Tania Simoncelli: Should you be able to patent a human gene?
ターニャ・シモンチェリ: 遺伝子特許業界と争い、勝利を収めるまで
Tania Simoncelli advises the White House on science and technology policy. Full bio
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as the organization's science advisor.
科学顧問として勤務していました
just a little bit discouraged.
to my colleague Chris Hansen's office.
同僚のクリス・ハンセンの部屋に行きました
for more than 30 years,
アメリカ自由人権協会で働いてきたので
knowledge and insights.
見識もありました
that I was feeling a little bit stuck.
クリスに打ち明けたのです
a number of issues
and civil liberties -- super interesting.
すごく面白い仕事です
these issues in a much bigger way,
こういった問題に関わって
make a difference.
to the chase, and he says,
looking at, what are the top five?"
トップ5は何だい?」
for lie detection, and ...
on part of the human body?
and sent Chris three articles.
クリスに記事を3つ送りました
he came bursting in my office.
私の部屋に入ってきて言いました
about patent law
but I wasn't even a lawyer,
弁護士ではないし
before we could file a lawsuit.
たくさん学ぶことがあるのは明らかでした
exactly what was patented
遺伝子特許では
dozens of claims,
数十の特許請求を含みますが
are to so-called "isolated DNA" --
いわゆる「単離DNA」 つまり
that has been removed from a cell.
the gene in your body,
身体の中にある遺伝子ではなく
of the gene requires that it be isolated.
必ず単離しなければならないことです
to a particular gene that they isolated,
単離した特定の遺伝子だけでなく
version of that gene.
含むのです
your gene to your doctor
不可能になります
has the right to stop anyone
研究や臨床試験を止めさせる権利を
in research or clinical testing.
was harming patients.
被害を受けるのは患者です
if left untreated,
genes associated with this condition
2つの遺伝子の特許を持つ企業が
開発しました
and they never offered it.
検査は実施されませんでした
threatened to sue the lab
その研究所を
診断を受けられず 亡くなりました
and were harming patients.
患者を苦しめていました
we could challenge them?
手段はあったのでしょうか?
through a long line of cases,
特許適格性のない物が
are not patent eligible.
elements of the periodic table.
載っている物質などです
特許は取れません
and must remain free to all
誰でも自由に使えるべきであり
of all of our proteins,
and a law of nature,
自然法則だと考えたのです
to speak with many different experts --
いろいろな専門家と話しました
lawyers, patent lawyers.
法律家や 特許法の専門家たちです
as a matter of policy,
理論上 法律面でも
as a matter of law.
a gene-patent challenge
had been issuing these patents
20年以上前から
of patents on human genes.
文字通り 数千件あったのです
entrenched in the status quo,
深く根付いていて
around this practice,
この慣行を基に成長していました
had been introduced
何年にも渡って
to overturn these patents.
覆すことはないだろうと言うのです
to shy away from a challenge,
逃げるタイプではありませんでした
just isn't enough,"
言われると なおさら
to take on this fight.
当然に思えました
Company A sues Company B
例えば A社が B社を
obscure technical issue.
技術上の問題を巡って訴えます
in that kind of case,
そういう訴訟に関心はなく
was much bigger than that.
はるかに重大だと考えました
medical progress,
そして患者の権利に関する
to develop a case
your typical patent case --
公民権訴訟という扱いに
a gene-patent holder
of plaintiffs and experts
専門家の集団を組織して
were harming patients and innovation.
主張する準備をしました
to sue in Myriad Genetics,
ミリアド・ジェネティクス社を見つけました
in Salt Lake City, Utah.
拠点とする企業です
特許を持っていました
along these genes
at a significantly increased risk
in the United States.
排他的独占権を維持しようとしており
that were offering BRCA testing to stop.
複数の研究所に待ったをかけました
scientific community.
to include additional mutations
新たに特定した変異を検査項目に加え
by a team of researchers in France.
拒否し続けたのです
that during that period,
undergoing testing
実に12%が
that should have been positive.
陰性という結果を受けていたのです
developed breast cancer at age 40
40歳の時に乳がんを発症し
most likely didn't run in the family,
おそらく家族からの遺伝ではなく
didn't need to be tested.
思ったからです
with advanced-stage ovarian cancer.
かなり進行していると診断されました
was among the 12 percent
誤って陰性と判定された
正しい検査結果を受けていれば
could have been prevented.
