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Patenting biology
生物技術專利
Prometheus unsound
被縛的普羅米修斯
America's Supreme Court wallops the biotech industry
美國最高法院沉重打擊生物技術產業(yè)
PATENTS are supposed to encourage innovation, not stifle it. On March 20th America's Supreme Court threw out two medical patents for doing the latter. The ruling in Mayo v Prometheus was unequivocal. So was the horrified reaction from the biotechnology industry.
專利本是用來鼓勵創(chuàng)新，而不是扼殺。3月20日，美國最高法院撤銷了兩個醫(yī)藥專利，就是為了達到后者的目的。對梅奧醫(yī)療機構和普羅米修斯實驗室的判決是毫不含糊的，而這就引發(fā)了生物技術產業(yè)的恐慌。
Prometheus is the most important case to date for biotech's most important new effort. "Personalised medicine" promises new treatments and much-needed new revenue. Different patients are predisposed to certain diseases and certain remedies. If firms understand these predispositions, they can offer diagnostic tests and targeted treatments. Not surprisingly, companies have sought patents for many tests. The Supreme Court may have made some of these patents worthless.
普羅米修斯測驗可以稱是生物技術上最重要的新成就。"個人醫(yī)療"希望得到新的治療和急需的新收入。不同的病人有不同的患病傾向，并有量身定制治療方案。如果公司了解了這些患病體質，就可以提供診斷測試并進行針對性治療。所以這些生物技術公司就費盡心思對這些測試爭取了專利。而現在最高法院卻要撤銷那些專利。
Prometheus, a subsidiary of Nestlé, had patented a test to determine the correct dose of thiopurines, drugs that have long been used to treat gastrointestinal disorders. Thiopurines' effect depends on how each patient processes the drug. Prometheus patented a way to determine the best dose for a given patient: concentrations of certain chemicals in the blood should be within a range, high enough to work but low enough to be safe. It sells its test to hospitals, including the prestigious Mayo Clinic. In 2004 Mayo developed a competing test with a different recommended range. Prometheus sued.
隸屬于雀巢公司的普羅米修斯實驗室獲得了一項專利，該專利包括幫助醫(yī)生測定巰基嘌呤藥物劑量是否適當的血液測試，巰基嘌呤是治療胃腸道功能紊亂的常用藥物。巰基嘌呤的作用取決于每個病人對其藥物吸收的程度。普羅米修斯專利就是為病人確定最適宜的藥量：某些化學物質在血液中的濃度應該維持在一定范圍內，既能保證藥性，也要足夠安全。普羅米修斯實驗室把這種測試方法賣給醫(yī)院，包括享有聲望的梅奧診所。而在2004年，梅奧就開發(fā)了一種類似的測試，但與普羅米修斯測試提出的藥劑量范圍不同，于是普羅米修斯實驗室起訴了。
In the subsequent eight years of litigation, arguments centred on a basic proposition. American law prohibits patents of nature. Mayo said that Prometheus had claimed ownership of a natural process. Big doctors' and hospitals' lobbies agreed. Uphold Prometheus's patents, they argued, and companies would rush to patent natural phenomena. The inevitable legal minefield would stifle new discoveries, they insisted.
在接下來的八年訴訟過程中，爭論主要集中在一個基本的定論上。美國法律規(guī)定自然現象不能被授予專利。梅奧稱普羅米修斯實驗室就是擁有這種自然的過程的所有權。私人醫(yī)生和醫(yī)院的大型游說團也同意這一說法。他們稱，如果擁護普羅米修斯專利，大公司們就會爭著搶著去申請自然現象的專利。這種無法避免的法律雷池將會扼殺新發(fā)明新發(fā)現，他們堅持到。
The Biotechnology Industry Organisation (BIO), a lobby, retorted that patents have long covered clever applications of natural laws. For example, a genetic mutation can identify patients who are susceptible to a given disease or treatment. The mutation is a natural occurrence, as is the reaction to the drug. But the invention comes in connecting the dots between these elements. Mayo itself, BIO pointed out, has licensed a test for a genetic mutation that predicts side-effects for a certain colon-cancer drug. If the court overturned Prometheus's patents, hundreds of others would capsize too, the industry warned.
游說團生物科技產業(yè)組織反駁道，專利一直都是涉及了對自然法則的靈活運用。比如，基因突變可以識別易患某種疾病和易接受某種治療的病人。這種突變是自然發(fā)生的，就像身體對于藥物的反應一樣。而普羅米修斯測試就是把這些因素結合到一起了。生物技術產業(yè)組織指出，梅奧診所自身也申請到了一種測試的專利，用于預測一種治療結腸癌藥物副作用的基因突變。如果法院撤回普羅米修斯專利，那么上百個類似的專利也將被推翻，該組織警告道。
Yet the Supreme Court sided unanimously with Mayo. Stephen Breyer, writing the court's opinion, affirmed that Prometheus's patents claimed a natural law and would restrict further innovation. Administering thiopurines, observing the body's reaction and offering dosing advice did not add up to a patentable process. "Einstein could not patent his celebrated law that E=mc2", wrote Mr Breyer. Nor could Einstein have patented the observation by "simply telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced."
然而，最高法院站到了梅奧診所一邊。法官斯蒂芬·布雷爾稱，普羅米修斯專利涉及到自然法則，而且會限制進一步的創(chuàng)新。監(jiān)管服用巰基嘌呤，觀察身體的反應，并提供定量的建議并不能算整個審核專利的過程。"愛因斯坦并不能為他的著名的公式E=mc2申請專利"，布雷爾先生寫到。而且愛因斯坦也不能就因為"告訴直線加速器運營商參考公式就能決定一定質量的東西能產生多少能量"就申請專利。
The biotechnology industry did not expect the ruling. It is now in a minor panic. Personalised medicine inevitably includes the application of natural laws. It is unclear which applications may be patented. The patent office and lower courts must now try to make sense of the ruling. BIO's annual conference usually features a crowded session on patent law. This year's meeting may need a bigger room.
生物技術產業(yè)沒有想到最高法院會來這一手，所以現在稍微有些恐慌。個人醫(yī)療肯定包括自然法則的應用，但該產業(yè)還并不清楚哪種應用應該申請專利。專利局和地方法院現在必須試著搞清楚最高法院的意思。生物技術產業(yè)組織的年度會議經常被看成是一堆人討論專利法的大會，今年的會議室可能會換個大點的地方。
