TEDxAmoskeagMillyard
Tania Simoncelli: Should you be able to patent a human gene?
Filmed:
Readability: 5.3
1,131,297 views
A decade ago, US law said human genes were patentable -- 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, Tania 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.
Tania Simoncelli - Policy expert
Tania Simoncelli advises the White House on science and technology policy. Full bio
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
00:17
I was working at the ACLU
as the organization's science advisor.
as the organization's science advisor.
1
5325
3599
00:21
I really, really loved my job,
2
9388
2607
00:24
but I was having one of those days
3
12019
1636
00:25
where I was feeling
just a little bit discouraged.
just a little bit discouraged.
4
13679
2569
00:29
So I wandered down the hallway
to my colleague Chris Hansen's office.
to my colleague Chris Hansen's office.
5
17265
4104
00:34
Chris had been at the ACLU
for more than 30 years,
for more than 30 years,
6
22367
3654
00:38
so he had deep institutional
knowledge and insights.
knowledge and insights.
7
26045
3075
00:41
I explained to Chris
that I was feeling a little bit stuck.
that I was feeling a little bit stuck.
8
29640
2973
00:45
I had been investigating
a number of issues
a number of issues
9
33512
2182
00:47
at the intersection of science
and civil liberties -- super interesting.
and civil liberties -- super interesting.
10
35718
5301
00:53
But I wanted the ACLU to engage
these issues in a much bigger way,
these issues in a much bigger way,
11
41043
3910
00:56
in a way that could really
make a difference.
make a difference.
12
44977
2245
01:01
So Chris cut right
to the chase, and he says,
to the chase, and he says,
13
49603
2100
01:03
"Well, of all the issues you've been
looking at, what are the top five?"
looking at, what are the top five?"
14
51727
3460
01:07
"Well, there's genetic discrimination,
15
55524
2656
01:10
and reproductive technologies,
16
58204
2425
01:12
and biobanking, and ...
17
60653
2141
01:14
oh, there's this really cool issue,
18
62818
1842
01:16
functional MRI and using it
for lie detection, and ...
for lie detection, and ...
19
64684
2649
01:19
oh, and of course, there's gene patents."
20
67357
2121
01:21
"Gene patents?"
21
69502
1629
01:23
"Yes, you know, patents on human genes."
22
71967
2082
01:26
"No!
23
74073
1506
01:27
You're telling me that the US government
24
75603
2461
01:30
has been issuing patents
on part of the human body?
on part of the human body?
25
78088
2924
01:33
That can't be right."
26
81543
1683
01:35
I went back to my office
and sent Chris three articles.
and sent Chris three articles.
27
83861
3459
01:39
And 20 minutes later,
he came bursting in my office.
he came bursting in my office.
28
87954
3327
01:43
"Oh my god! You're right! Who can we sue?"
29
91305
3616
01:47
(Laughter)
30
95330
1509
01:49
Now Chris is a really brilliant lawyer,
31
97713
2374
01:52
but he knew almost nothing
about patent law
about patent law
32
100111
2909
01:55
and certainly nothing about genetics.
33
103044
2436
01:57
I knew something about genetics,
but I wasn't even a lawyer,
but I wasn't even a lawyer,
34
105504
2878
02:00
let alone a patent lawyer.
35
108406
1661
02:02
So clearly we had a lot to learn
before we could file a lawsuit.
before we could file a lawsuit.
36
110091
3466
02:06
First, we needed to understand
exactly what was patented
exactly what was patented
37
114036
2858
02:08
when someone patented a gene.
38
116918
1681
02:11
Gene patents typically contain
dozens of claims,
dozens of claims,
39
119679
3822
02:15
but the most controversial of these
are to so-called "isolated DNA" --
are to so-called "isolated DNA" --
40
123525
4777
02:20
namely, a piece of DNA
that has been removed from a cell.
that has been removed from a cell.
41
128699
4441
02:26
Gene patent proponents say,
42
134073
1299
02:27
"See? We didn't patent
the gene in your body,
the gene in your body,
43
135396
3174
02:30
we patented an isolated gene."
