Should you be able to patent a human gene?
-
0:01 - 0:05It was an afternoon in the fall of 2005.
-
0:05 - 0:09I was working at the ACLU
as the organization's science advisor. -
0:09 - 0:12I really, really loved my job,
-
0:12 - 0:14but I was having one of those days
-
0:14 - 0:16where I was feeling
just a little bit discouraged. -
0:17 - 0:21So I wandered down the hallway
to my colleague Chris Hansen's office. -
0:22 - 0:26Chris had been at the ACLU
for more than 30 years, -
0:26 - 0:29so he had deep institutional
knowledge and insights. -
0:30 - 0:33I explained to Chris
that I was feeling a little bit stuck. -
0:34 - 0:36I had been investigating
a number of issues -
0:36 - 0:41at the intersection of science
and civil liberties -- super interesting. -
0:41 - 0:45But I wanted the ACLU to engage
these issues in a much bigger way, -
0:45 - 0:47in a way that could really
make a difference. -
0:50 - 0:52So Chris cut right
to the chase, and he says, -
0:52 - 0:55"Well, of all the issues you've been
looking at, what are the top five?" -
0:56 - 0:58"Well, there's genetic discrimination,
-
0:58 - 1:01and reproductive technologies,
-
1:01 - 1:03and biobanking, and ...
-
1:03 - 1:05oh, there's this really cool issue,
-
1:05 - 1:07functional MRI and using it
for lie detection, and ... -
1:07 - 1:09oh, and of course, there's gene patents."
-
1:10 - 1:11"Gene patents?"
-
1:12 - 1:14"Yes, you know, patents on human genes."
-
1:14 - 1:16"No!
-
1:16 - 1:18You're telling me that the US government
-
1:18 - 1:21has been issuing patents
on part of the human body? -
1:22 - 1:23That can't be right."
-
1:24 - 1:27I went back to my office
and sent Chris three articles. -
1:28 - 1:31And 20 minutes later,
he came bursting in my office. -
1:31 - 1:35"Oh my god! You're right! Who can we sue?"
-
1:35 - 1:37(Laughter)
-
1:38 - 1:40Now Chris is a really brilliant lawyer,
-
1:40 - 1:43but he knew almost nothing
about patent law -
1:43 - 1:45and certainly nothing about genetics.
-
1:46 - 1:48I knew something about genetics,
but I wasn't even a lawyer, -
1:48 - 1:50let alone a patent lawyer.
-
1:50 - 1:54So clearly we had a lot to learn
before we could file a lawsuit. -
1:54 - 1:57First, we needed to understand
exactly what was patented -
1:57 - 1:59when someone patented a gene.
-
2:00 - 2:04Gene patents typically contain
dozens of claims, -
2:04 - 2:08but the most controversial of these
are to so-called "isolated DNA" -- -
2:09 - 2:13namely, a piece of DNA
that has been removed from a cell. -
2:14 - 2:15Gene patent proponents say,
-
2:15 - 2:19"See? We didn't patent
the gene in your body, -
2:19 - 2:21we patented an isolated gene."
-
2:21 - 2:22And that's true,
-
2:22 - 2:29but the problem is that any use
of the gene requires that it be isolated. -
2:31 - 2:35And the patents weren't just
to a particular gene that they isolated, -
2:35 - 2:38but on every possible
version of that gene. -
2:38 - 2:40So what does that mean?
-
2:40 - 2:43That means that you can't give
your gene to your doctor -
2:43 - 2:45and ask him or her to look at it,
-
2:45 - 2:47say, to see if it has any mutations,
-
2:48 - 2:50without permission of the patent holder.
-
2:50 - 2:55It also means that the patent holder
has the right to stop anyone -
2:55 - 2:58from using that gene
in research or clinical testing. -
2:59 - 3:01Allowing patent holders,
-
3:01 - 3:02often private companies,
-
3:02 - 3:06to lock up stretches of the human genome
was harming patients. -
3:07 - 3:08Consider Abigail,
-
3:08 - 3:11a 10-year-old with long QT syndrome,
-
3:11 - 3:14a serious heart condition that,
if left untreated, -
3:14 - 3:16can result in sudden death.
