adiante.
05:39
So the bottom line:
107
327401
1214
En resumo:
05:41
courts just weren't going to be willing
to overturn these patents.
108
329027
3175
os tribunais non ían estar dispostos
a anular estas patentes.
05:44
Now, neither Chris nor I were the type
to shy away from a challenge,
109
332916
4595
Mais, nin a Chris nin a min
nos poñen medo os retos,
05:49
and hearing, "Being right
just isn't enough,"
110
337535
3144
e que nos dixeran, "ter razón non abonda",
05:52
seemed all the more reason
to take on this fight.
111
340703
2530
dábanos máis folgos para seguir loitando.
05:56
So we set out to build our case.
112
344311
1935
Así que comezamos a fixar a nosa causa.
05:59
Now, patent cases tend to be:
Company A sues Company B
113
347494
3490
Os xuízos por patentes adoitan ser:
Empresa A demanda a Empresa B
06:03
over some really narrow,
obscure technical issue.
114
351008
3183
por algún tema técnico, escuro e confuso.
06:06
We weren't really interested
in that kind of case,
115
354822
2365
A nós non nos interesaban
aquel tipo de causas,
06:09
and we thought this case
was much bigger than that.
116
357211
2389
pensamos que a nosa causa
abranguía moito máis.
06:11
This was about scientific freedom,
medical progress,
117
359624
2488
Tratábase da liberdade científica,
o progreso médico
06:14
the rights of patients.
118
362136
1459
e os dereitos dos pacientes.
06:15
So we decided we were going
to develop a case
119
363619
3103
Así que decidimos abrir unha causa
06:18
that was not like
your typical patent case --
120
366746
2518
que non sería coma
as típicas que hai por patentes,
06:21
more like a civil rights case.
121
369645
1882
senón unha causa
a prol dos dereitos civís.
06:24
We set out to identify
a gene-patent holder
122
372756
2842
Propuxémonos identificar
un titular de patentes xenéticas
06:27
that was vigorously enforcing its patents
123
375622
2785
que estivese a defender
tenazmente as súas patentes
06:30
and then to organize a broad coalition
of plaintiffs and experts
124
378431
3294
para despois organizarmos
unha coalición de demandantes e expertos
06:33
that could tell the court
125
381749
1890
que lles contasen ós tribunais
06:35
about all the ways that these patents
were harming patients and innovation.
126
383663
4389
como estas patentes actuaban
en detrimento de pacientes e innovación.
06:41
We found the prime candidate
to sue in Myriad Genetics,
127
389404
3122
Achamos que o candidato ideal
para demandar era Myriad Genetics,
06:44
a company that's based
in Salt Lake City, Utah.
128
392550
2855
unha empresa con sede
en Salt Lake City, Utah.
06:48
Myriad held patents on two genes,
129
396718
2250
Myriad posuía as patentes de dous xenes,
06:50
the BRCA1 and the BRCA2 genes.
130
398992
3321
os xenes BRCA1 e o BRCA2.
06:55
Women with certain mutations
along these genes
131
403150
2734
As mulleres
con certas mutacións nestes xenes
06:57
are considered to be
at a significantly increased risk
132
405908
2626
teñen máis probabilidades
07:00
of developing breast and ovarian cancer.
133
408558
1945
de padecer cancro de peito e de ovario.
Myriad empregara as patentes para manter
07:03
Myriad had used its patents to maintain
134
411834
1880
07:05
a complete monopoly on BRCA testing
in the United States.
135
413738
4209
un monopolio total sobre
as probas de BCRA nos Estados Unidos.
07:10
It had forced multiple labs
that were offering BRCA testing to stop.
136
418544
4188
Fixo que varios laboratorios
deixasen de ofrecer probas de BCRA.
07:14
It charged a lot of money for its test --
137
422756
2159
Cobraban moitos cartos polo seu exame:
07:16
over 3,000 dollars.
138
424939
1683
máis de 3.000 dólares.
07:19
It had stopped sharing its clinical data
139
427089
2335
Deixaran de compartir
os seus datos clínicos
07:21
with the international
scientific community.
140
429448
2287
coa comunidade científica internacional.
07:24
And perhaps worst of all,
141
432522
1903
E, se callar o peor de todo,
07:26
for a period of several years,
142
434449
2436
durante un período de varios anos,
07:28
Myriad refused to update its test
to include additional mutations
143
436909
3713
Myriad negouse a actualizar o seu exame
para que incluíse mutacións adicionais
07:32
that had been identified
by a team of researchers in France.
