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
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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。
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.
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2005年秋天的一個下午，
00:17
I was working at the ACLU
as the organization's science advisor.
as the organization's science advisor.
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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，
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 my job,
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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
just a little bit discouraged.
just a little bit discouraged.
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我感覺有一點提不起勁，
00:29
So I wandered down the hallway
to my colleague Chris Hansen's office.
to my colleague Chris Hansen's office.
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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。
我同事 Chris Hansen 的辦公室。
Chris Hansen 在 ACLU 工作三十幾年了，
00:34
Chris had been at the ACLU
for more than 30 years,
for more than 30 years,
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00:38
so he had deep institutional
knowledge and insights.
knowledge and insights.
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他對制度有相當深刻的認識和洞察。
00:41
I explained to Chris
that I was feeling a little bit stuck.
that I was feeling a little bit stuck.
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我向 Chris 解釋，
我最近感覺到有點束手無策。
我最近感覺到有點束手無策。
我當時在調查
00:45
I had been investigating
a number of issues
a number of issues
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00:47
at the intersection of science
and civil liberties -- super interesting.
and civil liberties -- super interesting.
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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。
一系列問題--這超級有意思。
00:53
But I wanted the ACLU to engage
these issues in a much bigger way,
these issues 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，
更廣泛的方式來處理這些問題，
00:56
in a way that could really
make a difference.
make a difference.
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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 cut right
to the chase, and he says,
to the chase, and he says,
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01:03
"Well, of all the issues you've been
looking at, what are the top five?"
looking at, what are the top 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？”
排前五名的是那些？”
“嗯，這裡面有遺傳歧視、
01:07
"Well, there's genetic discrimination,
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01:10
and reproductive technologies,
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生殖技術
01:12
and biobanking, and ...
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及生物樣本庫，還有...
01:14
oh, there's this really cool issue,
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哦，還有一個很酷的爭議，
01:16
functional MRI and using it
for lie detection, and ...
for lie detection, and ...
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功能性 MRI（核磁共振），
以及用它來測謊，還有……
以及用它來測謊，還有……
01:19
oh, and of course, there's gene patents."
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哦，當然，還有" 基因專利 "
01:21
"Gene patents?"
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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 on human genes."
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01:26
"No!
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“ 不可能！
01:27
You're telling me that the US government
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你是在跟我說，美國政府
01:30
has been issuing patents
on part of the human body?
on part of the human body?
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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
and sent Chris three articles.
and sent Chris three articles.
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我回到我的辦公室，
給 Chris 發了三篇文章。
給 Chris 發了三篇文章。
01:39
And 20 minutes later,
he came bursting in my office.
he came bursting in my office.
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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?"
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“ 天哪！你是對的！我們可以告誰？ ”
01:47
(Laughter)
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（笑聲）
01:49
Now Chris is a really brilliant lawyer,
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Chris 是一名傑出的律師，
01:52
but he knew almost nothing
about patent law
about patent law
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但是他幾乎完全不懂專利法，
01:55
and certainly nothing about genetics.
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而且肯定不懂遺傳學。
01:57
I knew something about genetics,
but I wasn't even a lawyer,
but I wasn't even a lawyer,
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我懂一點遺傳學，
但我連律師都不是，
但我連律師都不是，
02:00
let alone a patent lawyer.
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更別說是個專利律師了。
02:02
So clearly we had a lot to learn
before we could file a lawsuit.
before we could file a lawsuit.
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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。
我們需要學很多東西。
首先，我們需要先搞懂
02:06
First, we needed to understand
exactly what was patented
exactly what was patented
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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。
究竟是什麼被授予了專利。
02:08
when someone patented a gene.
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02:11
Gene patents typically contain
dozens of claims,
dozens of claims,
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基因專利基本上內含了很多權利，
02:15
but the most controversial of these
are to so-called "isolated DNA" --
are to so-called "isolated DNA" --
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但是最有爭議的是
所謂的“ 離體DNA（亦稱：單離DNA） ”--
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。
分離出來的 DNA 片段。
02:20
namely, a piece of DNA
that has been removed from a cell.
that has been removed from a cell.
