TEDxAmoskeagMillyard
Tania Simoncelli: Should you be able to patent a human gene?
塔尼娅·西蒙切利: 我是怎么在基因专利大战中获胜的
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人类基因可以被授予专利吗？2005 年，当塔尼娅·西蒙切利首次注意到这个复杂的问题，美国专利法认可此行为——因而意味着专利持有者有权阻止任何他人测序、检测甚至诊断病人的基因。因为法律这样做不但损害了病人的利益，而且为生物医疗创新制造了阻碍，西蒙切利和她在 ACLU （美国公民自由同盟）的同事对这一现象发起了挑战。在本次掷地有声的演讲中，听一听他们如何把一个所有人都认为他们必败无疑的案子一直打到（美国）最高法院。
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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那是 2005 年秋日的一个下午。
00:17
I was working at the ACLU
as the organization's science advisor.
as the organization's science advisor.
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我时任 ACLU
（美国公民自由联盟）的科学顾问。
（美国公民自由联盟）的科学顾问。
00:21
I really, really loved my job,
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我真的非常喜欢我的工作，
但是那段时间我时常
00:24
but I was having one of those days
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感到有一点点受挫。
00:25
where I was feeling
just a little bit discouraged.
just a little bit discouraged.
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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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于是我经过走廊晃荡到
同事克里斯·汉森的办公室。
同事克里斯·汉森的办公室。
00:34
Chris had been at the ACLU
for more than 30 years,
for more than 30 years,
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克里斯在 ACLU 供职三十多年了，
他对机构有深刻的了解和想法。
00:38
so he had deep institutional
knowledge and insights.
knowledge and insights.
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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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我向克里斯解释
我为什么觉得有些举步维艰。
我为什么觉得有些举步维艰。
00:45
I had been investigating
a number of issues
a number of issues
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我当时在调查一系列
处在科学和公民自由十字路口的问题
——非常有意思。
——非常有意思。
00:47
at the intersection of science
and civil liberties -- super interesting.
and civil liberties -- super interesting.
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但是我希望 ACLU 能够在
更高的层面参与这些问题。
更高的层面参与这些问题。
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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以一种能真正做出改变的方式。
00:56
in a way that could really
make a difference.
make a difference.
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01:01
So Chris cut right
to the chase, and he says,
to the chase, and he says,
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克里斯开门见山地说，
“那好，所有你正在考虑的问题里面，
排前五位的是什么？”
排前五位的是什么？”
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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01:07
"Well, there's genetic discrimination,
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“我想应该是遗传歧视，
生育技术，
01:10
and reproductive technologies,
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生物样本库，还有……
01:12
and biobanking, and ...
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哦，这个真的很酷，
01:14
oh, there's this really cool issue,
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功能性 MRI（核磁共振成像），
用它来测谎，还有……
用它来测谎，还有……
01:16
functional MRI and using it
for lie detection, and ...
for lie detection, and ...
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哦，当然，还有基因专利。”
01:19
oh, and of course, there's gene patents."
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“基因专利？”
01:21
"Gene patents?"
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01:23
"Yes, you know, patents on human genes."
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“是的，你知道的，
授予人类基因专利。”
授予人类基因专利。”
“不可能！
01:26
"No!
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你是说，美国政府
01:27
You're telling me that the US government
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正在对人身体的部分授予专利？
01:30
has been issuing patents
on part of the human body?
on part of the human body?
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01:33
That can't be right."
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这怎么可能嘛。”
01:35
I went back to my office
and sent Chris three articles.
and sent Chris three articles.
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我回到我的办公室，
给克里斯发了三篇文章。
给克里斯发了三篇文章。
01:39
And 20 minutes later,
he came bursting in my office.
he came bursting in my office.
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20分钟以后，
他冲进我的办公室。
他冲进我的办公室。
“天哪！你说中了！
我们可以起诉谁？”
我们可以起诉谁？”
01:43
"Oh my god! You're right! Who can we sue?"
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01:47
(Laughter)
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（笑声）
01:49
Now Chris is a really brilliant lawyer,
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克里斯是一名杰出的律师，
01:52
but he knew almost nothing
about patent law
about patent law
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但是他几乎完全不懂专利法，
而且肯定不懂遗传学。
01:55
and certainly nothing about genetics.
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我懂一点遗传学，
但我连律师都不是，
但我连律师都不是，
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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更别说专利律师了。
02:00
let alone a patent lawyer.
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所以很显然，在打官司之前，
我们需要学很多东西。
我们需要学很多东西。
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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02:06
First, we needed to understand
exactly what was patented
exactly what was patented
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首先，我们需要搞清楚
当有人为基因申请专利时，
当有人为基因申请专利时，
究竟是什么被授予了专利。
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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基因专利通常包含几十条要求，
但是最矛盾的是所谓的“离体 DNA”——
02:15
but the most controversial of these
are to so-called "isolated DNA" --
are to so-called "isolated DNA" --
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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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也就是从细胞中移出的 DNA 片段。
02:26
Gene patent proponents say,
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基因专利的支持者称，
“看见了吗？我们没有对你
身体中的基因申请专利，
身体中的基因申请专利，
02:27
"See? We didn't patent
the gene in your body,
the gene in your body,
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我们是为离体的基因申请专利。”
02:30
we patented an isolated gene."