144
440646
3621
que foran identificadas por un equipo
de investigadores en Francia.
07:36
It has been estimated
that during that period,
145
444974
2508
Estimouse que durante ese período,
07:39
for several years,
146
447506
1373
durante varios anos,
07:40
as many as 12 percent of women
undergoing testing
147
448903
3752
ata un 12% das mulleres
ás que lles fixeran a proba
07:44
received the wrong answer --
148
452679
2402
recibiran una resposta errada:
07:48
a negative test result
that should have been positive.
149
456377
3769
un resultado negativo
que debería de ser positivo.
07:53
This is Kathleen Maxian.
150
461485
1741
Esta é Kathleen Maxian.
07:56
Kathleen's sister Eileen
developed breast cancer at age 40
151
464172
3257
A irmá de Kathleen, Eileen,
desenvolveu cancro con 40 anos
07:59
and she was tested by Myriad.
152
467453
1840
e fixo os exames con Myriad.
08:02
The test was negative.
153
470032
1726
O exame deu negativo.
08:03
The family was relieved.
154
471782
1526
A familia acougou.
08:05
That meant that Eileen's cancer
most likely didn't run in the family,
155
473332
3788
O máis probable era que ese cancro
non estivese presente na familia,
08:09
and that other members of her family
didn't need to be tested.
156
477144
3015
polo que os outros membros da familia
non precisaban facer o exame.
08:12
But two years later,
157
480843
1230
Mais dous anos despois,
08:14
Kathleen was diagnosed
with advanced-stage ovarian cancer.
158
482097
4060
a Kathleen diagnosticáronlle
un cancro de ovario en estado avanzado.
08:18
It turned out that Kathleen's sister
was among the 12 percent
159
486927
3872
Resultou que a irmá de Kathleen
encontrábase entre ese 12%
08:22
who received a false-negative test result.
160
490823
2869
de persoas que recibiron
un resultado negativo falso.
08:26
Had Eileen received the proper result,
161
494347
3089
Se Eileen recibise o resultado correcto,
08:29
Kathleen would have then been tested,
162
497460
2373
Kathleen faría o exame,
08:31
and her ovarian cancer
could have been prevented.
163
499857
2913
e evitaría o seu cancro de ovario.
Unha vez que nos decidimos
por Myriad,
08:36
Once we settled on Myriad,
164
504818
1264
08:38
we then had to form a coalition
of plaintiffs and experts
165
506106
3885
tivemos que formar unha coalición
de demandantes e expertos
08:42
that could illuminate these problems.
166
510015
2088
que puidesen aclarar estes problemas.
Acabamos xuntando
20 demandantes moi comprometidos:
08:44
We ended up with 20
highly committed plaintiffs:
167
512127
2572
08:47
genetic counselors,
168
515325
1538
conselleiros xenéticos,
xenetistas que recibiran
cartas ameazantes,
08:48
geneticists who had received
cease and desist letters,
169
516887
3359
08:52
advocacy organizations,
170
520905
1849
organizacións de defensa,
08:55
four major scientific organizations
that collectively represented
171
523532
3065
catro organizacións científicas
que en conxunto representaban
08:58
more than 150,000 scientists
and medical professionals,
172
526621
3530
a máis de 150.000 científicos
e profesionais médicos,
09:02
and individual women who either
couldn't afford Myriad's test,
173
530755
3297
e mulleres individuais que ou ben
non podían pagar o exame de Myriad,
09:06
or who wanted to obtain
a second opinion but could not,
174
534076
3004
ou ben querían una segunda opinión
que non lles podían dar,
09:09
as a result of the patents.
175
537104
1744
por mor das patentes.
09:12
One of the major challenges
we had in preparing the case
176
540315
3440
Un dos principais retos
que afrontamos cando preparamos este caso
09:15
was figuring out how best
to communicate the science.
177
543779
2866
foi pensar a forma
na que explicar a ciencia.
09:19
So in order to argue that what Myriad did
was not an invention,
178
547079
3831
Para argumentar que o que fixera
Myriad non era un invento,
09:22
and that isolated BRCA genes
were products of nature,
179
550934
3277
e que os xenes illados BRCA
eran produtos da natureza,
09:27
we had to explain a couple
of basic concepts, like:
180
555124
2713
tivemos que explicar un par
de conceptos básicos, do tipo:
09:29
What's a gene? What's DNA?
