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,一個聯邦法官對美國生物科技行業產生了巨大影響。各家公司早就獲得了單個DNA的專利,2005年大約有20%的人類基因被授予專利。但2010年3月,一位法官判決基因是不能授予專利的。執行高管們一下燥熱不安。生物科技行業組織(BIO)是貿易組織,該組織認為這個判決是長期斗爭的一個前奏。
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,他們放松了一下,至少暫時放松了一會兒。聯邦上訴法院推翻了前面的判決,認為Myriad Genetics的確可以持有的兩個幫助預測女性乳腺癌的基因專利。位于猶他州的Myriad首席執行官說,這個判決對于公司和患者都是一種賜福。
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,正當公司繼續試圖個性化醫療的時候,法院將繼續忙于此事。Myriad案本身可能不會結束。批評人士有三個理由反對基因專利:基因是自然的產物,所以不可以給予專利;基因專利不會鼓勵創新反而會打壓創新;基因壟斷企業比如Myriad會限制其它公司進行基因測試。越來越多的人似乎同意這種說法。去年,聯邦特派組敦促基因檢測專利改革。十月,司法部在Myriad案中發表聲明,單個DNA分子和從棉籽上分離出來的棉纖維一樣,都是自然的產物。盡管上訴法院作出這樣的判決,但是重要的問題仍然沒有得到回答。比如說,基因組序列是否違背了其中單個基因專利仍無定論,這個問題可能要到最高法院裁決。
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,隨著該行業的發展,其它的案例可能會有更大的影響力。公司不大可能申請到更多的人類DNA專利——有些已經被其它公司申請或者處于共同申請的領域。公司正在研究基因是如何相互作用的,基因的相關性可以用來判斷疾病的起因或者預測藥物的功效。BIO的律師Hans Sauer解釋道,公司渴望獲得專利來以便歸納推理得出結論。
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。
他們是否成功可能要由Mayo Clinic帶來的這個案件的訴訟情況決定。最高法院將在下一輪審理此案。生物科技行業組織(BIO)最近開會討論聘用律師來處理搖擺不定的專利案。每個會議都人滿為患。