44
138594
1935
02:33
And that's true,
45
141148
1201
02:34
but the problem is that any use
of the gene requires that it be isolated.
of the gene requires that it be isolated.
46
142373
6733
02:42
And the patents weren't just
to a particular gene that they isolated,
to a particular gene that they isolated,
47
150510
4405
02:46
but on every possible
version of that gene.
version of that gene.
48
154939
2887
02:50
So what does that mean?
49
158183
1337
02:51
That means that you can't give
your gene to your doctor
your gene to your doctor
50
159981
3062
02:55
and ask him or her to look at it,
51
163067
2296
02:57
say, to see if it has any mutations,
52
165387
2100
02:59
without permission of the patent holder.
53
167511
2076
03:02
It also means that the patent holder
has the right to stop anyone
has the right to stop anyone
54
170363
4193
03:06
from using that gene
in research or clinical testing.
in research or clinical testing.
55
174580
3482
03:10
Allowing patent holders,
56
178871
1698
03:12
often private companies,
57
180593
1284
03:13
to lock up stretches of the human genome
was harming patients.
was harming patients.
58
181901
4486
03:18
Consider Abigail,
59
186958
1152
03:20
a 10-year-old with long QT syndrome,
60
188134
2393
03:22
a serious heart condition that,
if left untreated,
if left untreated,
61
190551
3424
03:25
can result in sudden death.
62
193999
1778
03:28
The company that obtained a patent on two
genes associated with this condition
genes associated with this condition
63
196911
3922
03:32
developed a test to diagnose the syndrome.
64
200857
2482
03:35
But then they went bankrupt
and they never offered it.
and they never offered it.
65
203363
2824
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
threatened to sue the lab
67
209012
2988
03:44
for patent infringement.
68
212024
1182
03:45
So as a result,
69
213230
1159
03:46
for 2 years, no test was available.
70
214413
2862
03:50
During that time,
71
218291
1150
03:51
Abigail died of undiagnosed long QT.
72
219465
3250
03:55
Gene patents clearly were a problem
and were harming patients.
and were harming patients.
73
223776
3237
03:59
But was there a way
we could challenge them?
we could challenge them?
74
227467
2406
04:02
Turns out that the Supreme Court
75
230266
1732
04:04
has made clear
through a long line of cases,
through a long line of cases,
76
232022
3114
04:07
that certain things
are not patent eligible.
are not patent eligible.
77
235160
2786
04:10
You can't patent products of nature --
78
238925
2374
04:14
the air, the water, minerals,
elements of the periodic table.
elements of the periodic table.
79
242148
4209
04:19
And you can't patent laws of nature --
80
247170
2112
04:22
the law of gravity, E = mc2.
81
250193
2279
04:24
These things are just too fundamental
and must remain free to all
and must remain free to all
82
252909
4806
04:29
and reserved exclusively to none.
83
257739
1823
04:32
It seemed to us that DNA,
84
260348
2147
04:34
the most fundamental structure of life,
85
262519
2516
04:37
that codes for the production
of all of our proteins,
of all of our proteins,
86
265059
2656
04:39
is both a product of nature
and a law of nature,
and a law of nature,
87
267739
3226
04:42
regardless of whether it's in our bodies
88
270989
2702
04:45
or sitting in the bottom of a test tube.
89
273715
2038
04:48
As we delved into this issue,
90
276523
1455
04:50
we traveled all over the country
to speak with many different experts --
to speak with many different experts --
91
278002
3908
04:54
scientists, medical professionals,
lawyers, patent lawyers.
lawyers, patent lawyers.
92
282588
3713
04:58
Most of them agreed that we were right
as a matter of policy,
as a matter of policy,
93
286753
3910
05:02
and, at least in theory,
as a matter of law.
as a matter of law.
94
290687
2785
05:06
All of them thought
95
294313
1155
05:07
our chances of winning
a gene-patent challenge
a gene-patent challenge
96
295492
2570
05:10
were about zero.
97
298086
1867
05:13
Why is that?
98
301628
1363
05:15
Well, the patent office
had been issuing these patents
had been issuing these patents
99
303015
3087
05:18
for more than 20 years.
100
306126
1701
05:20
There were literally thousands
of patents on human genes.
of patents on human genes.