181
557861
2144
Que é un xene? Que é o ADN?
09:32
How is DNA isolated,
and why isn't that an invention?
182
560029
3716
Como se illa o ADN,
e por que iso non é un invento?
09:37
We spent hours and hours
with our plaintiffs and experts,
183
565168
3862
Pasamos horas e horas
cos nosos demandantes e expertos,
09:41
trying to come up with ways
of explaining these concepts
184
569054
2936
tentando dar coa forma
de explicar estes conceptos
09:44
simply yet accurately.
185
572014
1543
de forma sinxela mais certeira.
09:46
And we ended up relying heavily
on the use of metaphors,
186
574306
3332
E ao final acabamos por botar man
das metáforas,
09:49
like gold.
187
577662
1156
coma a do ouro.
09:51
So isolating DNA --
188
579789
2284
Así que illar ADN
09:54
it's like extracting gold from a mountain
189
582097
2500
é coma extraer ouro dunha montaña.
09:57
or taking it out of a stream bed.
190
585105
2016
ou do leito dun río.
09:59
You might be able to patent
the process for mining the gold,
191
587145
3674
Pódese patentar o proceso
para extraer ouro,
10:02
but you can't patent the gold itself.
192
590843
2081
pero non podes patentar o propio ouro.
10:05
It might've taken a lot
of hard work and effort
193
593929
2743
Tanto ten canto traballo se requira
10:08
to dig the gold out of the mountain;
194
596696
1860
para extraer o ouro da montaña;
10:11
you still can't patent it,
it's still gold.
195
599127
2281
non se pode patentar, segue sendo ouro.
10:13
And the gold, once it's extracted,
196
601432
1756
E o ouro, unha vez extraído,
10:15
can clearly be used
for all sorts of things
197
603212
2088
pódese empregar en todo tipo de cousas
10:17
that it couldn't be used
for when it was in the mountain;
198
605324
2736
nas que non se podía empregar
cando estaba na montaña;
10:20
you can make jewelry
out of it for example --
199
608084
2182
con el pódense facer xoias, por exemplo.
10:22
still can't patent the gold,
it's still gold.
200
610290
2165
Pero non se pode patentar o ouro,
porque segue sendo ouro.
10:25
So now it's 2009,
and we're ready to file our case.
201
613364
3854
No 2009 xa estabamos listos
para presentar o caso.
10:30
We filed in federal court
in the Southern District of New York,
202
618286
3495
Presentámolo perante o Tribunal Federal
do distrito sur de Nova York,
10:34
and the case was randomly assigned
to Judge Robert Sweet.
203
622355
3366
e o caso foille asignado, ao chou,
ao xuíz Robert Sweet.
10:38
In March 2010, Judge Sweet
issued his opinion --
204
626599
3200
En marzo de 2010, o xuíz Sweet
emitiu o seu veredicto:
10:42
152 pages --
205
630569
1858
152 páxinas.
10:44
and a complete victory for our side.
206
632834
2252
Unha vitoria total para nós.
10:47
In reading the opinion,
207
635964
1431
Cando lemos a súa opinión,
10:49
we could not get over how eloquently
he described the science in the case.
208
637419
4715
impresionounos a elocuencia
coa que describiu a ciencia no caso.
10:54
I mean, our brief --
it was pretty good,
209
642504
2771
Quero dicir, o noso informe...
era bastante bo,
10:57
but not this good.
210
645299
1567
pero non tan bo.
10:59
How did he develop such a deep
understanding of this issue
211
647778
3377
Como puido desenvolver
un coñecemento tan profundo do tema
11:03
in such a short time?
212
651179
1160
en tan pouco tempo?
11:04
We just could not comprehend
how this had happened.
213
652363
3608
Non podiamos imaxinar
como fora posíbel algo así.
11:07
So it turned out,
214
655995
1264
Así que resultou
11:09
Judge Sweet's clerk
working for him at the time,
215
657283
3310
que o asistente co que traballaba
o xuíz Sweet daquela,
11:12
was not just a lawyer --
216
660617
1480
non só era avogado...
11:14
he was a scientist.
217
662121
1714
era científico.
11:15
He was not just a scientist --
218
663859
1598
E non só era científico...
11:17
he had a PhD in molecular biology.
219
665481
3146
tiña un doutoramento
en bioloxía molecular.
11:20
(Laughter)
220
668651
1751
(Risos)
11:22
What an incredible stroke of luck!