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02:33
And that's true,
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这话是没错，
但问题在于，无论如何，
要使用基因，就必须先进行分离。
要使用基因，就必须先进行分离。
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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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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而被授予专利的，
并非他们分离的某个特定的基因，
并非他们分离的某个特定的基因，
而是那个基因每一种可能的版本。
02:46
but on every possible
version of that gene.
version of that gene.
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02:50
So what does that mean?
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那么这意味着什么呢？
02:51
That means that you can't give
your gene to your doctor
your gene to your doctor
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这意味着你不能把你的基因给医生，
然后请他/她检查，
02:55
and ask him or her to look at it,
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比如说，检查是否有变异，
02:57
say, to see if it has any mutations,
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如果你没有专利持有者的授权。
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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这也意味着专利持有者
有权阻止任何人
有权阻止任何人
使用该基因从事研究或临床试验。
03:06
from using that gene
in research or clinical testing.
in research or clinical testing.
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03:10
Allowing patent holders,
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允许专利持有者，
通常是私有企业，
03:12
often private companies,
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关起开发人类基因组的大门，
会损害患者的利益。
会损害患者的利益。
03:13
to lock up stretches of the human genome
was harming patients.
was harming patients.
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03:18
Consider Abigail,
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比如，阿比盖尔，
一个10岁的孩子，
患有长 QT 综合症，
患有长 QT 综合症，
03:20
a 10-year-old with long QT syndrome,
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这是一种严重的心脏疾病，
如果不治疗，
如果不治疗，
03:22
a serious heart condition that,
if left untreated,
if left untreated,
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可能引发猝死。
03:25
can result in sudden death.
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03:28
The company that obtained a patent on two
genes associated with this condition
genes associated with this condition
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有个公司拥有与这种疾病有关的
两个基因的专利，
两个基因的专利，
他们开发了一种针对此病症的
检验方法。
检验方法。
03:32
developed a test to diagnose the syndrome.
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但随后公司倒闭了，
还没来得及推出这项检测服务。
还没来得及推出这项检测服务。
03:35
But then they went bankrupt
and they never offered it.
and they never offered it.
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03:39
So another lab tried to offer the test,
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于是另一个实验室尝试
提供这种检测，
提供这种检测，
但是这家持有专利的公司
起诉那个了实验室
起诉那个了实验室
03:41
but the company that held the patents
threatened to sue the lab
threatened to sue the lab
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专利侵权。
03:44
for patent infringement.
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所以，结果是，
03:45
So as a result,
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两年内，没有人提供这种检测服务。
03:46
for 2 years, no test was available.
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03:50
During that time,
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在此期间，
阿比盖尔因未诊断出长 QT 症去世。
03:51
Abigail died of undiagnosed long QT.
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03:55
Gene patents clearly were a problem
and were harming patients.
and were harming patients.
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基因专利明显是个问题，
并且在损害患者的利益。
并且在损害患者的利益。
03:59
But was there a way
we could challenge them?
we could challenge them?
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但是我们有没有办法挑战他们呢？
04:02
Turns out that the Supreme Court
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其实，（美国）最高法院
通过一系列的判例
已经清楚地表明，
已经清楚地表明，
04:04
has made clear
through a long line of cases,
through a long line of cases,
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有些东西是不能申请专利的。
04:07
that certain things
are not patent eligible.
are not patent eligible.
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04:10
You can't patent products of nature --
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你不能为自然界的产物申请专利——
04:14
the air, the water, minerals,
elements of the periodic table.
elements of the periodic table.
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空气、水、矿产、周期表里的元素。
04:19
And you can't patent laws of nature --
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你也不能为自然规律申请专利——
04:22
the law of gravity, E = mc2.
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引力定律，E=mc2 （质能方程），
04:24
These things are just too fundamental
and must remain free to all
and must remain free to all
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这些东西太基础了，
必须对所有人免费开放，
必须对所有人免费开放，
不该被任何人独自占有。
04:29
and reserved exclusively to none.
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04:32
It seemed to us that DNA,
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对我们来说，似乎 DNA，
生命最本质的结构，
04:34
the most fundamental structure of life,
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掌控所有蛋白质生产的编码，
04:37
that codes for the production
of all of our proteins,
of all of our proteins,
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既是自然界的产物，
也是自然规律，
也是自然规律，
04:39
is both a product of nature
and a law of nature,
and a law of nature,
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无论它是在我们的体内，
04:42
regardless of whether it's in our bodies
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还是沉在一根试管底部。
04:45
or sitting in the bottom of a test tube.
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04:48
As we delved into this issue,
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我们不断深入这个问题，
在国内四处奔波，
和许多专家交流——
和许多专家交流——
04:50
we traveled all over the country
to speak with many different experts --
to speak with many different experts --
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04:54
scientists, medical professionals,
lawyers, patent lawyers.
lawyers, patent lawyers.