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基因專利的支持者聲稱，
02:26
Gene patent proponents say,
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02:27
"See? We didn't patent
the gene in your body,
the gene in your body,
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" 你看？ 我們不是對你
身體中的基因申請專利，
身體中的基因申請專利，
02:30
we patented an isolated gene."
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我們是對離體基因申請專利。 ”
02:33
And that's true,
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這是事實，
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.
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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。
都需要把基因分離出來。
02:42
And the patents weren't just
to a particular gene that they isolated,
to a particular gene that they isolated,
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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，
並非他們分離出來的特定基因，
02:46
but on every possible
version of that gene.
version of that gene.
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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 that you can't give
your gene to your doctor
your gene to your doctor
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這意味著，
你不能把你的基因給你的醫生，
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,
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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 of the patent holder.
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03:02
It also means that the patent holder
has the right to stop anyone
has the right to stop anyone
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也就是說，專利持有者
有權利阻止任何人
有權利阻止任何人
03:06
from using that gene
in research or clinical testing.
in research or clinical testing.
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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 patent holders,
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03:12
often private companies,
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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
他們閉鎖住開發人類基因組的行為
03:13
to lock up stretches of the human genome
was harming patients.
was harming patients.
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會傷害到患者的權利。
03:18
Consider Abigail,
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想一下，Abigail，
03:20
a 10-year-old with long QT syndrome,
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一位10歲患有長QT綜合症的小女生，
03:22
a serious heart condition that,
if left untreated,
if left untreated,
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長QT綜合症是一種
嚴重的心臟疾病，如果不治療，
嚴重的心臟疾病，如果不治療，
03:25
can result in sudden death.
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可能會引發猝死。
03:28
The company that obtained a patent on two
genes associated with this condition
genes associated with this condition
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有個公司握有兩個
與這種疾病相關基因的專利，
與這種疾病相關基因的專利，
03:32
developed a test to diagnose the syndrome.
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他們開發了一種
診斷此病症的化驗方式。
診斷此病症的化驗方式。
03:35
But then they went bankrupt
and they never offered it.
and they never offered it.
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但之後他們倒閉了，
而他們從未提供此項服務。
而他們從未提供此項服務。
03:39
So another lab tried to offer the test,
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於是另一個實驗室
嘗試提供這項化驗，
嘗試提供這項化驗，
03:41
but the company that held the patents
threatened to sue the lab
threatened to sue the lab
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但是持有這項專利的公司
告發那個實驗室
告發那個實驗室
03:44
for patent infringement.
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專利侵權。
03:45
So as a result,
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所以，結果是，
03:46
for 2 years, no test was available.
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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 died of undiagnosed long QT.
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Abigail 因未診斷出
長 QT 綜合症而去世。
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。
並且損害患者的權利。
03:55
Gene patents clearly were a problem
and were harming patients.
and were harming patients.
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03:59
But was there a way
we could challenge them?
we could challenge them?
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但是我們有沒有方法
可以挑戰他們呢？
可以挑戰他們呢？
其實，最高法院
04:02
Turns out that the Supreme Court
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04:04
has made clear
through a long line of cases,
through a long line of cases,
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透過一系列的判例，
已經清楚地表明，
已經清楚地表明，
04:07
that certain things
are not patent eligible.
are not patent eligible.
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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--
的物質申請專利--
04:10
You can't patent products of nature --
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04:14
the air, the water, minerals,
elements of the periodic table.
elements of the periodic table.
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像是，空氣、水、礦物、
元素週期表裡的物質。
元素週期表裡的物質。
04:19
And you can't patent laws of nature --
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你也不能對自然法則申請專利--
04:22
the law of gravity, E = mc2.
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像是萬有引力公式 E=mc2。
04:24
These things are just too fundamental
and must remain free to all
and must remain free to all
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這些東西太基本了，
必須對所有人保持免費，
必須對所有人保持免費，
04:29
and reserved exclusively to none.
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且不能被任何人獨自佔有。
04:32
It seemed to us that DNA,
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DNA 對我們而言，
04:34
the most fundamental structure of life,
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像是生命最本質的結構，
04:37
that codes for the production
of all of our proteins,
of all of our proteins,
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它對我們所有的蛋白質產物編碼，
04:39
is both a product of nature
and a law of nature,
and a law of nature,
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既是自然界的物質，
也是自然的法則，
也是自然的法則，
04:42
regardless of whether it's in our bodies
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無論它是在我們的體內，
04:45
or sitting in the bottom of a test 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 into this issue,
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04:50
we traveled all over the country
to speak with many different experts --
to speak with many different experts --
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我們飛到全國各地，
和許多不同的專家談話--
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, medical professionals,
lawyers, patent lawyers.
lawyers, patent lawyers.