101
308686
2880
05:24
The patent bar was deeply
entrenched in the status quo,
entrenched in the status quo,
102
312843
2941
05:28
the biotech industry had grown up
around this practice,
around this practice,
103
316581
3623
05:32
and legislation to ban gene patents
had been introduced
had been introduced
104
320228
3119
05:35
year after year in Congress,
105
323371
1398
05:36
and had gone absolutely nowhere.
106
324793
1791
05:39
So the bottom line:
107
327401
1214
05:41
courts just weren't going to be willing
to overturn these patents.
to overturn these patents.
108
329027
3175
05:44
Now, neither Chris nor I were the type
to shy away from a challenge,
to shy away from a challenge,
109
332916
4595
05:49
and hearing, "Being right
just isn't enough,"
just isn't enough,"
110
337535
3144
05:52
seemed all the more reason
to take on this fight.
to take on this fight.
111
340703
2530
05:56
So we set out to build our case.
112
344311
1935
05:59
Now, patent cases tend to be:
Company A sues Company B
Company A sues Company B
113
347494
3490
06:03
over some really narrow,
obscure technical issue.
obscure technical issue.
114
351008
3183
06:06
We weren't really interested
in that kind of case,
in that kind of case,
115
354822
2365
06:09
and we thought this case
was much bigger than that.
was much bigger than that.
116
357211
2389
06:11
This was about scientific freedom,
medical progress,
medical progress,
117
359624
2488
06:14
the rights of patients.
118
362136
1459
06:15
So we decided we were going
to develop a case
to develop a case
119
363619
3103
06:18
that was not like
your typical patent case --
your typical patent case --
120
366746
2518
06:21
more like a civil rights case.
121
369645
1882
06:24
We set out to identify
a gene-patent holder
a gene-patent holder
122
372756
2842
06:27
that was vigorously enforcing its patents
123
375622
2785
06:30
and then to organize a broad coalition
of plaintiffs and experts
of plaintiffs and experts
124
378431
3294
06:33
that could tell the court
125
381749
1890
06:35
about all the ways that these patents
were harming patients and innovation.
were harming patients and innovation.
126
383663
4389
06:41
We found the prime candidate
to sue in Myriad Genetics,
to sue in Myriad Genetics,
127
389404
3122
06:44
a company that's based
in Salt Lake City, Utah.
in Salt Lake City, Utah.
128
392550
2855
06:48
Myriad held patents on two genes,
129
396718
2250
06:50
the BRCA1 and the BRCA2 genes.
130
398992
3321
06:55
Women with certain mutations
along these genes
along these genes
131
403150
2734
06:57
are considered to be
at a significantly increased risk
at a significantly increased risk
132
405908
2626
07:00
of developing breast and ovarian cancer.
133
408558
1945
07:03
Myriad had used its patents to maintain
134
411834
1880
07:05
a complete monopoly on BRCA testing
in the United States.
in the United States.
135
413738
4209
07:10
It had forced multiple labs
that were offering BRCA testing to stop.
that were offering BRCA testing to stop.
136
418544
4188
07:14
It charged a lot of money for its test --
137
422756
2159
07:16
over 3,000 dollars.
138
424939
1683
07:19
It had stopped sharing its clinical data
139
427089
2335
07:21
with the international
scientific community.
scientific community.
140
429448
2287
07:24
And perhaps worst of all,
141
432522
1903
07:26
for a period of several years,
142
434449
2436
07:28
Myriad refused to update its test
to include additional mutations
to include additional mutations
143
436909
3713
07:32
that had been identified
by a team of researchers in France.
by a team of researchers in France.
144
440646
3621
07:36
It has been estimated
that during that period,
that during that period,
145
444974
2508
07:39
for several years,
146
447506
1373
07:40
as many as 12 percent of women
undergoing testing
undergoing testing
147
448903
3752
07:44
received the wrong answer --
148
452679
2402
07:48
a negative test result
that should have been positive.
that should have been positive.
149
456377
3769
07:53
This is Kathleen Maxian.
