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?

塔尼婭.西蒙希利: 我是如何向基因專利行業宣戰--並且贏得勝利

Filmed:
1,131,297 views

人類基因是屬於專利適格性的嗎?回到2005 年,當塔尼婭.西蒙希利(Tania Simoncelli)首次注意到這個複雜的問題時,美國專利法說它們是可以的--這意味著,專利持有者有權利阻止任何人定序、檢測甚至診斷該專利基因。法律製造出來的麻煩,不但損害了病人的利益,而且阻礙了生物醫療的創新,西蒙希利和她在 ACLU(美國公民自由聯盟)的同事挑戰這條法律。在此次精彩的演講中,我們來聽一聽他們是如何打這場所有人都說會一路輸到最高法院的精彩戰役。
- 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下午 in the fall秋季 of 2005.
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2005年秋天的一個下午,
00:17
I was working加工 at the ACLUACLU
as the organization's組織的 science科學 advisor顧問.
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我在 ACLU(美國公民自由聯盟)
擔任該組織的科學顧問,
我真的很熱愛我的工作,
00:21
I really, really loved喜愛 my job工作,
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00:24
but I was having one of those days
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但那些日子的某一天,
00:25
where I was feeling感覺
just a little bit discouraged灰心.
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我感覺有一點提不起勁,
00:29
So I wandered逛到 down the hallway門廳
to my colleague同事 Chris克里斯 Hansen's漢森 office辦公室.
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我意興闌珊地經過走廊來到
我同事 Chris Hansen 的辦公室。
Chris Hansen 在 ACLU 工作三十幾年了,
00:34
Chris克里斯 had been at the ACLUACLU
for more than 30 years年份,
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00:38
so he had deep institutional制度
knowledge知識 and insights見解.
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他對制度有相當深刻的認識和洞察。
00:41
I explained解釋 to Chris克里斯
that I was feeling感覺 a little bit stuck卡住.
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我向 Chris 解釋,
我最近感覺到有點束手無策。
我當時在調查
00:45
I had been investigating調查
a number of issues問題
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00:47
at the intersection路口 of science科學
and civil國內 liberties自由 -- super interesting有趣.
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處在科學和公民自由十字路口的
一系列問題--這超級有意思。
00:53
But I wanted the ACLUACLU to engage從事
these issues問題 in a much bigger way,
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但我希望 ACLU 能夠用
更廣泛的方式來處理這些問題,
00:56
in a way that could really
make a difference區別.
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一個真正能做出改變的方式。
所以,Chris直接切入重點,他說,
01:01
So Chris克里斯 cut right
to the chase, and he says,
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01:03
"Well, of all the issues問題 you've been
looking at, what are the top最佳 five?"
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“ 那好,就你目前觀察的問題中,
排前五名的是那些?”
“嗯,這裡面有遺傳歧視、
01:07
"Well, there's genetic遺傳 discrimination區別,
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01:10
and reproductive生殖 technologies技術,
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生殖技術
01:12
and biobanking生物樣本庫, and ...
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及生物樣本庫,還有...
01:14
oh, there's this really cool issue問題,
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哦,還有一個很酷的爭議,
01:16
functional實用 MRIMRI and using運用 it
for lie謊言 detection發現, and ...
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功能性 MRI(核磁共振),
以及用它來測謊,還有……
01:19
oh, and of course課程, there's gene基因 patents專利."
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哦,當然,還有" 基因專利 "
01:21
"Gene基因 patents專利?"
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“ 基因專利?”
“ 是的,你知道的,人類基因專利 ”
01:23
"Yes, you know, patents專利 on human人的 genes基因."
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01:26
"No!
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“ 不可能!
01:27
You're telling告訴 me that the US government政府
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你是在跟我說,美國政府
01:30
has been issuing發行 patents專利
on part部分 of the human人的 body身體?
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已經對人體的部位授予專利?
01:33
That can't be right."
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這不對吧! ”
01:35
I went back to my office辦公室
and sent發送 Chris克里斯 three articles用品.
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我回到我的辦公室,
給 Chris 發了三篇文章。
01:39
And 20 minutes分鐘 later後來,
he came來了 bursting爆破 in my office辦公室.
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20分鐘後,他衝進來我的辦公室。
01:43
"Oh my god! You're right! Who can we sue起訴?"
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“ 天哪!你是對的!我們可以告誰? ”
01:47
(Laughter笑聲)
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(笑聲)
01:49
Now Chris克里斯 is a really brilliant輝煌 lawyer律師,
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Chris 是一名傑出的律師,
01:52
but he knew知道 almost幾乎 nothing
about patent專利 law
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但是他幾乎完全不懂專利法,
01:55
and certainly當然 nothing about genetics遺傳學.
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而且肯定不懂遺傳學。
01:57
I knew知道 something about genetics遺傳學,
but I wasn't even a lawyer律師,
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我懂一點遺傳學,
但我連律師都不是,
02:00
let alone單獨 a patent專利 lawyer律師.
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更別說是個專利律師了。
02:02
So clearly明確地 we had a lot to learn學習
before we could file文件 a lawsuit訴訟.
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所以很顯然的,在打官司之前,
我們需要學很多東西。
首先,我們需要先搞懂
02:06
First, we needed需要 to understand理解
exactly究竟 what was patented專利
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當有人為基因申請專利時,
究竟是什麼被授予了專利。
02:08
when someone有人 patented專利 a gene基因.
