June 2014
Exact Genetic Copies of Patent Ineligible Subject Matter Are Also Patent Ineligible
| Judges: Dyk (author), Moore, Wallach |
| [Appealed from Board] |
In In re Roslin Institute (Edinburgh), No. 13-1407 (Fed. Cir. May 8, 2014), the Federal Circuit affirmed the Board’s rejection of all pending claims of U.S. Patent Application No. 09/225,233 (“the ’233 application”) as unpatentable subject matter under 35 U.S.C. § 101.
Keith Henry Stockman Campbell (“Campbell”) and Ian Wilmut (“Wilmut”) of the Roslin Institute of Edinburgh, Scotland (“Roslin”), successfully produced the first mammal ever cloned from an adult somatic cell: Dolly the Sheep. Campbell and Wilmut produced Dolly using a breakthrough cloning method known as somatic cell nuclear transfer, which involves removing the nucleus of a somatic cell and implanting that nucleus into an enucleated oocyte. If implantation occurs at a certain stage, the resulting fused cell will develop into an embryo, and ultimately a baby animal, which is an exact genetic replica of the adult mammal from which the somatic cell nucleus was taken. Roslin is the assignee of the ’233 application, which claims not the cloning method, but rather the cattle, sheep, pigs, and goats that are the products of the cloning method.
The Board affirmed the examiner’s rejections of the claims to the cloned animals under 35 U.S.C. §§ 101, 102, and 103. Regarding § 101, the Board found that the claimed subject matter was ineligible for patent protection because it constituted a natural phenomenon that did not possess markedly different characteristics than any found in nature.
“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.” Slip op. at 11.
On appeal, the Federal Circuit affirmed. The Federal Circuit held that under the Supreme Court’s § 101 case law, including its most recent decision in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013), “Dolly’s genetic identity to her donor parent renders her unpatentable.” Slip op. at 7. The Court explained that, “[h]ere, as in Myriad, Roslin ‘did not create or alter any of the genetic information’ of its claimed clones, ‘[n]or did [Roslin] create or alter the genetic structure of [the] DNA’ used to make its clones.” Id. (alterations in original) (quoting Myriad, 133 S. Ct. at 2116). The Court also observed that its decision was reinforced by Supreme Court decisions regarding the preemptive force of federal patent law, which confirmed that “individuals are free to copy any unpatentable article, such as a live farm animal, so long as they do not infringe a patented method of copying.” Id. at 8 (citing Sears Roebuck & Co. v. Stiffel Co., 376 U.S. 225, 232-33 (1964)).
The Federal Circuit rejected Roslin’s arguments that “its claimed clones are patent eligible because they are distinguishable from the donor mammals used to create them.” Id. at 9. The Court first rejected Roslin’s assertion that environmental factors led to phenotypic differences between its clones and their donor mammals, concluding that the differences were not only unclaimed, but also acknowledged by Roslin to have come about “quite independently of any effort of the patentee.” Id. (quoting Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948)).
The Court also rejected Roslin’s argument that mitochondrial DNA, which originated from the donor oocyte rather than the donor nucleus, rendered its claimed clones distinguishable from their original donor mammals. The Court again concluded that any differences based on mitochondrial DNA were unclaimed. Moreover, according to the Court, Roslin’s patent application did not identify how differences in mitochondrial DNA could influence the clones’ characteristics.
Finally, the Court rejected Roslin’s contention that the claimed clones were patent eligible because they were time-delayed versions of their donor mammals. The Court explained that time delay cannot confer patentability because, as the Board noted, this is true of any copy of an original.
Accordingly, the Federal Circuit affirmed the Board, holding that because “[t]he clones are defined in terms of the identity of their nuclear DNA to that of the donor mammals” and “do not describe clones that have markedly different characteristics from the donor animals of which they are copies,” Roslin’s clones are unpatentable subject matter under § 101. Id. at 11.