221
670426
2575
Vaia golpe de sorte!
11:26
Myriad then appealed
222
674058
1300
Entón Myriad apelou
11:27
to the US Court of Appeals
for the Federal Circuit.
223
675382
2495
perante o Tribunal de Apelación
do Circuíto Federal.
11:30
And here things got really interesting.
224
678496
2016
E aquí as cousas puxéronse interesantes.
11:33
First, in a pivotal moment of this case,
225
681465
3060
Primeiro, nun momento vital deste caso,
11:37
the US government switched sides.
226
685187
2631
o goberno dos Estados Unidos
mudou de lado.
11:40
So in the district court the government
submitted a brief on Myriad's side.
227
688739
3749
No tribunal do distrito, o goberno
emitiu un informe a prol de Myriad.
11:44
But now in direct opposition
to its own patent office,
228
692512
5128
Pero en oposición directa
á súa propia oficina de patentes,
11:49
the US government files a brief
that states that is has
229
697664
2708
o goberno presentou
un informe no que dicía
11:52
reconsidered this issue
in light of the district court's opinion,
230
700396
3688
que reconsiderara este tema
á luz da decisión do tribunal do distrito,
11:56
and has concluded that isolated DNA
is not patent eligible.
231
704108
3186
e concluía que o ADN illado
non era susceptíbel de ser patentado.
11:59
This was a really big deal,
232
707818
1811
Isto foi moi importante,
12:01
totally unexpected.
233
709653
1562
e totalmente inesperado.
12:04
The Court of Appeals
for the Federal Circuit
234
712773
2080
O Tribunal de Apelación
do Circuíto Federal
12:06
hears all patent cases,
235
714877
1683
leva todos os casos de patentes,
12:08
and it has a reputation for being
very, very pro-patent.
236
716584
3158
e é coñecida a súa reputación
moi, moi a prol das patentes.
12:12
So even with this remarkable development,
237
720305
2426
Así que mesmo con este
acontecemento notorio,
12:14
we expected to lose.
238
722755
1679
contabamos con perder.
12:16
And we did.
239
724458
1347
E así foi.
12:18
Sort of.
240
726389
1152
Máis ou menos.
12:20
Ends up split decision, 2 to 1.
241
728357
2587
A decisión foi de 2 contra 1.
12:23
But the two judges who ruled against us,
242
731743
2496
Mais os dous xuíces que
votaron contra nós,
12:26
did so for completely different reasons.
243
734263
2241
fixérono por motivos totalmente distintos.
12:29
The first one, Judge Lourie,
244
737275
1826
O primeiro, o xuíz Lourie,
12:31
made up his own novel,
biological theory --
245
739125
3015
creou a súa propia
e nova teoría biolóxica,
12:34
totally wrong.
246
742164
1168
totalmente errada.
12:35
(Laughter)
247
743356
1011
(Risos)
Decidiu que Myriad creara
unha nova substancia química,
12:36
He decided Myriad had created
a new chemical --
248
744391
2218
12:38
made absolutely no sense.
249
746633
1865
o que non tiña sentido ningún.
12:40
Myriad didn't even argue this,
so it came out of the blue.
250
748522
2786
Myriad xamais argumentou iso,
polo que non tiña sentido.
12:43
The other, Judge Moore,
251
751632
1977
O outro xuíz, a xuíza Moore,
12:45
said she basically agreed with us
that isolated DNA is a product of nature.
252
753633
3878
dixo que concordaba con nós en canto
a ser o ADN illado un produto da natureza.
12:49
But she's like, "I don't want
to shake up the biotech industry."
253
757987
3333
Pero que "Non quero zarapallar
a industria da biotecnoloxía".
12:54
The third, Judge Bryson,
254
762248
2572
O terceiro, o xuíz Bryson,
12:57
agreed with us.
255
765233
1216
deunos a razón.
Daquela interpuxemos recurso
perante o Tribunal Supremo.
12:59
So now we sought review
by the Supreme Court.
256
767750
2531
13:02
And when you petition the Supreme Court,
257
770305
2703
E cando interpós un recurso
perante o Tribunal Supremo
13:05
you have to present a question
that you want the Court to answer.
258
773032
3122
tes que presentar unha pregunta
que queiras que che responda o Tribunal.
