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  • It was an afternoon in the fall of 2005.

    翻訳: Kazunori Akashi 校正: Eriko T

  • I was working at the ACLU as the organization's science advisor.

    2005年 ある秋の日の午後のことです

  • I really, really loved my job,

    私はアメリカ自由人権協会で 科学顧問として勤務していました

  • but I was having one of those days


  • where I was feeling just a little bit discouraged.


  • So I wandered down the hallway to my colleague Chris Hansen's office.


  • Chris had been at the ACLU for more than 30 years,

    それで ふらっと廊下に出て 同僚のクリス・ハンセンの部屋に行きました

  • so he had deep institutional knowledge and insights.

    クリスは30年以上も アメリカ自由人権協会で働いてきたので

  • I explained to Chris that I was feeling a little bit stuck.

    組織の知識が豊富で 見識もありました

  • I had been investigating a number of issues

    だから「行き詰った気がする」と クリスに打ち明けたのです

  • at the intersection of science and civil liberties -- super interesting.


  • But I wanted the ACLU to engage these issues in a much bigger way,

    いろいろな問題を調査してきました すごく面白い仕事です

  • in a way that could really make a difference.

    ただ 協会がもっと深く こういった問題に関わって

  • So Chris cut right to the chase, and he says,


  • "Well, of all the issues you've been looking at, what are the top five?"


  • "Well, there's genetic discrimination,

    「君が手がけている問題で トップ5は何だい?」

  • and reproductive technologies,

    「そうね 遺伝差別と

  • and biobanking, and ...


  • oh, there's this really cool issue,

    バイオバンク それから

  • functional MRI and using it for lie detection, and ...

    そう すごい問題があった

  • oh, and of course, there's gene patents."


  • "Gene patents?"


  • "Yes, you know, patents on human genes."


  • "No!

    「そう ヒト遺伝子の特許を取るの」

  • You're telling me that the US government


  • has been issuing patents on part of the human body?


  • That can't be right."


  • I went back to my office and sent Chris three articles.

    それは おかしいだろう」

  • And 20 minutes later, he came bursting in my office.

    そこで自分の部屋に戻って クリスに記事を3つ送りました

  • "Oh my god! You're right! Who can we sue?"

    20分後 彼がすごい勢いで 私の部屋に入ってきて言いました

  • (Laughter)

    「本当だ! 誰を訴える?」

  • Now Chris is a really brilliant lawyer,


  • but he knew almost nothing about patent law


  • and certainly nothing about genetics.

    特許法については ほとんど知識が無く

  • I knew something about genetics, but I wasn't even a lawyer,


  • let alone a patent lawyer.

    私は 遺伝学の知識はありますが 弁護士ではないし

  • So clearly we had a lot to learn before we could file a lawsuit.


  • First, we needed to understand exactly what was patented

    だから提訴するには たくさん学ぶことがあるのは明らかでした

  • when someone patented a gene.

    まず理解する必要があったのは 遺伝子特許では

  • Gene patents typically contain dozens of claims,


  • but the most controversial of these are to so-called "isolated DNA" --

    普通 遺伝子特許は 数十の特許請求を含みますが

  • namely, a piece of DNA that has been removed from a cell.

    中でも物議を醸しているのは いわゆる「単離DNA」 つまり

  • Gene patent proponents say,


  • "See? We didn't patent the gene in your body,

    遺伝子特許 擁護派は こう主張します

  • we patented an isolated gene."

    「我々が特許を取るのは 身体の中にある遺伝子ではなく

  • And that's true,


  • but the problem is that any use of the gene requires that it be isolated.

    確かに そうですが

  • And the patents weren't just to a particular gene that they isolated,

    問題なのは 遺伝子を利用するには 必ず単離しなければならないことです

  • but on every possible version of that gene.

    そして 特許の対象となるのは 単離した特定の遺伝子だけでなく

  • So what does that mean?

    その遺伝子のあらゆる変異を 含むのです

  • That means that you can't give your gene to your doctor


  • and ask him or her to look at it,


  • say, to see if it has any mutations,


  • without permission of the patent holder.


  • It also means that the patent holder has the right to stop anyone

    特許権者の許可がない限り 不可能になります

  • from using that gene in research or clinical testing.

    さらに その遺伝子を使った 研究や臨床試験を止めさせる権利を

  • Allowing patent holders,


  • often private companies,


  • to lock up stretches of the human genome was harming patients.

