Keith Campbell and Ian Wilmut successfully cloned a sheep, which they called "Dolly", using a process known as somatic cell nuclear transfer. (Dolly lived from 1996 to 2003.) The process of cloning Dolly involved fusing “the nucleus of an adult, somatic mammary cell with an enucleated oocyte.” Campbell and Wilmut obtained US Patent No. 7,514,258 on the somatic method of cloning mammals and assigned this patent to Roslin Institute of Edinburgh, Scotland (Roslin). Campbell and Wilmut filed U.S. Patent Application No. 09/225,233 (the ‘233 application), which they also assigned to Roslin, for products of their cloning method. The following are representative claims from the ’233 application:
155. A live-born clone of a pre-existing, non-embryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats.
164. The clone of any of claims 155-159, wherein the donor mammal is non-foetal.
The Patent and Trademark Office (PTO) examiner rejected the claims of the ‘233 patent application on the basis that they were directed to non-statutory subject matter under 35 USC 101 and that they were anticipated under 35 USC 102 and obvious under 35 USC 103. Roslin appealed to the Patent Trial and Appeal Board (Board) against the rejections, but the Board affirmed the examiner’s rejection. Roslin then appealed to the Federal Circuit, the decision of which can be found in In Re Roslin Institute, Appeal No. 2013-1407, Decided 8 May 2014.
The Federal Circuit noted that the Supreme Court had already “made clear that naturally occurring organisms are not patentable” (Chakrabarty and Funk Bros. Seed Co., v. Kalo Inoculant Co., 333 U.S. 127 (1948)). The Federal Circuit further noted that a modified organism having “new and markedly different characteristics from any found in nature” and “the potential for significant utility” is patentable (Diamond v. Chakrabarty, 447 U.S. 303, 305 (1980)). The Federal Circuit also noted that naturally occurring, isolated genes are not patentable because they are products of nature (Myriad Genetics, Inc., 133 S. Ct. 2107 (2013)).
Roslin argued that “copies (clones) are eligible for protection because they are ‘the product of human ingenuity’ and ‘not nature’s handiwork, but their own.’” The Federal Circuit argued that the clone is an exact replica of another sheep and therefore does not satisfy the “new and markedly different characteristics from any found in nature.”
Roslin argued that there are phenotypic differences between the clones and the donor mammals used to create them due to environmental factors. The Federal Circuit argued that phenotypic differences were not claimed and that any phenotypic differences were not due to any effort on the part of the patentee. The Federal Circuit noted that the phenotypic differences due to environmental factors are the work of nature, and patents cannot be issued for discovery of phenomena of nature.
Roslin further argued that there are differences in mitochondrial DNA of the clones and the donor mammals used to create them because the mitochondrial DNA of the clones came from the donor oocyte rather than the donor nucleus. The Federal Circuit argued that these mitochondrial DNA differences are not claimed and that the claims and specification do not suggest that the clones have markedly different characteristics from their donor animals.
Roslin also argued that the “clones are patent-eligible because they are time-delayed versions of their donor mammals, and therefore different from their original mammals.” The Federal Circuit argued that time delay cannot be used as a basis for patent eligibility. The Federal Circuit further noted that any copy of an original will necessarily be a time-delayed version of the original.