-
3:17 - 3:21The company that obtained a patent on two
genes associated with this condition -
3:21 - 3:23developed a test to diagnose the syndrome.
-
3:23 - 3:26But then they went bankrupt
and they never offered it. -
3:27 - 3:29So another lab tried to offer the test,
-
3:29 - 3:32but the company that held the patents
threatened to sue the lab -
3:32 - 3:33for patent infringement.
-
3:33 - 3:34So as a result,
-
3:34 - 3:37for 2 years, no test was available.
-
3:38 - 3:39During that time,
-
3:39 - 3:43Abigail died of undiagnosed long QT.
-
3:44 - 3:47Gene patents clearly were a problem
and were harming patients. -
3:47 - 3:50But was there a way
we could challenge them? -
3:50 - 3:52Turns out that the Supreme Court
-
3:52 - 3:55has made clear
through a long line of cases, -
3:55 - 3:58that certain things
are not patent eligible. -
3:59 - 4:01You can't patent products of nature --
-
4:02 - 4:06the air, the water, minerals,
elements of the periodic table. -
4:07 - 4:09And you can't patent laws of nature --
-
4:10 - 4:12the law of gravity, E = mc2.
-
4:13 - 4:18These things are just too fundamental
and must remain free to all -
4:18 - 4:20and reserved exclusively to none.
-
4:20 - 4:22It seemed to us that DNA,
-
4:23 - 4:25the most fundamental structure of life,
-
4:25 - 4:28that codes for the production
of all of our proteins, -
4:28 - 4:31is both a product of nature
and a law of nature, -
4:31 - 4:34regardless of whether it's in our bodies
-
4:34 - 4:36or sitting in the bottom of a test tube.
-
4:37 - 4:38As we delved into this issue,
-
4:38 - 4:42we traveled all over the country
to speak with many different experts -- -
4:43 - 4:46scientists, medical professionals,
lawyers, patent lawyers. -
4:47 - 4:51Most of them agreed that we were right
as a matter of policy, -
4:51 - 4:53and, at least in theory,
as a matter of law. -
4:54 - 4:55All of them thought
-
4:55 - 4:58our chances of winning
a gene-patent challenge -
4:58 - 5:00were about zero.
-
5:02 - 5:03Why is that?
-
5:03 - 5:06Well, the patent office
had been issuing these patents -
5:06 - 5:08for more than 20 years.
-
5:09 - 5:12There were literally thousands
of patents on human genes. -
5:13 - 5:16The patent bar was deeply
entrenched in the status quo, -
5:17 - 5:20the biotech industry had grown up
around this practice, -
5:20 - 5:23and legislation to ban gene patents
had been introduced -
5:23 - 5:25year after year in Congress,
-
5:25 - 5:27and had gone absolutely nowhere.
-
5:27 - 5:29So the bottom line:
-
5:29 - 5:32courts just weren't going to be willing
to overturn these patents. -
5:33 - 5:38Now, neither Chris nor I were the type
to shy away from a challenge, -
5:38 - 5:41and hearing, "Being right
just isn't enough," -
5:41 - 5:43seemed all the more reason
to take on this fight. -
5:44 - 5:46So we set out to build our case.
-
5:47 - 5:51Now, patent cases tend to be:
Company A sues Company B -
5:51 - 5:54over some really narrow,
obscure technical issue. -
5:55 - 5:57We weren't really interested
in that kind of case, -
5:57 - 6:00and we thought this case
was much bigger than that. -
6:00 - 6:02This was about scientific freedom,
medical progress, -
6:02 - 6:04the rights of patients.
-
6:04 - 6:07So we decided we were going
to develop a case -
6:07 - 6:09that was not like
your typical patent case -- -
6:10 - 6:12more like a civil rights case.
