In re Roslin Institute (Edinburgh)  

Addressing patent eligible subject matter under 35 U.S.C. § 101, the U.S. Court of Appeals for the Federal Circuit affirmed the decision of the U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB) finding that claims covering Dolly the sheep involved “product of nature or natural phenomenon” and therefore were not patent eligible.  In re Roslin Institute (Edinburgh), Case No. 13-1407 (Fed. Cir., May 8, 2014) (Dyk, J.)

After obtaining a patent on the breakthrough cloning method of somatic cell nuclear transfer, which was used to create Dolly, Roslin sought to obtain a patent for claims directed to the products of that cloning method.  Roslin’s representative product claim reads as follows:

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

After the PTAB held that the claimed subject matter was not patent eligible under § 101 because it “constituted a natural phenomenon that did not possess ‘markedly different characteristics than any found in nature,’” Roslin appealed.

At the Federal Circuit, Roslin argued that the claimed clones were distinguishable from the naturally occurring mammals used in creating them and thus patent eligible for two main reasons: environmental factors and physiological and morphological changes associated with aging lead to phenotypic differences between the clones and the donor mammals, and there were genetic differences between the clones and their donor mammals in that the cells in each clone received their mitochondrial DNA from a first donor mammal and their nuclear DNA from a second donor mammal.  The Federal Circuit disagreed.

With regard to phenotypic differences, the Federal Circuit explained that these differences (if any) are unclaimed, and any phenotypic differences that came about were produced quite independently of any effort of the patentee.  With regard to genetic differences, the Federal Circuit explained that any difference in mitochondrial DNA between the donor and cloned mammals is unclaimed, and “Roslin’s patent application does not identify how differences in mitochondrial DNA influence or could influence the characteristics of cloned mammals.”

Practice Note: In line with the two-prong test of Chakrabarty, the Federal Circuit’s reasoning suggested that the Roslin claims could be patent eligible if it could be shown that (i) the clone embodied “markedly different characteristics from any found in nature” in the form of genetic, phenotypic or morphological differences, and these differences were claimed and/or explained in the specification, and that (ii) these differences were the products of human ingenuity and did not come about independently of any effort by the applicant.

On June 18, 2014, the Roslin Institute petitioned the Federal Circuit for rehearing en banc, arguing that the panel decision improperly created a new category of patent ineligible inventions.