In 2010. a federal judge shook America's biotech industry to its core. Companies had won patents for isolated DNA for decades——by 2005 some 20% of human genes were patented. But in March 2010 a judge ruled that genes were unpatentable. Executives were violently agitated. The Biotechnology Industry Organization (BIO),a trade group, assured members that this was just a "preliminary step" in a longer battle.
2010年,一个联邦法官对美国生物科技行业产生了巨大影响。各家公司早就获得了单个DNA的专利,2005年大约有20%的人类基因被授予专利。但2010年3月,一位法官判决基因是不能授予专利的。执行高管们一下燥热不安。生物科技行业组织(BIO)是贸易组织,该组织认为这个判决是长期斗争的一个前奏。
On July 29th they were relieved, at least temporarily. A federal appeals court overturned the prior decision, ruling that Myriad Genetics could indeed hold patents to two genes that help forecast a woman's risk of breast cancer. The chief executive of Myriad, a company in Utah, said the ruling was a blessing to firms and patients alike.
7月29日,他们放松了一下,至少暂时放松了一会儿。联邦上诉法院推翻了前面的判决,认为Myriad Genetics的确可以持有的两个帮助预测女性乳腺癌的基因专利。位于犹他州的Myriad首席执行官说,这个判决对于公司和患者都是一种赐福。
But as companies continue their attempts at personalized medicine, the courts will remain rather busy. The Myriad case itself is probably not over. Critics make three main arguments against gene patents: a gene is a product of nature, so it may not be patented; gene patents suppress innovation rather than reward it; and patents' monopolies restrict access to genetic tests such as Myriad's. A growing number seem to agree. Last year a federal task-force urged reform for patents related to genetic tests. In October the Department of Justice filed a brief in the Myriad case, arguing that an isolated DNA molecule "is no less a product of nature... than are cotton fibres that have been separated from cotton seeds." Despite the appeals court's decision, big questions remain unanswered. For example, it is unclear whether the sequencing of a whole genome violates the patents of individual genes within it. The case may yet reach the Supreme Court。
但是,正当公司继续试图个性化医疗的时候,法院将继续忙于此事。Myriad案本身可能不会结束。批评人士有三个理由反对基因专利:基因是自然的产物,所以不可以给予专利;基因专利不会鼓励创新反而会打压创新;基因垄断企业比如Myriad会限制其它公司进行基因测试。越来越多的人似乎同意这种说法。去年,联邦特派组敦促基因检测专利改革。十月,司法部在Myriad案中发表声明,单个DNA分子和从棉籽上分离出来的棉纤维一样,都是自然的产物。尽管上诉法院作出这样的判决,但是重要的问题仍然没有得到回答。比如说,基因组序列是否违背了其中单个基因专利仍无定论,这个问题可能要到最高法院裁决。
As the industry advances, however, other suits may have an even greater impact. Companies are unlikely to file many more patents for human DNA molecules——most are already patented or in the public domain. Firms are now studying how genes interact, looking for correlations that might be used to determine the causes of disease or predict a drug's efficacy. Companies are eager to win patents for "connecting the dots", explains Hans Sauer, a lawyer for the BIO。
但是,随着该行业的发展,其它的案例可能会有更大的影响力。公司不大可能申请到更多的人类DNA专利——有些已经被其它公司申请或者处于共同申请的领域。公司正在研究基因是如何相互作用的,基因的相关性可以用来判断疾病的起因或者预测药物的功效。BIO的律师Hans Sauer解释道,公司渴望获得专利来以便归纳推理得出结论。
Their success may be determined by a suit related to this issue, brought by the Mayo Clinic, which the Supreme Court will hear in its next term. The BIO recently held a convention which included sessions to coach lawyers on the shifting landscape for patents. Each meeting was packed。
他们是否成功可能要由Mayo Clinic带来的这个案件的诉讼情况决定。最高法院将在下一轮审理此案。生物科技行业组织(BIO)最近开会讨论聘用律师来处理摇摆不定的专利案。每个会议都人满为患。