13:08
Usually these questions take the form
of a super-long paragraph,
259
776534
3727
Polo xeral, estas preguntas
collen a forma dun parágrafo superlongo,
13:12
like a whole page long
with lots and lots of clauses,
260
780285
3023
a miúdo unha páxina
con moreas de cláusulas,
13:15
"wherein this" and "therefore that."
261
783332
2457
"onde tal" e "polo tanto".
13:18
We submitted perhaps
the shortest question presented ever.
262
786294
3907
Nós fixemos a que se callar foi a pregunta
máis curta que xamais recibiron.
13:23
Four words:
263
791312
1213
Cinco palabras:
13:26
Are human genes patentable?
264
794220
2051
Son patentábeis os xenes humanos?
13:28
Now when Chris first asked me
what I thought of these words,
265
796922
2824
Cando Chris me preguntou
o que pensaba desas palabras,
13:31
I said, "Well, I don't know.
266
799770
1374
díxenlle "Pois non o sei.
13:33
I think you have to say,
'Is isolated DNA patentable?'"
267
801168
3167
Penso que terías que dicir,
'é o ADN illlado patentábel?"
13:36
"Nope.
268
804968
1169
"Non.
13:38
I want the justices to have
the very same reaction that I had
269
806487
4621
Quero que os xuíces teñan
a mesma reacción que tiven eu
13:43
when you brought this issue
to me seven years ago."
270
811132
3087
o día que me falaches
deste tema hai sete anos".
13:46
Well, I certainly couldn't
argue with that.
271
814896
2157
E claro, que ía dicir eu?
13:49
The Supreme Court only hears
about one percent
272
817981
2883
O Tribunal Supremo só oe
ao redor dun un por cento
13:52
of the cases that it receives,
273
820888
1666
dos casos que recibe,
13:54
and it agreed to hear ours.
274
822578
1591
e aceptou oír o noso.
13:57
The day of the oral argument arrives,
and it was really, really exciting --
275
825772
4127
Chega o día das alegacións orais
e foi moi, moi emocionante...
14:01
long line of people outside,
276
829923
1435
con moita xente fóra,
14:03
people had been standing in line
since 2:30 in the morning
277
831382
2764
xente que levaba agardando
desde as 2:30 da madrugada
14:06
to try to get into the courthouse.
278
834170
1734
para tentar entrar no xulgado.
14:07
Two breast cancer organizations,
279
835928
1971
Dúas organizacións
contra o cancro de peito,
14:09
Breast Cancer Action and FORCE,
280
837923
1668
Breast Cancer Action e FORCE,
14:11
had organized a demonstration
on the courthouse steps.
281
839615
2701
organizaran unha manifestación
á entrada do xulgado.
14:15
Chris and I sat quietly in the hallway,
282
843232
2870
Chris e eu agardabamos xuntos no corredor,
14:18
moments before he was to walk in and argue
283
846776
3014
momentos antes de que el
entrase a defender
14:21
the most important case of his career.
284
849814
2316
o caso máis importante da súa carreira.
14:24
I was clearly more nervous than he was.
285
852765
2379
Eu estaba moito máis nerviosa ca el.
14:28
But any remaining panic subsided
as I walked into the courtroom
286
856096
4760
Pero todo aquel pánico
esvaeceuse cando entrei na sala
14:32
and looked around
at a sea of friendly faces:
287
860880
2813
e vin ao meu redor
unha morea de rostros coñecidos:
14:36
our individual women clients
288
864059
1765
mulleres que coñecía
14:37
who had shared their
deeply personal stories,
289
865848
2441
e que partillaran
as súas historias persoais,
14:41
the geneticists who had taken huge chunks
of time out of their busy careers
290
869210
3626
os xenetistas que sacrificaran moitísimo
tempo das súas atarefadas carreiras
14:44
to dedicate themselves to this fight
291
872860
1825
para dedicarllo a esta loita,
14:47
and representatives from a diverse array
292
875122
2579
representantes dun diverso espectro
de organizacións médicas,
de defensa dos pacientes,
14:49
of medical, patient advocacy,
293
877725
1887
14:51
environmental and religious organizations,
294
879636
2076
medioambientais e relixiosas,
14:53
who had submitted friend of the court
briefs in the case.
295
881736
3532
que presentaran observacións ao tribunal.
