Tania Simoncelli: Should you be able to patent a human gene?
Tanja Simončeli (Tania Simoncelli): Treba li omogućiti patentiranje ljudskih gena?
Tania Simoncelli advises the White House on science and technology policy. Full bio
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as the organization's science advisor.
za građanske slobode kao naučni savetnik.
just a little bit discouraged.
to my colleague Chris Hansen's office.
do kancelarije mog kolege Krisa Hansena.
for more than 30 years,
duže od 30 godina,
knowledge and insights.
funkcionisanje organizacije.
that I was feeling a little bit stuck.
a number of issues
and civil liberties -- super interesting.
i slobode građana - super zanimljivo.
these issues in a much bigger way,
mnogo ozbiljnije posveti ovim pitanjima,
make a difference.
to the chase, and he says,
looking at, what are the top five?"
kojih pet izdvajaš?“
i njeno korišćenje za otkrivanje laži
for lie detection, and ...
on part of the human body?
and sent Chris three articles.
i poslala Krisu tri članka.
he came bursting in my office.
uleteo je u moju kancelariju.
Koga možemo da tužimo?“
about patent law
o Zakonu o patentima,
but I wasn't even a lawyer,
ali nisam bila advokat,
before we could file a lawsuit.
pre nego što podnesemo tužbu.
exactly what was patented
šta se tačno patentira
dozens of claims,
obično sadrže više desetina tvrdnji,
are to so-called "isolated DNA" --
je takozvana izolovana DNK -
that has been removed from a cell.
the gene in your body,
gen u vašem telu,
of the gene requires that it be isolated.
zahteva da on bude izolovan.
to a particular gene that they isolated,
samo određene izolovane gene,
version of that gene.
your gene to your doctor
svoj gen svom lekaru
kakvih mutacija
has the right to stop anyone
ima pravo da zabrani bilo kome
in research or clinical testing.
ili za klinička ispitivanja.
was harming patients.
štetilo je pacijentima.
sa sindrom produženog QT intervala,
if left untreated,
ako se ne leči,
genes associated with this condition
nad dva gena vezana za ovu bolest
za dijagnozu ovog sindroma.
and they never offered it.
i nikad ga nisu ponudili.
threatened to sue the lab
pretila im je tužbom
produženog QT intervala.
and were harming patients.
problem i štetili su pacijentima.
we could challenge them?
through a long line of cases,
are not patent eligible.
nije moguće patentirati.
elements of the periodic table.
elementi periodnog sistema.
and must remain free to all
i moraju biti besplatne za sve,
of all of our proteins,
svih naših belančevina,
and a law of nature,
proizvod prirode i zakon prirode,
da li se nalazi u našim telima
to speak with many different experts --
razgovarali sa različitim stručnjacima
lawyers, patent lawyers.
advokatima, zastupnicima za patente.
as a matter of policy,
da smo u pravu u pogledu politike
as a matter of law.
a gene-patent challenge
patentiranje nad genima
had been issuing these patents
je izdavala ove patente
of patents on human genes.
nad ljudskim genima.
entrenched in the status quo,
se duboko ukopala u status kvo,
around this practice,
se razvila oko ovakve prakse,
had been introduced
to overturn these patents.
da ponište ove patente.
to shy away from a challenge,
što se povlače pred izazovima,
just isn't enough,"
samo biti u pravu“
to take on this fight.
da započnemo ovu borbu.
Company A sues Company B
kompanija A tuži kompaniju B
obscure technical issue.
in that kind of case,
mnogo širi od toga.
was much bigger than that.
napretku medicine,
medical progress,
to develop a case
your typical patent case --
vezanih za patente,
građanskih prava.
a gene-patent holder
nosioca patenta nad genima
svoja patentna prava,
of plaintiffs and experts
široku koaliciju tužitelja i stručnjaka
were harming patients and innovation.
štete pacijentima i inovacijama.
to sue in Myriad Genetics,
smo pronašli u Mirijad Dženetiks,
in Salt Lake City, Utah.
u Solt Lejk Sitiju, u Juti.
along these genes
u ovim genima
at a significantly increased risk
znatno većem riziku
da bi zadržao potpuni monopol
in the United States.
that were offering BRCA testing to stop.
sa ponudom testiranja BRCA da to prekinu.
scientific community.
to include additional mutations
kako bi uključio dodatne mutacije
by a team of researchers in France.
iz Francuske.
that during that period,
undergoing testing
that should have been positive.
koji je trebalo da bude pozitivan.
developed breast cancer at age 40
rak dojke sa 40 godina
most likely didn't run in the family,
najverovatnije nije nasledan
didn't need to be tested.
ne treba da se testiraju.
with advanced-stage ovarian cancer.
rak jajnika u odmakloj fazi.
was among the 12 percent
među onih 12 procenata
could have been prevented.
of plaintiffs and experts
tužitelja i stručnjaka
highly committed plaintiffs:
20 veoma posvećenih tužitelja:
cease and desist letters,
pisma sa zahtevom o obustavi rada,
that collectively represented
koje su zajedno predstavljale
and medical professionals,
i medicinskih stručnjaka,
couldn't afford Myriad's test,
da priušte Mirijadov test,
a second opinion but could not,
drugo mišljenje, ali nisu mogle,
we had in preparing the case
u pripremi predmeta
to communicate the science.