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絕大多數都同意，
在政策層面我們是正確的，
在政策層面我們是正確的，
04:58
Most of them agreed that we were right
as a matter of policy,
as a matter of policy,
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05:02
and, at least in theory,
as a matter of law.
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。
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 of winning
a gene-patent challenge
a gene-patent challenge
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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 office
had been issuing these patents
had been issuing these patents
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好吧，因為專利局核發這些專利
05:18
for more than 20 years.
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已經超過 20 年了，
05:20
There were literally thousands
of patents on human genes.
of patents on human genes.
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的確已經有數千個人類基因專利。
05:24
The patent bar was deeply
entrenched in the status quo,
entrenched in the status quo,
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專利的測驗評量已行之有年，
05:28
the biotech industry had grown up
around this practice,
around this practice,
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生物科技產業在這個
機制下蓬勃發展，
機制下蓬勃發展，
05:32
and legislation to ban gene patents
had been introduced
had been introduced
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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,
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05:36
and had gone absolutely nowhere.
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但已經不知道被丟到哪裡去了。
05:39
So the bottom 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。
去推翻這些專利。
05:41
courts just weren't going to be willing
to overturn these patents.
to overturn these patents.
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現在，無論是 Chris 或我
都不是那種臨陣脫逃的人，
都不是那種臨陣脫逃的人，
05:44
Now, neither Chris nor I were the type
to shy away from a challenge,
to shy away from a challenge,
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05:49
and hearing, "Being right
just isn't enough,"
just isn't enough,"
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而且聽到“正確又能何哉”，
05:52
seemed all the more reason
to take on this fight.
to take on this fight.
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更激起我們奮戰的理由。
05:56
So we set out to build our case.
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所以，我們打算建立
我們的訴訟方式，
我們的訴訟方式，
05:59
Now, patent cases tend to be:
Company A sues Company B
Company A sues Company B
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現在，專利訴訟法案通常是：
A公司告B公司，
A公司告B公司，
06:03
over some really narrow,
obscure technical issue.
obscure technical issue.
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總是在一些非常狹隘、
晦澀的技術問題上打轉，
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
in that kind of case,
in that kind of case,
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06:09
and we thought this case
was much bigger than that.
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。
要比那些重大得多。
06:11
This was about scientific freedom,
medical progress,
medical progress,
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這個案件關乎
科學自由、醫療進步、
科學自由、醫療進步、
06:14
the rights of patients.
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病患權利。
06:15
So we decided we were going
to develop a case
to develop a case
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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 patent case --
your typical patent case --
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和你通常看到的專利官司不同--
06:21
more like a civil rights case.
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它更像是公民權利的官司。
06:24
We set out to identify
a gene-patent holder
a gene-patent holder
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我們打算去找一位
強硬推行它的專利的
強硬推行它的專利的
06:27
that was vigorously enforcing its patents
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這樣一個基因專利持有者，
06:30
and then to organize a broad coalition
of plaintiffs and experts
of plaintiffs and experts
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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
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去告訴法院
06:35
about all the ways that these patents
were harming patients and innovation.
were harming patients and innovation.
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這些專利損害病人
並阻礙創新的種種劣跡。
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，
可以作為我們要告發的主要目標，
06:41
We found the prime candidate
to sue in Myriad Genetics,
to sue in Myriad Genetics,
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06:44
a company that's based
in Salt Lake City, Utah.
in Salt Lake City, Utah.
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這是一家總部設在
猶他州鹽湖城的公司，
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 held patents on two genes,
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06:50
the BRCA1 and the BRCA2 genes.
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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 with certain mutations
along these genes
along these genes
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06:57
are considered to be
at a significantly increased risk
at a significantly increased risk
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罹患乳腺癌和卵巢癌
07:00
of developing breast and ovarian cancer.
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的風險會顯著升高。
07:03
Myriad had used its patents to maintain
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Myriad 利用這項專利來維持
07:05
a complete monopoly on BRCA testing
in the United States.
in the United States.
