Dolly the sheep was all over the news as the first mammal cloned from an adult cell before dying of lung disease in 2003. But in a 10-year an fight to patent Dolly and lay commercial claim to animals produced by cloning came to a screeching halt last week when a federal appeals court ruled against giving a patent to Dolly’s creators, according to ScienceInsider.
Back in 2009, the Roslin Institute of the University of Edinburgh, where Dolly’s creators Keith Campbell and Ian Wilmut made their discovery, received a patent on the method used to make her: somatic cell nuclear transfer (SCNT). Her creators submitted another claim including other cattle, sheep, pigs, and goats produced using SCNT. The US Patent and Trademark Office (USPTO_ turned down that application citing a law that restricts the subject matter of a patent to exclude laws of nature, natural phenomena, and abstract ideas. Roslin later appealed the USPTO’s rejection, but it was upheld by the Patent Trial and Appeal Board in February 2013. In May, the U.S. Court of Appeals for the Federal Circuit agreed with that decision. Dolly and cloned animals cannot be patented because they are identical to animals found in nature.
“This seems like a pretty straightforward interpretation of the most recent Supreme Court cases, and I don’t find it terribly surprising,” said Robert Cook-Deegan, a genetics policy expert at Duke University in Durham, North Carolina.
In 2013, the Supreme Court ruled that isolated sequences of human DNA are not patentable. In an older case, Diamond v. Chakrabarty in 1980, the 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 clones did differ in meaningful ways from the donor animals. Environmental influences on their behavior might make them unique, as would the mitochondrial DNA they carry, which comes from the egg cell donor.
The decision could have some short-run effects in animal cloning, Gregory Graff, an economist at Colorado State University, told Science Insider. For instance, the Food and Drug Administration is evaluating ways to use cloned animals in livestock, and the inability to patent these products could influence that industry. Meanwhile, others see the Roslin decision as evidence of an alarming trend. “The whole area of personalized medicine is going to get impacted by this sort of rationale,” said Carl Gulbrandsen, managing director of the Wisconsin Alumni Research Foundation, in a statement.
The fear is that if the USPTO is hostile to granting patents on manmade 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, such products might not receive patent protection. Although inventors could still patent the methods used to create such products, Gulbrandsen said, “A product patent is much more valuable, and investors are much more comfortable with that than with a method of use” patent.
These 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 The National Law Review. That anxiety is likely misplaced, Cook-Deegan said. “I don’t think [this case] is probably going to have a big echo effect,” he told ScienceInsider. “I don’t think it has huge implications for other cases.”
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