    私企業ですが 彼らが

  • Consider Abigail,

    ヒトゲノムの一部を確保できるなら 被害を受けるのは患者です

  • a 10-year-old with long QT syndrome,


  • a serious heart condition that, if left untreated,


  • can result in sudden death.

    これは深刻な心臓病で 治療しないと

  • The company that obtained a patent on two genes associated with this condition


  • developed a test to diagnose the syndrome.

    この病気に関係する 2つの遺伝子の特許を持つ企業が

  • But then they went bankrupt and they never offered it.

    この症候群を診断する検査を 開発しました

  • So another lab tried to offer the test,

    ところが この企業は倒産し 検査は実施されませんでした

  • but the company that held the patents threatened to sue the lab


  • for patent infringement.

    特許を持っていた企業は その研究所を

  • So as a result,


  • for 2 years, no test was available.


  • During that time,

    2年間 検査ができませんでした

  • Abigail died of undiagnosed long QT.


  • Gene patents clearly were a problem and were harming patients.

    アビゲイルはQT延長症候群の 診断を受けられず 亡くなりました

  • But was there a way we could challenge them?

    遺伝子特許には明らかに問題があり 患者を苦しめていました

  • Turns out that the Supreme Court

    でもこの状況に対抗する 手段はあったのでしょうか?

  • has made clear through a long line of cases,


  • that certain things are not patent eligible.

    最高裁は多くの訴訟を通じて 特許適格性のない物が

  • You can't patent products of nature --


  • the air, the water, minerals, elements of the periodic table.

    特許が取れないのは天然物 すなわち

  • And you can't patent laws of nature --

    空気や水、鉱物、元素周期表に 載っている物質などです

  • the law of gravity, E = mc2.

    また自然法則について 特許は取れません

  • These things are just too fundamental and must remain free to all

    万有引力の法則や E=mc^2 はだめです

  • and reserved exclusively to none.

    こういった極めて根本的な自然界の存在は 誰でも自由に使えるべきであり

  • It seemed to us that DNA,


  • the most fundamental structure of life,


  • that codes for the production of all of our proteins,


  • is both a product of nature and a law of nature,


  • regardless of whether it's in our bodies

    私たちは それを天然物であり 自然法則だと考えたのです

  • or sitting in the bottom of a test tube.


  • As we delved into this issue,


  • we traveled all over the country to speak with many different experts --


  • scientists, medical professionals, lawyers, patent lawyers.

    私たちは国中を飛び回って いろいろな専門家と話しました

  • Most of them agreed that we were right as a matter of policy,

    科学者や 医療の専門家 法律家や 特許法の専門家たちです

  • and, at least in theory, as a matter of law.

    ほとんどの人が政策面でも 理論上 法律面でも

  • All of them thought


  • our chances of winning a gene-patent challenge


  • were about zero.

    遺伝子特許を相手に訴えて 勝つ見込みは

  • Why is that?


  • Well, the patent office had been issuing these patents


  • for more than 20 years.

    実は特許庁は遺伝子特許を 20年以上前から

  • There were literally thousands of patents on human genes.


  • The patent bar was deeply entrenched in the status quo,

    ヒト遺伝子の特許は 文字通り 数千件あったのです

  • the biotech industry had grown up around this practice,

    特許による参入障壁が 深く根付いていて

  • and legislation to ban gene patents had been introduced

    バイオ産業は この慣行を基に成長していました

  • year after year in Congress,

    遺伝特許を禁ずる法案は 何年にも渡って

  • and had gone absolutely nowhere.


  • So the bottom line:


  • courts just weren't going to be willing to overturn these patents.


  • Now, neither Chris nor I were the type to shy away from a challenge,

    裁判所が これらの特許を 覆すことはないだろうと言うのです

  • and hearing, "Being right just isn't enough,"

    クリスも私も困難なことから 逃げるタイプではありませんでした

  • seemed all the more reason to take on this fight.

    それに「正しいだけではだめ」などと 言われると なおさら

  • So we set out to build our case.

    勝負を受けて立つのが 当然に思えました

  • Now, patent cases tend to be: Company A sues Company B


  • over some really narrow, obscure technical issue.

    特許訴訟の一般的な形では 例えば A社が B社を

  • We weren't really interested in that kind of case,

    とても細かく難解な 技術上の問題を巡って訴えます

  • and we thought this case was much bigger than that.

    でも私たちは そういう訴訟に関心はなく

  • This was about scientific freedom, medical progress,

    このテーマは はるかに重大だと考えました

  • the rights of patients.

    科学の自由と医療の進歩 そして患者の権利に関する

  • So we decided we were going to develop a case


  • that was not like your typical patent case --

    だから私たちは この訴訟の方向性を

  • more like a civil rights case.