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02:11
Gene基因 patents專利 typically一般 contain包含
dozens許多 of claims索賠,
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基因專利基本上內含了很多權利,
02:15
but the most controversial爭論的 of these
are to so-called所謂 "isolated孤立 DNA脫氧核糖核酸" --
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但是最有爭議的是
所謂的“ 離體DNA(亦稱:單離DNA) ”--
顧名思義,就是從細胞中
分離出來的 DNA 片段。
02:20
namely亦即, a piece of DNA脫氧核糖核酸
that has been removed去除 from a cell細胞.
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基因專利的支持者聲稱,
02:26
Gene基因 patent專利 proponents支持者 say,
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02:27
"See? We didn't patent專利
the gene基因 in your body身體,
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" 你看? 我們不是對你
身體中的基因申請專利,
02:30
we patented專利 an isolated孤立 gene基因."
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我們是對離體基因申請專利。 ”
02:33
And that's true真正,
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這是事實,
02:34
but the problem問題 is that any use
of the gene基因 requires要求 that it be isolated孤立.
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但問題是,任何基因上的運用,
都需要把基因分離出來。
02:42
And the patents專利 weren't just
to a particular特定 gene基因 that they isolated孤立,
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故獲取專利的部分,
並非他們分離出來的特定基因,
02:46
but on every一切 possible可能
version of that gene基因.
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而是那個基因的每個可能版本。
所以這意味著什麼?
02:50
So what does that mean?
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02:51
That means手段 that you can't give
your gene基因 to your doctor醫生
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這意味著,
你不能把你的基因給你的醫生,
02:55
and ask him or her to look at it,
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請他或她幫你檢查,
02:57
say, to see if it has any mutations突變,
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像是,檢查是否有變異,
在沒有專利持有者的同意下。
02:59
without permission允許 of the patent專利 holder持有人.
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03:02
It also means手段 that the patent專利 holder持有人
has the right to stop anyone任何人
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也就是說,專利持有者
有權利阻止任何人
03:06
from using運用 that gene基因
in research研究 or clinical臨床 testing測試.
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使用該基因從事研究或臨床試驗。
允許專利持有者
03:10
Allowing允許 patent專利 holders持有人,
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03:12
often經常 private私人的 companies公司,
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通常是私人企業,
他們閉鎖住開發人類基因組的行為
03:13
to lock up stretches舒展 of the human人的 genome基因組
was harming漢寧波 patients耐心.
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會傷害到患者的權利。
03:18
Consider考慮 Abigail阿比蓋爾,
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想一下,Abigail,
03:20
a 10-year-old-歲 with long QTQT syndrome綜合徵,
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一位10歲患有長QT綜合症的小女生,
03:22
a serious嚴重 heart condition條件 that,
if left untreated未處理,
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長QT綜合症是一種
嚴重的心臟疾病,如果不治療,
03:25
can result結果 in sudden突然 death死亡.
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可能會引發猝死。
03:28
The company公司 that obtained獲得 a patent專利 on two
genes基因 associated相關 with this condition條件
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有個公司握有兩個
與這種疾病相關基因的專利,
03:32
developed發達 a test測試 to diagnose診斷 the syndrome綜合徵.
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他們開發了一種
診斷此病症的化驗方式。
03:35
But then they went bankrupt破產者
and they never offered提供 it.
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但之後他們倒閉了,
而他們從未提供此項服務。
03:39
So another另一個 lab實驗室 tried試著 to offer提供 the test測試,
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於是另一個實驗室
嘗試提供這項化驗,
03:41
but the company公司 that held保持 the patents專利
threatened受威脅 to sue起訴 the lab實驗室
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但是持有這項專利的公司
告發那個實驗室
03:44
for patent專利 infringement侵害.
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專利侵權。
03:45
So as a result結果,
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所以,結果是,
03:46
for 2 years年份, no test測試 was available可得到.
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兩年內,沒有人提供化驗服務。
這段期間,
03:50
During that time,
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03:51
Abigail阿比蓋爾 died死亡 of undiagnosed確診 long QTQT.
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Abigail 因未診斷出
長 QT 綜合症而去世。
基因專利顯然是個問題,
並且損害患者的權利。
03:55
Gene基因 patents專利 clearly明確地 were a problem問題
and were harming漢寧波 patients耐心.
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03:59
But was there a way
we could challenge挑戰 them?
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但是我們有沒有方法
可以挑戰他們呢?
其實,最高法院
04:02
Turns out that the Supreme最高 Court法庭
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04:04
has made製作 clear明確
through通過 a long line of cases,
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透過一系列的判例,
已經清楚地表明,
04:07
that certain某些 things
are not patent專利 eligible合格.
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有些東西是不能申請專利的。
你不能對自然界中
的物質申請專利--
04:10
You can't patent專利 products製品 of nature性質 --
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04:14
the air空氣, the water, minerals礦物質,
elements分子 of the periodic定期 table.
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像是,空氣、水、礦物、
元素週期表裡的物質。
04:19
And you can't patent專利 laws法律 of nature性質 --
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你也不能對自然法則申請專利--
04:22
the law of gravity重力, E = mcMC2.
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像是萬有引力公式 E=mc2。
04:24
These things are just too fundamental基本的
and must必須 remain free自由 to all
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這些東西太基本了,
必須對所有人保持免費,
04:29
and reserved保留的 exclusively to none沒有.
