Dolly the sheep enjoyed a brief and highly publicized life as the first mammal cloned from an adult cell before succumbing to lung disease in 2003 at age 6. But an attempt to patent Dolly, and lay commercial claim to animals produced by cloning, survived much longer. But that nearly 10-year-long saga also appears to have ended last week when a U.S. federal appeals court ruled against giving a patent to Dolly’s creators. Although the ruling did not surprise patent experts, it is adding to the jitters that some biotech firms and patent attorneys are feeling over the broader fate of U.S. biomedical patents in the wake of recent court decisions.
In 2009, the Roslin Institute of the University of Edinburgh, where Dolly’s creators Keith Campbell and Ian Wilmut made their discovery, received a U.S. patent on the method used to make her: somatic cell nuclear transfer (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 and Trademark Office (PTO) turned down that application, however, citing a federal law that restricts the subject matter of a patent to exclude “laws of nature, natural phenomena, and abstract ideas.”
Roslin later appealed PTO’s rejection, but it was upheld by the Patent Trial and Appeal Board in February 2013. On 8 May, the U.S. Court of Appeals for the Federal Circuit in Washington, which specializes in patent cases, agreed with that decision. Dolly and other cloned animals cannot be patented, a three-judge panel ruled, because they are identical to animals found in nature—namely, the animals whose DNA is used to make them. “Dolly’s genetic identity to her donor parent renders her unpatentable,” Judge Timothy Dyk wrote in the decision.
“This seems like a pretty straightforward interpretation of the most recent Supreme Court cases, and I don’t find it terribly surprising,” says Robert Cook-Deegan, a genetics policy expert at Duke University 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 Association for Molecular Pathology v. Myriad Genetics—that isolated sequences of human DNA are not patentable. And in a much older case, Diamond v. Chakrabarty in 1980, the high court established that a natural product could be patented only if it had “markedly different characteristics from any found in nature.”
The Roslin Institute argued that Dolly and other clones did, in fact, differ in meaningful ways from the donor animals. Environmental influences on their appearance and behavior might make them unique, as would the mitochondrial DNA they 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 patent application, the appeals court judges decided.
The decision could have some short-run effects in the world of animal cloning, says Gregory Graff, an economist at Colorado State University, Fort Collins, who specializes in intellectual property for the life sciences. For example, the Food and Drug Administration is evaluating ways to use cloned animals in livestock, and the inability to patent such products could influence that industry, if it ever takes off.
Others, however, see the Roslin decision as evidence of a more alarming and wide-ranging trend. “The whole area of personalized medicine is going to get impacted by this sort of rationale,” says Carl Gulbrandsen, managing director of the Wisconsin Alumni Research Foundation in Madison, which works to commercialize academic discoveries.
The fear, he says, is that if PTO is hostile to granting patents on humanmade products that are identical to products of nature, then investors might back away from promising areas of biomedical research. If similar logic were applied to patent applications on cells modified to resemble human stem cells, for example, or (maybe someday) lab-grown organs, such products might not receive patent protection, he tells ScienceInsider. Although inventors could still patent the methods used to create such products, Gulbrandsen says his own experience suggests “a product patent is much more valuable, and investors are much more comfortable with that than with a method of use” patent.
These long-standing anxieties were amplified after this past Thursday’s ruling. “This storm front is about to become even more threatening. Take cover!” wrote patent attorney Warren Woessner in a response to the decision, published online on Friday in The National Law Review. Gene Quinn, a patent attorney and founder of intellectual property blog IPWatchdog, concluded a Dolly-themed post with the pronouncement, “Sadly, until further notice, personalized medicine is dead!”
That anxiety is likely misplaced, Cook-Deegan says. “I don’t think [this case] is probably going to have a big echo effect,” he tells ScienceInsider. “I don’t think 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 from cloning competition. A product patent on Dolly herself would be useful only if the institute wanted to try to sue a company that managed to create cloned mammals by some other technique.
Margo Bagley, a law professor at the University of Virginia in Charlottesville, also can’t relate to the “sky is falling” mentality. Roslin’s broad claim to a variety of cloned animals conflicts with long-standing Supreme Court precedent, she says, but a more narrow claim would have stood a better chance. And she predicts that innovations will still find their way to patent protection. “For a while 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 is still definitely on the tree.”
PTO guidelines draw fire
Bagley is, however, somewhat more concerned about a new set of guidelines for patent eligibility that 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 a public hearing on Friday in Alexandria, Virginia. At the event, the agency took heat from patent attorneys who felt its interpretation of that decision was too broad. Hans Sauer, an intellectual property counsel for the Biotechnology Industry Organization called PTO’s approach “draconian,” claiming the new guidelines are leading patent examiners to reject applications in fields such as pharmaceutical composition, which are outside of the genetics and diagnostics applications discussed in the Myriad case.
PTO officials say they’ll welcome input before finalizing the guidelines and encourage the public to submit written comments through the end of June.