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经济学人下载:生物技术专利 被缚的普罗米修斯
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Patenting biology
生物技术专利
Prometheus unsound
被缚的普罗米修斯
America's Supreme Court wallops the biotech industry
美国最高法院沉重打击生物技术产业
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.
专利本是用来鼓励创新,而不是扼杀。3月20日,美国最高法院撤销了两个医药专利,就是为了达到后者的目的。对梅奥医疗机构和普罗米修斯实验室的判决是毫不含糊的,而这就引发了生物技术产业的恐慌。
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.
普罗米修斯测验可以称是生物技术上最重要的新成就。"个人医疗"希望得到新的治疗和急需的新收入。不同的病人有不同的患病倾向,并有量身定制治疗方案。如果公司了解了这些患病体质,就可以提供诊断测试并进行针对性治疗。所以这些生物技术公司就费尽心思对这些测试争取了专利。而现在最高法院却要撤销那些专利。
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.
隶属于雀巢公司的普罗米修斯实验室获得了一项专利,该专利包括帮助医生测定巯基嘌呤药物剂量是否适当的血液测试,巯基嘌呤是治疗胃肠道功能紊乱的常用药物。巯基嘌呤的作用取决于每个病人对其药物吸收的程度。普罗米修斯专利就是为病人确定最适宜的药量:某些化学物质在血液中的浓度应该维持在一定范围内,既能保证药性,也要足够安全。普罗米修斯实验室把这种测试方法卖给医院,包括享有声望的梅奥诊所。而在2004年,梅奥就开发了一种类似的测试,但与普罗米修斯测试提出的药剂量范围不同,于是普罗米修斯实验室起诉了。
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.
在接下来的八年诉讼过程中,争论主要集中在一个基本的定论上。美国法律规定自然现象不能被授予专利。梅奥称普罗米修斯实验室就是拥有这种自然的过程的所有权。私人医生和医院的大型游说团也同意这一说法。他们称,如果拥护普罗米修斯专利,大公司们就会争着抢着去申请自然现象的专利。这种无法避免的法律雷池将会扼杀新发明新发现,他们坚持到。
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.
游说团生物科技产业组织反驳道,专利一直都是涉及了对自然法则的灵活运用。比如,基因突变可以识别易患某种疾病和易接受某种治疗的病人。这种突变是自然发生的,就像身体对于药物的反应一样。而普罗米修斯测试就是把这些因素结合到一起了。生物技术产业组织指出,梅奥诊所自身也申请到了一种测试的专利,用于预测一种治疗结肠癌药物副作用的基因突变。如果法院撤回普罗米修斯专利,那么上百个类似的专利也将被推翻,该组织警告道。
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,最高法院站到了梅奥诊所一边。法官斯蒂芬·布雷尔称,普罗米修斯专利涉及到自然法则,而且会限制进一步的创新。监管服用巯基嘌呤,观察身体的反应,并提供定量的建议并不能算整个审核专利的过程。"爱因斯坦并不能为他的著名的公式E=mc2申请专利",布雷尔先生写到。而且爱因斯坦也不能就因为"告诉直线加速器运营商参考公式就能决定一定质量的东西能产生多少能量"就申请专利。
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.
生物技术产业没有想到最高法院会来这一手,所以现在稍微有些恐慌。个人医疗肯定包括自然法则的应用,但该产业还并不清楚哪种应用应该申请专利。专利局和地方法院现在必须试着搞清楚最高法院的意思。生物技术产业组织的年度会议经常被看成是一堆人讨论专利法的大会,今年的会议室可能会换个大点的地方。