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在美國境內 BRCA 檢測市場
的完全壟斷地位。
的完全壟斷地位。
07:10
It had forced multiple labs
that were offering BRCA testing to stop.
that were offering BRCA testing 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。
的實驗室停止這項服務。
07:14
It charged a lot of money for its test --
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它收取相當昂貴的檢測費用--
07:16
over 3,000 dollars.
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超過3,000美金。
07:19
It had stopped sharing its clinical data
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它已經停止與國際科學界
07:21
with the international
scientific community.
scientific community.
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共享它的臨床數據。
以及可能最糟糕的，
07:24
And perhaps worst of all,
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07:26
for a period of several years,
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曾經有幾年，
07:28
Myriad refused to update its test
to include additional mutations
to include additional mutations
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Myriad 公司拒絕在他們的檢測中更新
07:32
that had been identified
by a team of researchers in France.
by a team of researchers in France.
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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，
鑑別出來的其他變種數據，
07:36
It has been estimated
that during that period,
that during that period,
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據估計，在此期間，
07:39
for several years,
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有數年，
07:40
as many as 12 percent of women
undergoing testing
undergoing testing
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將近12％的婦女進行的測試
07:44
received the wrong answer --
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得到了錯誤檢測結果--
07:48
a negative test result
that should have been positive.
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）。
陰性反應（假陰性）。
07:53
This is Kathleen Maxian.
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這位是 Kathleen Maxian，
07:56
Kathleen's sister Eileen
developed breast cancer at age 40
developed breast cancer at age 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 by Myriad.
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08:02
The test was negative.
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測試結果是呈現陰性，
08:03
The family was relieved.
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家人如釋重負，
08:05
That meant that Eileen's cancer
most likely didn't run in the family,
most likely didn't run in the family,
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這說明艾琳的癌症
很可能不會在家族中重現。
很可能不會在家族中重現。
08:09
and that other members of her family
didn't need to be tested.
didn't need to be tested.
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其他的家族成員
也不需要再接受檢驗。
也不需要再接受檢驗。
但，二年後，
08:12
But two years later,
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08:14
Kathleen was diagnosed
with advanced-stage ovarian cancer.
with advanced-stage ovarian cancer.
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Kathleen 被診斷出卵巢癌末期，
08:18
It turned out that Kathleen's sister
was among the 12 percent
was among the 12 percent
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原來卡瑟琳的姐姐就是那12%
08:22
who received a false-negative test result.
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得到了假陰性結果的病人之一。
08:26
Had Eileen received the proper result,
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Eileen 如果得到正確的結果，
08:29
Kathleen would have then been tested,
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Kathleen 就會去做化驗，
08:31
and her ovarian cancer
could have been prevented.
could have been prevented.
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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 we settled on Myriad,
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08:38
we then had to form a coalition
of plaintiffs and experts
of plaintiffs and experts
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我們需要組建一個
08:42
that could illuminate these problems.
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能夠陳述這些問題的原告和專家團。
08:44
We ended up with 20
highly committed plaintiffs:
highly committed plaintiffs:
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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 counselors,
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08:48
geneticists who had received
cease and desist letters,
cease and desist 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 organizations,
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08:55
four major scientific organizations
that collectively represented
that collectively represented
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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
and medical professionals,
and medical professionals,
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超過 15 萬名科學工作者和醫療專家，
09:02
and individual women who either
couldn't afford Myriad's test,
couldn't afford Myriad's test,
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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
a second opinion but could not,
a second opinion 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 of the patents.
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09:12
One of the major challenges
we had in preparing the case
we had in preparing the case
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我們準備訴訟時其中一個最大挑戰是
09:15
was figuring out how best
to communicate the science.
to communicate the science.
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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 to argue that what Myriad did
was not an invention,
was not an invention,
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所以為了辯明 Myriad 所為並不是發明，
09:22
and that isolated BRCA genes
were products of nature,
were products of nature,
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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 a couple
of basic concepts, like:
of basic concepts, like:
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09:29
What's a gene? What's DNA?
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基因是什麼？DNA 是什麼？
09:32
How is DNA isolated,
and why isn't that an invention?
and why isn't that an invention?