-
6:13 - 6:16We set out to identify
a gene-patent holder -
6:16 - 6:18that was vigorously enforcing its patents
-
6:18 - 6:22and then to organize a broad coalition
of plaintiffs and experts -
6:22 - 6:24that could tell the court
-
6:24 - 6:28about all the ways that these patents
were harming patients and innovation. -
6:29 - 6:33We found the prime candidate
to sue in Myriad Genetics, -
6:33 - 6:35a company that's based
in Salt Lake City, Utah. -
6:37 - 6:39Myriad held patents on two genes,
-
6:39 - 6:42the BRCA1 and the BRCA2 genes.
-
6:43 - 6:46Women with certain mutations
along these genes -
6:46 - 6:49are considered to be
at a significantly increased risk -
6:49 - 6:51of developing breast and ovarian cancer.
-
6:52 - 6:54Myriad had used its patents to maintain
-
6:54 - 6:58a complete monopoly on BRCA testing
in the United States. -
6:59 - 7:03It had forced multiple labs
that were offering BRCA testing to stop. -
7:03 - 7:05It charged a lot of money for its test --
-
7:05 - 7:07over 3,000 dollars.
-
7:07 - 7:09It had stopped sharing its clinical data
-
7:09 - 7:12with the international
scientific community. -
7:13 - 7:14And perhaps worst of all,
-
7:14 - 7:17for a period of several years,
-
7:17 - 7:21Myriad refused to update its test
to include additional mutations -
7:21 - 7:24that had been identified
by a team of researchers in France. -
7:25 - 7:27It has been estimated
that during that period, -
7:28 - 7:29for several years,
-
7:29 - 7:33as many as 12 percent of women
undergoing testing -
7:33 - 7:35received the wrong answer --
-
7:36 - 7:40a negative test result
that should have been positive. -
7:41 - 7:43This is Kathleen Maxian.
-
7:44 - 7:47Kathleen's sister Eileen
developed breast cancer at age 40 -
7:47 - 7:49and she was tested by Myriad.
-
7:50 - 7:52The test was negative.
-
7:52 - 7:53The family was relieved.
-
7:53 - 7:57That meant that Eileen's cancer
most likely didn't run in the family, -
7:57 - 8:00and that other members of her family
didn't need to be tested. -
8:01 - 8:02But two years later,
-
8:02 - 8:06Kathleen was diagnosed
with advanced-stage ovarian cancer. -
8:07 - 8:11It turned out that Kathleen's sister
was among the 12 percent -
8:11 - 8:14who received a false-negative test result.
-
8:14 - 8:17Had Eileen received the proper result,
-
8:17 - 8:20Kathleen would have then been tested,
-
8:20 - 8:23and her ovarian cancer
could have been prevented. -
8:25 - 8:26Once we settled on Myriad,
-
8:26 - 8:30we then had to form a coalition
of plaintiffs and experts -
8:30 - 8:32that could illuminate these problems.
-
8:32 - 8:35We ended up with 20
highly committed plaintiffs: -
8:35 - 8:37genetic counselors,
-
8:37 - 8:40geneticists who had received
cease and desist letters, -
8:41 - 8:43advocacy organizations,
-
8:44 - 8:47four major scientific organizations
that collectively represented -
8:47 - 8:50more than 150,000 scientists
and medical professionals, -
8:51 - 8:54and individual women who either
couldn't afford Myriad's test, -
8:54 - 8:57or who wanted to obtain
a second opinion but could not, -
8:57 - 8:59as a result of the patents.
-
9:00 - 9:04One of the major challenges
we had in preparing the case -
9:04 - 9:07was figuring out how best
to communicate the science. -
9:07 - 9:11So in order to argue that what Myriad did
was not an invention, -
9:11 - 9:14and that isolated BRCA genes
were products of nature, -
9:15 - 9:18we had to explain a couple
of basic concepts, like: -
9:18 - 9:20What's a gene? What's DNA?
-
9:20 - 9:24How is DNA isolated,
and why isn't that an invention? -
9:25 - 9:29We spent hours and hours
with our plaintiffs and experts, -
9:29 - 9:32trying to come up with ways
of explaining these concepts -
9:32 - 9:34simply yet accurately.