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科学家、医疗专家、
律师、专利律师。
律师、专利律师。
04:58
Most of them agreed that we were right
as a matter of policy,
as a matter of policy,
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绝大多数都同意，
在政策层面我们是正确的，
在政策层面我们是正确的，
并且在法律层面，
至少在理论上是正确的。
至少在理论上是正确的。
05:02
and, at least in theory,
as a matter of law.
as a matter of law.
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05:06
All of them thought
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但他们全都认为
我们挑战基因专利授权的成功概率
05:07
our chances of winning
a gene-patent challenge
a gene-patent challenge
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几乎为零。
05:10
were about zero.
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05:13
Why is that?
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为什么呢？
因为专利局签发这些专利
05:15
Well, the patent office
had been issuing these patents
had been issuing these patents
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已经超过 20 年了。
05:18
for more than 20 years.
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05:20
There were literally thousands
of patents on human genes.
of patents on human genes.
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毫不夸张地说，现在已经
有上千个人类基因专利。
有上千个人类基因专利。
05:24
The patent bar was deeply
entrenched in the status quo,
entrenched in the status quo,
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专利律师已经深陷其中，
05:28
the biotech industry had grown up
around this practice,
around this practice,
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生物技术产业已经
通过这个司法实践壮大，
通过这个司法实践壮大，
禁止基因专利的立法提案
05:32
and legislation to ban gene patents
had been introduced
had been introduced
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年年在国会被提出，
05:35
year after year in Congress,
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但很显然根本没出国会的门。
05:36
and had gone absolutely nowhere.
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05:39
So the bottom line:
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所以归根结底：
05:41
courts just weren't going to be willing
to overturn these patents.
to overturn these patents.
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法院就是不愿意去推翻这些专利。
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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只不过，我和克里斯都不是
那种遇到挑战就退缩的人，
那种遇到挑战就退缩的人，
听到“站在正义一边还不够，”
05:49
and hearing, "Being right
just isn't enough,"
just isn't enough,"
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这就更值得我们去为此战斗。
05:52
seemed all the more reason
to take on this fight.
to take on this fight.
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05:56
So we set out to build our case.
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所以我们着手准备自己的案件。
05:59
Now, patent cases tend to be:
Company A sues Company B
Company A sues Company B
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现在，专利案通常是：
公司 A 起诉公司 B，
公司 A 起诉公司 B，
只针对一些非常局限、
隐晦的技术问题。
隐晦的技术问题。
06:03
over some really narrow,
obscure technical issue.
obscure technical issue.
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06:06
We weren't really interested
in that kind of case,
in that kind of case,
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我们对那种案件并不十分感兴趣，
我们认为这个案件
要比那些重大得多。
要比那些重大得多。
06:09
and we thought this case
was much bigger than that.
was much bigger than that.
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这个案件关乎科学自由，医疗进步，
06:11
This was about scientific freedom,
medical progress,
medical progress,
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患者权利。
06:14
the rights of patients.
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所以我们决定要做和你们通常看到的
06:15
So we decided we were going
to develop a case
to develop a case
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专利案不同的事情——
06:18
that was not like
your typical patent case --
your typical patent case --
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06:21
more like a civil rights case.
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它更像是针对公民权利的申诉。
06:24
We set out to identify
a gene-patent holder
a gene-patent holder
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我们着手寻找
这样一个基因专利持有者：
这样一个基因专利持有者：
他要非常强硬地推行专利；
06:27
that was vigorously enforcing its patents
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然后组织一个广泛的原告和专家联盟
06:30
and then to organize a broad coalition
of plaintiffs and experts
of plaintiffs and experts
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来告诉法庭
06:33
that could tell the court
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这些专利侵害病人、
阻碍创新的种种劣迹。
阻碍创新的种种劣迹。
06:35
about all the ways that these patents
were harming patients and innovation.
were harming patients and innovation.
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06:41
We found the prime candidate
to sue in Myriad Genetics,
to sue in Myriad Genetics,
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我们发现 Myriad Genetics
可以作为起诉的主要目标。
可以作为起诉的主要目标。
这是一家总部设在
犹他州盐湖城的公司。
犹他州盐湖城的公司。
06:44
a company that's based
in Salt Lake City, Utah.
in Salt Lake City, Utah.
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06:48
Myriad held patents on two genes,
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Myriad 持有两个基因的专利，
BRCA1 和 BRCA2 基因。
06:50
the BRCA1 and the BRCA2 genes.
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06:55
Women with certain mutations
along these genes
along these genes
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携带有这两个基因某些变异的女性
罹患乳腺癌和卵巢癌的风险
会显著升高。
会显著升高。
06:57
are considered to be
at a significantly increased risk
at a significantly increased risk
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07:00
of developing breast and ovarian cancer.
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07:03
Myriad had used its patents to maintain
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Myriad 公司使用他们的专利来维持
美国境内化验 BRCA 的全面垄断地位。
07:05
a complete monopoly on BRCA testing
in the United States.
in the United States.