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DNA要如何被分離？
為什這個東西不是發明？
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 hours and hours
with our plaintiffs and experts,
with our plaintiffs and experts,
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09:41
trying to come up with ways
of explaining these concepts
of explaining these concepts
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嘗試地想出一些簡單又精確的方法
09:44
simply yet accurately.
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來解釋這些概念。
09:46
And we ended up relying heavily
on the use of metaphors,
on the use of metaphors,
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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 DNA --
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2284
09:54
it's like extracting gold from a mountain
189
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像是從山裡挖出黃金，
09:57
or taking it out of a stream bed.
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2016
或是從河床裡掏出黃金。
09:59
You might be able to patent
the process for mining the gold,
the process for mining the gold,
191
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你或許可以為採集黃金
的流程申請專利，
的流程申請專利，
10:02
but you can't patent the gold itself.
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2081
但你不能把黃金本身申請專利。
10:05
It might've taken a lot
of hard work and effort
of hard work and effort
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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 it,
it's still gold.
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。
黃金還是黃金。
10:13
And the gold, once it's extracted,
196
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1756
而黃金，一旦被萃取出來，
10:15
can clearly be used
for all sorts of things
for all sorts of things
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2088
顯然可以被用於各種
10:17
that it couldn't be used
for when it was in the mountain;
for when it was in the mountain;
198
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它埋在山中時不能實現的用途；
10:20
you can make jewelry
out of it for example --
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 the gold,
it's still gold.
it's still gold.
200
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但仍然不能把黃金申請專利，
它仍然是黃金。
它仍然是黃金。
10:25
So now it's 2009,
and we're ready to file our case.
and we're ready to file our case.
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2009年，我們準備遞交我們的案件，
10:30
We filed in federal court
in the Southern District of New York,
in the Southern District of New York,
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我們遞交到紐約南區的聯邦法院，
10:34
and the case was randomly assigned
to Judge Robert Sweet.
to Judge Robert Sweet.
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案件被隨機指派到
一位 Robert Sweet 法官，
一位 Robert Sweet 法官，
2010年3月Sweet法官發表他的看法--
10:38
In March 2010, Judge Sweet
issued his opinion --
issued his opinion --
204
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152頁--
10:42
152 pages --
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對我們這邊完全有利，
10:44
and a complete victory for our side.
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2252
10:47
In reading the opinion,
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在閱讀他的看法時，
10:49
we could not get over how eloquently
he described the science in the case.
he described the science in the case.
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4715
我們搞不懂，他在描述科學時
怎麼那麼頭頭是道，
怎麼那麼頭頭是道，
10:54
I mean, our brief --
it was pretty good,
it was pretty good,
209
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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 such a deep
understanding of this issue
understanding of this issue
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建立出對這此議題這麼深厚的認知？
11:03
in such a short time?
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11:04
We just could not comprehend
how this had happened.
how this had happened.
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我們真的無法理解這是怎麼發生的。
11:07
So it turned out,
214
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原來，
11:09
Judge Sweet's clerk
working for him at the time,
working for him at the time,
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3310
當時 Sweet 法官底下的書記員
不僅是位律師--
11:12
was not just a lawyer --
216
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1480
11:14
he was a scientist.
217
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1714
也是位科學家，
11:15
He was not just a scientist --
218
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1598
且不僅是科學家，
11:17
he had a PhD in molecular biology.
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3146
他還有分子生物學的博士學位，
11:20
(Laughter)
220
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1751
（笑聲）
11:22
What an incredible stroke of luck!
221
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真是太幸運了！
Myriad 隨後上訴到
11:26
Myriad then appealed
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11:27
to the US Court of Appeals
for the Federal Circuit.
for the Federal Circuit.
223
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2495
美國聯邦巡迴上訴法院。
11:30
And here things got really interesting.
224
678496
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然後事情就變得非常有意思了。
11:33
First, in a pivotal moment of this case,
225
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首先，本案中的一個關鍵時刻，
11:37
the US government switched sides.
226
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2631
美國政府倒戈了，
11:40
So in the district court the government
submitted a brief on Myriad's side.
submitted a brief on Myriad's side.
