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人类DNA中的20,000余种基因已有近20%被授予了专利-第1页

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生KEVIN KIMBERLIN物科技行业始于1978年，当年加利福尼亚大学(University of California)提出了人体生长激素基因的专利申请。自该次专利申请以来，人类DNA中的20,000余种基因已有近20%被授予了专利。


The biotech industry began in 1978 when the University of California applied for a patent on the gene for the human growth hormone. Since that filing nearly 20% of the 20,000-plus genes in our DNA have been patented.


美国联邦最高法院当前审理的质疑乳腺癌基因专利的案件──即美国分子病理学会(Association for Molecular Pathology)与生物科技公司Myriad Genetics的诉讼案──可能会使其中的数千项专利失效，对数百种诊断及治疗产品造成影响。生物科技行业挽救了成千上万人的生命，也创造了成千上万的就业岗位。然而，若法院判决那些专利无效，那么随着投资者不再支持此类科学发现，未来拯救生命的技术也将消亡。


The current Supreme Court case challenging the patent on the breast cancer gene (Association for Molecular Pathology v. Myriad Genetics) could invalidate thousands of these patents, affecting hundreds of diagnostic and therapeutic products. The biotech industry saves tens of thousands of lives and creates as many jobs. However, a ruling against the patent will deep-six future life-saving technologies as investor support for such discoveries disappears.


我之所以知道这一点，是因为当年创立Myriad Genetics──拥有乳腺癌基因专利的这家公司──的支票是我开的，而且我还说服了约200名投资者对它进行风险投资。


I know this because I wrote the check to start Myriad Genetics -the firm that holds the patent on the breast cancer gene-and talked some 200 investors into its first venture funding.


这些投资者希望带来改变，也希望获得财务回报。对我们而言，专利前景是至关重要的。Myriad Genetics在1993年的首次公开募股书的首页就阐明了这种关联："本公司已提交了要求获得BRCA1基因及其检测方法专利的申请。"


These investors hoped to make a difference as well as a financial return. To us, the promise of a patent was crucial. The first page of Myriad's initialoffering in 1993 made this connection clear: 'The Company has filed a patentapplication claiming the BRCA1 gene and methods for its detection.'


Myriad Genetics的乳腺癌检测方法BRAC Analysis向一百万女性发出了遗传乳腺癌与卵巢癌潜在风险的预警。在发现自己携带突变BRCA1基因后，安吉丽娜·朱莉(Angelina Jolie)选择了预防性双侧乳腺切除手术。


BRACAnalysis, Myriad's breast cancer test, has warned one million women about potential genetic breast and ovarian cancer risk. Angelina Jolie's discovery that she carried the mutated BRCA1 gene led her to choose a preventive double mastectomy.


虽然并非所有携带该基因的女性都会做此选择，但她们应当知道自己的遗传倾向以权衡选择。尽早检测总是更好。BRCA1与BRCA2突变可能还预示着卵巢癌的遗传倾向，而早期卵巢癌非常难诊断出来。像安吉丽娜·朱莉这样收到预警并就此采取行动的女性可大幅降低患卵巢癌的风险。


Although not all women carrying the gene make this choice, they should know their predispositions in order to weigh their options. Early detection is always better. The same BRCA1 and BRCA2 anomalies may also signal a genetic predisposition to ovarian cancer, which is extremely difficult to diagnose in its early stages. Women like Angelina Jolie who receive and act on this genetic warning can significantly reduce their ovarian cancer risk.


可以理解的是，有些人对授予基于人类DNA的专利的观念感到不安。但是，请让我们记住以下这四点：


Understandably, some people are uncomfortable with the concept of awarding patents based on human DNA. But let's keep four points in mind:


- 没有人"拥有"你身体的一部分。问题的核心是BRCA1与BRCA2基因的变体。


-No one 'owns' a part of you. At issue are mutations of the BRCA1 and BRCA2 genes.


有些人辩称，这些基因序列显然是自然的产物，因此是不可授予专利的。事实是，发现它们耗费了逾17年的高强度研究，发现和分离处于乳腺癌检测方法核心的分子涉及精密的基因图谱绘制技术和基因排序方法。把这些分子提炼出来需要非常复杂的操作，它们绝非是显而易见的东西。


Some argue that these sequences are obvious products of nature and not patentable. The reality is it took more than 17 years of intense research, involving sophisticated genetic mapping and sequencing skills to discover and isolate the molecules at the heart of the breast-cancer test. The complexity required to purify these molecules makes them anything but obvious.