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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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他们强行叫停了数个
提供 BRCA化验的实验室。
提供 BRCA化验的实验室。
他们对化验收取高额费用——
07:14
It charged a lot of money for its test --
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超过三千美元。
07:16
over 3,000 dollars.
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424939
1683
07:19
It had stopped sharing its clinical data
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他们停止向国际科学界共享临床数据。
07:21
with the international
scientific community.
scientific community.
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07:24
And perhaps worst of all,
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1903
还有可能最糟糕的，
曾经有几年，
07:26
for a period of several years,
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Myriad 拒绝在他们的化验中增加
07:28
Myriad refused to update its test
to include additional mutations
to include additional mutations
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由法国的一个研究团队
鉴别出来的新变异类型。
鉴别出来的新变异类型。
07:32
that had been identified
by a team of researchers in France.
by a team of researchers in France.
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07:36
It has been estimated
that during that period,
that during that period,
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据估计，在此期间，
数年间，
07:39
for several years,
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1373
有近 12% 接受化验的女性
07:40
as many as 12 percent of women
undergoing testing
undergoing testing
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3752
得到了错误的结果——
07:44
received the wrong answer --
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452679
2402
07:48
a negative test result
that should have been positive.
that should have been positive.
149
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也就是本应该是阳性的
阴性结果（假阴性）。
阴性结果（假阴性）。
07:53
This is Kathleen Maxian.
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这是卡瑟琳·马克西安。
07:56
Kathleen's sister Eileen
developed breast cancer at age 40
developed breast cancer at age 40
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卡瑟琳的姐姐艾琳 40 岁得了乳腺癌。
她曾做过 Myriad 的化验，
07:59
and she was tested by Myriad.
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08:02
The test was negative.
153
470032
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结果是阴性。
这家人松了口气。
08:03
The family was relieved.
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这说明艾琳的癌症
很可能不会在家族中重现。
很可能不会在家族中重现。
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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她的家人也不需要再接受化验。
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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3015
08:12
But two years later,
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480843
1230
但是两年后，
卡瑟琳被诊断出晚期卵巢癌。
08:14
Kathleen was diagnosed
with advanced-stage ovarian cancer.
with advanced-stage ovarian cancer.
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08:18
It turned out that Kathleen's sister
was among the 12 percent
was among the 12 percent
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486927
3872
原来卡瑟琳的姐姐就是那 12%
得到了假阴性结果的病人之一。
08:22
who received a false-negative test result.
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2869
08:26
Had Eileen received the proper result,
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如果艾琳得到了正确的化验结果，
卡瑟琳就也会去做化验，
08:29
Kathleen would have then been tested,
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她的卵巢癌就可能得到预防。
08:31
and her ovarian cancer
could have been prevented.
could have been prevented.
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08:36
Once we settled on Myriad,
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我们确定目标为 Myriad 后，
就需要组建一个
08:38
we then had to form a coalition
of plaintiffs and experts
of plaintiffs and experts
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能够陈述这些问题的原告和专家团。
08:42
that could illuminate these problems.
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我们找到了 20 位非常积极的原告：
08:44
We ended up with 20
highly committed plaintiffs:
highly committed plaintiffs:
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08:47
genetic counselors,
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遗传学咨询顾问，
收到叫停信件的遗传学家：
08:48
geneticists who had received
cease and desist letters,
cease and desist letters,
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3359
08:52
advocacy organizations,
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520905
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支持我们的组织，
08:55
four major scientific organizations
that collectively represented
that collectively represented
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四个主要科学组织，集中代表了
超过 15 万名科学工作者和医疗专家，
08:58
more than 150,000 scientists
and medical professionals,
and medical professionals,
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09:02
and individual women who either
couldn't afford Myriad's test,
couldn't afford Myriad's test,
173
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3297
以及无力支付 Myriad 的检测
或者希望有其他选择，
但因为专利原因
但因为专利原因
09:06
or who wanted to obtain
a second opinion but could not,
a second opinion but could not,
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3004
无法实现的女性个体。
09:09
as a result of the patents.
175
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1744
09:12
One of the major challenges
we had in preparing the case
we had in preparing the case
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我们在准备案件期间
遇到的主要挑战是，
遇到的主要挑战是，
搞清楚如何最有效地阐述科学观点。
09:15
was figuring out how best
to communicate the science.
to communicate the science.
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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，为了辩明
Myriad 的成果并不属于创新，
Myriad 的成果并不属于创新，
以及离体的 BRCA 基因
是自然界的产物，
是自然界的产物，
09:22
and that isolated BRCA genes
were products of nature,
were products of nature,
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3277
09:27
we had to explain a couple
of basic concepts, like:
of basic concepts, like:
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我们必须解释一些基本概念，比如：
基因是什么？DNA 是什么？
09:29
What's a gene? What's DNA?
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如何分离 DNA，
以及为什么这不是创新？
以及为什么这不是创新？
09:32
How is DNA isolated,
and why isn't that an invention?
and why isn't that an invention?
