This is an update to Part 1 of the 10-part series examining patent eligible subject matter in the U.S., BRIC and several non-BRIC countries.

In Re Roslin Institute (Edinburgh)

In part 1 of this series (which can be found here), the statutory classes of patentable subject matter in the U.S. as well as the guidance issued by the United States Patent and Trademark Office (USPTO) for evaluating subject matter eligibility (Guidance) were discussed. As an update to that discussion, provided below is a brief overview of a recent decision by the United States Court of Appeals for the Federal Circuit (CAFC) regarding patentable subject matter. In the U.S. court system, the CAFC hears appeals relating to patent law and any appeals to CAFC decisions are to the U.S. Supreme Court (Supreme Court). Specifically, the CAFC decided on May 8, 2014 in In Re Roslin Institute (Edinburgh) (Roslin) that Roslin’s clone (i.e., Dolly the Sheep) was unpatentable subject matter under Section 101.

In Roslin, the application at issue was U.S. Patent Application No. 09/225,233 (the ‘233 Application), which contained product claims to clones resulting from somatic cell nuclear transfer (i.e., a clone from an adult or differentiated cell). A representative claim is claim 155, which stated:

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

In its opinion, the CAFC stated that “Roslin’s claimed clones are exact copies of patent ineligible subject matter [i.e., the donor mammal].” These exact copies (e.g., Dolly the Sheep), according to the CAFC, did not possess markedly different characteristics from any farm animals found in nature. The genetic information and genetic structure of the DNA used to make the clones was not created or altered by the inventors.

Additionally, while the Appellant argued that Dolly possessed distinguishable characteristics from the donor mammal (i.e., phenotype and mitochondrial DNA), the CAFC pointed out that these differences were not indicated in the claims directed to the clone. The CAFC further stated that the phenotypic differences arose independent of the inventors’ efforts and the specification of the ‘233 Application did not identify how differences in mitochondrial DNA would have influenced characteristics of the cloned mammals.

Accordingly, the CAFC concluded that the claimed clones were defined in terms of the identity of their nuclear DNA relative to the nuclear DNA of the donor mammals. The CAFC thus decided that Dolly’s genetic identity to her donor parent rendered her unpatentable subject matter, and as the claims did not describe clones that had markedly different characteristics from the donor animals of which they were copies, the claims were directed to patent ineligible subject matter under Section 101.

It should be noted that the CAFC did not comment upon what may or may not constitute a markedly different characteristic. While the characteristic considered by the CAFC here in Roslin was genetic identity (i.e., genetic information and nuclear DNA structure), does a markedly different characteristic always have to be a marked difference in structure as stated in factors a and g of the Guidance or can a markedly different characteristic be, in certain instances, differences in function, use, and the like, where no change in structure occurs? It will be interesting to see how the U.S. courts interpret the term “markedly different characteristic” in future cases in relation to the patent eligibility of product claims.