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且不能被任何人獨自佔有。
04:32
It seemed似乎 to us that DNA脫氧核糖核酸,
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DNA 對我們而言,
04:34
the most fundamental基本的 structure結構體 of life,
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像是生命最本質的結構,
04:37
that codes代碼 for the production生產
of all of our proteins蛋白質,
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它對我們所有的蛋白質產物編碼,
04:39
is both a product產品 of nature性質
and a law of nature性質,
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既是自然界的物質,
也是自然的法則,
04:42
regardless而不管 of whether是否 it's in our bodies身體
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無論它是在我們的體內,
04:45
or sitting坐在 in the bottom底部 of a test測試 tube.
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或是沉在一根試管底部。
我們不斷深入這個問題,
04:48
As we delved鑽研 into this issue問題,
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04:50
we traveled旅行 all over the country國家
to speak說話 with many許多 different不同 experts專家 --
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我們飛到全國各地,
和許多不同的專家談話--
科學家、醫療專家、律師、專利律師。
04:54
scientists科學家們, medical professionals專業人士,
lawyers律師, patent專利 lawyers律師.
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絕大多數都同意,
在政策層面我們是正確的,
04:58
Most of them agreed約定 that we were right
as a matter of policy政策,
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05:02
and, at least最小 in theory理論,
as a matter of law.
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並且在法律層面,
至少在理論上是正確的。
但他們全都認為
05:06
All of them thought
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05:07
our chances機會 of winning勝利
a gene-patent基因專利 challenge挑戰
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我們挑戰基因專利贏的機率
05:10
were about zero.
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幾乎是零。
05:13
Why is that?
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為什麼呢?
05:15
Well, the patent專利 office辦公室
had been issuing發行 these patents專利
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好吧,因為專利局核發這些專利
05:18
for more than 20 years年份.
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已經超過 20 年了,
05:20
There were literally按照字面 thousands數千
of patents專利 on human人的 genes基因.
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的確已經有數千個人類基因專利。
05:24
The patent專利 bar酒吧 was deeply
entrenched根深蒂固 in the status狀態 quo現狀,
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專利的測驗評量已行之有年,
05:28
the biotech生物技術 industry行業 had grown長大的 up
around this practice實踐,
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生物科技產業在這個
機制下蓬勃發展,
05:32
and legislation立法 to ban禁止 gene基因 patents專利
had been introduced介紹
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立法禁止基因專利的提案
每年都會在國會被提出來審議,
05:35
year after year in Congress國會,
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05:36
and had gone走了 absolutely絕對 nowhere無處.
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但已經不知道被丟到哪裡去了。
05:39
So the bottom底部 line:
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所以底線是:
法院就是沒有意願
去推翻這些專利。
05:41
courts法院 just weren't going to be willing願意
to overturn顛覆 these patents專利.
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現在,無論是 Chris 或我
都不是那種臨陣脫逃的人,
05:44
Now, neither也不 Chris克里斯 nor也不 I were the type類型
to shy害羞 away from a challenge挑戰,
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05:49
and hearing聽力, "Being存在 right
just isn't enough足夠,"
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而且聽到“正確又能何哉”,
05:52
seemed似乎 all the more reason原因
to take on this fight鬥爭.
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更激起我們奮戰的理由。
05:56
So we set out to build建立 our case案件.
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所以,我們打算建立
我們的訴訟方式,
05:59
Now, patent專利 cases tend趨向 to be:
Company公司 A sues起訴 Company公司 B
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現在,專利訴訟法案通常是:
A公司告B公司,
06:03
over some really narrow狹窄,
obscure朦朧 technical技術 issue問題.
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總是在一些非常狹隘、
晦澀的技術問題上打轉,
我們對這類的問題真的不感興趣,
06:06
We weren't really interested有興趣
in that kind of case案件,
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06:09
and we thought this case案件
was much bigger than that.
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而且我們認為這個案件
要比那些重大得多。
06:11
This was about scientific科學 freedom自由,
medical progress進展,
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這個案件關乎
科學自由、醫療進步、
06:14
the rights權利 of patients耐心.
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病患權利。
06:15
So we decided決定 we were going
to develop發展 a case案件
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所以,所以我們決定我們要做的,
06:18
that was not like
your typical典型 patent專利 case案件 --
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和你通常看到的專利官司不同--
06:21
more like a civil國內 rights權利 case案件.
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它更像是公民權利的官司。
06:24
We set out to identify鑑定
a gene-patent基因專利 holder持有人
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我們打算去找一位
強硬推行它的專利的
06:27
that was vigorously大力 enforcing強制執行 its patents專利
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這樣一個基因專利持有者,
06:30
and then to organize組織 a broad廣闊 coalition聯盟
of plaintiffs原告 and experts專家
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然後組織一個原告和專家的大聯盟,
06:33
that could tell the court法庭
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去告訴法院
06:35
about all the ways方法 that these patents專利
were harming漢寧波 patients耐心 and innovation革新.
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這些專利損害病人
並阻礙創新的種種劣跡。
我們發現 Myriad Genetics
可以作為我們要告發的主要目標,
06:41
We found發現 the prime主要 candidate候選人
to sue起訴 in Myriad無數的 Genetics遺傳學,
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06:44
a company公司 that's based基於
in Salt Lake City, Utah猶他州.
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這是一家總部設在
猶他州鹽湖城的公司,
Myriad 這家公司持有兩個基因專利,
06:48
Myriad無數的 held保持 patents專利 on two genes基因,
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06:50
the BRCABRCA1 and the BRCABRCA2 genes基因.
