May 12, 2014

Federal Circuit: Animal Clones Are Not Patentable Subject Matter

Last week, the Federal Circuit issued an opinion, In re Roslin Institute (Edinburgh), that addressed the eligibility of patent claims to a cloned mammal. The Roslin Institute in Scotland accomplished the cloning of the sheep, Dolly, in 1997. This feat was the first reported cloning of a mammal accomplished by the technique of somatic cell nuclear transfer (SCNT). Subsequently, Roslin received U.S. Patent No. 7,514,258 in 2009 directed to the SCNT cloning method. Claim 1:
1. A method for producing a mammalian cultured inner cell mass cell by nuclear transfer comprising:
(i) inserting a nucleus of a quiescent mammalian differentiated cell into an enucleated mammalian oocyte of the same species to reconstruct an embryo;
(ii) culturing the reconstructed embryo; and
(iii) isolating and culturing inner cell mass cells obtained from said cultured, reconstructed embryo to obtain a cultured inner cell mass cell. 
The current patenting dispute arose from Roslin’s attempt to patent the actual clones derived from SCNT. These are product claims; here is representative Claim 155: 
155. A live-born clone of a pre-existing, nonembryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats. 
The Patent Trial and Appeal Board (Board) rejected the proposed claims for failure to satisfy 35 U.S.C. § 101 (patentable subject matter) 35 U.S.C. § 102 (novelty) and 35 U.S.C. § 103 (nonobviousness). With respect to the patentable subject matter issue, the Board described the claims as directed to a natural phenomenon, which is not patentable. Roslin attempted to distinguish the clones from the naturally occurring animals by noting environmentally-induced phenotypic differences in a clone and by noting that the SCNT technique creates a clone with mitochonodrial DNA contributed by a donated egg. These arguments were not successful. The Federal Circuit discounted any patentable difference afforded by the presence of new phenotypic differences from the natural animal or by the presence of unrelated mitochondrial DNA – Roslin arguing for some functional difference in phenotypic divergence and for a structural/functional difference with the mitochondrial DNA. In both cases, these alleged differences were unclaimed and the Federal Circuit therefore discounted these arguments. The legal relevance of the differences between a natural organism and a scientifically altered one dates back to the beginning of the era of patenting the products and techniques in biotechnology (and even earlier). Genetically engineered animals and organisms are eligible for patenting, as established by the Supreme Court in Diamond v. Chakrabarty (1980). In that opinion, a bacterium genetically engineered to degrade oil was deemed to be an invention: 
Here, by contrast, the patentee has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility. His discovery is not nature's handiwork, but his own; accordingly it is patentable subject matter under § 101. 
Here, the Federal Circuit found no invention in the existence of the clone, even while noting technical achievement: 
[R]oslin’s chief innovation was the preservation of the donor DNA such that the clone is an exact copy of the mammal from which the somatic cell was taken. Such a copy is not eligible for patent protection. 
The court reaffirmed the relevance of the Chakrabarty standard: 
Roslin argues that such copies are either compositions of matter or manufactures within the scope of § 101. However, Dolly herself is an exact genetic replica of another sheep and does not possess “markedly different characteristics from any [farm animals] found in nature.” (citing Chakrabarty). 
The recent 2013 Supreme Court decision on the patenting of isolated genes, Association for Molecular Pathology v. Myriad Genetics, was also cited for its analysis of the fault line between natural products and inventive-level human alteration: 
In Myriad, the Court concluded that “isolated,” naturally occurring DNA strands are not eligible for patent protection. 133 S. Ct. at 2111. Here, as in Myriad, Roslin “did not create or alter any of the genetic information” of its claimed clones, “[n]or did [Roslin] create or alter the genetic structure of [the] DNA” used to make its clones. Myriad, 133 S. Ct. at 2116. 
The Federal Circuit did acknowledge that strict nuclear genetic identity might not be fatal: 
To be clear, having the same nuclear DNA as the donor mammal may not necessarily result in patent ineligibility in every case. Here, however, the claims do not describe clones that have markedly different characteristics from the donor animals of which they are copies. 
Further work remains to be done on clarifying the relative roles of structure and function in the elucidation of “differences” because these very different attributes can be conflated in patent eligibility analysis. The Roslin decision’s reliance on “marked differences” leaves more of that work to be done. Roslin still holds valuable patent rights in the use of the SCNT technique itself, which can be used for reproductive cloning (as here) or therapeutic cloning (see recent post on SCNT-derived human stem cells).

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