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09:37
We spent hours and hours
with our plaintiffs and experts,
with our plaintiffs and experts,
183
565168
3862
我们和原告以及专家团
花费了无数日夜，
花费了无数日夜，
努力寻找能够简洁又不失准确地
解释这些概念的方式。
解释这些概念的方式。
09:41
trying to come up with ways
of explaining these concepts
of explaining these concepts
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09:44
simply yet accurately.
185
572014
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09:46
And we ended up relying heavily
on the use of metaphors,
on the use of metaphors,
186
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我们最终非常依赖比喻，
比如说黄金。
09:49
like gold.
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09:51
So isolating DNA --
188
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2284
因此，分离 DNA ——
就像从大山中挖出黄金，
09:54
it's like extracting gold from a mountain
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2500
09:57
or taking it out of a stream bed.
190
585105
2016
或者从溪流河床里淘出黄金。
你或许可以为
采集黄金的流程申请专利，
采集黄金的流程申请专利，
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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3674
但你不能为黄金本身申请专利。
10:02
but you can't patent the gold itself.
192
590843
2081
10:05
It might've taken a lot
of hard work and effort
of hard work and effort
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593929
2743
你可能要靠无数艰辛努力
才能从山中挖到黄金；
10:08
to dig the gold out of the mountain;
194
596696
1860
10:11
you still can't patent it,
it's still gold.
it's still gold.
195
599127
2281
但你仍旧不能为它申请专利，
黄金还是黄金。
黄金还是黄金。
而黄金，一旦被挖掘出来，
10:13
And the gold, once it's extracted,
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601432
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显然可以被用于各种
10:15
can clearly be used
for all sorts of things
for all sorts of things
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603212
2088
它藏在山中时不能实现的用途；
10:17
that it couldn't be used
for when it was in the mountain;
for when it was in the mountain;
198
605324
2736
比如，你可以把它做成珠宝——
10:20
you can make jewelry
out of it for example --
out of it for example --
199
608084
2182
但仍然不能为金子申请专利，
金子还是金子。
金子还是金子。
10:22
still can't patent the gold,
it's still gold.
it's still gold.
200
610290
2165
10:25
So now it's 2009,
and we're ready to file our case.
and we're ready to file our case.
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3854
然后就到了 2009 年，
我们准备起诉了。
我们准备起诉了。
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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我们向纽约南区的联邦法庭递交了诉讼，
10:34
and the case was randomly assigned
to Judge Robert Sweet.
to Judge Robert Sweet.
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3366
然后案子被随机分配给了
法官罗伯特·斯威特。
法官罗伯特·斯威特。
10:38
In March 2010, Judge Sweet
issued his opinion --
issued his opinion --
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2010 年 3 月，斯威特法官
宣布了他的判决意见。
宣布了他的判决意见。
10:42
152 pages --
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1858
152 页。
10:44
and a complete victory for our side.
206
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2252
我方完胜。
10:47
In reading the opinion,
207
635964
1431
在判决意见里，
我们对他在案子中
如此雄辩地陈述科学事实激动不已。
如此雄辩地陈述科学事实激动不已。
10:49
we could not get over how eloquently
he described the science in the case.
he described the science in the case.
208
637419
4715
10:54
I mean, our brief --
it was pretty good,
it was pretty good,
209
642504
2771
我是说，我们的简述——
挺不错的，
挺不错的，
但没有这么出彩。
10:57
but not this good.
210
645299
1567
10:59
How did he develop such a deep
understanding of this issue
understanding of this issue
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3377
他是如何在这么短的时间内
做出如此深刻的理解？
11:03
in such a short time?
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1160
我们真的无法想象
一切是怎么发生的。
一切是怎么发生的。
11:04
We just could not comprehend
how this had happened.
how this had happened.
213
652363
3608
后来我们才发现，
11:07
So it turned out,
214
655995
1264
当时斯威特法官手下的助手
11:09
Judge Sweet's clerk
working for him at the time,
working for him at the time,
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657283
3310
不仅仅是一个律师——
11:12
was not just a lawyer --
216
660617
1480
他还是个科学家。
11:14
he was a scientist.
217
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1714
他又不仅仅是个科学家——
11:15
He was not just a scientist --
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663859
1598
他是分子生物学博士。
11:17
he had a PhD in molecular biology.
219
665481
3146
（笑声）
11:20
(Laughter)
220
668651
1751
我们真是太走运了！
11:22
What an incredible stroke of luck!
221
670426
2575
11:26
Myriad then appealed
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674058
1300
Myriad 随后
向美国联邦巡回上诉法庭上诉。
11:27
to the US Court of Appeals
for the Federal Circuit.
for the Federal Circuit.
223
675382
2495
11:30
And here things got really interesting.
224
678496
2016
然后事情就变得非常有意思了。
11:33
First, in a pivotal moment of this case,
225
681465
3060
首先，本案中的一个关键时刻，
11:37
the US government switched sides.