    一般的な特許訴訟ではなく 公民権訴訟という扱いに

  • We set out to identify a gene-patent holder


  • that was vigorously enforcing its patents

    まず 特許権を積極的に主張していた

  • and then to organize a broad coalition of plaintiffs and experts


  • that could tell the court

    大規模な原告団と 専門家の集団を組織して

  • about all the ways that these patents were harming patients and innovation.

    裁判所に このような特許が

  • We found the prime candidate to sue in Myriad Genetics,

    あらゆる面で患者や技術革新に害を及ぼすと 主張する準備をしました

  • a company that's based in Salt Lake City, Utah.

    そして訴訟相手の第一候補 ミリアド・ジェネティクス社を見つけました

  • Myriad held patents on two genes,

    ユタ州ソルトレイクを 拠点とする企業です

  • the BRCA1 and the BRCA2 genes.


  • Women with certain mutations along these genes

    BRCA1と BRCA2遺伝子の 特許を持っていました

  • are considered to be at a significantly increased risk

    この遺伝子に ある種の変異がある女性は

  • of developing breast and ovarian cancer.


  • Myriad had used its patents to maintain


  • a complete monopoly on BRCA testing in the United States.

    ミリアド社は この特許を使って

  • It had forced multiple labs that were offering BRCA testing to stop.

    アメリカにおけるBRCA検査の 排他的独占権を維持しようとしており

  • It charged a lot of money for its test --

    この検査をしようとしていた 複数の研究所に待ったをかけました

  • over 3,000 dollars.


  • It had stopped sharing its clinical data


  • with the international scientific community.


  • And perhaps worst of all,


  • for a period of several years,


  • Myriad refused to update its test to include additional mutations

    数年間に渡って ミリアド社は

  • that had been identified by a team of researchers in France.

    フランスの研究グループが 新たに特定した変異を検査項目に加え

  • It has been estimated that during that period,

    検査を更新することを 拒否し続けたのです

  • for several years,

    推計によれば 数年に渡る

  • as many as 12 percent of women undergoing testing


  • received the wrong answer --

    検査を受けた女性の 実に12%が

  • a negative test result that should have been positive.


  • This is Kathleen Maxian.

    陽性の可能性があるのに 陰性という結果を受けていたのです

  • Kathleen's sister Eileen developed breast cancer at age 40


  • and she was tested by Myriad.

    彼女の妹 アイリーンは 40歳の時に乳がんを発症し

  • The test was negative.


  • The family was relieved.


  • That meant that Eileen's cancer most likely didn't run in the family,


  • and that other members of her family didn't need to be tested.

    結果によると アイリーンのがんは おそらく家族からの遺伝ではなく

  • But two years later,

    家族は検査を受けなくてもよいと 思ったからです

  • Kathleen was diagnosed with advanced-stage ovarian cancer.


  • It turned out that Kathleen's sister was among the 12 percent

    キャスリーンは卵巣がんが かなり進行していると診断されました

  • who received a false-negative test result.

    キャスリーンの妹は 誤って陰性と判定された

  • Had Eileen received the proper result,


  • Kathleen would have then been tested,

    もしアイリーンが 正しい検査結果を受けていれば

  • and her ovarian cancer could have been prevented.


  • Once we settled on Myriad,

    卵巣がんは予防できていた かもしれません

  • we then had to form a coalition of plaintiffs and experts


  • that could illuminate these problems.

    この問題を解明できる専門家を含む 原告団を組織する

  • We ended up with 20 highly committed plaintiffs:


  • genetic counselors,

    最終的に 20人の 意欲的な原告が集まりました

  • geneticists who had received cease and desist letters,


  • advocacy organizations,

    特許侵害の停止通告書を受けた 遺伝学者

  • four major scientific organizations that collectively represented


  • more than 150,000 scientists and medical professionals,

    合わせて15万人の 科学者と医療関係者を代表する

  • and individual women who either couldn't afford Myriad's test,


  • or who wanted to obtain a second opinion but could not,

    特許のせいで ミリアド社の検査を 受けるお金がなかったり

  • as a result of the patents.

    セカンドオピニオンを聞きたくても 聞けなかった

  • One of the major challenges we had in preparing the case


  • was figuring out how best to communicate the science.

    訴訟の準備で とても大変だったことは

  • So in order to argue that what Myriad did was not an invention,

    科学について どう解りやすく 伝えるかということでした

  • and that isolated BRCA genes were products of nature,

    ミリアド社がしたことは 「発明」ではなく

  • we had to explain a couple of basic concepts, like:

    単離されたBRCA遺伝子は 天然物だと立証するために

  • What's a gene? What's DNA?

