Business Biotech patents Taking it personally
商業 生物技術專利 對人下藥
A legal fight over a new generation of medicine
新一代藥品的法律糾紛
DRUG research is in dark times, as pipelines dry up and development budgets are cut.
但有一束光帶來了一線希望。
But one shaft of light pierces the gloom.
隨著新藥品種開發減少,藥品的研發資金縮減,藥品研究正處于黑暗時期。
"Personalised medicine" promises to craft drugs for individuals.
"個性化藥品"承諾為個人定制藥品。
Genetic tests will identify those who will benefit from specific medicines.
基因測試將識別出那些從特制藥品中獲益的人。
Treatment will be more effective; waste will drop.
從而加強治療效果;降低浪費水平。
Personalised medicine has sparked excitement among drugmakers, doctors, hospitals and patients.
個性化藥品讓制藥商、醫生和病人均欣喜若狂。
It has also sparked a legal brawl.
這也引發了法律糾紛。
On December 7th America's Supreme Court heard arguments in Mayo v Prometheus.
2011年12月7日美國高等法院聽取了梅奧V普羅米修斯的辯論。
The suit, despite a name that suggests an ancient liver sandwich, may be crucial for biotechnology firms.
這一訴訟雖然以暗示古代肝三明治的名義進行,但是對于生物公司來說至關重要。
America is the world's hub for drug research.
美國是全球藥品研究中心。
By definition, personalised medicine includes the study of genetic mutations and other personal characteristics.
按定義,定制藥品包括對于基因突變的研究和其他個性化特征。
However, American law bars patents of nature and abstract ideas.
但是美國的法律禁止給自然和抽象的概念頒發專利。
The question is which discoveries in personalised medicine may be patented.
問題在于個性化藥品的哪一種發現可能授予專利。
Prometheus is part of a series of suits over biotech patents.
普羅米修斯公司是陷入一系列生物技術專利權之爭的公司之一。
Courts have been active because Congress has not.
因國會無動于衷,法庭便積極地應對。
A recent patent reform provided little clarity.
最近的專利改革提供模棱兩可的解釋。
Congress merely ordered a study of genetic testing.
國會僅是指示對基因測試進行研究。
Judges have been bolder: in July a federal court ruled that genes could be patented.
法官們是更加的大膽:7月份聯邦法庭裁決基因可獲得專利。
On December 7th the suit's losers appealed to the Supreme Court.
12月7日該案件的敗訴方上訴至最高法院。
But Prometheus may have greater practical import, says Hans Sauer of the Biotechnology Industry Organisation (BIO), a trade group.
生物科技產業組織(BIO)的漢斯.薩奧爾說,但普羅米修斯案可能實際起的作用更大。
Firms are studying genetic correlations that might predict a drug's efficacy or determine the cause of a disease.
研究遺傳相關的公司可能預計到藥品的功效或決定疾病的緣由。
Prometheus may determine whether methods using such correlations may be patented.
普羅米修斯案可能裁定使用這種相關方法是否能授予專利。
The fight has attracted the heavyweights of health care.
這場官司吸引了衛生保健業重量級人物的眼球。
On one side is Prometheus Laboratories, a Californian company that has patented a way to optimise certain drug treatments for individuals.
一方是因優化某種個性化藥物治療的方法獲得專利的加州普羅米修斯公司,
On the other is the Mayo Clinic, a health and research centre.
另一方是健康研究中心,梅奧診所。
Prometheus's supporters include BIO and several tech firms.
普羅米修斯公司的支持者包括BIO和幾個高科技公司。
Roche and Abbott, two big drugmakers, gave warning against invalidating patents on diagnostic tests.
兩大醫藥巨頭羅氏制藥和雅培公司對診斷試驗專利無效提出了警告。
Mayo's allies include the American Medical Association.
梅奧的聯盟包括美國醫學協會。
The patents in question do not concern genetic tests, though the suit's outcome will affect them.
對于專利權的爭議與基因測試無關,盡管這一案件的審理結果會影響到基因測試。
They concern tests for the effectiveness of thiopurines, drugs that have long been used to treat gastrointestinal disorders such as Crohn's disease.
他們關心的是巰基嘌呤是否適當的測試。巰基嘌呤是一直用來治療胃腸道功能失調如克羅恩病的藥物。
Their effect depends on how they are metabolised.
該藥物的是否有效取決于其是如何新陳代謝的。
Neither thiopurines nor tests for metabolites (substances produced by metabolism) were new when Prometheus's patents were filed in 1998.
在普羅米修斯公司申請專利時不管是巰基嘌呤還是代謝物(由新陳代謝引起的物質)的測試都不是什么新鮮事物。
But the patents cover the process for determining whether a given dose produces concentrations of metabolites within a recommended range.
但是這一專利包括決定是否給定的藥物劑量在推薦范圍內能產生大量的代謝物過程。
The dose of thiopurines could be adjusted accordingly.
巰基嘌呤的劑量可以隨之調整過來。
Prometheus sells a test based on its patents to hospitals and clinics.
普羅米修斯公司因測試方法申請了專利權而將其賣給醫院和診所。
In 2004 Mayo developed a competing test, with different recommended levels of metabolites.
2004年梅奧研制出了有競爭力的測試,對代謝物使用不同的推薦指數。
Prometheus sued.
普羅米修斯公司以此狀告梅奧診所。
Mayo's lawyers say Prometheus has patented a mere observation of the body's natural workings.
梅奧的律師說普羅米修斯公司申請的僅僅是觀察人體自然運行的專利。
Let the claim stand, Mayo argues, and firms will win broad patents over basic biological relationships, stifling innovation.
梅奧辯道,若讓普羅米修斯公司勝訴,公司將超越基本的生物基礎而獲得廣泛意義的專利權從而阻礙創新。
Prometheus and its allies warn of an alternative apocalypse.
普羅米修斯公司和其聯盟則警告這是另一場大災難。
A judgment in Mayo's favour, they contend, will undermine existing patents and shrivel investment in personalised medicine.
偏向于梅奧的支持方爭辯道這將破壞現有的專利及導致對個性化藥品的投資減少。
The Supreme Court may not make such a broad judgment.
最高法院可能不會做出廣泛的評判。
It may instead hand down a narrower ruling that leaves many questions unanswered.
相反,最高法院有可能將采用較小范圍的裁定使得許多問題懸而未決。
A natural phenomenon may not be patented, but which applications of that phenomenon might be?
自由現象有可能不會授予專利,但是自然現象的哪種應用屬于專利范圍呢?
When studying genetic correlations, which so-called discoveries are truly novel?
在研究遺傳相關的命題時,哪一種所謂的發現是真的新鮮出爐?
Eventually personalised medicine may transform patients' care and firms' business models.
最終個性化藥品可能轉變病人的護理和企業的經營模式。
In the near future, the greatest beneficiaries may be patent lawyers.
在不久的將來,最大的的受益者將是打專利權官司的律師。