-
9:34 - 9:38And we ended up relying heavily
on the use of metaphors, -
9:38 - 9:39like gold.
-
9:40 - 9:42So isolating DNA --
-
9:42 - 9:45it's like extracting gold from a mountain
-
9:45 - 9:47or taking it out of a stream bed.
-
9:47 - 9:51You might be able to patent
the process for mining the gold, -
9:51 - 9:53but you can't patent the gold itself.
-
9:54 - 9:57It might've taken a lot
of hard work and effort -
9:57 - 9:59to dig the gold out of the mountain;
-
9:59 - 10:01you still can't patent it,
it's still gold. -
10:01 - 10:03And the gold, once it's extracted,
-
10:03 - 10:05can clearly be used
for all sorts of things -
10:05 - 10:08that it couldn't be used
for when it was in the mountain; -
10:08 - 10:10you can make jewelry
out of it for example -- -
10:10 - 10:12still can't patent the gold,
it's still gold. -
10:13 - 10:17So now it's 2009,
and we're ready to file our case. -
10:18 - 10:22We filed in federal court
in the Southern District of New York, -
10:22 - 10:26and the case was randomly assigned
to Judge Robert Sweet. -
10:27 - 10:30In March 2010, Judge Sweet
issued his opinion -- -
10:31 - 10:32152 pages --
-
10:33 - 10:35and a complete victory for our side.
-
10:36 - 10:37In reading the opinion,
-
10:37 - 10:42we could not get over how eloquently
he described the science in the case. -
10:43 - 10:45I mean, our brief --
it was pretty good, -
10:45 - 10:47but not this good.
-
10:48 - 10:51How did he develop such a deep
understanding of this issue -
10:51 - 10:52in such a short time?
-
10:52 - 10:56We just could not comprehend
how this had happened. -
10:56 - 10:57So it turned out,
-
10:57 - 11:01Judge Sweet's clerk
working for him at the time, -
11:01 - 11:02was not just a lawyer --
-
11:02 - 11:04he was a scientist.
-
11:04 - 11:05He was not just a scientist --
-
11:05 - 11:09he had a PhD in molecular biology.
-
11:09 - 11:10(Laughter)
-
11:10 - 11:13What an incredible stroke of luck!
-
11:14 - 11:15Myriad then appealed
-
11:15 - 11:18to the US Court of Appeals
for the Federal Circuit. -
11:18 - 11:21And here things got really interesting.
-
11:21 - 11:25First, in a pivotal moment of this case,
-
11:25 - 11:28the US government switched sides.
-
11:29 - 11:32So in the district court the government
submitted a brief on Myriad's side. -
11:33 - 11:38But now in direct opposition
to its own patent office, -
11:38 - 11:40the US government files a brief
that states that is has -
11:40 - 11:44reconsidered this issue
in light of the district court's opinion, -
11:44 - 11:47and has concluded that isolated DNA
is not patent eligible. -
11:48 - 11:50This was a really big deal,
-
11:50 - 11:51totally unexpected.
-
11:53 - 11:55The Court of Appeals
for the Federal Circuit -
11:55 - 11:57hears all patent cases,
-
11:57 - 12:00and it has a reputation for being
very, very pro-patent. -
12:00 - 12:03So even with this remarkable development,
-
12:03 - 12:04we expected to lose.
-
12:04 - 12:06And we did.
-
12:06 - 12:08Sort of.
-
12:08 - 12:11Ends up split decision, 2 to 1.
-
12:12 - 12:14But the two judges who ruled against us,
-
12:14 - 12:17did so for completely different reasons.
-
12:17 - 12:19The first one, Judge Lourie,
-
12:19 - 12:22made up his own novel,
biological theory -- -
12:22 - 12:23totally wrong.
-
12:23 - 12:24(Laughter)
-
12:24 - 12:27He decided Myriad had created
a new chemical -- -
12:27 - 12:28made absolutely no sense.