    基本的な概念を いくつか説明する必要がありました

  • How is DNA isolated, and why isn't that an invention?

    遺伝子とは何か? DNAとは何か?

  • We spent hours and hours with our plaintiffs and experts,

    どのようにDNAを単離し なぜ それは発明とは言えないのか?

  • trying to come up with ways of explaining these concepts

    私たちは何時間も 原告団や専門家と一緒に

  • simply yet accurately.

    そういった概念をシンプルかつ 正確に説明する方法を

  • And we ended up relying heavily on the use of metaphors,


  • like gold.

    その結果 比喩に頼ることが 多くなりました

  • So isolating DNA --


  • it's like extracting gold from a mountain


  • or taking it out of a stream bed.


  • You might be able to patent the process for mining the gold,


  • but you can't patent the gold itself.

    金の採掘方法の特許を取ることは できるかもしれませんが

  • It might've taken a lot of hard work and effort


  • to dig the gold out of the mountain;

    山から金を掘り出すには 重労働と大変な努力が

  • you still can't patent it, it's still gold.


  • And the gold, once it's extracted,

    それでも特許は取れません 金なのですから

  • can clearly be used for all sorts of things


  • that it couldn't be used for when it was in the mountain;


  • you can make jewelry out of it for example --

    山の中にある時は 利用できませんが

  • still can't patent the gold, it's still gold.

    掘り出せば 例えば宝飾品を作れます

  • So now it's 2009, and we're ready to file our case.

    それでも特許は取れません 金は金なのです

  • We filed in federal court in the Southern District of New York,

    2009年になって 訴訟を起こす準備ができました

  • and the case was randomly assigned to Judge Robert Sweet.

    ニューヨーク南部地区 連邦裁判所に提訴し

  • In March 2010, Judge Sweet issued his opinion --

    無作為の割当で ロバート・スウィート判事が担当になりました

  • 152 pages --

    2010年3月 スウィート判事は 意見を公表しました

  • and a complete victory for our side.


  • In reading the opinion,


  • we could not get over how eloquently he described the science in the case.


  • I mean, our brief -- it was pretty good,

    この訴訟の科学的な内容を とても雄弁に説明していることに驚きました

  • but not this good.

    私たちの準備書面は 結構いい出来でしたが

  • How did he develop such a deep understanding of this issue


  • in such a short time?

    では 判事はどうやって この件を これほど短期間に 深く

  • We just could not comprehend how this had happened.


  • So it turned out,

    私たちには どうやったのか わかりませんでした

  • Judge Sweet's clerk working for him at the time,


  • was not just a lawyer --

    当時スウィート判事の下で働いていた 事務官は

  • he was a scientist.


  • He was not just a scientist --


  • he had a PhD in molecular biology.

    しかも ただの科学者ではなく

  • (Laughter)


  • What an incredible stroke of luck!


  • Myriad then appealed


  • to the US Court of Appeals for the Federal Circuit.


  • And here things got really interesting.


  • First, in a pivotal moment of this case,


  • the US government switched sides.

    まずはじめに この訴訟の重要な局面で

  • So in the district court the government submitted a brief on Myriad's side.


  • But now in direct opposition to its own patent office,

    政府は 地区裁判所ではミリアド社を 擁護する書面を提出していました

  • the US government files a brief that states that is has

    ところが控訴審で政府は 特許庁とは正反対の立場をとり

  • reconsidered this issue in light of the district court's opinion,

    書面で こう述べました

  • and has concluded that isolated DNA is not patent eligible.

    地区裁判所の判断に基づいて この件を再検討した結果

  • This was a really big deal,

    単離DNAは 特許の対象にならないと 結論づけたのです

  • totally unexpected.

    これは とても重要なことで

  • The Court of Appeals for the Federal Circuit


  • hears all patent cases,


  • and it has a reputation for being very, very pro-patent.


  • So even with this remarkable development,

    特許保護を かなり重視することで 知られています

  • we expected to lose.

    ですから こんな目覚ましい 進展があっても

  • And we did.


  • Sort of.


  • Ends up split decision, 2 to 1.


  • But the two judges who ruled against us,


  • did so for completely different reasons.

    ただ 2人の判事が 敗訴判決を下した理由は

  • The first one, Judge Lourie,

    それぞれ まったく異なるものでした

  • made up his own novel, biological theory --