Last week, in In re Roslin Institute (Edinburgh), the Federal Circuit affirmed the rejection by the United States Patent and Trademark Office (USPTO) of product claims covering cloned mammals. This case relates to Dolly, commonly known as the “world’s most famous sheep.” Dolly was the first mammal to be successfully cloned from a differentiated (i.e., adult) somatic cell through the process of somatic cell nuclear transfer, where her genetic material was copied from the adult animal from which she was cloned. Dolly was cloned by Ian Wilmut, Keith Campbell, and others at the Roslin Institute of the University of Edinburgh (Roslin).

Wilmut and Campbell obtained a patent on the somatic cell nuclear transfer method of cloning mammals (U.S. Patent No. 7,514,258). The claims at issue, which were rejected by the USPTO, were in a separate application assigned to Roslin that sought to cover the clones themselves (U.S. Patent Application No. 09/224,233). The Federal Circuit analyzed the following representative claims:

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

164. The clone of any of claims 155-159, wherein the donor mammal is non-foetal.

In November of 2008, the USPTO rejected the claims as non-statutory subject matter under 35 U.S.C § 101 as well as anticipated and obvious under §§ 102 and 103. This rejection was affirmed by the Board of Patent Appeals and Interferences (Board) in February of 2013. Though the Board acknowledged that the claimed clones “may be called a composition of matter or a manufacture,” the claims were ineligible for patent protection under § 101 because they sought to cover a natural phenomenon that do not possess “markedly different characteristics than any found in nature.” The Board also found that the claimed clones were anticipated and obvious because they would be indistinguishable from clones made through prior art cloning methods.

Citing to Funk Bros. Seed Co. v. Kalo Inoculant Co., the Federal Circuit began its analysis by noting that “naturally occurring organisms are not patentable.” 333 U.S. 127 (1948). In Funk Bros., the Supreme Court explained that claims covering a mixture of naturally occurring strains of bacteria that helped plants extract nitrogen from the air were not patentable because the patentee did not alter the bacteria in any way, and that the beneficial qualities of the bacteria strains were “the work of nature.” Likewise, claims covering isolated, but naturally occurring genes have been deemed not patentable. Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013). By contrast, genetically engineered bacteria that display markedly different characteristics from any bacteria found in nature would be patentable. See Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).

Roslin agreed that the genetic material from the donor sheep could not be patented, but argued that the clones are eligible for patent protection because they are the “product of human ingenuity” qualifying as compositions of matter or manufacture under § 101. The Federal Circuit disagreed. Referring to Myriad, the Federal Circuit found that Roslin “did not create or alter any of the genetic information” of its claimed clones. The Federal Circuit noted that the “chief innovation” here was the preservation of an “exact copy” of donor DNA and that the claimed clones were “exact genetic copies of patent ineligible subject matter.”

Roslin also argued that 1) “environmental factors” can lead to phenotypic differences that distinguish its clones from their donor mammals, 2) clones are distinguishable from their original donor mammals because of differences in mitochondrial DNA, and 3) clones are time-delayed versions of their donor animals, which makes them patent-eligible. The Federal Circuit found that the phenotypic differences and differences in mitochondrial DNA were unclaimed and that the changes were produced independent of the actions of the patentee. Moreover, the fact that the clone is a “time-delayed version” of the donor mammal does not confer patentability.

Although this case appears to be a straight-forward application of the prohibition against claiming a natural phenomenon pursuant to § 101, the opinion leaves open the possibility of obtaining patents on modified clones. Indeed, the Federal Circuit infers that “modified” clones would be patentable pursuant to its analysis of Funk Bros. and Chakrabarty in stating that “having the same nuclear DNA as the donor animal may not necessarily result in patent ineligibility in every case.” To the extent the patentee can identify and claim “clones that have markedly different characteristics from the donor animals from which they are copies,” whereby the differences between the claimed clone and its donor are attributable to the patentee, the Federal Circuit suggests that such clones may be patentable.