14:58
Also in the room were three leaders
of the Human Genome Project,
296
886609
3025
Na sala tamén estaban tres líderes
do Proxecto Xenoma Humano,
15:01
including the co-discoverer
of DNA himself,
297
889658
2672
incluído o co-descubridor do ADN,
15:04
James Watson,
298
892354
1290
James Watson,
15:05
who had submitted a brief to the court,
299
893668
2146
quen lle presentara
un informe ao tribunal,
15:07
where he referred
to gene patenting as "lunacy."
300
895838
3511
no que dicía que
patentar xenes era unha "tolería".
15:11
(Laughter)
301
899373
1848
(Risos)
15:13
The diversity of the communities
represented in this room
302
901245
3637
A diversidade das comunidades
representadas na sala
15:16
and the contributions each had made
to make this day a reality
303
904906
3441
e as contribucións que cada unha achegou
para facer realidade este día
15:20
spoke volumes to what was at stake.
304
908371
2297
dicía moito do que tiñamos en xogo.
15:23
The argument itself was riveting.
305
911386
2213
A alegación era cativadora.
15:26
Chris argued brilliantly.
306
914205
1663
Chris alegou de forma brillante.
15:27
But for me,
307
915892
1245
Pero para min,
15:29
the most thrilling aspect was watching
the Supreme Court justices grapple
308
917161
3764
o máis apaixonante foi ver ós xuíces
do Tribunal Supremo tentando entender
15:32
with isolated DNA,
309
920949
1569
o ADN illado,
15:34
through a series of colorful analogies
and feisty exchanges,
310
922542
3226
mediante unha serie de analoxías vistosas
e diálogos enérxicos,
15:37
very much the same way
as our legal team had done
311
925792
3340
de forma moi semellante
a como fixera o noso equipo legal
15:41
for the past seven years.
312
929156
1690
durante os últimos sete anos.
15:43
Justice Kagan likened isolating DNA
313
931666
2656
A xuíza Kagan asociou o illamento do ADN
15:46
to extracting a medicinal plant
from the Amazon.
314
934346
2776
con extraer unha planta medicinal
do Amazonas.
15:50
Justice Roberts distinguished it
from carving a baseball bat from a tree.
315
938516
4010
O xuíz Roberts asociouno con facer
un bate de béisbol a partir dunha árbore.
15:55
And in one of my absolutely
favorite moments,
316
943995
2482
E no que sen dúbida foi
o meu momento favorito,
15:58
Justice Sotomayor proclaimed isolated DNA
to be "just nature sitting there."
317
946501
5269
a xuíza Sotomayor determinou
que o ADN illado "era natureza á espera".
16:03
(Laughter)
318
951794
1100
(Risos)
16:05
We felt pretty confident
leaving the courtroom that day,
319
953318
2875
Cando saímos aquel día do xulgado
sentiámonos moi confiados,
16:08
but I could never have
anticipated the outcome:
320
956217
3006
pero xamais podería anticipar o resultado:
16:12
nine to zero.
321
960574
1507
nove a cero.
16:15
"A naturally occurring DNA segment
is a product of nature,
322
963025
3722
"Un segmento natural de ADN
é un produto da natureza
16:18
and not patent-eligible merely because
it has been isolated.
323
966771
3047
e non é susceptible de ser patentado
tan só porque fora illado.
16:22
And furthermore,
324
970394
1347
E o que é máis,
16:23
Myriad did not create anything."
325
971765
2545
Myriad non creou nada."
16:28
Within 24 hours of the decision,
326
976160
1996
Vinte e catro horas após a decisión,
16:30
five labs had announced
327
978180
1392
cinco laboratorios anunciaron
16:31
that they would begin to offer testing
for the BRCA genes.
328
979596
3014
que comezarían a ofrecer o exame
para os xenes BRCA.
16:35
Some of them promised to offer the tests
at a lower price than Myriad's.
329
983149
3483
Algúns deles prometeron ofrecer os exames
máis baratos ca Myriad.
16:39
Some promised to provide
a more comprehensive test
330
987142
2920
Algúns prometeron ofrecer
un exame máis exhaustivo
16:42
than the one Myriad was offering.
331
990086
1683
có que ofrecía Myriad.
16:44
But of course the decision
goes far beyond Myriad.
332
992490
2838
Pero a decisión do tribunal
ía alén de Myriad.
16:47
It ends a 25-year practice
of allowing patents on human genes
333
995352
4396
Rematou cunha práctica de 25 anos
que permitía patentar xenes humanos
16:51
in the United States.
334
999772
1207
nos Estados Unidos.
16:53
It clears a significant barrier
to biomedical discovery and innovation.