- 专利可促进研究和竞争。专利持有人确实拥有将他们的研究发现商业化的独有权，但是他们也必须披露所有细节。如此一来，专利实际上为进一步研究及竞争提供了信息。自BRCA1专利被授予以来，已经有9,600多项以该基因为基础的研究发表。也有其他一些检测乳腺癌的方法被研究出来了，但是现在还没有更好的倾向检测方法。


- Patents promoteresearch and competition. Patent-holders do get the exclusive right to commercialize their discoveries, but they must disclose all the details. In that way, a patentactually provides the information for further research and competition. Since the BRCA1 patent was granted, more than 9,600 studies have been published based on this gene. Several other ways to detect breast cancer have been developed-but there is still no better predisposition test.


- 科学上的赞誉并不够，创新需要资金。在创建Myriad之前，它的联合创始人之一、哈佛大学(Harvard)的沃尔特·吉尔伯特(Walter Gilbert)就因联合研究出测定DNA序列的方法而获得诺贝尔化学奖。另一名联合创始人、犹他大学(University of Utah)的马克·斯科尔尼克(Mark Skolnick)与几名同事发明了基因图谱绘制技术，促进了人类基因组计划(Human Genome Project)的发展。然而，这两名研究者最终都未能将他们的科学创新转变为可行的检测方法。


- Scientific acclaim is not enough; innovation requires money. Before forming Myriad, one of the co-founders, Walter Gilbert of Harvard, won the Nobel Prize in chemistry for co-developing DNA sequencing. Co-founder Mark Skolnick of the University of Utah, and some of his colleagues created the gene-mapping technique that catalyzed the Human Genome Project. Ultimately, neither researcher could translate his scientific innovations into a viable test.


斯科尔尼克后来指出："我帮助发现了世界上最好的探明癌症潜在遗传原因的办法，但是我没有利用它的财力。"将BRAC Analysis检测法商业化耗费了五亿美元的投资。


'I'd helped uncover the best resource on the planet for getting at the underlying genetic cause of cancer,' Mr. Skolnick later observed. 'I just didn't have the resources to take advantage of it.' It took an investment of $500 million to commercialize the BRACAnalysis test.


- 专利可吸引到投资者，医学创新要求投资者愿意长期承担巨大的风险。Myriad收回巨额投资就花了20年时间，如果没有专利保护，它不可能获得这笔投资。


- Patents lure investors: Medical innovations require investors willing to take great risks over long periods. Two decades passed before Myriad recouped its enormous investment-an investment that would not have happened without patent protection.


我们已经迈入基因组技术的黄金时代。想想近期一些尖端的研究发现，比如有关基因突变造成的产前心脏缺陷及遗传性心脏病风险的研究，如果没有专利，谁愿意承担将这些医学研究发现推向市场的财务风险？


We have entered the golden age of the genome. Consider recent cutting-edge discoveries such as the studies on prenatal heart defects due to genetic mutation, and inherited heart disease risks. Without patents, who will take the financial risk to bring such medical findings to market?


有了保护医学创新的专利制度的鼓励，投资者才会做出这些类型的长期赌注。判决有关已分离出的DNA的专利无效将把这些风险资本赶到别处。


A patentsystem that protects medicalinnovation encourages investors to make these types of long-shot bets. Ruling against patents on isolated DNA will drive this risk capital elsewhere.


不利的判决也会压制研究者。具备商业潜力的研究结果会消失于行业机密之中，就像可口可乐(Coca-Cola)将它的配方保密了100年时间一样。那些现在通过专利信息披露而可为所有人了解的非凡的见解和科学发现将会成为秘密。


An adverse decision would also silence researchers. Findings with commercialpotential will disappear into trade secrets, much as Coca-Cola has kept its formula under wraps for 100 years. Brilliant insight and scientific discovery, now available to all through patent disclosures, will be kept confidential.


现在，分享推动人类进步的生命科学奇迹的体系正岌岌可危。最高法院必须维持允许为分离出的DNA授予专利的资格，如此一来这台创新引擎才能继续全速前进。


At stake is a system that shares the life-science miracles that propelhumanity forward. The Supreme Court must uphold the ability to patent isolated DNA to keep this innovation engine going at full speed.


（编者按：本文原文发表于2013年5月20日。本文作者为Myriad Genetics公司的联合创始人之一，同时也是高科技风投公司Spencer Trask & Co.的董事长。）


Mr. Kimberlin is a co-founder of Myriad Genetics Inc. and chairman of Spencer Trask & Co., an advanced-technology venture firm.




KEVIN KIMBERLIN

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