za objašnjenje nauke.
was not an invention,
da ono što je Mirijad uradio nije izum
were products of nature,
produkti prirode,
of basic concepts, like:
osnovne koncepte poput:
and why isn't that an invention?
with our plaintiffs and experts,
s našim tužiteljima i stručnjacima,
of explaining these concepts
da objasnimo ove pojmove
on the use of metaphors,
oslonili na upotrebu metafora,
the process for mining the gold,
proces vađenja zlata,
of hard work and effort
mnogo truda i rada
to je i dalje zlato.
it's still gold.
for all sorts of things
for when it was in the mountain;
dok je još uvek bilo u planini.
out of it for example --
i dalje je u pitanju zlato.
it's still gold.
and we're ready to file our case.
spremni smo da podnesemo našu tužbu.
in the Southern District of New York,
u Južnom okrugu Njujorka
to Judge Robert Sweet.
sudiji Robertu Svitu.
issued his opinion --
je objavio je svoje mišljenje
he described the science in the case.
opisao nauku u našem predmetu.
it was pretty good,
je bio prilično dobar,
understanding of this issue
tako duboko razumevanje ovog problema
how this had happened.
kako se to dogodilo.
working for him at the time,
koji je radio za njega u to vreme
for the Federal Circuit.
submitted a brief on Myriad's side.
dostavila podnesak u korist Mirijada.
to its own patent office,
svojoj kancelariji za patente,
that states that is has
u kom se navodi
in light of the district court's opinion,
mišljenja okružnog suda
is not patent eligible.
ne može biti patentirana.
for the Federal Circuit
very, very pro-patent.
da je izuzetno naklonjen patentima.
koji su doneli odluku protiv nas
biological theory --
neispitanu biološku teoriju,
a new chemical --
stvorio novu hemikaliju,
so it came out of the blue.
pa je bilo sasvim neočekivano.
that isolated DNA is a product of nature.
da je izolovana DNK produkt prirode,
to shake up the biotech industry."
biotehnološku industriju.“
by the Supreme Court.
pred Vrhovnim sudom.
that you want the Court to answer.
na koje želite da vam sud odgovori.
of a super-long paragraph,
super dugih pasusa,
with lots and lots of clauses,
sa mnogo, mnogo klauzula,
the shortest question presented ever.
najkraće pitanje ikada.
what I thought of these words,
šta mislim o ovim rečima,
'Može li se izolovana DNK patentirati?'“
'Is isolated DNA patentable?'"
the very same reaction that I had
na potpuno isti način kao i ja
to me seven years ago."
pre sedam godina.“
argue with that.
about one percent
and it was really, really exciting --
i bilo je veoma, veoma uzbudljivo -
since 2:30 in the morning
on the courthouse steps.
na stepeništu suda.
pre no što je trebalo da uđe
u svojoj karijeri.
as I walked into the courtroom
kad sam ušla u sudnicu
at a sea of friendly faces:
deeply personal stories,
of time out of their busy careers
veliki deo svog vremena
briefs in the case.
prijatelja suda u ovom predmetu.
of the Human Genome Project,
projekta Ljudski genom,
of DNA himself,
od pronalazača DNK lično,
to gene patenting as "lunacy."
opisao kao „ludilo“.
represented in this room
predstavljenih u toj prostoriji
to make this day a reality
da ovaj dan postane stvarnost,
o tome šta je na kocki.
je bilo upečatljivo.
the Supreme Court justices grapple
kako se sudije Vrhovnog suda bore
and feisty exchanges,
i eksplozivnih razmena,
as our legal team had done
na koji je naš pravni tim to radio
from the Amazon.
from carving a baseball bat from a tree.
s rezbarenjem palice za bejzbol iz drveta.
favorite moments,
najomiljenijih trenutaka,
to be "just nature sitting there."
proglasila je izolovanu DNK
leaving the courtroom that day,
kad smo napustili sudnicu tog dana,
anticipated the outcome:
is a product of nature,
jeste proizvod prirode
it has been isolated.
samo zato što je izolovan.
for the BRCA genes.
testiranje na BRCA gene.
at a lower price than Myriad's.
niže od Mirijadovih.
a more comprehensive test
goes far beyond Myriad.
od samog Mirijada.
of allowing patents on human genes
ljudskih gena u Sjedinjenim Državama.
to biomedical discovery and innovation.
biomedicinskim otkrićima i inovacijama
like Abigail, Kathleen and Eileen
poput Abigejl, Ketlin i Ajlin
koji su im potrebni.
issued its decision,
nakon što je sud doneo odluku,
Chris and I went to visit
koje smo Kris i ja posetili
whether to bring this case.
da li da pokrenemo ovaj slučaj.
a small stuffed animal.
ovu plišanu životinjicu.
pokrenuvši ovaj slučaj.
to take that risk
da preuzmemo taj rizik
the right thing.
da radimo pravu stvar.
from the start to finish,
od početka do kraja,
that we bridged,
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