かもしれません
of plaintiffs and experts
原告団を組織する
highly committed plaintiffs:
意欲的な原告が集まりました
cease and desist letters,
遺伝学者
that collectively represented
科学者と医療関係者を代表する
and medical professionals,
couldn't afford Myriad's test,
受けるお金がなかったり
a second opinion but could not,
聞けなかった
we had in preparing the case
to communicate the science.
伝えるかということでした
was not an invention,
「発明」ではなく
were products of nature,
天然物だと立証するために
of basic concepts, like:
いくつか説明する必要がありました
and why isn't that an invention?
なぜ それは発明とは言えないのか?
with our plaintiffs and experts,
原告団や専門家と一緒に
of explaining these concepts
正確に説明する方法を
on the use of metaphors,
多くなりました
the process for mining the gold,
できるかもしれませんが
of hard work and effort
重労働と大変な努力が
it's still gold.
金なのですから
for all sorts of things
for when it was in the mountain;
利用できませんが
out of it for example --
例えば宝飾品を作れます
it's still gold.
金は金なのです
and we're ready to file our case.
訴訟を起こす準備ができました
in the Southern District of New York,
連邦裁判所に提訴し
to Judge Robert Sweet.
ロバート・スウィート判事が担当になりました
issued his opinion --
意見を公表しました
he described the science in the case.
とても雄弁に説明していることに驚きました
it was pretty good,
結構いい出来でしたが
understanding of this issue
この件を これほど短期間に 深く
how this had happened.
わかりませんでした
working for him at the time,
事務官は
for the Federal Circuit.
submitted a brief on Myriad's side.
擁護する書面を提出していました
to its own patent office,
特許庁とは正反対の立場をとり
that states that is has
in light of the district court's opinion,
この件を再検討した結果
is not patent eligible.
結論づけたのです
for the Federal Circuit
very, very pro-patent.
知られています
進展があっても
敗訴判決を下した理由は
biological theory --
仮説を立てましたが
a new chemical --
作ったと判断したのです
so it came out of the blue.
唐突な判断でした
that isolated DNA is a product of nature.
基本的には私たちに賛成しましたが
to shake up the biotech industry."
いう意見でした
by the Supreme Court.
再審理の申し立てをしました
that you want the Court to answer.
質問を提出する必要があります
of a super-long paragraph,
非常に長い文章になります
with lots and lots of clauses,
「それゆえ」といった
the shortest question presented ever.
史上 最も短いものでしょう
what I thought of these words,
クリスが最初に聞いてきた時
「どうでしょう —
'Is isolated DNA patentable?'"
言うべきでは」
the very same reaction that I had
私のところに持ってきた時と
to me seven years ago."
裁判官にも味わわせたいんだ」
argue with that.
about one percent
and it was really, really exciting --
私は本当に興奮していました
since 2:30 in the morning
午前2時半から
on the courthouse steps.
静かに座っていました
重要な訴訟で口頭弁論をする
as I walked into the courtroom
聞こえていた外の喧騒は静まりました
at a sea of friendly faces:
deeply personal stories,
of time out of their busy careers
この法廷闘争に身を捧げてくれた
briefs in the case.
代表者たちもいました
of the Human Genome Project,
3名もいました
of DNA himself,
to gene patenting as "lunacy."
「狂気の沙汰」と言いました
represented in this room
様々な団体が
to make this day a reality
それぞれ 貢献してきたこと自体
the Supreme Court justices grapple
単離DNAに取り組む最高裁判事たちの
and feisty exchanges,
活発に議論する様子は
as our legal team had done
過去7年間してきたのと
from the Amazon.
成分を抽出することにたとえました
from carving a baseball bat from a tree.
木からバットを作るのとは違うと述べました
favorite moments,
to be "just nature sitting there."
「ただ そこに自然があるだけ」と述べたのです
leaving the courtroom that day,
かなり自信はありましたが
anticipated the outcome:
予想していませんでした
is a product of nature,
天然物であり
it has been isolated.
特許保護適格性を持たない
for the BRCA genes.
開始すると発表しました
at a lower price than Myriad's.
実施するという所もいくつかありました
a more comprehensive test
goes far beyond Myriad.
ミリアド社問題に留まらず
of allowing patents on human genes
アメリカで25年間続いた慣例に
to biomedical discovery and innovation.
大きな障壁を取り払っています
like Abigail, Kathleen and Eileen
アイリーンのような患者たちが
issued its decision,
数週間後
Chris and I went to visit
検討し始めた頃
whether to bring this case.
a small stuffed animal.
入っていました
訴訟を起こしました
to take that risk
the right thing.
from the start to finish,
8年近くかかり
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