作为第一个克隆哺乳动物，多利成为世界最著名的绵羊。2003年，多利羊因为肺部疾病去世。多利之父申请的多利专利的命运终于最终确定。他们在美国申请了两个专利，一个是细胞核转移技术，就是制造多利的关键生物学技术，这个专利已经获得授权。另一个是所有使用这种方法制造的克隆哺乳动物，例如牛、羊、猪等。这个专利没有获得授权，于是他们提出上诉，经过10年的拉锯战。最终美国高等上诉法庭叛决这个专利不能授予。美国专利局之所有没有授权这个专利，依据一个联邦法律条文是，“自然法则、自然现象和抽象的想法”不能授予专利。

参考资料

绵羊多利（Dolly，1996年7月5日-2003年2月14日）是用细胞核移植技术将哺乳动物的成年体细胞培育出新个体。是第一个被成功克隆的哺乳动物。它是由苏格兰罗斯林研究所和PPL Therapeutics生物技术公司的伊恩·威尔穆特和基思·坎贝尔领导的小组培育的。克隆的研究经费来源于PPL Therapeutics生物技术公司和英国农业部。

多利是由移植母羊的乳腺细胞到被摘除细胞核的卵子细胞中发育而成的。它证明了一个哺乳动物的特异性分化的细胞也可以发展成一个完整的生物体。这引发了公众对于克隆人的想象。在受到赞誉的同时也引来了争议。它被英国广播公司和科学美国人杂志等媒体称为世界上最著名的动物。

按照伊恩·威尔穆特的说法，因为多利是由乳腺细胞发育而来的，所以用胸部异常丰满的美国乡村音乐天后多利·巴顿的名字命名了多利。

Dollythe sheep enjoyed a brief and highly publicized life as the first mammal clonedfrom an adult cell before succumbing to lung disease in 2003 at age 6. But anattempt to patent Dolly, and lay commercial claim to animals produced bycloning, survived much longer. But that nearly 10-year long saga also appearsto have ended last week when a U.S. federal appeals court ruled against givinga patent to Dolly’s creators. Although the ruling did not surprise patentexperts, it is adding to the jitters that some biotech firms and patentattorneys are feeling over the broader fate of U.S. biomedical patents in thewake of recent court decisions.

In2009, the Roslin Institute of Edinburgh, where Dolly’s creators Keith Campbelland Ian Wilmut made their discovery, received a U.S. patent on the method usedto make her:  somatic cell nucleartransfer (SCNT). But they had also submitted a second claim on the product:Dolly herself, and any other cattle, sheep, pigs and goats produced using SCNT.The U.S. Patent Office (PTO) turned down that application, however, citing afederal law that restricts the subject matter of a patent to exclude “laws ofnature, natural phenomena, and abstract ideas.”

Roslinlater appealed the PTO’s rejection, but it was upheld by the Patent Trial andAppeal Board in February 2013. On 8 May the United States Court of Appeals forthe Federal Circuit in Washington, which specializes in patent cases, agreedwith that decision. Dolly and other cloned animals cannot be patented, a3-judge panel ruled, because they are identical to animals found innature--namely, the animals whose DNA is used to make them. “Dolly’s geneticidentity to her donor parent renders her unpatentable,” judge Timothy Dyk wrotein the decision.

“This seems like a pretty straightforwardinterpretation of the most recent Supreme Court cases, and I don’t find itterribly surprising,” says Robert Cook-Deegan, a genetics policy expert at DukeUniversity in Durham, North Carolina. And it is in keeping with past decisions,he notes. Last year, the U.S. Supreme Court ruled -- in the high-profile case Associationfor Molecular Pathology vs. Myriad Genetics -- that isolated sequences of humanDNA are not patentable. And in a much older case, Diamond vs. Chakrabarty in1980, the high court established that a natural product could be patented onlyif it had “markedly different characteristics from any found in nature.”

TheRoslin Institute argued that Dolly and other clones did, in fact, differ inmeaningful ways from the donor animals. Environmental influences on theirappearance and behavior might make them unique, as would the mitochondrial DNAthey carry, which comes from the egg cell donor, not the somatic cell donor.But such differences were not stated in the broad claims of Roslin’s patentapplication, the appeals court judges decided.

Thedecision could have some short-run effects in the world of animal cloning, saysGregory Graff, an economist at Colorado State University in Fort Collins whospecializes in intellectual property for the life sciences. For example, theFood and Drug Administration is evaluating ways to use cloned animals inlivestock, and the inability to patent such products could influence thatindustry, if it ever takes off.

Alarmingtrend?

Others,however, see the Roslin decision as evidence of a more alarming and wideranging trend. “The whole area of personalized medicine is going to getimpacted by this sort of rationale,” says Carl Gulbrandsen, managing directorof the Wisconsin Alumni Research Foundation in Madison, which works tocommercialize academic discoveries.

 Thefear, he says, is that if the PTO is hostile to granting patents on human-madeproducts that are identical to products of nature, then investors might backaway from promising areas of biomedical research. If similar logic were appliedto patent applications on cells modified to resemble human stem cells, forexample, or (maybe someday) lab-grown organs, such products might not receivepatent protection, he tells ScienceInsider. Although inventors could stillpatent the methods used to create such products, Gulbrandsen says his ownexperience suggests “a product patent is much more valuable, and investors aremuch more comfortable with that than with a method of use” patent.

 Theselong-standing anxieties were amplified after this past Thursday’s ruling. “Thisstorm front is about to become even more threatening. Take cover!” patentattorney Warren Woessner wrote in a response to the decision, published onlineFriday in the National Law Review. Gene Quinn, a patent attorney and founder ofintellectual property blog IPWatchdog, concluded a Dolly-themed post with thepronouncement, “Sadly, until further notice, personalized medicine is dead!”

 Thatanxiety is likely misplaced, says Cook-Deegan. “I don’t think [this case] isprobably going to have a big echo effect,” he tells ScienceInsider. “I don’tthink it has huge implications for other cases.” As for the Roslin Institute,he says its patent on the SCNT method has been enough to protect it fromcloning competition. A product patent on Dolly herself would only be useful ifthe institute wanted to try to sue a company that managed to create clonedmammals by some other technique.

 MargoBagley, a law professor at the University of Virginia in Charlottesville, alsocan’t relate to the “sky is falling” mentality. Roslin’s broad claim to avariety of cloned animals conflicts with long-standing Supreme Court precedent,she says, but a more narrow claim would have stood a better chance. And shepredicts that innovations will still find their way to patent protection. “For awhile now, people have been able to patent, in a sense, the low-hanging fruit,”she says. “The fruit may be little higher up on the tree, but the fruit isstill definitely on the tree.”

 PTO guidelines draw fire

 Bagleyis, however, somewhat more concerned about a new set of guidelines for patenteligibility that the PTO issued this past March in the wake of the Myriad case.The Dolly decision came down just as those guidelines were being discussed at apublic hearing on Friday in Alexandria, Virginia. At the event, the agency tookheat from patent attorneys who felt its interpretation of that decision was toobroad. Hans Sauer, an intellectual property counsel for the BiotechnologyIndustry Organization (BIO) called the PTO’s approach “draconian,” claiming thenew guidelines are leading patent examiners to reject applications in fieldssuch as pharmaceutical composition, which are outside of the genetics anddiagnostics applications discussed in the Myriad case.

 PTO officials say they’ll welcome input before finalizing the guidelines, andencourage the public to submit written comments through the end of June.

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