-
12:29 - 12:31Myriad didn't even argue this,
so it came out of the blue. -
12:32 - 12:34The other, Judge Moore,
-
12:34 - 12:38said she basically agreed with us
that isolated DNA is a product of nature. -
12:38 - 12:41But she's like, "I don't want
to shake up the biotech industry." -
12:42 - 12:45The third, Judge Bryson,
-
12:45 - 12:46agreed with us.
-
12:48 - 12:50So now we sought review
by the Supreme Court. -
12:50 - 12:53And when you petition the Supreme Court,
-
12:53 - 12:56you have to present a question
that you want the Court to answer. -
12:57 - 13:00Usually these questions take the form
of a super-long paragraph, -
13:00 - 13:03like a whole page long
with lots and lots of clauses, -
13:03 - 13:06"wherein this" and "therefore that."
-
13:06 - 13:10We submitted perhaps
the shortest question presented ever. -
13:11 - 13:13Four words:
-
13:14 - 13:16Are human genes patentable?
-
13:17 - 13:20Now when Chris first asked me
what I thought of these words, -
13:20 - 13:21I said, "Well, I don't know.
-
13:21 - 13:24I think you have to say,
'Is isolated DNA patentable?'" -
13:25 - 13:26"Nope.
-
13:26 - 13:31I want the justices to have
the very same reaction that I had -
13:31 - 13:34when you brought this issue
to me seven years ago." -
13:35 - 13:37Well, I certainly couldn't
argue with that. -
13:38 - 13:41The Supreme Court only hears
about one percent -
13:41 - 13:43of the cases that it receives,
-
13:43 - 13:44and it agreed to hear ours.
-
13:46 - 13:50The day of the oral argument arrives,
and it was really, really exciting -- -
13:50 - 13:51long line of people outside,
-
13:51 - 13:54people had been standing in line
since 2:30 in the morning -
13:54 - 13:56to try to get into the courthouse.
-
13:56 - 13:58Two breast cancer organizations,
-
13:58 - 14:00Breast Cancer Action and FORCE,
-
14:00 - 14:02had organized a demonstration
on the courthouse steps. -
14:03 - 14:06Chris and I sat quietly in the hallway,
-
14:07 - 14:10moments before he was to walk in and argue
-
14:10 - 14:12the most important case of his career.
-
14:13 - 14:15I was clearly more nervous than he was.
-
14:16 - 14:21But any remaining panic subsided
as I walked into the courtroom -
14:21 - 14:24and looked around
at a sea of friendly faces: -
14:24 - 14:26our individual women clients
-
14:26 - 14:28who had shared their
deeply personal stories, -
14:29 - 14:33the geneticists who had taken huge chunks
of time out of their busy careers -
14:33 - 14:35to dedicate themselves to this fight
-
14:35 - 14:38and representatives from a diverse array
-
14:38 - 14:40of medical, patient advocacy,
-
14:40 - 14:42environmental and religious organizations,
-
14:42 - 14:45who had submitted friend of the court
briefs in the case. -
14:47 - 14:50Also in the room were three leaders
of the Human Genome Project, -
14:50 - 14:52including the co-discoverer
of DNA himself, -
14:52 - 14:54James Watson,
-
14:54 - 14:56who had submitted a brief to the court,
-
14:56 - 14:59where he referred
to gene patenting as "lunacy." -
14:59 - 15:01(Laughter)
-
15:01 - 15:05The diversity of the communities
represented in this room -
15:05 - 15:08and the contributions each had made
to make this day a reality -
15:08 - 15:11spoke volumes to what was at stake.
-
15:11 - 15:14The argument itself was riveting.
-
15:14 - 15:16Chris argued brilliantly.
-
15:16 - 15:17But for me,
-
15:17 - 15:21the most thrilling aspect was watching
the Supreme Court justices grapple -
15:21 - 15:23with isolated DNA,
-
15:23 - 15:26through a series of colorful analogies
and feisty exchanges, -
15:26 - 15:29very much the same way
as our legal team had done -
15:29 - 15:31for the past seven years.