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分別是 BRCA1 和 BRCA2 基因,
攜帶有這兩個基因某些變種的女性,
06:55
Women婦女 with certain某些 mutations突變
along沿 these genes基因
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06:57
are considered考慮 to be
at a significantly顯著 increased增加 risk風險
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罹患乳腺癌和卵巢癌
07:00
of developing發展 breast乳房 and ovarian卵巢 cancer癌症.
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的風險會顯著升高。
07:03
Myriad無數的 had used its patents專利 to maintain保持
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Myriad 利用這項專利來維持
07:05
a complete完成 monopoly壟斷 on BRCABRCA testing測試
in the United聯合的 States狀態.
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在美國境內 BRCA 檢測市場
的完全壟斷地位。
07:10
It had forced被迫 multiple labs實驗室
that were offering BRCABRCA testing測試 to stop.
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它迫使多個提供 BRCA 測試
的實驗室停止這項服務。
07:14
It charged帶電 a lot of money for its test測試 --
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它收取相當昂貴的檢測費用--
07:16
over 3,000 dollars美元.
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超過3,000美金。
07:19
It had stopped停止 sharing分享 its clinical臨床 data數據
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它已經停止與國際科學界
07:21
with the international國際
scientific科學 community社區.
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共享它的臨床數據。
以及可能最糟糕的,
07:24
And perhaps也許 worst最差 of all,
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07:26
for a period of several一些 years年份,
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曾經有幾年,
07:28
Myriad無數的 refused拒絕 to update更新 its test測試
to include包括 additional額外 mutations突變
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Myriad 公司拒絕在他們的檢測中更新
07:32
that had been identified確定
by a team球隊 of researchers研究人員 in France法國.
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已被法國一個研究團隊
鑑別出來的其他變種數據,
07:36
It has been estimated預計
that during that period,
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據估計,在此期間,
07:39
for several一些 years年份,
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有數年,
07:40
as many許多 as 12 percent百分 of women婦女
undergoing經歷 testing測試
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將近12%的婦女進行的測試
07:44
received收到 the wrong錯誤 answer回答 --
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得到了錯誤檢測結果--
07:48
a negative test測試 result結果
that should have been positive.
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原本陽性反應卻被檢測成
陰性反應(假陰性)。
07:53
This is Kathleen凱瑟琳 Maxian麻線.
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這位是 Kathleen Maxian,
07:56
Kathleen's凱瑟琳的 sister妹妹 Eileen艾琳
developed發達 breast乳房 cancer癌症 at age年齡 40
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Kathleen 的姊姊在40歲時得到乳腺癌,
她是找 Myriad 檢測的。
07:59
and she was tested測試 by Myriad無數的.
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08:02
The test測試 was negative.
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測試結果是呈現陰性,
08:03
The family家庭 was relieved安心.
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家人如釋重負,
08:05
That meant意味著 that Eileen's艾琳的 cancer癌症
most likely容易 didn't run in the family家庭,
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這說明艾琳的癌症
很可能不會在家族中重現。
08:09
and that other members會員 of her family家庭
didn't need to be tested測試.
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其他的家族成員
也不需要再接受檢驗。
但,二年後,
08:12
But two years年份 later後來,
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08:14
Kathleen凱瑟琳 was diagnosed確診
with advanced-stage晚期 ovarian卵巢 cancer癌症.
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Kathleen 被診斷出卵巢癌末期,
08:18
It turned轉身 out that Kathleen's凱瑟琳的 sister妹妹
was among其中 the 12 percent百分
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原來卡瑟琳的姐姐就是那12%
08:22
who received收到 a false-negative假陰性 test測試 result結果.
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得到了假陰性結果的病人之一。
08:26
Had Eileen艾琳 received收到 the proper正確 result結果,
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Eileen 如果得到正確的結果,
08:29
Kathleen凱瑟琳 would have then been tested測試,
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Kathleen 就會去做化驗,
08:31
and her ovarian卵巢 cancer癌症
could have been prevented防止.
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那她的卵巢癌就可以被提早預防,
我們確定目標為 Myriad 後,
08:36
Once一旦 we settled安定 on Myriad無數的,
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08:38
we then had to form形成 a coalition聯盟
of plaintiffs原告 and experts專家
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我們需要組建一個
08:42
that could illuminate照亮 these problems問題.
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能夠陳述這些問題的原告和專家團。
08:44
We ended結束 up with 20
highly高度 committed提交 plaintiffs原告:
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我們找到了 20 位非常積極的原告:
遺傳學顧問、
08:47
genetic遺傳 counselors心理諮詢師,
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08:48
geneticists遺傳學家 who had received收到
cease停止 and desist斷念 letters,
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曾經收到停止和終止信函的遺傳學家、
理念相同的組織、
08:52
advocacy擁護 organizations組織,
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08:55
four major重大的 scientific科學 organizations組織
that collectively represented代表
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四個主要科學組織,集中起來代表了
08:58
more than 150,000 scientists科學家們
and medical professionals專業人士,
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超過 15 萬名科學工作者和醫療專家,
09:02
and individual個人 women婦女 who either
couldn't不能 afford給予 Myriad'sMyriad的 test測試,
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及幾位無力負擔 Myriad 檢測的各別女性,
09:06
or who wanted to obtain獲得
a second第二 opinion意見 but could not,
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或者因為此專利的關係,
想要獲得其它醫學意見,但無法取得的人。
09:09
as a result結果 of the patents專利.