335
1001383
4693
Eliminou atrancos que sufría a innovación
e a investigación biomédica.
16:58
And it helps to ensure that patients
like Abigail, Kathleen and Eileen
336
1006484
4901
E axudou a que pacientes coma Abigail,
Kathleen e Eileen
17:03
have access to the tests that they need.
337
1011409
2156
tivesen acceso aos exames que precisaban.
17:06
A few weeks after the court
issued its decision,
338
1014991
3215
Poucas semanas despois de que o tribunal
emitise a súa decisión,
17:10
I received a small package in the mail.
339
1018230
2260
recibín un pequeno paquete
na caixa do correo.
17:13
It was from Bob Cook-Deegan,
340
1021246
1607
Era de Bob Cook-Deegan,
17:14
a professor at Duke University
341
1022877
2269
un profesor da Universidade de Duke
17:17
and one the very first people
Chris and I went to visit
342
1025170
3224
e unha das primeiras persoas
que eu e Chris fomos visitar
cando comezamos a barallar a idea
de presentar ou non o caso.
17:20
when we started to consider
whether to bring this case.
343
1028418
2699
Abrino e encontreime
cun pequeno boneco de peluche.
17:24
I opened it up to find
a small stuffed animal.
344
1032033
2809
17:28
(Laughter)
345
1036344
2959
(Risos)
17:33
We took a big risk in taking this case.
346
1041568
2328
Arriscámonos moito con este caso.
17:36
Part of what gave us the courage
to take that risk
347
1044722
2510
Parte do que nos deu a coraxe
de afrontar eses riscos
17:39
was knowing that we were doing
the right thing.
348
1047256
2438
foi saber
que estabamos a facer o correcto.
17:42
The process took nearly eight years
from the start to finish,
349
1050079
3730
O proceso durou case oito anos
desde o principio ata a fin,
17:45
with many twists and turns along the way.
350
1053833
2221
con moitos xiros e imprevistos
polo camiño.
17:48
A little luck certainly helped,
351
1056578
1691
Claro que a sorte axudou,
17:50
but it was the communities
that we bridged,
352
1058888
2812
pero foron as comunidades que unimos,
17:53
the alliances that we created,
353
1061724
2091
e as alianzas que creamos,
17:55
that made pigs fly.
354
1063839
1420
as que nos deron ás.
17:57
Thank you.
355
1065802
1156
Grazas.
17:58
(Applause)
356
1066982
5514
(Aplausos)

▲Back to top

ABOUT THE SPEAKER
Tania Simoncelli - Policy expert
Tania Simoncelli advises the White House on science and technology policy.

Why you should listen

Tania Simoncelli is Assistant Director for Forensic Science in the White House Office of Science and Technology Policy (OSTP). She came to OSTP from the U.S. Food and Drug Administration (FDA), where she served as Senior Advisor in the Office of Medical Products and Tobacco, providing guidance and leadership on complex initiatives that required coordination across the centers for drugs, biologics, medical devices and tobacco products. Prior to this role, she served for two years as Special Assistant to FDA Commissioner Margaret Hamburg, where she advised the Commissioner and her staff on a wide range of issues, including nutrition labeling, food safety, genetically modified foods, scientific integrity, drug safety communication, direct-to-consumer genetic testing and personalized medicine.

From 2003-2010, Simoncelli worked as the Science Advisor to the American Civil Liberties Union, where she guided the organization’s responses to cutting-edge developments in science and technology that pose challenges for civil liberties. In this capacity, she spearheaded the development of ACLU’s successful Supreme Court challenge to the patenting of human genes and advised ACLU leadership and staff on a number of other science policy issues. 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.

Simoncelli is co-author with Sheldon Krimsky of Genetic Justice: DNA Data Banks, Criminal Investigations, and Civil Liberties (Columbia University Press: 2010). She has published articles in a range of scientific, legal and policy journals, including the Journal of the American Medical Association (JAMA), The Journal of Law, Medicine & Ethics (JLME) and Genewatch Magazine.

Simoncelli holds a BA in Biology & Society from Cornell University and an MS in Energy and Resources from the University of California, Berkeley. She has worked as a researcher, analyst, and consultant for a range of nonprofit environmental and social justice organizations, including the Environmental Defense Fund and the Center for Genetics and Society, and served for five years as a board member of the Council for Responsible Genetics.

More profile about the speaker
Tania Simoncelli | Speaker | TED.com