227
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3749
在地方法院上，政府遞交了
一份簡述支持 Myriad。
一份簡述支持 Myriad。
11:44
But now in direct opposition
to its own patent office,
to its own patent office,
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但是這回美國政府
直接反對它自己的專利局，
直接反對它自己的專利局，
11:49
the US government files a brief
that states that is has
that states that is has
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2708
美國政府發了一個簡短的聲明，
11:52
reconsidered this issue
in light of the district court's opinion,
in light of the district court's opinion,
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他們基於地區法庭的判決，
已重新考慮了問題，
已重新考慮了問題，
11:56
and has concluded that isolated DNA
is not patent eligible.
is not patent eligible.
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並總結出" 離體DNA "
不具備專利適格性，
不具備專利適格性，
這簡直是大逆轉，
11:59
This was a really big deal,
232
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1811
12:01
totally unexpected.
233
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1562
完全意想不到。
聯邦巡迴上訴法院
12:04
The Court of Appeals
for the Federal Circuit
for the Federal Circuit
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聽審過所有的專利官司，
12:06
hears all patent cases,
235
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1683
12:08
and it has a reputation for being
very, very pro-patent.
very, very pro-patent.
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 development,
237
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所以即使有這個卓越的發展，
12:14
we expected to lose.
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 of.
240
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1152
在某種程度上啦．．．
12:20
Ends up split decision, 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 who ruled against 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 different reasons.
243
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2241
卻持完全不同的理由，
第一位 Lourie 法官，
12:29
The first one, Judge Lourie,
244
737275
1826
12:31
made up his own novel,
biological theory --
biological theory --
245
739125
3015
編造了他自己的新生物理論--
12:34
totally wrong.
246
742164
1168
完全是胡說八道。
12:35
(Laughter)
247
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1011
（笑聲）
12:36
He decided Myriad had created
a new chemical --
a new chemical --
248
744391
2218
他判定 Myriad 創造了一個新的化學成份--
12:38
made absolutely no sense.
249
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1865
完全不合理。
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
Myriad 本身甚至不曾如此聲稱，
完全意想不到。
完全意想不到。
12:43
The other, Judge Moore,
251
751632
1977
另一位法官，Moore，
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
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3878
她說，她完全同意
離體 DNA 屬於自然界的產物。
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 industry."
to shake up the biotech industry."
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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, Judge Bryson,
254
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2572
12:57
agreed with us.
255
765233
1216
認同我們。
12:59
So now we sought review
by the Supreme Court.
by the Supreme Court.
256
767750
2531
所以，我們上訴到最高法院，
13:02
And when you petition the Supreme Court,
257
770305
2703
當你上訴到最高法院時，
13:05
you have to present a question
that you want the Court to answer.
that you want the Court to answer.
258
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3122
你需要提出一個
你希望法院回應的問題。
你希望法院回應的問題。
13:08
Usually these questions take the form
of a super-long paragraph,
of a super-long paragraph,
259
776534
3727
通常，這些問題都是
落落長的問句，
落落長的問句，
13:12
like a whole page long
with lots and lots of clauses,
with lots and lots of clauses,
260
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3023
像是一整頁很多很多子句、
13:15
"wherein this" and "therefore that."
261
783332
2457
“是否就在”、“因此那樣”的問題，
13:18
We submitted perhaps
the shortest question presented ever.
the shortest question presented ever.
262
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3907
我們提交了可能是
有史以來最短的問題。
有史以來最短的問題。
13:23
Four words:
263
791312
1213
四個詞：
Are human genes patentable?
（人類基因可以專利化嗎？）
（人類基因可以專利化嗎？）
13:26
Are human genes patentable?
264
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2051
13:28
Now when Chris first asked me
what I thought of these words,
what I thought of these words,
265
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2824
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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1374
我說，" 我不知道 ，
13:33
I think you have to say,
'Is isolated DNA patentable?'"
'Is isolated DNA patentable?'"
267
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3167
我認為你應該要說，
’離體DNA是可以專利化的嗎？’ "
’離體DNA是可以專利化的嗎？’ "
13:36
"Nope.
268
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1169
"不，
13:38
I want the justices to have
the very same reaction that I had
the very same reaction 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
to me seven years ago."
to me seven years ago."
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你問我這個問題時一模一樣。 ”
13:46
Well, I certainly couldn't
argue with that.
argue with that.