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09:12
One of the major重大的 challenges挑戰
we had in preparing準備 the case案件
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我們準備訴訟時其中一個最大挑戰是
09:15
was figuring盤算 out how best最好
to communicate通信 the science科學.
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要找出如何用最佳的方式來闡述科學。
09:19
So in order訂購 to argue爭論 that what Myriad無數的 did
was not an invention發明,
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所以為了辯明 Myriad 所為並不是發明,
09:22
and that isolated孤立 BRCABRCA genes基因
were products製品 of nature性質,
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分離出來的 BRCA 基因是自然的產物,
我們得舉例解釋這些基本概念,像是:
09:27
we had to explain說明 a couple一對
of basic基本 concepts概念, like:
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09:29
What's a gene基因? What's DNA脫氧核糖核酸?
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基因是什麼?DNA 是什麼?
09:32
How is DNA脫氧核糖核酸 isolated孤立,
and why isn't that an invention發明?
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DNA要如何被分離?
為什這個東西不是發明?
我們和原告和專家團花了很多時間,
09:37
We spent花費 hours小時 and hours小時
with our plaintiffs原告 and experts專家,
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09:41
trying to come up with ways方法
of explaining說明 these concepts概念
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嘗試地想出一些簡單又精確的方法
09:44
simply只是 yet然而 accurately準確.
185
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來解釋這些概念。
09:46
And we ended結束 up relying依托 heavily嚴重
on the use of metaphors隱喻,
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最後我們相當倚賴用比喻的方式,
09:49
like gold.
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像是黃金,
所以分離 DNA--
09:51
So isolating隔離 DNA脫氧核糖核酸 --
188
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09:54
it's like extracting提取 gold from a mountain
189
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像是從山裡挖出黃金,
09:57
or taking服用 it out of a stream bed.
190
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2016
或是從河床裡掏出黃金。
09:59
You might威力 be able能夠 to patent專利
the process處理 for mining礦業 the gold,
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你或許可以為採集黃金
的流程申請專利,
10:02
but you can't patent專利 the gold itself本身.
192
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2081
但你不能把黃金本身申請專利。
10:05
It might've可能已經 taken採取 a lot
of hard work and effort功夫
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從山裡面開採黃金也許
10:08
to dig the gold out of the mountain;
194
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1860
需要花很大的功夫及心力;
10:11
you still can't patent專利 it,
it's still gold.
195
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2281
但你仍舊不能把黃金申請專利,
黃金還是黃金。
10:13
And the gold, once一旦 it's extracted提取,
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而黃金,一旦被萃取出來,
10:15
can clearly明確地 be used
for all sorts排序 of things
197
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顯然可以被用於各種
10:17
that it couldn't不能 be used
for when it was in the mountain;
198
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2736
它埋在山中時不能實現的用途;
10:20
you can make jewelry首飾
out of it for example --
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2182
例如,你可以把它製成珠寶飾品--
10:22
still can't patent專利 the gold,
it's still gold.
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2165
但仍然不能把黃金申請專利,
它仍然是黃金。
10:25
So now it's 2009,
and we're ready準備 to file文件 our case案件.
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2009年,我們準備遞交我們的案件,
10:30
We filed提交 in federal聯邦 court法庭
in the Southern南部的 District of New York紐約,
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我們遞交到紐約南區的聯邦法院,
10:34
and the case案件 was randomly隨機 assigned分配
to Judge法官 Robert羅伯特 Sweet.
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3366
案件被隨機指派到
一位 Robert Sweet 法官,
2010年3月Sweet法官發表他的看法--
10:38
In March遊行 2010, Judge法官 Sweet
issued發行 his opinion意見 --
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152頁--
10:42
152 pages網頁 --
205
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對我們這邊完全有利,
10:44
and a complete完成 victory勝利 for our side.
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10:47
In reading the opinion意見,
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在閱讀他的看法時,
10:49
we could not get over how eloquently雄辯地
he described描述 the science科學 in the case案件.
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我們搞不懂,他在描述科學時
怎麼那麼頭頭是道,
10:54
I mean, our brief簡要 --
it was pretty漂亮 good,
209
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2771
我的意思是,我們的聲明--已經相當不錯,
10:57
but not this good.
210
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1567
但沒他的好,
他是如何在這樣的短時間內
10:59
How did he develop發展 such這樣 a deep
understanding理解 of this issue問題
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建立出對這此議題這麼深厚的認知?
11:03
in such這樣 a short time?
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11:04
We just could not comprehend理解
how this had happened發生.
213
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3608
我們真的無法理解這是怎麼發生的。
11:07
So it turned轉身 out,
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原來,
11:09
Judge法官 Sweet's甜的 clerk書記
working加工 for him at the time,
215
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當時 Sweet 法官底下的書記員
不僅是位律師--
11:12
was not just a lawyer律師 --
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11:14
he was a scientist科學家.
217
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也是位科學家,
11:15
He was not just a scientist科學家 --
218
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且不僅是科學家,
11:17
he had a PhD博士 in molecular分子 biology生物學.
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他還有分子生物學的博士學位,
11:20
(Laughter笑聲)
220
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1751
(笑聲)
11:22
What an incredible難以置信 stroke行程 of luck運氣!
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真是太幸運了!
Myriad 隨後上訴到
11:26
Myriad無數的 then appealed上訴
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1300
11:27
to the US Court法庭 of Appeals上訴
for the Federal聯邦 Circuit電路.
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2495
美國聯邦巡迴上訴法院。
11:30
And here things got really interesting有趣.
