In re Roslin Institute (Edinburgh)

Docket No. 2013-1407

May 8, 2014

Brief Summary: Board decision that Roslin Insitute’s claims to cloned cattle, sheep, pigs and goats non-patentable subject matter under 35 U.S.C. § 101 affirmed in view of Funk Bros., Chakrabarty, In re Beineke and Myriad (no “markedly different characteristics from any [farm animals] found in nature”).

Summary: Roslin Institute appealed from final decision by PTAB that the claims of U.S. Patent appln. No. 09/225,233 encompassing “[a] live-born clone of a pre-existing, non-embryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats” (e.g., Dolly the Sheep) is non-patentable subject matter under 35 U.S.C. § 101 (as well as anticipated and obvious (not discussed in this opinion)). The method for producing such clones was separately patented (US Pat. No. 7,514,258). Roslin made two main arguments regarding patentability of the ‘233 claims: 1) copies (clones) are eligible for protection as products of human ingenuity and “not nature’s handiwork, but their own”; 2) the clones are distinguishable from the donor animals used to create them because environmental factors lead to phenotypic differences, their mitochondrial DNA is different, and the clones are “time-delayed versions of their donor mammals”. The opinion first reviewed Funk Bros. (US 1948) (mixture of bacteria strains for helping plants extract nitrogen from the air and fix it in the soil not patentable because bacteria were not altered in any way), Chakrabarty (US 1980) (genetically engineered bacterium capable of breaking down crude oil patentable, “markedly different characteristics from any found in nature”), In re Beineke (FC 2012, SC cert. denied 2013 (newly discovered type of plant ineligible for plant patent protection since it “was not ‘in any way the result of the patent applicant’s] creative efforts”)), and Myriad (US, 2013) (naturally occurring, isolated genes unpatentable products of nature (although cDNA claims were found patentable)). Regarding Roslin’s first argument, the FC panel concluded that “Dolly herself is an exact replica of another sheep and does not posses ‘markedly different chanracteristics from any [farm animals] found in nature’” (citing Chakrabarty, Myriad (Roslin did not “‘create or alter the structure of [the] DNA’ used to make its clones” but preserved “the donor DNA such that the clone is an exact copy”) and Sears Roebuck (US 1964 (Sears not liable “for copying lamp design whose patent protection had expired” as it was in the public domain…similarly, “Roslin’s claims clones are exact copies of patent ineligible subject matter.”)) Regarding Roslin’s second main argument, the FC panel noted that none of the alleged differences were actually claimed and “Roslin acknowledges that any phenotypic differences came about or were produced ‘quite independently of any effort of the patentee’” (citing Funk Bros.) Thus, the Board’s finding that Roslin’s clones are unpatentable subject matter was affirmed.

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