150
461485
1741
07:56
Kathleen's sister Eileen
developed breast cancer at age 40
developed breast cancer at age 40
151
464172
3257
07:59
and she was tested by Myriad.
152
467453
1840
08:02
The test was negative.
153
470032
1726
08:03
The family was relieved.
154
471782
1526
08:05
That meant that Eileen's cancer
most likely didn't run in the family,
most likely didn't run in the family,
155
473332
3788
08:09
and that other members of her family
didn't need to be tested.
didn't need to be tested.
156
477144
3015
08:12
But two years later,
157
480843
1230
08:14
Kathleen was diagnosed
with advanced-stage ovarian cancer.
with advanced-stage ovarian cancer.
158
482097
4060
08:18
It turned out that Kathleen's sister
was among the 12 percent
was among the 12 percent
159
486927
3872
08:22
who received a false-negative test result.
160
490823
2869
08:26
Had Eileen received the proper result,
161
494347
3089
08:29
Kathleen would have then been tested,
162
497460
2373
08:31
and her ovarian cancer
could have been prevented.
could have been prevented.
163
499857
2913
08:36
Once we settled on Myriad,
164
504818
1264
08:38
we then had to form a coalition
of plaintiffs and experts
of plaintiffs and experts
165
506106
3885
08:42
that could illuminate these problems.
166
510015
2088
08:44
We ended up with 20
highly committed plaintiffs:
highly committed plaintiffs:
167
512127
2572
08:47
genetic counselors,
168
515325
1538
08:48
geneticists who had received
cease and desist letters,
cease and desist letters,
169
516887
3359
08:52
advocacy organizations,
170
520905
1849
08:55
four major scientific organizations
that collectively represented
that collectively represented
171
523532
3065
08:58
more than 150,000 scientists
and medical professionals,
and medical professionals,
172
526621
3530
09:02
and individual women who either
couldn't afford Myriad's test,
couldn't afford Myriad's test,
173
530755
3297
09:06
or who wanted to obtain
a second opinion but could not,
a second opinion but could not,
174
534076
3004
09:09
as a result of the patents.
175
537104
1744
09:12
One of the major challenges
we had in preparing the case
we had in preparing the case
176
540315
3440
09:15
was figuring out how best
to communicate the science.
to communicate the science.
177
543779
2866
09:19
So in order to argue that what Myriad did
was not an invention,
was not an invention,
178
547079
3831
09:22
and that isolated BRCA genes
were products of nature,
were products of nature,
179
550934
3277
09:27
we had to explain a couple
of basic concepts, like:
of basic concepts, like:
180
555124
2713
09:29
What's a gene? What's DNA?
181
557861
2144
09:32
How is DNA isolated,
and why isn't that an invention?
and why isn't that an invention?
182
560029
3716
09:37
We spent hours and hours
with our plaintiffs and experts,
with our plaintiffs and experts,
183
565168
3862
09:41
trying to come up with ways
of explaining these concepts
of explaining these concepts
184
569054
2936
09:44
simply yet accurately.
185
572014
1543
09:46
And we ended up relying heavily
on the use of metaphors,
on the use of metaphors,
186
574306
3332
09:49
like gold.
187
577662
1156
09:51
So isolating DNA --
188
579789
2284
09:54
it's like extracting gold from a mountain
189
582097
2500
09:57
or taking it out of a stream bed.
190
585105
2016
09:59
You might be able to patent
the process for mining the gold,
the process for mining the gold,
191
587145
3674
10:02
but you can't patent the gold itself.
192
590843
2081
10:05
It might've taken a lot
of hard work and effort
of hard work and effort
193
593929
2743
10:08
to dig the gold out of the mountain;
194
596696
1860
10:11
you still can't patent it,
it's still gold.
it's still gold.
195
599127
2281
10:13
And the gold, once it's extracted,
196
601432
1756
10:15
can clearly be used
for all sorts of things
for all sorts of things
197
603212
2088
10:17
that it couldn't be used
for when it was in the mountain;
for when it was in the mountain;
198
605324
2736
10:20
you can make jewelry
out of it for example --
out of it for example --
199
608084
2182
10:22
still can't patent the gold,
it's still gold.
it's still gold.