-
15:32 - 15:34Justice Kagan likened isolating DNA
-
15:34 - 15:37to extracting a medicinal plant
from the Amazon. -
15:39 - 15:43Justice Roberts distinguished it
from carving a baseball bat from a tree. -
15:44 - 15:46And in one of my absolutely
favorite moments, -
15:47 - 15:52Justice Sotomayor proclaimed isolated DNA
to be "just nature sitting there." -
15:52 - 15:53(Laughter)
-
15:53 - 15:56We felt pretty confident
leaving the courtroom that day, -
15:56 - 15:59but I could never have
anticipated the outcome: -
16:01 - 16:02nine to zero.
-
16:03 - 16:07"A naturally occurring DNA segment
is a product of nature, -
16:07 - 16:10and not patent-eligible merely because
it has been isolated. -
16:10 - 16:12And furthermore,
-
16:12 - 16:14Myriad did not create anything."
-
16:16 - 16:18Within 24 hours of the decision,
-
16:18 - 16:20five labs had announced
-
16:20 - 16:23that they would begin to offer testing
for the BRCA genes. -
16:23 - 16:27Some of them promised to offer the tests
at a lower price than Myriad's. -
16:27 - 16:30Some promised to provide
a more comprehensive test -
16:30 - 16:32than the one Myriad was offering.
-
16:32 - 16:35But of course the decision
goes far beyond Myriad. -
16:35 - 16:40It ends a 25-year practice
of allowing patents on human genes -
16:40 - 16:41in the United States.
-
16:41 - 16:46It clears a significant barrier
to biomedical discovery and innovation. -
16:46 - 16:51And it helps to ensure that patients
like Abigail, Kathleen and Eileen -
16:51 - 16:54have access to the tests that they need.
-
16:55 - 16:58A few weeks after the court
issued its decision, -
16:58 - 17:00I received a small package in the mail.
-
17:01 - 17:03It was from Bob Cook-Deegan,
-
17:03 - 17:05a professor at Duke University
-
17:05 - 17:08and one the very first people
Chris and I went to visit -
17:08 - 17:11when we started to consider
whether to bring this case. -
17:12 - 17:15I opened it up to find
a small stuffed animal. -
17:16 - 17:19(Laughter)
-
17:22 - 17:24We took a big risk in taking this case.
-
17:25 - 17:27Part of what gave us the courage
to take that risk -
17:27 - 17:30was knowing that we were doing
the right thing. -
17:30 - 17:34The process took nearly eight years
from the start to finish, -
17:34 - 17:36with many twists and turns along the way.
-
17:37 - 17:38A little luck certainly helped,
-
17:39 - 17:42but it was the communities
that we bridged, -
17:42 - 17:44the alliances that we created,
-
17:44 - 17:45that made pigs fly.
-
17:46 - 17:47Thank you.
-
17:47 - 17:52(Applause)
- Title:
- Should you be able to patent a human gene?
- Speaker:
- Tania Simoncelli
- Description:
-
Are human genes patentable? Back in 2005, when Tania Simoncelli first contemplated this complex question, US patent law said they were -- which meant patent holders had the right to stop anyone from sequencing, testing or even looking at a patented gene. Troubled by the way this law both harmed patients and created a barrier to biomedical innovation, Simoncelli and her colleagues at the ACLU challenged it. In this riveting talk, hear the story of how they took a case everybody told them they would lose all the way to the Supreme Court.
- Video Language:
- English
- Team:
- closed TED
- Project:
- TEDTalks
- Duration:
- 18:05
Brian Greene commented on English subtitles for Should you be able to patent a human gene? | ||
Brian Greene edited English subtitles for Should you be able to patent a human gene? | ||
Brian Greene edited English subtitles for Should you be able to patent a human gene? | ||
Brian Greene approved English subtitles for Should you be able to patent a human gene? | ||
Brian Greene edited English subtitles for Should you be able to patent a human gene? | ||
Brian Greene edited English subtitles for Should you be able to patent a human gene? | ||
Brian Greene edited English subtitles for Should you be able to patent a human gene? | ||
Brian Greene edited English subtitles for Should you be able to patent a human gene? |
Brian Greene
The headline for this talk has been changed.
The new headline is:
Should you be able to patent a human gene?