In re Roslin Institute (Edinburgh), 750 F.3d 1333 (Fed. Cir. 2014), is a 2014 decision of the United States Court of Appeals for the Federal Circuit rejecting a patent for a cloned sheep known as "Dolly the Sheep"— the first mammal ever cloned from an adult somatic cell.
Background
Dolly was cloned in 1996 by Ian Wilmut, Keith Campbell and colleagues at the Roslin Institute, part of the University of Edinburgh Scotland. The cloning method Campbell and Wilmut used to create Dolly constituted a breakthrough in scientific discovery. Known as somatic cell nuclear transfer, this process involves removing the nucleus of a regular body cell and implanting that nucleus into an egg cell that has had its cell nucleus removed. A nucleus is the organelle that holds a cell's genetic material (its DNA). Campbell and Wilmut found that if the donor, somatic cell is arrested in the stage of the cell cycle where it is dormant and non-replicating (the quiescent phase) prior to nuclear transfer, the resulting fused cell will develop into an embryo. The resulting cloned animal is an exact genetic replica of the adult mammal from which the somatic cell nucleus was taken.
The patent application claims the cloned animal. Claim 155 is representative: 155. A live-born clone of a pre-existing, non-embryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats.
The US Patent and Trademark Office (USPTO) rejected the claims as patent ineligible under 35 U.S.C. § 101 "because it constituted a natural phenomenon that did not possess 'markedly different characteristics than any found in nature.' " A patent on the method was allowed, but it is not involved in this case.
Ruling by Federal Circuit
The Federal Circuit unanimously affirmed the PTO rejection of the claims in opinion by Judge Timothy Dyk joined by Judges Kimberly Ann Moore and Evan Wallach.
It is "clear that naturally occurring organisms are not patentable." The patent in Chakrabarty claimed a genetically engineered bacterium that was capable of breaking down various components of crude oil. The patent applicant created this non-naturally occurring bacterium by adding four plasmids to a specific strain of bacteria. The Court held that the modified bacterium was patentable because it was "new" with "markedly different characteristics from any found in nature and one having the potential for significant utility." Accordingly, discoveries that possess "markedly different characteristics from any found in nature" are eligible for patent protection, but any existing organism or newly discovered plant found in the wild is not patentable. Similarly in Association for Molecular Pathology v. Myriad Genetics, Inc., the Court held that claims on two naturally occurring, isolated genes (BRCA1 and BRCA2), which can be examined to determine whether a person is likely to develop breast cancer, were patent ineligible invalid under § 101, because the BRCA genes themselves were unpatentable products of nature.
It is not disputed that the donor sheep from which Dolly was cloned could not be patented, but Dolly is an exact copy of that unpatentable sheep. "Dolly's genetic identity to her donor parent renders her unpatentable." An exact copy of a preexisting animal in not patent eligible. The court added that related Supreme Court rulings "reinforce this conclusion":
For example, Supreme Court decisions regarding the preemptive force of federal patent law confirm 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. Sears, Roebuck & Co. v. Stiffel Co. clarified that a state may not "prohibit the copying of [an] article itself or award damages for such copying" when that article is ineligible for patent protection. In Sears, the question was whether the defendant, Sears Roebuck & Co., could be held liable under state law for copying a lamp design whose patent protection had expired. The Court explained that "when the patent expires the monopoly created by it expires, too, and the right to make the article—including the right to make it in precisely the shape it carried when patented—passes to the public." The Court further clarified that "[a]n unpatentable article, like an article on which the patent has expired, is in the public domain and may be made and sold by whoever chooses to do so." Roslin's claimed clones are exact genetic copies of patent ineligible subject matter. Accordingly, they are not eligible for patent protection.