200
610290
2165
10:25
So now it's 2009,
and we're ready to file our case.
and we're ready to file our case.
201
613364
3854
10:30
We filed in federal court
in the Southern District of New York,
in the Southern District of New York,
202
618286
3495
10:34
and the case was randomly assigned
to Judge Robert Sweet.
to Judge Robert Sweet.
203
622355
3366
10:38
In March 2010, Judge Sweet
issued his opinion --
issued his opinion --
204
626599
3200
10:42
152 pages --
205
630569
1858
10:44
and a complete victory for our side.
206
632834
2252
10:47
In reading the opinion,
207
635964
1431
10:49
we could not get over how eloquently
he described the science in the case.
he described the science in the case.
208
637419
4715
10:54
I mean, our brief --
it was pretty good,
it was pretty good,
209
642504
2771
10:57
but not this good.
210
645299
1567
10:59
How did he develop such a deep
understanding of this issue
understanding of this issue
211
647778
3377
11:03
in such a short time?
212
651179
1160
11:04
We just could not comprehend
how this had happened.
how this had happened.
213
652363
3608
11:07
So it turned out,
214
655995
1264
11:09
Judge Sweet's clerk
working for him at the time,
working for him at the time,
215
657283
3310
11:12
was not just a lawyer --
216
660617
1480
11:14
he was a scientist.
217
662121
1714
11:15
He was not just a scientist --
218
663859
1598
11:17
he had a PhD in molecular biology.
219
665481
3146
11:20
(Laughter)
220
668651
1751
11:22
What an incredible stroke of luck!
221
670426
2575
11:26
Myriad then appealed
222
674058
1300
11:27
to the US Court of Appeals
for the Federal Circuit.
for the Federal Circuit.
223
675382
2495
11:30
And here things got really interesting.
224
678496
2016
11:33
First, in a pivotal moment of this case,
225
681465
3060
11:37
the US government switched sides.
226
685187
2631
11:40
So in the district court the government
submitted a brief on Myriad's side.
submitted a brief on Myriad's side.
227
688739
3749
11:44
But now in direct opposition
to its own patent office,
to its own patent office,
228
692512
5128
11:49
the US government files a brief
that states that is has
that states that is has
229
697664
2708
11:52
reconsidered this issue
in light of the district court's opinion,
in light of the district court's opinion,
230
700396
3688
11:56
and has concluded that isolated DNA
is not patent eligible.
is not patent eligible.
231
704108
3186
11:59
This was a really big deal,
232
707818
1811
12:01
totally unexpected.
233
709653
1562
12:04
The Court of Appeals
for the Federal Circuit
for the Federal Circuit
234
712773
2080
12:06
hears all patent cases,
235
714877
1683
12:08
and it has a reputation for being
very, very pro-patent.
very, very pro-patent.
236
716584
3158
12:12
So even with this remarkable development,
237
720305
2426
12:14
we expected to lose.
238
722755
1679
12:16
And we did.
239
724458
1347
12:18
Sort of.
240
726389
1152
12:20
Ends up split decision, 2 to 1.
241
728357
2587
12:23
But the two judges who ruled against us,
242
731743
2496
12:26
did so for completely different reasons.
243
734263
2241
12:29
The first one, Judge Lourie,
244
737275
1826
12:31
made up his own novel,
biological theory --
biological theory --
245
739125
3015
12:34
totally wrong.
246
742164
1168
12:35
(Laughter)
247
743356
1011
12:36
He decided Myriad had created
a new chemical --
a new chemical --
248
744391
2218
12:38
made absolutely no sense.
249
746633
1865
12:40
Myriad didn't even argue this,
so it came out of the blue.
so it came out of the blue.
250
748522
2786
12:43
The other, Judge Moore,
251
751632
1977
12:45
said she basically agreed with us
that isolated DNA is a product of nature.
that isolated DNA is a product of nature.
252
753633
3878
12:49
But she's like, "I don't want
to shake up the biotech industry."
to shake up the biotech industry."
253
757987
3333
12:54
The third, Judge Bryson,
254
762248
2572
12:57
agreed with us.
255
765233
1216
12:59
So now we sought review
by the Supreme Court.
by the Supreme Court.