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好吧，我當然不能反駁。
13:49
The Supreme Court only hears
about one percent
about one percent
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最高法院只受理大約 1%
13:52
of the cases that it receives,
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它所收到的案件，
13:54
and it agreed to hear ours.
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而法院同意要聽審我們的。
13:57
The day of the oral argument arrives,
and it was really, really exciting --
and it was really, really exciting --
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口頭辯論的那天到來，
這真的是相當刺激--
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 in line
since 2:30 in the morning
since 2:30 in the morning
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有人凌晨兩點半就來排隊，
14:06
to try to get into the courthouse.
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就為了要擠進法庭。
14:07
Two breast cancer organizations,
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1971
兩個乳腺癌組織，
14:09
Breast Cancer Action and FORCE,
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乳腺癌行動組織和 FORCE，
14:11
had organized a demonstration
on the courthouse steps.
on the courthouse steps.
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在法庭台階上組織了抗議行動，
14:15
Chris and I sat quietly in the hallway,
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Chris 和我靜靜地坐在走廊上，
在他步入法庭
14:18
moments before he was to walk in and argue
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並為他職業生涯中最重要的案件辯護之前，
14:21
the most important case of his career.
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14:24
I was clearly more nervous than he was.
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我很明顯地比他還緊張，
14:28
But any remaining panic subsided
as I walked into the courtroom
as I walked into the courtroom
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但所以有的恐懼就在我
步入法庭時消失殆盡，
步入法庭時消失殆盡，
14:32
and looked around
at a sea of friendly faces:
at a sea of friendly faces:
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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 women clients
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14:37
who had shared their
deeply personal stories,
deeply personal stories,
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在庭上訴說著切身的故事，
14:41
the geneticists who had taken huge chunks
of time out of their busy careers
of time out of their busy careers
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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 themselves to this fight
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14:47
and representatives from a diverse array
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還有來自許多不同領域的代表：
14:49
of medical, patient advocacy,
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醫療、患者救助、
14:51
environmental and religious organizations,
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環保和宗教組織，
14:53
who had submitted friend of the court
briefs in the case.
briefs in the case.
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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，
三位人類基因組計劃的領導者，
14:58
Also in the room were three leaders
of the Human Genome Project,
of the Human Genome Project,
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15:01
including the co-discoverer
of DNA himself,
of DNA himself,
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包括DNA的共同發現者本人，
15:04
James Watson,
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James Watson，
15:05
who had submitted a brief to the court,
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他也遞交了陳情書，
15:07
where he referred
to gene patenting as "lunacy."
to gene patenting as "lunacy."
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他指出把基因專利是"瘋子行為”。
15:11
(Laughter)
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（笑聲）
15:13
The diversity of the communities
represented in this room
represented in this room
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法庭中出席群體的廣度，
15:16
and the contributions each had made
to make this day a reality
to make this day a reality
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以及他們每一位為實現
這一天而做出的貢獻
這一天而做出的貢獻
15:20
spoke volumes to what was at stake.
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讓我們的聲勢壯大了許多。
15:23
The argument itself was riveting.
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辯論主體非常的精彩。
15:26
Chris argued brilliantly.
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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 aspect was watching
the Supreme Court justices grapple
the Supreme Court justices grapple
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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 DNA,
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1569
15:34
through a series of colorful analogies
and feisty exchanges,
and feisty exchanges,
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透過一系列精彩的比喻
及精力充沛的交叉辯論，
及精力充沛的交叉辯論，
15:37
very much the same way
as our legal team had done
as our legal team had done
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就和我們法律團隊過去七年
15:41
for the past seven years.
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1690
所做過的演練如出一轍。
15:43
Justice Kagan likened isolating DNA
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Kagan 法官把離體DNA比喻成
15:46
to extracting a medicinal plant
from the Amazon.
from the Amazon.
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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。
把樹木雕成棒球棒。
15:50
Justice Roberts distinguished it
from carving a baseball bat from a tree.
from carving a baseball bat from a tree.
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而絕對是我最喜歡的一個瞬間是，
15:55
And in one of my absolutely
favorite moments,
favorite moments,
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2482
15:58
Justice Sotomayor proclaimed isolated DNA
to be "just nature sitting there."
to be "just nature sitting there."
