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Dolly, the first mammal to be cloned using somatic cell nuclear transfer, would not have been eligible for patenting, according to a US appeals court. This was because she was genetically identical to her donor parent.
The current appeal was based on the rejection of a patent application for Dolly the sheep (US 09225233) by the US Patent and Trademark Office. (A method of cloning mammals using somatic cell nuclear transfer (US 7514258) was not part of the current case.)
The Roslin Institute, which cloned Dolly, argued that mammalian clones were eligible for protection because they are the product of human ingenuity. But the appeals court drew on the recent Myriad case (see Nature Rev. Drug Discov. 12, 570–571; 2013) to emphasize that discoveries must have “markedly different characteristics from any found in nature” to be eligible for patent protection.
In response to this, the Roslin Institute asserted that several features of mammals produced by somatic cell nuclear transfer make them patent eligible. For example, it said that environmental factors lead to phenotypic differences that make clones distinct from their donor. In addition, it said that mammalian clones are distinguishable from donor mammals because of differences in mitochondrial DNA.
But the court highlighted that these differences were not claimed in the patent application, and held that Dolly and other mammals cloned using the same technique would be exact genetic copies of an animal that exists in nature, and as such were not eligible for patent protection.
PATENT ADVISORS
Daniel M. Becker: Dechert, Mountain View, CA, USA.
Luke Kempton: Wragge & Co., London, UK.
Leslie Meyer-Leon: IP Legal Strategies, Boston, MA, USA.
George W. Schlich: Schlich & Co., London, UK.
John A. Tessensohn: Shusaku Yamamoto, Osaka, Japan.
Philip Webber: Frank B. Dehn & Co., London, UK.
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Harrison, C. Lamb chopped: Dolly not patent eligible. Nat Rev Drug Discov 13, 408 (2014). https://doi.org/10.1038/nrd4353
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DOI: https://doi.org/10.1038/nrd4353