The Scottish scientists famous for concocting "Dolly" the sheep lost a bid to get U.S. patent protection for the cloned animal as a court said their creations are just genetic copies of naturally occurring beings.
The Roslin Institute in Edinburgh had argued that Dolly, which was created in 1996, and any other clones of live animals are eligible to be patented because they are the "product of human ingenuity." The U.S. Court of Appeals for the Federal Circuit in Washington today disagreed.
The court, in an opinion posted on its website, upheld the U.S. Patent and Trademark Office’s rejection of an application by Roslin for cloned animals, with Circuit Judge Timothy Dyk writing that "Dolly’s genetic identity to her donor parent renders her unpatentable."
"This is a very important and fascinating opinion," said Arthur Caplan, head of the division of medical ethics at NYU Langone Medical School. "They’ve just ruled one of the most novel, innovative ways to create new living things is nothing more than copying."
To produce clones, scientists grow copies of cells from the original animal in a lab dish, and then extract genetic material. The DNA from the animal to be cloned is inserted into an egg whose nucleus has been removed, and the resulting embryo is implanted in an animal that will serve as the clone’s surrogate mother.
The court rejected Roslin’s arguments that the cloned animal was different because it might have mitochondrial DNA from the host egg, and may look or act differently from the original animal through environmental factors that would alter its shape, size, color, and behavior. None of those issues were raised in the application, the court said.
There’s nothing "that suggests that the clones are distinct in any relevant way from the donor animals of which they are copies," Dyk wrote for the three-judge panel. "The clones are defined in terms of the identity of their nuclear DNA to that of the donor mammals."
Roslin’s patent on the process of cloning and any other related patents may protect the innovation, said Tom Filarski a partner at the law firm Steptoe & Johnson in Chicago, who specializes in biotechnology.
"They’re looking for something more than just a farm animal," he said. "They did not create or alter any of the genetic information, they just preserved it."