226
685187
2631
美国政府倒戈了。
11:40
So in the district court the government
submitted a brief on Myriad's side.
submitted a brief on Myriad's side.
227
688739
3749
在地区法庭上，
政府递交了一份简述支持 Myriad。
政府递交了一份简述支持 Myriad。
但是这回美国政府
直接反对了它自己的专利局，
直接反对了它自己的专利局，
11:44
But now in direct opposition
to its own patent office,
to its own patent office,
228
692512
5128
政府递交了一份摘要声明，
11:49
the US government files a brief
that states that is has
that states that is has
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697664
2708
他们基于地区法庭的判决，
重新考虑了问题，
重新考虑了问题，
11:52
reconsidered this issue
in light of the district court's opinion,
in light of the district court's opinion,
230
700396
3688
并认定离体 DNA
不具备申请专利的条件。
不具备申请专利的条件。
11:56
and has concluded that isolated DNA
is not patent eligible.
is not patent eligible.
231
704108
3186
11:59
This was a really big deal,
232
707818
1811
这件事意义非凡，
完全出人意料。
12:01
totally unexpected.
233
709653
1562
12:04
The Court of Appeals
for the Federal Circuit
for the Federal Circuit
234
712773
2080
联邦巡回上诉法庭
受理过所有的专利案例，
12:06
hears all patent cases,
235
714877
1683
对专利持坚决支持态度
也是众所周知。
也是众所周知。
12:08
and it has a reputation for being
very, very pro-patent.
very, very pro-patent.
236
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3158
12:12
So even with this remarkable development,
237
720305
2426
所以即使取得了如此长足的进步，
我们仍然觉得会败诉。
12:14
we expected to lose.
238
722755
1679
我们是败诉了。
12:16
And we did.
239
724458
1347
12:18
Sort of.
240
726389
1152
差不多吧。
12:20
Ends up split decision, 2 to 1.
241
728357
2587
结果是 2 比 1 的意见。
12:23
But the two judges who ruled against us,
242
731743
2496
但是两位反对我们的法官
选择了完全不同的理由。
12:26
did so for completely different reasons.
243
734263
2241
12:29
The first one, Judge Lourie,
244
737275
1826
第一位，法官洛里，
胡编乱造了他自己的生物理论 ——
12:31
made up his own novel,
biological theory --
biological theory --
245
739125
3015
完全是胡说八道。
12:34
totally wrong.
246
742164
1168
（笑声）
12:35
(Laughter)
247
743356
1011
他觉得 Myriad 制造了
一种新化学物质 ——
一种新化学物质 ——
12:36
He decided Myriad had created
a new chemical --
a new chemical --
248
744391
2218
驴唇不对马嘴。
12:38
made absolutely no sense.
249
746633
1865
Myriad 竟然对这一点没有争议，
真是令人大跌眼镜。
真是令人大跌眼镜。
12:40
Myriad didn't even argue this,
so it came out of the blue.
so it came out of the blue.
250
748522
2786
12:43
The other, Judge Moore,
251
751632
1977
另一位，法官莫尔，
说她基本同意我们说的
离体 DNA 是自然界的产物。
离体 DNA 是自然界的产物。
12:45
said she basically agreed with us
that isolated DNA is a product of nature.
that isolated DNA is a product of nature.
252
753633
3878
12:49
But she's like, "I don't want
to shake up the biotech industry."
to shake up the biotech industry."
253
757987
3333
但是她声称“我不想动摇
生物技术产业的根基”，等等。
生物技术产业的根基”，等等。
12:54
The third, Judge Bryson,
254
762248
2572
第三位，法官布里森，
12:57
agreed with us.
255
765233
1216
同意我们。
12:59
So now we sought review
by the Supreme Court.
by the Supreme Court.
256
767750
2531
于是我们申请最高法院复审。
当你向最高法院情愿时，
13:02
And when you petition the Supreme Court,
257
770305
2703
你需要提出一个
希望法院回应的问题。
希望法院回应的问题。
13:05
you have to present a question
that you want the Court to answer.
that you want the Court to answer.
258
773032
3122
13:08
Usually these questions take the form
of a super-long paragraph,
of a super-long paragraph,
259
776534
3727
通常这些问题都是长长的一段话，
从句套从句，可以写满一页，
13:12
like a whole page long
with lots and lots of clauses,
with lots and lots of clauses,
260
780285
3023
“其中包括”、“由此得知”，等等。
13:15
"wherein this" and "therefore that."
261
783332
2457
13:18
We submitted perhaps
the shortest question presented ever.
the shortest question presented ever.
262
786294
3907
我们提交了可能是
有史以来最短的问题。
有史以来最短的问题。
13:23
Four words:
263
791312
1213
四个词：
13:26
Are human genes patentable?
264
794220
2051
能否授予人类基因专利？
13:28
Now when Chris first asked me
what I thought of these words,
what I thought of these words,
265
796922
2824
克里斯第一次问我
觉得这个问题靠不靠谱时，
觉得这个问题靠不靠谱时，
我说，“我不知道。
13:31
I said, "Well, I don't know.
