Blog

US CAFC squelches patent for cloned sheep

The Court of Appeals for the Federal Circuit Court recently upheld the USPTO’s rejection of patent claims directed to cloned farm animals such as Dolly the Sheep. Dolly is best known as the first mammal ever cloned from an adult somatic cell. Scottish researchers Keith Henry Stockman Campbell and Ian Wilmut, working at the Roslin Institute, transferred the nucleus of a mammary cell into an enucleated oocyte, creating an embryo that was implanted into a surrogate that gave birth to Dolly.

The broadest claim considered by the Federal Circuit reads as follows:

155. A live-born clone of a pre-existing, nonembryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats.

The Court’s focused its analysis on the established legal principle: “Laws of nature, natural phenomena, and abstract ideas are not eligible for patent protection.”

The Federal Circuit held that Dolly is an exact genetic replica and does not possess “markedly different characteristics from any [farm animals] found in nature.” This was sufficient to distinguish the case of Chakrabarty, where a patent for a genetically modified bacterium was upheld because the claimed subject matter was “new” with “markedly different characteristics from any found in nature.”

The Court focused on genetic identity because other differences, including phenotypic differences, mitochondrial DNA were not claimed by the applicant. The applicant acknowledged that any phenotypic (non-genetic) differences came about or were produced “quite independently of any effort of the patentee.” The applicant argued that the clone’s mitochondrial DNA are derived from the donor oocyte rather than the nucleus donor cell, but the Court determined that the patent application did not identify how this could influence the characteristics of cloned mammals. The applicant also argued that the claimed clones should be patent eligible because they are time-delayed copies of the original. The Court dismissed this argument, noting that time delay is “true of any copy of an original.”

The Court restricted its analysis to the claims in issue, and did not preclude the possibility of future claims for clones that clearly distinguish the claimed clone from the natural parent:

 There is nothing in the claims, or even in the specification, that suggests that the clones are distinct in any relevant way from the donor animals of which they are copies. The clones are defined in terms of the identity of their nuclear DNA to that of the donor mammals. To be clear, having the same nuclear DNA as the donor mammal may not necessarily result in patent ineligibility in every case. Here, however, the claims do not describe clones that have markedly different characteristics from the donor animals of which they are copies.

The Court observed that the applicant had already received a US Patent for its method for producing clones (U.S. Patent No. 7,514,258), and similar method patents have issued in Canada (CA 2,229,568 issued November 22, 2011, containing method claims only) and Europe (EP 0 849 990 issued February 14, 2001, containing method claims only; and EP 0 847 237 issued July 9, 2008, containing method claims only).

It is, however, notable that the applicant received a patent in the UK (GB 2 331 751, issued on January 19, 2000) with claims for cloned non-human animals.

A copy of the opinion may be found here.