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然後事情就變得非常有意思了。
11:33
First, in a pivotal關鍵的 moment時刻 of this case案件,
225
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首先,本案中的一個關鍵時刻,
11:37
the US government政府 switched交換的 sides雙方.
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2631
美國政府倒戈了,
11:40
So in the district court法庭 the government政府
submitted提交 a brief簡要 on Myriad'sMyriad的 side.
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3749
在地方法院上,政府遞交了
一份簡述支持 Myriad。
11:44
But now in direct直接 opposition反對
to its own擁有 patent專利 office辦公室,
228
692512
5128
但是這回美國政府
直接反對它自己的專利局,
11:49
the US government政府 files a brief簡要
that states狀態 that is has
229
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2708
美國政府發了一個簡短的聲明,
11:52
reconsidered重新考慮 this issue問題
in light of the district court's法院 opinion意見,
230
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3688
他們基於地區法庭的判決,
已重新考慮了問題,
11:56
and has concluded總結 that isolated孤立 DNA脫氧核糖核酸
is not patent專利 eligible合格.
231
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3186
並總結出" 離體DNA "
不具備專利適格性,
這簡直是大逆轉,
11:59
This was a really big deal合同,
232
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1811
12:01
totally完全 unexpected意外.
233
709653
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完全意想不到。
聯邦巡迴上訴法院
12:04
The Court法庭 of Appeals上訴
for the Federal聯邦 Circuit電路
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聽審過所有的專利官司,
12:06
hears就听 all patent專利 cases,
235
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1683
12:08
and it has a reputation聲譽 for being存在
very, very pro-patent親專利.
236
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3158
它傾向專利的看法非常出名。
12:12
So even with this remarkable卓越 development發展,
237
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所以即使有這個卓越的發展,
12:14
we expected預期 to lose失去.
238
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1679
我們仍預測應該會敗訴。
12:16
And we did.
239
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1347
而我們真的敗訴了,
12:18
Sort分類 of.
240
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1152
在某種程度上啦...
12:20
Ends up split分裂 decision決定, 2 to 1.
241
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2587
最後,非一致性判定,兩票對一票
12:23
But the two judges法官 who ruled統治 against反對 us,
242
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2496
但那兩個做出不利於我們判定的法官,
12:26
did so for completely全然 different不同 reasons原因.
243
734263
2241
卻持完全不同的理由,
第一位 Lourie 法官,
12:29
The first one, Judge法官 LourieLourie,
244
737275
1826
12:31
made製作 up his own擁有 novel小說,
biological生物 theory理論 --
245
739125
3015
編造了他自己的新生物理論--
12:34
totally完全 wrong錯誤.
246
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1168
完全是胡說八道。
12:35
(Laughter笑聲)
247
743356
1011
(笑聲)
12:36
He decided決定 Myriad無數的 had created創建
a new chemical化學 --
248
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2218
他判定 Myriad 創造了一個新的化學成份--
12:38
made製作 absolutely絕對 no sense.
249
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1865
完全不合理。
12:40
Myriad無數的 didn't even argue爭論 this,
so it came來了 out of the blue藍色.
250
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2786
Myriad 本身甚至不曾如此聲稱,
完全意想不到。
12:43
The other, Judge法官 Moore穆爾,
251
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1977
另一位法官,Moore,
12:45
said she basically基本上 agreed約定 with us
that isolated孤立 DNA脫氧核糖核酸 is a product產品 of nature性質.
252
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3878
她說,她完全同意
離體 DNA 屬於自然界的產物。
12:49
But she's like, "I don't want
to shake up the biotech生物技術 industry行業."
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3333
但她說," 我並不想要撼動生物科技界 "
第三位 Bryson 法官,
12:54
The third第三, Judge法官 Bryson布賴森,
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12:57
agreed約定 with us.
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認同我們。
12:59
So now we sought追捧 review評論
by the Supreme最高 Court法庭.
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所以,我們上訴到最高法院,
13:02
And when you petition請願 the Supreme最高 Court法庭,
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當你上訴到最高法院時,
13:05
you have to present當下 a question
that you want the Court法庭 to answer回答.
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你需要提出一個
你希望法院回應的問題。
13:08
Usually平時 these questions問題 take the form形成
of a super-long超長 paragraph,
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通常,這些問題都是
落落長的問句,
13:12
like a whole整個 page long
with lots and lots of clauses條款,
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像是一整頁很多很多子句、
13:15
"wherein其中, this" and "therefore因此 that."
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“是否就在”、“因此那樣”的問題,
13:18
We submitted提交 perhaps也許
the shortest最短 question presented呈現 ever.
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我們提交了可能是
有史以來最短的問題。
13:23
Four words:
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四個詞:
Are human genes patentable?
(人類基因可以專利化嗎?)
13:26
Are human人的 genes基因 patentable申請專利?
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13:28
Now when Chris克里斯 first asked me
what I thought of these words,
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當 Chris 第一次問我對這幾個字的想法時,
13:31
I said, "Well, I don't know.
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我說," 我不知道 ,
13:33
I think you have to say,
'Is'是 isolated孤立 DNA脫氧核糖核酸 patentable申請專利?'"
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我認為你應該要說,
’離體DNA是可以專利化的嗎?’ "
13:36
"Nope.
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"不,
13:38
I want the justices法官 to have
the very same相同 reaction反應 that I had
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我希望大法官的反應能和我在七年前
13:43
when you brought this issue問題
to me seven years年份 ago."