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5269
Sotomayor法官宣布
離體DNA "就是自然存在那裡"
離體DNA "就是自然存在那裡"
16:03
(Laughter)
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951794
1100
（笑聲）
我們那天離開法院時
感覺相當有信心，
感覺相當有信心，
16:05
We felt pretty confident
leaving the courtroom that day,
leaving the courtroom that day,
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2875
16:08
but I could never have
anticipated the outcome:
anticipated the outcome:
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3006
但令我意想不到的結局竟是：
16:12
nine to zero.
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1507
九比零。
16:15
"A naturally occurring DNA segment
is a product of nature,
is a product of nature,
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3722
"一段自然形成的DNA片段
是自然界的產物，
是自然界的產物，
16:18
and not patent-eligible merely because
it has been isolated.
it has been isolated.
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3047
並不能因為它被分離出體外
就可以授予專利。
就可以授予專利。
16:22
And furthermore,
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1347
另外，
16:23
Myriad did not create anything."
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2545
Myriad 並沒有創造任何東西。 ”
16:28
Within 24 hours of the decision,
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976160
1996
判決後 24 小時內，
16:30
five labs had announced
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1392
五個實驗室宣布
16:31
that they would begin to offer testing
for the BRCA genes.
for the BRCA genes.
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979596
3014
他們將開始提供 BRCA 基因的檢驗服務。
16:35
Some of them promised to offer the tests
at a lower price than Myriad's.
at a lower price than Myriad's.
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3483
他們有些承諾檢驗的價格
會比 Myriad 的還低。
會比 Myriad 的還低。
16:39
Some promised to provide
a more comprehensive test
a more comprehensive test
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2920
有些承諾將提供更全面的檢測，
16:42
than the one Myriad was offering.
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1683
比 Myriad 提供的更多。
16:44
But of course the decision
goes far beyond Myriad.
goes far beyond Myriad.
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2838
不過這個判決遠遠不止影響了 Myriad，
16:47
It ends a 25-year practice
of allowing patents on human genes
of allowing patents on human genes
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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 States.
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999772
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16:53
It clears a significant barrier
to biomedical discovery and innovation.
to biomedical discovery and innovation.
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1001383
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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。
掃除了一個重要的障礙。
16:58
And it helps to ensure that patients
like Abigail, Kathleen and Eileen
like Abigail, Kathleen and Eileen
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它也有助於保證像 Abigail,、
Kathleen 和 Eileen 這樣的患者
Kathleen 和 Eileen 這樣的患者
17:03
have access to the tests that they need.
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2156
能夠獲得她們需要的檢測。
17:06
A few weeks after the court
issued its decision,
issued its decision,
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最高法院宣判判決幾週後，
17:10
I received a small package in the mail.
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我在信箱收到了一個郵件小包，
17:13
It was from Bob Cook-Deegan,
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1021246
1607
是一位杜克大學教授
17:14
a professor at Duke University
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1022877
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Bob Cook-Deegan 寄來的，
17:17
and one the very first people
Chris and I went to visit
Chris and I went to visit
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1025170
3224
他是我和 Chris 開始考慮
是否要接下此案時
是否要接下此案時
17:20
when we started to consider
whether to bring this case.
whether to bring this case.
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2699
第一個拜訪的人，
17:24
I opened it up to find
a small stuffed animal.
a small stuffed animal.
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2809
我把它打開，發現裡面
是一個小小的毛絨動物。
是一個小小的毛絨動物。
17:28
(Laughter)
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2959
（笑聲）
17:33
We took a big risk in taking this case.
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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 of what gave us the courage
to take that risk
to take that risk
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1044722
2510
17:39
was knowing that we were doing
the right thing.
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 took nearly eight years
from the start to finish,
from the start to finish,
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從開始到結束，整個過程將近八年，
17:45
with many twists and turns along the way.
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這一路走來相當的曲折。
17:48
A little luck certainly helped,
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當然有一點運氣的幫忙，
17:50
but it was the communities
that we bridged,
that we bridged,
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但，是我們搭建的社群、
17:53
the alliances that we created,
353
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是我們創造的聯盟，
17:55
that made pigs fly.
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讓不可能變成可能。
17:57
Thank you.
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謝謝。
17:58
(Applause)
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（掌聲）
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