256
767750
2531
13:02
And when you petition the Supreme Court,
257
770305
2703
13:05
you have to present a question
that you want the Court to answer.
that you want the Court to answer.
258
773032
3122
13:08
Usually these questions take the form
of a super-long paragraph,
of a super-long paragraph,
259
776534
3727
13:12
like a whole page long
with lots and lots of clauses,
with lots and lots of clauses,
260
780285
3023
13:15
"wherein this" and "therefore that."
261
783332
2457
13:18
We submitted perhaps
the shortest question presented ever.
the shortest question presented ever.
262
786294
3907
13:23
Four words:
263
791312
1213
13:26
Are human genes patentable?
264
794220
2051
13:28
Now when Chris first asked me
what I thought of these words,
what I thought of these words,
265
796922
2824
13:31
I said, "Well, I don't know.
266
799770
1374
13:33
I think you have to say,
'Is isolated DNA patentable?'"
'Is isolated DNA patentable?'"
267
801168
3167
13:36
"Nope.
268
804968
1169
13:38
I want the justices to have
the very same reaction that I had
the very same reaction that I had
269
806487
4621
13:43
when you brought this issue
to me seven years ago."
to me seven years ago."
270
811132
3087
13:46
Well, I certainly couldn't
argue with that.
argue with that.
271
814896
2157
13:49
The Supreme Court only hears
about one percent
about one percent
272
817981
2883
13:52
of the cases that it receives,
273
820888
1666
13:54
and it agreed to hear ours.
274
822578
1591
13:57
The day of the oral argument arrives,
and it was really, really exciting --
and it was really, really exciting --
275
825772
4127
14:01
long line of people outside,
276
829923
1435
14:03
people had been standing in line
since 2:30 in the morning
since 2:30 in the morning
277
831382
2764
14:06
to try to get into the courthouse.
278
834170
1734
14:07
Two breast cancer organizations,
279
835928
1971
14:09
Breast Cancer Action and FORCE,
280
837923
1668
14:11
had organized a demonstration
on the courthouse steps.
on the courthouse steps.
281
839615
2701
14:15
Chris and I sat quietly in the hallway,
282
843232
2870
14:18
moments before he was to walk in and argue
283
846776
3014
14:21
the most important case of his career.
284
849814
2316
14:24
I was clearly more nervous than he was.
285
852765
2379
14:28
But any remaining panic subsided
as I walked into the courtroom
as I walked into the courtroom
286
856096
4760
14:32
and looked around
at a sea of friendly faces:
at a sea of friendly faces:
287
860880
2813
14:36
our individual women clients
288
864059
1765
14:37
who had shared their
deeply personal stories,
deeply personal stories,
289
865848
2441
14:41
the geneticists who had taken huge chunks
of time out of their busy careers
of time out of their busy careers
290
869210
3626
14:44
to dedicate themselves to this fight
291
872860
1825
14:47
and representatives from a diverse array
292
875122
2579
14:49
of medical, patient advocacy,
293
877725
1887
14:51
environmental and religious organizations,
294
879636
2076
14:53
who had submitted friend of the court
briefs in the case.
briefs in the case.
295
881736
3532
14:58
Also in the room were three leaders
of the Human Genome Project,
of the Human Genome Project,
296
886609
3025
15:01
including the co-discoverer
of DNA himself,
of DNA himself,
297
889658
2672
15:04
James Watson,
298
892354
1290
15:05
who had submitted a brief to the court,
299
893668
2146
15:07
where he referred
to gene patenting as "lunacy."
to gene patenting as "lunacy."
300
895838
3511
15:11
(Laughter)
301
899373
1848
15:13
The diversity of the communities
represented in this room
represented in this room
302
901245
3637
15:16
and the contributions each had made
to make this day a reality
to make this day a reality
303
904906
3441
15:20
spoke volumes to what was at stake.
304
908371
2297
15:23
The argument itself was riveting.
305
911386
2213
15:26
Chris argued brilliantly.