266
799770
1374
我想你可能得说，
‘能否授予离体 DNA 专利？’”
‘能否授予离体 DNA 专利？’”
13:33
I think you have to say,
'Is isolated DNA patentable?'"
'Is isolated DNA patentable?'"
267
801168
3167
13:36
"Nope.
268
804968
1169
“非也。
13:38
I want the justices to have
the very same reaction that I had
the very same reaction that I had
269
806487
4621
我希望大法官的反应能和我在七年前
你跟我提这个问题时一模一样。”
13:43
when you brought this issue
to me seven years ago."
to me seven years ago."
270
811132
3087
13:46
Well, I certainly couldn't
argue with that.
argue with that.
271
814896
2157
好吧，我当然没理由反驳。
13:49
The Supreme Court only hears
about one percent
about one percent
272
817981
2883
最高法院只受理大约 1%
收到的案件，
13:52
of the cases that it receives,
273
820888
1666
他们接受了我们的。
13:54
and it agreed to hear ours.
274
822578
1591
13:57
The day of the oral argument arrives,
and it was really, really exciting --
and it was really, really exciting --
275
825772
4127
口头辩论那天到来时，
真的是太激动人心了——
真的是太激动人心了——
法庭外排起了长队，
14:01
long line of people outside,
276
829923
1435
人们从凌晨 2:30 起就开始排队，
14:03
people had been standing in line
since 2:30 in the morning
since 2:30 in the morning
277
831382
2764
希望能挤进法庭。
14:06
to try to get into the courthouse.
278
834170
1734
两个乳腺癌的组织，
14:07
Two breast cancer organizations,
279
835928
1971
乳腺癌行动组织和 FORCE，
14:09
Breast Cancer Action and FORCE,
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在法庭台阶上组织声援。
14:11
had organized a demonstration
on the courthouse steps.
on the courthouse steps.
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14:15
Chris and I sat quietly in the hallway,
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克里斯和我坐在走廊里一声不响，
14:18
moments before he was to walk in and argue
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随后他走进法庭，
为他职业生涯中最重要的案件辩护。
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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我显然比他更紧张。
14:28
But any remaining panic subsided
as I walked into the courtroom
as I walked into the courtroom
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但是当我走进法庭时，
所有的慌张都不见了。
所有的慌张都不见了。
我看到周围都是熟悉的面孔：
14:32
and looked around
at a sea of friendly faces:
at a sea of friendly faces:
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14:36
our individual women clients
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我们的一位位女性客户，
她们毫无保留地分享了
自己的亲身经历；
自己的亲身经历；
14:37
who had shared their
deeply personal stories,
deeply personal stories,
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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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有在百忙之中抽出大量时间
投身于这场斗争的遗传学家，
14:44
to dedicate themselves to this fight
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14:47
and representatives from a diverse array
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还有来自许多不同领域的代表：
医疗、患者救助、
14:49
of medical, patient advocacy,
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环保和宗教组织，
14:51
environmental and religious organizations,
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以及本案中向法院递交摘要的朋友。
14:53
who had submitted friend of the court
briefs in the case.
briefs in the case.
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14:58
Also in the room were three leaders
of the Human Genome Project,
of the Human Genome Project,
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同时在场的还有
三位人类基因组计划的先驱者，
三位人类基因组计划的先驱者，
包括 DNA 的发现者之一，
15:01
including the co-discoverer
of DNA himself,
of DNA himself,
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詹姆斯·沃森。
15:04
James Watson,
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他也向法庭递交了简述，
15:05
who had submitted a brief to the court,
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其中他指出基因专利是“疯子行为”。
15:07
where he referred
to gene patenting as "lunacy."
to gene patenting as "lunacy."
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（笑声）
15:11
(Laughter)
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出席法庭的群体背景之广，
15:13
The diversity of the communities
represented in this room
represented in this room
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以及他们中每一位
为实现这一天而做出的贡献，
为实现这一天而做出的贡献，
15:16
and the contributions each had made
to make this day a reality
to make this day a reality
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都为我们岌岌可危的局势
打了一剂了强心针。
打了一剂了强心针。
15:20
spoke volumes to what was at stake.
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15:23
The argument itself was riveting.
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辩论本身非常有说服力。
15:26
Chris argued brilliantly.
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1663
克里斯出色地完成了辩论。
但是对我而言，
15:27
But for me,
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最激动人心的一刻是
看着最高法院的大法官
看着最高法院的大法官
15:29
the most thrilling aspect was watching
the Supreme Court justices grapple
the Supreme Court justices grapple
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3764
为离体 DNA 激烈争论，
15:32
with isolated DNA,
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920949
1569
换着花样打比方，
激烈地交换意见，
激烈地交换意见，
15:34
through a series of colorful analogies
and feisty exchanges,
and feisty exchanges,
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就和我们的法律团队
15:37
very much the same way
as our legal team had done
as our legal team had done
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过去七年中所做的一样。
15:41
for the past seven years.