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你問我這個問題時一模一樣。 ”
13:46
Well, I certainly當然 couldn't不能
argue爭論 with that.
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好吧,我當然不能反駁。
13:49
The Supreme最高 Court法庭 only hears就听
about one percent百分
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最高法院只受理大約 1%
13:52
of the cases that it receives收到,
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它所收到的案件,
13:54
and it agreed約定 to hear ours我們的.
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1591
而法院同意要聽審我們的。
13:57
The day of the oral口服 argument論據 arrives到達,
and it was really, really exciting扣人心弦 --
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825772
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口頭辯論的那天到來,
這真的是相當刺激--
14:01
long line of people outside,
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外面排了很多人,
14:03
people had been standing常設 in line
since以來 2:30 in the morning早上
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有人凌晨兩點半就來排隊,
14:06
to try to get into the courthouse法院.
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就為了要擠進法庭。
14:07
Two breast乳房 cancer癌症 organizations組織,
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1971
兩個乳腺癌組織,
14:09
Breast乳房 Cancer癌症 Action行動 and FORCE,
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乳腺癌行動組織和 FORCE,
14:11
had organized有組織的 a demonstration示範
on the courthouse法院 steps腳步.
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839615
2701
在法庭台階上組織了抗議行動,
14:15
Chris克里斯 and I satSAT quietly悄悄 in the hallway門廳,
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843232
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Chris 和我靜靜地坐在走廊上,
在他步入法庭
14:18
moments瞬間 before he was to walk步行 in and argue爭論
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3014
並為他職業生涯中最重要的案件辯護之前,
14:21
the most important重要 case案件 of his career事業.
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14:24
I was clearly明確地 more nervous緊張 than he was.
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我很明顯地比他還緊張,
14:28
But any remaining其餘 panic恐慌 subsided消退
as I walked into the courtroom法庭
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856096
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但所以有的恐懼就在我
步入法庭時消失殆盡,
14:32
and looked看著 around
at a sea of friendly友善 faces面孔:
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860880
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環顧四週都是孰悉的面孔:
我們的各別女性客戶,
14:36
our individual個人 women婦女 clients客戶
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864059
1765
14:37
who had shared共享 their
deeply personal個人 stories故事,
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在庭上訴說著切身的故事,
14:41
the geneticists遺傳學家 who had taken採取 huge巨大 chunks
of time out of their busy careers職業生涯
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還有在百忙之中抽出大量時間
奉獻在這場戰役的遺傳學家,
14:44
to dedicate奉獻 themselves他們自己 to this fight鬥爭
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1825
14:47
and representatives代表 from a diverse多種 array排列
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還有來自許多不同領域的代表:
14:49
of medical, patient患者 advocacy擁護,
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醫療、患者救助、
14:51
environmental環境的 and religious宗教 organizations組織,
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2076
環保和宗教組織,
14:53
who had submitted提交 friend朋友 of the court法庭
briefs內褲 in the case案件.
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3532
本案中向法院遞交陳情書的朋友。
同在法庭內的還有
三位人類基因組計劃的領導者,
14:58
Also in the room房間 were three leaders領導者
of the Human人的 Genome基因組 Project項目,
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15:01
including包含 the co-discoverer共同發現者
of DNA脫氧核糖核酸 himself他自己,
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包括DNA的共同發現者本人,
15:04
James詹姆士 Watson沃森,
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James Watson,
15:05
who had submitted提交 a brief簡要 to the court法庭,
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他也遞交了陳情書,
15:07
where he referred簡稱
to gene基因 patenting專利 as "lunacy瘋狂行為."
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他指出把基因專利是"瘋子行為”。
15:11
(Laughter笑聲)
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899373
1848
(笑聲)
15:13
The diversity多樣 of the communities社區
represented代表 in this room房間
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法庭中出席群體的廣度,
15:16
and the contributions捐款 each had made製作
to make this day a reality現實
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3441
以及他們每一位為實現
這一天而做出的貢獻
15:20
spoke volumes to what was at stake賭注.
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908371
2297
讓我們的聲勢壯大了許多。
15:23
The argument論據 itself本身 was riveting.
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辯論主體非常的精彩。
15:26
Chris克里斯 argued爭論 brilliantly出色.
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Chris 辯論地相當出色,
15:27
But for me,
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但對我而言,
15:29
the most thrilling驚險 aspect方面 was watching觀看
the Supreme最高 Court法庭 justices法官 grapple抓鉤
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917161
3764
最激烈的戰況是,看著最高法院的大法官
為離體DNA激烈爭論,
15:32
with isolated孤立 DNA脫氧核糖核酸,
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920949
1569
15:34
through通過 a series系列 of colorful華美 analogies類比
and feisty易怒的 exchanges交流,
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922542
3226
透過一系列精彩的比喻
及精力充沛的交叉辯論,
15:37
very much the same相同 way
as our legal法律 team球隊 had doneDONE
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925792
3340
就和我們法律團隊過去七年
15:41
for the past過去 seven years年份.
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929156
1690
所做過的演練如出一轍。
15:43
Justice正義 Kagan卡根 likened比喻 isolating隔離 DNA脫氧核糖核酸
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931666
2656
Kagan 法官把離體DNA比喻成
15:46
to extracting提取 a medicinal藥用 plant
from the Amazon亞馬遜.
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934346
2776
從亞馬遜森林中提取醫療植物。
Roberts 法官把它比喻作
把樹木雕成棒球棒。
15:50
Justice正義 Roberts羅伯茨 distinguished傑出的 it
from carving雕刻 a baseball棒球 bat蝙蝠 from a tree.