306
914205
1663
15:27
But for me,
307
915892
1245
15:29
the most thrilling aspect was watching
the Supreme Court justices grapple
the Supreme Court justices grapple
308
917161
3764
15:32
with isolated DNA,
309
920949
1569
15:34
through a series of colorful analogies
and feisty exchanges,
and feisty exchanges,
310
922542
3226
15:37
very much the same way
as our legal team had done
as our legal team had done
311
925792
3340
15:41
for the past seven years.
312
929156
1690
15:43
Justice Kagan likened isolating DNA
313
931666
2656
15:46
to extracting a medicinal plant
from the Amazon.
from the Amazon.
314
934346
2776
15:50
Justice Roberts distinguished it
from carving a baseball bat from a tree.
from carving a baseball bat from a tree.
315
938516
4010
15:55
And in one of my absolutely
favorite moments,
favorite moments,
316
943995
2482
15:58
Justice Sotomayor proclaimed isolated DNA
to be "just nature sitting there."
to be "just nature sitting there."
317
946501
5269
16:03
(Laughter)
318
951794
1100
16:05
We felt pretty confident
leaving the courtroom that day,
leaving the courtroom that day,
319
953318
2875
16:08
but I could never have
anticipated the outcome:
anticipated the outcome:
320
956217
3006
16:12
nine to zero.
321
960574
1507
16:15
"A naturally occurring DNA segment
is a product of nature,
is a product of nature,
322
963025
3722
16:18
and not patent-eligible merely because
it has been isolated.
it has been isolated.
323
966771
3047
16:22
And furthermore,
324
970394
1347
16:23
Myriad did not create anything."
325
971765
2545
16:28
Within 24 hours of the decision,
326
976160
1996
16:30
five labs had announced
327
978180
1392
16:31
that they would begin to offer testing
for the BRCA genes.
for the BRCA genes.
328
979596
3014
16:35
Some of them promised to offer the tests
at a lower price than Myriad's.
at a lower price than Myriad's.
329
983149
3483
16:39
Some promised to provide
a more comprehensive test
a more comprehensive test
330
987142
2920
16:42
than the one Myriad was offering.
331
990086
1683
16:44
But of course the decision
goes far beyond Myriad.
goes far beyond Myriad.
332
992490
2838
16:47
It ends a 25-year practice
of allowing patents on human genes
of allowing patents on human genes
333
995352
4396
16:51
in the United States.
334
999772
1207
16:53
It clears a significant barrier
to biomedical discovery and innovation.
to biomedical discovery and innovation.
335
1001383
4693
16:58
And it helps to ensure that patients
like Abigail, Kathleen and Eileen
like Abigail, Kathleen and Eileen
336
1006484
4901
17:03
have access to the tests that they need.
337
1011409
2156
17:06
A few weeks after the court
issued its decision,
issued its decision,
338
1014991
3215
17:10
I received a small package in the mail.
339
1018230
2260
17:13
It was from Bob Cook-Deegan,
340
1021246
1607
17:14
a professor at Duke University
341
1022877
2269
17:17
and one the very first people
Chris and I went to visit
Chris and I went to visit
342
1025170
3224
17:20
when we started to consider
whether to bring this case.
whether to bring this case.
343
1028418
2699
17:24
I opened it up to find
a small stuffed animal.
a small stuffed animal.
344
1032033
2809
17:28
(Laughter)
345
1036344
2959
17:33
We took a big risk in taking this case.
346
1041568
2328
17:36
Part of what gave us the courage
to take that risk
to take that risk
347
1044722
2510
17:39
was knowing that we were doing
the right thing.
the right thing.
348
1047256
2438
17:42
The process took nearly eight years
from the start to finish,
from the start to finish,
349
1050079
3730
17:45
with many twists and turns along the way.
350
1053833
2221
17:48
A little luck certainly helped,
351
1056578
1691
17:50
but it was the communities
that we bridged,
that we bridged,
352
1058888
2812
17:53
the alliances that we created,
353
1061724
2091
17:55
that made pigs fly.
354
1063839
1420
17:57
Thank you.
355
1065802
1156
17:58
(Applause)
356
1066982
5514
ABOUT THE SPEAKER
Tania Simoncelli - Policy expertTania 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.
Tania Simoncelli | Speaker | TED.com