No Patent for Dolly the Cloned Sheep, Court Rules, Adding to Industry Jitters

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.

“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.

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