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938516
4010
而絕對是我最喜歡的一個瞬間是,
15:55
And in one of my absolutely絕對
favorite喜愛 moments瞬間,
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943995
2482
15:58
Justice正義 Sotomayor索托馬約爾 proclaimed宣稱的 isolated孤立 DNA脫氧核糖核酸
to be "just nature性質 sitting坐在 there."
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946501
5269
Sotomayor法官宣布
離體DNA "就是自然存在那裡"
16:03
(Laughter笑聲)
318
951794
1100
(笑聲)
我們那天離開法院時
感覺相當有信心,
16:05
We felt pretty漂亮 confident信心
leaving離開 the courtroom法庭 that day,
319
953318
2875
16:08
but I could never have
anticipated預期 the outcome結果:
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956217
3006
但令我意想不到的結局竟是:
16:12
nine to zero.
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960574
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九比零。
16:15
"A naturally自然 occurring發生 DNA脫氧核糖核酸 segment分割
is a product產品 of nature性質,
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963025
3722
"一段自然形成的DNA片段
是自然界的產物,
16:18
and not patent-eligible專利資格 merely僅僅 because
it has been isolated孤立.
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3047
並不能因為它被分離出體外
就可以授予專利。
16:22
And furthermore此外,
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另外,
16:23
Myriad無數的 did not create創建 anything."
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Myriad 並沒有創造任何東西。 ”
16:28
Within 24 hours小時 of the decision決定,
326
976160
1996
判決後 24 小時內,
16:30
five labs實驗室 had announced公佈
327
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五個實驗室宣布
16:31
that they would begin開始 to offer提供 testing測試
for the BRCABRCA genes基因.
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3014
他們將開始提供 BRCA 基因的檢驗服務。
16:35
Some of them promised許諾 to offer提供 the tests測試
at a lower降低 price價錢 than Myriad'sMyriad的.
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983149
3483
他們有些承諾檢驗的價格
會比 Myriad 的還低。
16:39
Some promised許諾 to provide提供
a more comprehensive全面 test測試
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987142
2920
有些承諾將提供更全面的檢測,
16:42
than the one Myriad無數的 was offering.
331
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1683
比 Myriad 提供的更多。
16:44
But of course課程 the decision決定
goes far beyond Myriad無數的.
332
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2838
不過這個判決遠遠不止影響了 Myriad,
16:47
It ends結束 a 25-year-年 practice實踐
of allowing允許 patents專利 on human人的 genes基因
333
995352
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它還終結了美國境內 25 年來
允許授予人類基因專利的行為。
16:51
in the United聯合的 States狀態.
334
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16:53
It clears清零 a significant重大 barrier屏障
to biomedical生物醫藥 discovery發現 and innovation革新.
335
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它為生物醫療的發現和創新
掃除了一個重要的障礙。
16:58
And it helps幫助 to ensure確保 that patients耐心
like Abigail阿比蓋爾, Kathleen凱瑟琳 and Eileen艾琳
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4901
它也有助於保證像 Abigail,、
Kathleen 和 Eileen 這樣的患者
17:03
have access訪問 to the tests測試 that they need.
337
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能夠獲得她們需要的檢測。
17:06
A few少數 weeks after the court法庭
issued發行 its decision決定,
338
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3215
最高法院宣判判決幾週後,
17:10
I received收到 a small package in the mail郵件.
339
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2260
我在信箱收到了一個郵件小包,
17:13
It was from Bob短發 Cook-Deegan庫克 - 迪根,
340
1021246
1607
是一位杜克大學教授
17:14
a professor教授 at Duke公爵 University大學
341
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2269
Bob Cook-Deegan 寄來的,
17:17
and one the very first people
Chris克里斯 and I went to visit訪問
342
1025170
3224
他是我和 Chris 開始考慮
是否要接下此案時
17:20
when we started開始 to consider考慮
whether是否 to bring帶來 this case案件.
343
1028418
2699
第一個拜訪的人,
17:24
I opened打開 it up to find
a small stuffed填充的 animal動物.
344
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2809
我把它打開,發現裡面
是一個小小的毛絨動物。
17:28
(Laughter笑聲)
345
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2959
(笑聲)
17:33
We took a big risk風險 in taking服用 this case案件.
346
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2328
我們冒了很大的風險接下這個案件,
而給予我們勇氣面對風險的部分原因是
17:36
Part部分 of what gave us the courage勇氣
to take that risk風險
347
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2510
17:39
was knowing會心 that we were doing
the right thing.
348
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2438
我們知道我們在做對的事情。
17:42
The process處理 took nearly幾乎 eight years年份
from the start開始 to finish,
349
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3730
從開始到結束,整個過程將近八年,
17:45
with many許多 twists曲折 and turns along沿 the way.
350
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2221
這一路走來相當的曲折。
17:48
A little luck運氣 certainly當然 helped幫助,
351
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1691
當然有一點運氣的幫忙,
17:50
but it was the communities社區
that we bridged橋接,
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2812
但,是我們搭建的社群、
17:53
the alliances聯盟 that we created創建,
353
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2091
是我們創造的聯盟,
17:55
that made製作 pigs fly.
354
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1420
讓不可能變成可能。
17:57
Thank you.
355
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謝謝。
17:58
(Applause掌聲)
356
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(掌聲)
Translated by Yi-Fan Yu
Reviewed by Coco Shen

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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