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1690
15:43
Justice Kagan likened isolating DNA
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2656
大法官卡根把离体 DNA 比作
从亚马孙雨林中提取医疗植物。
15:46
to extracting a medicinal plant
from the Amazon.
from the Amazon.
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2776
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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4010
大法官罗伯茨把它比作
把树木雕成棒球棒。
把树木雕成棒球棒。
15:55
And in one of my absolutely
favorite moments,
favorite moments,
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以及绝对是我最喜欢的一个瞬间，
大法官索托马约尔宣称
离体 DNA “就是自然存在的”。
离体 DNA “就是自然存在的”。
15:58
Justice Sotomayor proclaimed isolated DNA
to be "just nature sitting there."
to be "just nature sitting there."
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（笑声）
16:03
(Laughter)
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1100
16:05
We felt pretty confident
leaving the courtroom that day,
leaving the courtroom that day,
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2875
我们那天离开法庭时信心满满，
但我从未奢望这样的结局：
16:08
but I could never have
anticipated the outcome:
anticipated the outcome:
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3006
16:12
nine to zero.
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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
是自然界的产物，
是自然界的产物，
并不因为它被分离出体外
就可以被授予专利。
就可以被授予专利。
16:18
and not patent-eligible merely because
it has been isolated.
it has been isolated.
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3047
16:22
And furthermore,
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1347
另外，
Myriad 并没有创造任何东西。”
16:23
Myriad did not create anything."
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2545
16:28
Within 24 hours of the decision,
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1996
判决生效后 24 小时内，
就有五个实验室宣布
16:30
five labs had announced
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1392
他们将开始提供 BRCA 基因的检测服务。
16:31
that they would begin to offer testing
for the BRCA genes.
for the BRCA genes.
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979596
3014
16:35
Some of them promised to offer the tests
at a lower price than Myriad's.
at a lower price than Myriad's.
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3483
他们有些承诺检测的价格
将比 Myriad 的要低。
将比 Myriad 的要低。
16:39
Some promised to provide
a more comprehensive test
a more comprehensive test
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2920
有些承诺将提供更全面的检测，
比 Myriad 提供的更多。
16:42
than the one Myriad was offering.
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1683
16:44
But of course the decision
goes far beyond Myriad.
goes far beyond Myriad.
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992490
2838
不过显然，
这个决定远远不止影响 Myriad。
这个决定远远不止影响 Myriad。
它终结了美国境内 25 年来
允许授予人类基因专利的行为。
允许授予人类基因专利的行为。
16:47
It ends a 25-year practice
of allowing patents on human genes
of allowing patents on human genes
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4396
16:51
in the United States.
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1207
16:53
It clears a significant barrier
to biomedical discovery and innovation.
to biomedical discovery and innovation.
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4693
它为生物医疗领域的发现和创新
扫除了一个重要的障碍。
扫除了一个重要的障碍。
16:58
And it helps to ensure that patients
like Abigail, Kathleen and Eileen
like Abigail, Kathleen and Eileen
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它也有助于保证
像阿比盖尔、卡瑟琳和艾琳这样的患者
像阿比盖尔、卡瑟琳和艾琳这样的患者
能够获得她们所需要的检测。
17:03
have access to the tests that they need.
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17:06
A few weeks after the court
issued its decision,
issued its decision,
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最高法院宣判几周之后，
我收到了一个邮件小包。
17:10
I received a small package in the mail.
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2260
17:13
It was from Bob Cook-Deegan,
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1021246
1607
是鲍勃·库克-德根寄来的，
他是杜克大学的教授，
17:14
a professor at Duke University
341
1022877
2269
是我和克里斯开始考虑
是否要开始准备此案时
是否要开始准备此案时
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
最先拜访的人之一。
17:20
when we started to consider
whether to bring this case.
whether to bring this case.
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2699
17:24
I opened it up to find
a small stuffed animal.
a small stuffed animal.
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2809
我打开包裹，
里面是一个小小的毛绒玩具。
里面是一个小小的毛绒玩具。
17:28
(Laughter)
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2959
（笑声）
17:33
We took a big risk in taking this case.
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2328
为了这个案件，
我们冒了很大的风险。
我们冒了很大的风险。
17:36
Part of what gave us the courage
to take that risk
to take that risk
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1044722
2510
给予我们勇气面对风险的部分原因
是我们知道我们在做正确的事。
17:39
was knowing that we were doing
the right thing.
the right thing.
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2438
17:42
The process took nearly eight years
from the start to finish,
from the start to finish,
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1050079
3730
从开始到结束，
整个过程将近八年，
整个过程将近八年，
经历了许多曲折和反复。
17:45
with many twists and turns along the way.
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2221
17:48
A little luck certainly helped,
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1056578
1691
当然还借助了一点点运气，
17:50
but it was the communities
that we bridged,
that we bridged,
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2812
但正是我们牵线拉到一起的群体，
正是我们创造的同盟，
17:53
the alliances that we created,
353
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2091
让猪也飞上了天。
17:55
that made pigs fly.
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1420
17:57
Thank you.
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1156
谢谢。
（掌声）
17:58
(Applause)
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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